A Multi-Center Prospective Open Label Study of a Web-based Application for Pulse Rate in Adult Patients
Conditions: Vital Sign Evaluation
Sponsor: Mindset Medical

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TITLE: 
 
Informed Vital Core, Pulse Rate Clinical Study Protocol    
IDENTIFICATION: 
 
IVC-400-006 
EFFECTIVE DATE: 
 
March 31, 2023 
AUTHOR: 
 
Chris Joslin 
APPROVED BY: 
 
Mark Whitehouse 
 
 
 
Confidential – Mindset Medical, LLC 
Do not distribute without permission.  
 
 
 
 
 
Informed Vital Core  
Pulse Rate Clinical Study Protocol 
 
IVC-400-006 
Rev. 1 
 
Mindset Medical, LLC 
 
 
 
 
 
 
 
 
 

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Active 
TITLE: 
 
Informed Vital Core, Pulse Rate Clinical Study Protocol    
IDENTIFICATION: 
 
IVC-400-006 
EFFECTIVE DATE: 
 
March 31, 2023 
AUTHOR: 
 
Chris Joslin 
APPROVED BY: 
 
Mark Whitehouse 
 
 
 
Confidential – Mindset Medical, LLC 
Do not distribute without permission.  
 
 
 
 
 
 
 
A Multi-Center Prospective Open Label Study of a Web-based Application for Pulse Rate in Adult 
Patients 
 
Original date: March 31, 2023 
 
Principal Investigator: Daniel Lubelski, M.D. 
 

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TITLE: 
 
Informed Vital Core, Pulse Rate Clinical Study Protocol    
IDENTIFICATION: 
 
IVC-400-006 
EFFECTIVE DATE: 
 
March 31, 2023 
AUTHOR: 
 
Chris Joslin 
APPROVED BY: 
 
Mark Whitehouse 
 
 
 
Confidential – Mindset Medical, LLC 
Do not distribute without permission.  
 
PROTOCOL APPROVAL FORM 
 
Protocol Number: IVC-400-006 
Study Title: A Multi-Center Prospective Open Label Study of a Web-based Application for Pulse Rate in Adult Patients 
Version Number: Version 1.0 dated March 31, 2023. 
 
This study protocol was subjected to critical review.  The information it contains is consistent with Mindset Medical, LLC's current knowledge 
of the risks and benefits of the investigational technology, as well as with the moral, ethical, and scientific principles governing clinical research 
as set out in the Declaration of Helsinki, as amended in 2000 and clarified in 2004, and the guidelines on Good Clinical Practice. 
 
 
The study protocol has been reviewed and approved by the following: 

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Active 
TITLE: 
 
Informed Vital Core, Pulse Rate Clinical Study Protocol    
IDENTIFICATION: 
 
IVC-400-006 
EFFECTIVE DATE: 
 
March 31, 2023 
AUTHOR: 
 
Chris Joslin 
APPROVED BY: 
 
Mark Whitehouse 
Confidential – Mindset Medical, LLC 
Do not distribute without permission.  
 

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Active 
TITLE: 
 
Informed Vital Core, Pulse Rate Clinical Study Protocol    
IDENTIFICATION: 
 
IVC-400-006 
EFFECTIVE DATE: 
 
March 31, 2023 
AUTHOR: 
 
Chris Joslin 
APPROVED BY: 
 
Mark Whitehouse 
 
 
 
Confidential – Mindset Medical, LLC 
Do not distribute without permission.  
 
Contents 
PROTOCOL SYNOPSIS ....................................................................................................................................................................................................................... 10 
STUDY OBJECTIVES ........................................................................................................................................................................................................................... 12 
STUDY HYPOTHESIS .......................................................................................................................................................................................................................... 13 
STUDY ENDPOINTS ........................................................................................................................................................................................................................... 13 
Primary Endpoint ..................................................................................................................................................................................................................................... 13 
BACKGROUND .................................................................................................................................................................................................................................. 13 
STUDY DESIGN ................................................................................................................................................................................................................................. 15 
NUMBER OF SITES ............................................................................................................................................................................................................................ 15 
NUMBER OF SUBJECTS ..................................................................................................................................................................................................................... 16 
STUDY DURATION ............................................................................................................................................................................................................................ 16 
SCHEDULE OF ASSESSMENTS ............................................................................................................................................................................................................ 17 
ELIGIBILITY ....................................................................................................................................................................................................................................... 18 
Inclusion Criteria ...................................................................................................................................................................................................................................... 18 
Exclusion Criteria ..................................................................................................................................................................................................................................... 18 
SUBJECT IDENTIFICATION ................................................................................................................................................................................................................. 18 
STUDY EXECUTION ........................................................................................................................................................................................................................... 19 
Enrollment ............................................................................................................................................................................................................................................... 19 
Pre-intervention screening ...................................................................................................................................................................................................................... 19 
Study Procedure ...................................................................................................................................................................................................................................... 20 

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TITLE: 
 
Informed Vital Core, Pulse Rate Clinical Study Protocol    
IDENTIFICATION: 
 
IVC-400-006 
EFFECTIVE DATE: 
 
March 31, 2023 
AUTHOR: 
 
Chris Joslin 
APPROVED BY: 
 
Mark Whitehouse 
 
 
 
Confidential – Mindset Medical, LLC 
Do not distribute without permission.  
 
ADVERSE EVENTS ............................................................................................................................................................................................................................. 21 
Definitions ............................................................................................................................................................................................................................................... 21 
Required Reporting Timelines per Regulatory Guidance ......................................................................................................................................................................... 22 
WITHDRAWAL AND LOST TO FOLLOW UP ......................................................................................................................................................................................... 22 
STATISTICAL METHODS ..................................................................................................................................................................................................................... 23 
Sample Size .............................................................................................................................................................................................................................................. 23 
Statistical Analysis ................................................................................................................................................................................................................................... 23 
Analysis of the primary endpoint ............................................................................................................................................................................................................. 23 
DATA MANAGEMENT ....................................................................................................................................................................................................................... 24 
ELECTRONIC CASE REPORT FORMS (ECRFS) AND SOURCE DOCUMENTATION ................................................................................................................................................................ 24 
ACCESS TO SOURCE DATA AND MONITORING ......................................................................................................................................................................................................... 24 
ARCHIVING STUDY RECORDS ............................................................................................................................................................................................................................... 25 
ETHICAL, LEGAL, AND ADMINISTRATIVE ASPECTS ............................................................................................................................................................................. 26 
SPONSOR RESPONSIBILITIES ................................................................................................................................................................................................................................. 26 
INVESTIGATOR RESPONSIBILITIES .......................................................................................................................................................................................................................... 26 
GOOD CLINICAL PRACTICE................................................................................................................................................................................................................................... 26 
PROTOCOL APPROVAL AND AMENDMENT .............................................................................................................................................................................................................. 26 
TERMINATION OF THE STUDY ............................................................................................................................................................................................................................... 27 
CONFIDENTIALITY .............................................................................................................................................................................................................................................. 27 
PUBLICATION ................................................................................................................................................................................................................................................... 28 
SITE TRAINING .................................................................................................................................................................................................................................................. 28 
REQUIRED REPORTS ........................................................................................................................................................................................................................................... 29 
PRODUCT COMPLAINTS ...................................................................................................................................................................................................................................... 29 
CONTACT INFORMATION .................................................................................................................................................................................................................. 30 
DEVICE REGULATORY APPROVAL/CLEARANCE .................................................................................................................................................................................. 31 

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Active 
TITLE: 
 
Informed Vital Core, Pulse Rate Clinical Study Protocol    
IDENTIFICATION: 
 
IVC-400-006 
EFFECTIVE DATE: 
 
March 31, 2023 
AUTHOR: 
 
Chris Joslin 
APPROVED BY: 
 
Mark Whitehouse 
 
 
 
Confidential – Mindset Medical, LLC 
Do not distribute without permission.  
 
TABLE OF COMMON ACRONYMS ...................................................................................................................................................................................................... 32 
REFERENCES ..................................................................................................................................................................................................................................... 33 
 
 
 
 
 

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Active 
TITLE: 
 
Informed Vital Core, Pulse Rate Clinical Study Protocol    
IDENTIFICATION: 
 
IVC-400-006 
EFFECTIVE DATE: 
 
March 31, 2023 
AUTHOR: 
 
Chris Joslin 
APPROVED BY: 
 
Mark Whitehouse 
 
 
 
Confidential – Mindset Medical, LLC 
Do not distribute without permission.  
 
 
 
  
 
 
 
 
 
 
 
 
 
 
 
 
   
 
 
  
  
Mindset Medical will conduct a clinical study to evaluate the accuracy of measurement for pulse rate using the IVC App, compared to 
appropriate reference devices.  The study will recruit subjects from clinics, hospitals, and the general public. 

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Active 
TITLE: 
 
Informed Vital Core, Pulse Rate Clinical Study Protocol    
IDENTIFICATION: 
 
IVC-400-006 
EFFECTIVE DATE: 
 
March 31, 2023 
AUTHOR: 
 
Chris Joslin 
APPROVED BY: 
 
Mark Whitehouse 
 
 
 
Confidential – Mindset Medical, LLC 
Do not distribute without permission.  
 
Study Design  
This is a multi-center prospective open label study where the same subjects are assigned the IVC Application and the 
.   
 
The study will recruit subjects from clinics, hospitals, and the general public.  
 
 
  
  
 
All subjects will be asked to have facial assessment conducted and undergo two PR measurements using the IVC App.  
 
  
 
. 
 
 
 
 
The PR obtained by the IVC App will be compared to the HR obtained by the 
 
 
Subjects will visit the clinic only once for the vital signs assessments unless a technical fallback session is required.   
Number of Sites   
The study will be conducted in up to ten (10) investigational sites in the United States.  Enrollment will be competitive and each site will not 
enroll more than 25% of the total patient population without the written consent of the sponsor. 

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Active 
TITLE: 
 
Informed Vital Core, Pulse Rate Clinical Study Protocol    
IDENTIFICATION: 
 
IVC-400-006 
EFFECTIVE DATE: 
 
March 31, 2023 
AUTHOR: 
 
Chris Joslin 
APPROVED BY: 
 
Mark Whitehouse 
 
 
 
Confidential – Mindset Medical, LLC 
Do not distribute without permission.  
 
Number of Subjects  
    
Study Duration 
Study assessment is one day.   
 
 

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Active 
TITLE: 
 
Informed Vital Core, Pulse Rate Clinical Study Protocol    
IDENTIFICATION: 
 
IVC-400-006 
EFFECTIVE DATE: 
 
March 31, 2023 
AUTHOR: 
 
Chris Joslin 
APPROVED BY: 
 
Mark Whitehouse 
 
 
 
Confidential – Mindset Medical, LLC 
Do not distribute without permission.  
 
Eligibility  
 
Inclusion Criteria 
● Subjects 22 - 85 years of age  
● Subjects willing to sign the Informed Consent Form and comply with the protocol 
 
Exclusion Criteria  
● Subjects required to wear mask or bandage that obstructs forehead, cheeks, or chin 
● Refusal to remove makeup, sunscreen, lotion, clothing, or items obstructing the face for the duration of measurement 
● Presence of facial tattoos, large birthmarks, or other skin alterations (scars, hemangiomas, vitiligo) on upper cheeks (cheekbone) or 
forehead of the subject 
● Condition that does not allow the subject to remain still for 60 seconds at a time 
● Subjects with cardiac arrhythmia  
● Any known medical condition which may result in an inaccurate measurement using the reference device  
● Subjects with the inability to complete an ECG  
Subject Identification  
Subjects will be enrolled per the inclusion and exclusion criteria.  Written informed consent, including Health Insurance Portability and 
Accountability Act (HIPAA) authorization, must be obtained prior to initiation of any study-specific investigative procedures.  Eligible subjects 
will be enrolled and given a 6-digit identification code that consists of the three-digit site code, followed by a three-digit subject ID beginning 
with 001 and assigned sequentially (e.g., 301 001; site 301 and the first subject screened 001).   

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Active 
TITLE: 
Informed Vital Core, Pulse Rate Clinical Study Protocol   
IDENTIFICATION: 
IVC-400-006 
EFFECTIVE DATE: 
March 31, 2023 
AUTHOR: 
Chris Joslin 
APPROVED BY: 
Mark Whitehouse 
Confidential – Mindset Medical, LLC 
Do not distribute without permission.  
Study Execution 
Enrollment 
Subjects that meet the protocol qualifications and provide written informed consent shall be offered enrollment in the study.  Concomitant 
study enrollment may be allowed with approval of the Sponsor.  Study subjects may be enrolled in this study only once.  A subject will be 
considered enrolled when the subject has signed the Informed Consent Form (ICF).   
Pre-intervention screening  
Review of Eligibility Criteria 
Review the list of inclusion and exclusion criteria to ensure the subject is eligible to participate. 
Informed Consent 
Prior to conducting any study-specific tests or procedures required in this protocol, the Investigator or designee will obtain informed consent 
in writing from all subjects prior to any screening or study procedures.  The Investigator will follow a standard process for obtaining consent 
that complies with all applicable regulatory requirements.   
If the ICF is amended during the study, the investigator must follow all applicable regulatory requirements pertaining to approval of the 
amended ICF by the IEC/IRB and use of the amended form.  Ongoing subjects will be required to re-confirm consent by signing the amended 
form. 
The original and any amended signed and dated ICFs must be retained at the study site, and a copy of the signed and dated ICFs must be given 
to the subject.  During the study, the subject will be informed if information becomes available that may be relevant to the subject’s willingness 
to participate in the study.  

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Active 
TITLE: 
 
Informed Vital Core, Pulse Rate Clinical Study Protocol    
IDENTIFICATION: 
 
IVC-400-006 
EFFECTIVE DATE: 
 
March 31, 2023 
AUTHOR: 
 
Chris Joslin 
APPROVED BY: 
 
Mark Whitehouse 
 
 
 
Confidential – Mindset Medical, LLC 
Do not distribute without permission.  
 
The subject will be informed of procedures to protect subject privacy.  Under U.S. federal law (the Privacy Rule) any protected health 
information (PHI) that is created or obtained during this study cannot be used or disclosed without permission.  Informed consent on data 
processing will be obtained in writing directly from the subject before recording of any data.  Authorization to use and disclose PHI will be 
obtained in writing directly from the subject before recording of any data.  Recorded data will be pseudonymized before transferring to 
authorized individuals.  The investigator will maintain source documents that link unique subject numbers with subject names. 
 
Study Procedure 
• 
Review the subject’s medical history and concomitant medications and document on the appropriate Electronic Case Report Form (eCRF).  
• 
Assign the Fitzpatrick Scale Category.  Fitzpatrick category assignment must be completed by an Investigator.  
• 
Record the subject’s demographics on the appropriate eCRF.  
• 
  
• 
 
 
 
• 
 
 
 
• 
Record any adverse events, protocol deviations, device failures. 
• 
Complete subject disposition eCRF. 
 
 
 

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STATUS: 
 
Active 
TITLE: 
 
Informed Vital Core, Pulse Rate Clinical Study Protocol    
IDENTIFICATION: 
 
IVC-400-006 
EFFECTIVE DATE: 
 
March 31, 2023 
AUTHOR: 
 
Chris Joslin 
APPROVED BY: 
 
Mark Whitehouse 
 
 
 
Confidential – Mindset Medical, LLC 
Do not distribute without permission.  
 
Adverse Events  
 
Definitions  
An Adverse Event (AE) is any untoward event that occurs after device implantation, any condition that increases in severity or frequency after 
device implantation, or any medical condition present at or before implantation that worsens after device implantation.  All adverse events 
should be reported whether or not their occurrence has a causal relationship with the administration of the study material.   
 
A Serious Adverse Event (SAE) is defined as any experience that: 
● Is fatal or life-threatening 
● Is permanently incapacitating or disabling 
● Requires or prolongs in-patient hospitalization 
● Results in a congenital anomaly or birth defect 
● Results in permanent disability or incapacity 
● Necessitates medical or surgical intervention to preclude a permanent disability or incapacity 
 
Adverse events are not anticipated in this clinical study, since the study involves collection of pulse rate data using a remote software 
application and heart rate using an ECG device for a short period of time at the clinical study sites.    
 
An Unanticipated Adverse Device Effect (UADE) is "any serious" adverse effect on health or safety or any life-threatening problem or death 
caused by, or associated with a device, if that effect, problem, or death was not previously identified in any nature, severity, or degree of 
incidence in the investigational plan or any other unanticipated serious problem associated with a device that relates to the rights, safety, 
and welfare of subjects. 
 

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Active 
TITLE: 
 
Informed Vital Core, Pulse Rate Clinical Study Protocol    
IDENTIFICATION: 
 
IVC-400-006 
EFFECTIVE DATE: 
 
March 31, 2023 
AUTHOR: 
 
Chris Joslin 
APPROVED BY: 
 
Mark Whitehouse 
 
 
 
Confidential – Mindset Medical, LLC 
Do not distribute without permission.  
 
A record of each AE, including details of the nature, onset, duration, severity, relationship to the device will be recorded.  AEs, should they 
occur, will be summarized and presented at each annual renewal for all subjects participating in the study.  SAEs and UADEs should be reported 
to the FDA under the MDR reporting requirements and to the manufacturer.   
 
Required Reporting Timelines per Regulatory Guidance 
Required reporting time limit for the Sponsor is the number of days between the company's first knowledge of a reportable event (i.e., the 
receipt of information by any employee of the company) and the date the Food and Drug Administration (FDA) must be notified.  Day one 
begins the day after the company receives information which reasonably suggests that a reportable event has occurred.  Device related death, 
serious injury, or malfunction must be reported to FDA within 30 calendar days (no allowances are made for weekends or holidays). 
 
However, if the event necessitates a correction or removal action, to prevent an unreasonable risk of substantial harm to the public health, 
then a report must be submitted within five (5) workdays, notwithstanding days including Saturdays, Sundays, and scheduled federal holidays.   
Withdrawal and Lost to Follow Up  
Subjects have the right to withdraw from the study at any time for any reason.  The Investigator, acting in the subject's best interests, also 
has the right to withdraw subjects from the study.  Since this study is a one-time assessment, early withdrawal is unlikely.  However, it is 
possible for a subject withdrawal after signing consent and prior to study procedures.  In all cases, the reason(s) for withdrawal must be 
recorded on the eCRF.   
 
While adverse events are not anticipated in this clinical study, if the reason for removal of a subject from the study is an adverse event, the 
event will be recorded on the appropriate eCRF(s) and will be reported to Mindset Medical per the AE reporting guidelines (Required Reporting 
Timelines per Regulatory Guidance).  All efforts will be made to follow the subject until the condition resolves, or the Investigator determines 
that the subject's health has returned to an acceptable state.   

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STATUS: 
 
Active 
TITLE: 
 
Informed Vital Core, Pulse Rate Clinical Study Protocol    
IDENTIFICATION: 
 
IVC-400-006 
EFFECTIVE DATE: 
 
March 31, 2023 
AUTHOR: 
 
Chris Joslin 
APPROVED BY: 
 
Mark Whitehouse 
 
 
 
Confidential – Mindset Medical, LLC 
Do not distribute without permission.  
 
Statistical Methods 
 
Sample Size  
Inclusion of Incompetent Subjects 
Subjects who lack the capacity to provide written informed consent shall not be enrolled in this study. 
 
Statistical Analysis  
Detailed methodology for descriptive and inferential statistical analyses of the data collected in this study will be documented in the Statistical 
Analysis Plan (SAP).  Analysis populations will be defined in the SAP and any methodology to be used for missing data.  The SAP will be 
prepared and agreed upon by signature and date by the Sponsor prior to database lock.  In addition to the SAP, other graphical representations 
of the results may be produced after review of the data (post hoc).  Any major modifications of the definition of the endpoints or analysis will 
be reflected in a protocol amendment. 
 
The SAP will define how missing data will be handled, where applicable, including the use of imputation or sensitivity analyses. 
 
Analysis of the primary endpoint  
The Intent-to-Capture (ITC) population will be defined as all consented subjects who passed screening and completed at least one data 
collection session without withdrawing.  
 
The Per Protocol analysis group for the primary endpoint will consist of subjects from whom PR measurements from the IVC App and HR from 
the
 were collected during the same window. 
 

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STATUS: 
 
Active 
TITLE: 
 
Informed Vital Core, Pulse Rate Clinical Study Protocol    
IDENTIFICATION: 
 
IVC-400-006 
EFFECTIVE DATE: 
 
March 31, 2023 
AUTHOR: 
 
Chris Joslin 
APPROVED BY: 
 
Mark Whitehouse 
 
 
 
Confidential – Mindset Medical, LLC 
Do not distribute without permission.  
 
 
 
 
 
The reference device Rhythm Analysis will be performed on the ECG rhythm strip using the procedure described in the Rhythm Analysis 
Procedure IVC-400-006i. 
Data Management 
Data will be reviewed throughout the study to identify any missing data, errors in data entry, or inconsistencies in the data provided.  A query 
process will be used to resolve any discrepancies identified during the data review process and follow a Data Management Plan (DMP) that 
will be prepared and agreed upon by signature and date by the Sponsor prior to database lock.  
 
Electronic Case Report Forms (eCRFs) and Source Documentation 
All data obtained during the study should be entered on the eCRFs promptly.  All source documents from which eCRF entries are derived 
should be placed in the subject's medical records.  The eCRFs for each subject may be checked against source documents at the study site by 
the clinical site monitor. 
 
Access to Source Data and Monitoring 
During the course of the study, a representative of the Sponsor or a designated representative, i.e., a Clinical Research Associate (CRA) or 
monitor, may make site visits as frequently as necessary to review protocol compliance, compare eCRFs and individual subjects’ medical 
records, assess clinical supply inventory as appropriate, and ensure that the study is being conducted in accordance with pertinent regulatory 
requirements.  eCRF entries will be verified with source documentation.  The review of medical records will be performed in a manner to 
ensure that subject confidentiality is maintained. 

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STATUS: 
 
Active 
TITLE: 
 
Informed Vital Core, Pulse Rate Clinical Study Protocol    
IDENTIFICATION: 
 
IVC-400-006 
EFFECTIVE DATE: 
 
March 31, 2023 
AUTHOR: 
 
Chris Joslin 
APPROVED BY: 
 
Mark Whitehouse 
 
 
 
Confidential – Mindset Medical, LLC 
Do not distribute without permission.  
 
 
It is the Investigator's obligation to ensure that documentation of all relevant data such as medical history, concomitant diseases, date of 
study enrollment, visit dates, results of examinations, administrations of medication(s), and AEs are correctly entered in the subject's file.   
 
Checking of the eCRFs for completeness and clarity, and cross-checking with source documents in the presence of the Investigator or designee, 
will be required to monitor the progress of the study.  Moreover, regulatory authorities, IRB/REB, and/or the Sponsor's Clinical Quality 
Assurance group, or designee, may wish to carry out such source data checks and/or on-site audit inspections.  Direct access to source data 
will be required for these inspections and audits; they will be carried out giving due consideration to data protection and medical 
confidentiality.  The Investigator agrees to give the auditor access to all relevant documents for review.  The same procedure applies in the 
case of an inspection by the regulatory authorities.  Access to the eCRF will be password controlled and will conform with 21 CFR Part 11. 
 
After every on-site audit, the Investigator will receive an audit confirmation by the auditor.  This must be filed together with the study 
documentation and be made available to the regulatory authorities in case of supervision.  At the end of the study, audit certificates will be 
included in the final report. 
 
The Sponsor or designated representatives will affirm and uphold the principle of the subject's right to protection against the invasion of 
privacy.  Throughout the study, all data will only be identified by subject number.  Anonymity of the data will be maintained in all data 
analyses. 
 
Archiving Study Records 
Study records are to be maintained for a period defined by the laws and regulations of the participating country.  For this study, a minimum 
of 2 years is required after the latter of the following two dates: the date the investigation was terminated or completed or the date the 
records are no longer required for purposes of supporting an FDA approval application. 
 

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STATUS: 
 
Active 
TITLE: 
 
Informed Vital Core, Pulse Rate Clinical Study Protocol    
IDENTIFICATION: 
 
IVC-400-006 
EFFECTIVE DATE: 
 
March 31, 2023 
AUTHOR: 
 
Chris Joslin 
APPROVED BY: 
 
Mark Whitehouse 
 
 
 
Confidential – Mindset Medical, LLC 
Do not distribute without permission.  
 
Copies of all case report forms completed on subjects will be retained in individual subject files by the Investigator in a secure location.   
 
ETHICAL, LEGAL, AND ADMINISTRATIVE ASPECTS 
 
Sponsor Responsibilities 
The Sponsor or their designee will conduct a remote or in-person site visit to verify the qualification of each Investigator, inspect the site 
facilities, and inform the Investigator of responsibilities and the procedures for ensuring adequate and correct documentation. 
 
Investigator Responsibilities 
The Investigator is required to prepare and maintain adequate and accurate case histories designed to record all observations and other data 
pertinent to the study for each study subject.  All information recorded on the eCRFs must be consistent with the subjects' source 
documentation, i.e., medical records. 
 
Good Clinical Practice  
The procedures set out in this study protocol are designated to ensure that the Sponsor and the Investigator abide by the principles of the 
Good Clinical Practice (GCP) guidelines of the International Conference on Harmonization (ICH) and of the Declaration of Helsinki (2000 with 
clarification in 2004 and as amended thereto).  The study also will be carried out in keeping with local legal requirements, as appropriate. 
 
Protocol Approval and Amendment 
Before the start of the study, the study protocol and/or other relevant documents will be approved by the IRB/REB or other Competent 
Regulatory Authorities in accordance with local legal requirements.  The Sponsor must ensure that all ethical and legal requirements have 
been met before the first subject is enrolled in the study. 
 

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STATUS: 
 
Active 
TITLE: 
 
Informed Vital Core, Pulse Rate Clinical Study Protocol    
IDENTIFICATION: 
 
IVC-400-006 
EFFECTIVE DATE: 
 
March 31, 2023 
AUTHOR: 
 
Chris Joslin 
APPROVED BY: 
 
Mark Whitehouse 
 
 
 
Confidential – Mindset Medical, LLC 
Do not distribute without permission.  
 
The protocol is to be followed exactly.  To alter the protocol, amendments must be written, receive approval from the appropriate personnel, 
and receive IRB or other Competent Regulatory Authorities approval prior to implementation, as appropriate.  If preliminary or interim review 
indicates that modification should be made in the experimental design, study parameters, subject selection, etc., these changes will be made 
after appropriate amendment(s) to this protocol with the mutual approval of the Sponsor and the Investigator.  Any protocol change that 
may significantly affect the safety of study subjects must also be submitted for review and approval by the IRB prior to implementation. 
 
Administrative changes not affecting the subject risk/benefit may be made without the need for a formal amendment.  All amendments will 
be distributed to all protocol recipients, with appropriate instructions. 
 
Termination of the Study 
If the Investigator or Sponsor becomes aware of conditions or events that suggest a possible study-related hazard to subjects if the study 
continues, they may recommend to the Sponsor that the study be terminated after appropriate consultation between the relevant parties. 
The decision to terminate the study remains with the Sponsor.  The study may also be terminated early at the Sponsor's discretion in the 
absence of such a finding.  All enrolled subjects to that point will be notified of the study termination and reassured regarding 
depersonalization of any accrued specimens. 
 
Conditions that may warrant termination by the Sponsor may include, but are not limited to, the discovery that in the opinion of the Sponsor, 
the study poses an unexpected, significant, or unacceptable risk to the subjects enrolled in the study.  Additionally, a decision on the part of 
the Sponsor to suspend or discontinue development of the investigational device may be made. 
 
Confidentiality 
All study findings and documents will be regarded as confidential.  The Investigator and members of his/her staff must not disclose such 
information without prior written approval from the Sponsor. 
 

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STATUS: 
 
Active 
TITLE: 
 
Informed Vital Core, Pulse Rate Clinical Study Protocol    
IDENTIFICATION: 
 
IVC-400-006 
EFFECTIVE DATE: 
 
March 31, 2023 
AUTHOR: 
 
Chris Joslin 
APPROVED BY: 
 
Mark Whitehouse 
 
 
 
Confidential – Mindset Medical, LLC 
Do not distribute without permission.  
 
The anonymity of participating study subjects must be maintained.  Subjects will be identified on eCRFs and other documents submitted to 
the Sponsor by their subject number, not by name.  Documents not to be submitted to the Sponsor that identify the subject (e.g., the signed 
informed consent) must be maintained in confidence by the Investigator. 
 
Publication 
At the conclusion of the study, publication of the primary study outcomes may be prepared for publication in a reputable scientific journal.  
The publication of the principal results from any single center or other collaborative experience within the study is not allowed until the 
preparation and publication of the primary study outcomes.  Publication of the study results with the assent of the Sponsor and Investigators 
should not be delayed for more than 12 months after completion of the study.  
 
Site Training 
All Investigators and appropriate study staff will be required to participate in an on-site or web-based training (or initiation if appropriate) to 
provide orientation and training regarding the applicable study-specific procedures, protocol, and eCRFs. 
 
 
 

DOCUMENT VERSION: 1 
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PAGE: 
 
31 OF 33 
STATUS: 
 
Active 
TITLE: 
 
Informed Vital Core, Pulse Rate Clinical Study Protocol    
IDENTIFICATION: 
 
IVC-400-006 
EFFECTIVE DATE: 
 
March 31, 2023 
AUTHOR: 
 
Chris Joslin 
APPROVED BY: 
 
Mark Whitehouse 
 
 
 
Confidential – Mindset Medical, LLC 
Do not distribute without permission.  
 
Device Regulatory Approval/Clearance 
 
   
 
 
 
 
  
 
  
 
 
 
 
Per FDA Guidance document, Information Sheet Guidance For IRBs, Clinical Investigators, and Sponsors Significant Risk and Nonsignificant 
Risk Medical Device Studies, NSR device studies do not have to have an IDE application approved by FDA.  However, an IRB's NSR determination 
of this study is required.  
 
 

DOCUMENT VERSION: 1 
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PAGE: 
 
1 OF 25 
STATUS: 
 
Active 
TITLE: 
 
Informed Vital Core –Clinical Study Instruction Guide: 
Pulse Rate 
IDENTIFICATION: 
 
IVC-400-006g 
EFFECTIVE DATE: 
 
April 5, 2023 
AUTHOR: 
 
Chris Joslin 
APPROVED BY: 
 
Mark Whitehouse 
 
 
Confidential – Mindset Medical, LLC 
Do not distribute without permission.  
 
 
 
 
 
 
 
Informed Vital Core 
Clinical Study Instruction Guide:  
Pulse Rate 
 
 
 
 
 
 
 

DOCUMENT VERSION: 1 
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PAGE: 
 
2 OF 25 
STATUS: 
 
Active 
TITLE: 
 
Informed Vital Core –Clinical Study Instruction Guide: 
Pulse Rate 
IDENTIFICATION: 
 
IVC-400-006g 
EFFECTIVE DATE: 
 
April 5, 2023 
AUTHOR: 
 
Chris Joslin 
APPROVED BY: 
 
Mark Whitehouse 
 
 
Confidential – Mindset Medical, LLC 
Do not distribute without permission.  
 
Table of Contents 
1. 
INTRODUCTION ...................................................................................................................................................................... 3 
2. 
CLINICAL STUDY MATERIALS AND EQUIPMENT ....................................................................................................................... 3 
3. 
EQUIPMENT/ITEMS NEEDEDSTUDY ENVIRONMENT REQUIREMENTS ...................................................................................... 3 
3.1. WARNINGS ........................................................................................................................................................................................ 4 
4. 
VERIFY ECG SETTINGS ............................................................................................................................................................. 5 
5. 
ECG PREPARATION ................................................................................................................................................................. 9 
6. 
SENDING THE IVC APP .......................................................................................................................................................... 12 
7. 
PREPARING THE IVC APP FOR PR MEASUREMENT ................................................................................................................. 14 
8. 
UPLOADING THE ECG DATA FROM THE THUMB DRIVE .......................................................................................................... 17 
9. 
VERIFY XML FILES ARE IN GOOGLE DRIVE.............................................................................................................................. 22 
APPENDIX A – CLOCK SYNCHRONIZATION BETWEEN ECG AND IVC APP MOBILE PHONE ............................................................... 24 
 
 
 
 

DOCUMENT VERSION: 1 
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PAGE: 
 
3 OF 25 
STATUS: 
 
Active 
TITLE: 
 
Informed Vital Core –Clinical Study Instruction Guide: 
Pulse Rate 
IDENTIFICATION: 
 
IVC-400-006g 
EFFECTIVE DATE: 
 
April 5, 2023 
AUTHOR: 
 
Chris Joslin 
APPROVED BY: 
 
Mark Whitehouse 
 
 
Confidential – Mindset Medical, LLC 
Do not distribute without permission.  
 
Informed Vital Core Instructions  
IVC-PR-CLINICAL-STUDY  
Pulse Rate PRO  
1. Introduction 
The instruction guide details the equipment used and the steps necessary to conduct the Informed Vital Core 
Pulse Rate Clinical Study IVC-400-006 comparing pulse rate (PR) measurements using the Informed Vital Core 
Application (IVC App) and a heart rate (HR) measured by an ECG device. 
 
2. Clinical Study Materials and Equipment 
Mindset Medical (Sponsor) will provide the following materials: 
● One mobile phone to run the Informed Vital Core Application, equipped with Google Voice phone 
number, Google Drive, and Gmail address (IVC Mobile Phone) 
● Edan SE-301 ECG device with patient cable 
● ECG Power Cord 
● Spare disposable tab electrodes (one-time use per subject) 
● Alcohol wipes 
● Thumb drive 
● USB-C to USB-A cable 
● Make-up removal wipes 
● Informed Vital Core PRO (IVC-PR-CLINICAL-STUDY) 
● Phone Stand 
● Phone Charger  
3. Study Environment Requirements 
The study environment has the following requirements: 
● Quiet room  
● Comfortable chair 
● Table at normal height (i.e., office desk or kitchen table) 
● Wi-fi access 
● Normal lighting with face being uniformly lit  
o Ensure there are no shadows, dark spots, or bright spots on the subject’s face 
o No movement in the background behind the subjects 
o No varied lighting from windows, computer screens, or TV on the subject’s face or behind the 
subject. 
 

DOCUMENT VERSION: 1 
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PAGE: 
 
4 OF 25 
STATUS: 
 
Active 
TITLE: 
 
Informed Vital Core –Clinical Study Instruction Guide: 
Pulse Rate 
IDENTIFICATION: 
 
IVC-400-006g 
EFFECTIVE DATE: 
 
April 5, 2023 
AUTHOR: 
 
Chris Joslin 
APPROVED BY: 
 
Mark Whitehouse 
 
 
Confidential – Mindset Medical, LLC 
Do not distribute without permission.  
 
3.1. Warnings 
• The subject’s face must be well illuminated with no shadows, including shadows cast from eyeglasses on 
the cheeks, no dark spots or bright spots falling across their face.  Ensure the lighting direction is in front 
of the subject. 
• Do not place subjects in front of windows or open spaces that would allow for bright light to shine from 
behind the subject, lowering the quality of the lighting on the face. 
• Subjects should have no movement in background – no TVs, people walking behind, flashing lights or 
shadows, or moving fans. 
• No hats, do-rags, or masks should be worn by the subject.  The forehead, cheeks, and chin need to be 
visible. 
• Heavy bangs and hair should be pulled away from the subject’s face. 
• Ensure the subject does not have any makeup, lotion, sunscreen, etc. on their cheeks, forehead, and 
chin.  Clean, bare skin on the subject’s face is required and makeup removal wipes may be used to 
remove anything on the cheeks, forehead, or chin.   
• The subject must remain still during the 60-second measurement session. 
o No talking 
o No movement of the head, mouth, leg, or arms to which ECG electrodes are attached. 
• Ensure that the disposable ECG tabs and electrodes are securely adhered to the subject.  You may need 
to use medical tape to properly secure the electrodes to the subject and ensure the disposable tabs are 
not pulling away from the skin. 
o The disposable tabs are to be used once per subject and then discarded.   
o Excessive hair may need to be shaved away from the subject’s skin to ensure adherence with the 
disposable electrodes. 
 
 
 

Mindset Medical, LLC / Protocol Number IVC-400-006 
Page 1 of 13 
 
 
«PiFullName» 
Advarra IRB Approved Version 9 May 2023 
Revised «PIApprovalDate» 
 
INFORMED CONSENT FORM 
AND  
AUTHORIZATION TO USE AND DISCLOSE PROTECTED HEALTH INFORMATION 
 
Sponsor / Study Title: 
  
Mindset Medical, LLC / “A Multi-Center Prospective Open 
Label Study of a Web-based Application for Pulse Rate in Adult 
Patients” 
 
Protocol Number: 
 
IVC-400-006 
Principal Investigator: 
(Study Doctor) 
 
«PiFullName» 
 
Telephone: 
 
«IcfPhoneNumber» 
 
Address: 
«PiLocations» 
 
 
KEY INFORMATION 
You are invited to take part in a research study. This research study is designed to evaluate the 
accuracy of Informed Vital Core (IVC App, IVC), a web-based application designed for 
measurements of vital signs including pulse rate (PR). Your Investigator will explain the clinical 
study to you. Clinical studies include only people who choose to take part voluntarily, after 
considering all the information in this document. Please take your time to make your decisions 
about taking part. 
  
Clinical studies help us improve and grow our knowledge on the safety and effectiveness of 
investigational devices. For this reason, the law requires that investigational devices must be 
clinically tested. As required by law, this clinical study has been reviewed by an Institution 
Review Board, (IRB) and the United States Food and Drug Administration (FDA). This clinical 
study will be conducted in the United Sates. The clinical study is being investigated, organized, 
and financed by Mindset Medical, LLC. 
  
Your participation in this clinical study is voluntary. Therefore, you will only be included in the 
clinical study if you give your written consent. You may choose to not participate, or you may 
withdraw from the study for any reason without penalty or loss of benefits to which you are 
otherwise entitled and without any effect on your future medical care. The Investigator or the 
sponsor can stop your participation at any time without your consent for the following reasons: 
 
• If you fail to follow directions for participating in the study; 
• If it is discovered that you do not meet the study requirements; 
• If the study is canceled; or  
• For administrative reasons. 
 

Mindset Medical, LLC / Protocol Number IVC-400-006 
Page 2 of 13 
 
 
«PiFullName» 
Advarra IRB Approved Version 9 May 2023 
Revised «PIApprovalDate» 
 
Please do not hesitate to discuss questions with your Investigator. Afterward, you will be given 
plenty of time to think about whether you wish to take part in this study before you will be 
asked to decide.  
 
WHY IS THE CLINCIAL STUDY BEING CONDUCTED? 
The clinical study involves research. The objective of this study is to evaluate the investigational 
software (IVC APP, IVC) as a simple and non-invasive way to measure vital signs. This is a 
research study to test a new software application detecting Pulse Rate (PR). This study will 
compare the PR measurement using the IVC App to the heart rate (HR) measured by an 
electrocardiogram (ECG) device (reference device).  
 
It is hypothesized that the accuracy of the IVC App is non-inferior to the accuracy of an FDA-
cleared/approved vital sign monitoring device (reference device). This research is to evaluate 
the accuracy of measurement for each Pulse Rate vital sign with the IVC App, compared to 
appropriate reference devices.  
 
You are being asked to participate in this research study because you are between the ages of 
22-85. 
 
WHAT INFORMATION WILL BE COLLECTED AND USED FOR THIS STUDY? 
The study staff working on the study will collect information about you. This includes your 
health information. 
 
Data collected will be entered into the electronic data capture (EDC) system and used for 
analysis.  
 
The following data will be collected: 
• Date of Birth/Age 
• Gender 
• Ethnicity 
• Skin Tone as rated by the Fitzpatrick Scale 
• Facial variables (glasses, facial hair, facial tattoos, and/or makeup) 
• Cardiac Medical History 
• Chronic Medical Conditions 
• Pulse Rate taken by IVC App (conducted twice) 
• Heart Rate taken by ECG (conducted twice)  
 
In the future, we may publish results of this study in scientific journals and may present it at 
scientific meetings. If we do, we will not identify you. Only summarized data from the entire 
study will be presented. 
 
If the researchers learn about potential serious harm to you or someone else or other public 
health concerns, it will be shared with the appropriate authorities. 

Mindset Medical, LLC / Protocol Number IVC-400-006 
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«PiFullName» 
Advarra IRB Approved Version 9 May 2023 
Revised «PIApprovalDate» 
 
to read the ECG results. At the same time you will be asked to sit still for one minute looking at 
the phone in the stand while the IVC App takes measurements of your face.  
 
You will then be asked if there were any adverse events (side effects) that you experienced 
while in the study.  
 
HOW LONG WILL I BE IN THIS STUDY? 
Your participation in this study is less than one hour unless there is a technical issue 
encountered, in which case you will be asked to come back and complete the visit if the study is 
still enrolling subjects.  
 
WHAT SIDE EFFECTS OR RISKS CAN I EXPECT FROM BEING IN THE STUDY? 
There are no foreseeable risks or known side effects to this study.  
 
There may be slight discomfort from remaining still for 1 minute. 
 
Skin irritation is rare but could occur during an ECG from the electrodes or gel that is used. 
 
You will have photographs of your face taken for this study.  It is possible that your face may be 
recognizable and your identity may be known. 
 
UNFORESEEN RISKS  
Since the study is using investigational software, there may be other risks that are unknown but 
it is highly unlikely.  
 
ARE THERE BENEFITES TO TAKING PART IN THE STUDY? 
This study is for research purposes only. There is no direct benefit to you from your 
participation in the study. Information learned from the study may help other people in the 
future. 
 
Since the IVC App is a web-based application, it can easily be utilized at hospitals (replacing vital 
signs carts), physician offices, clinics, and at patient's homes without the need for a trained 
nurse to capture the vitals. The IVC App can easily be utilized at a patient’s home without the 
need to purchase specialized equipment. 
 
Traditional pulse rate devices rely on physical contact of a patient, either placed on a wrist, 
arm, fingertip, or some other part of the body. This IVC App does not require any physical 
contact of a patient, rather they will simply look directly into the camera embedded on the 
phone device.  
 
ALTERNATIVES 
This research study is for research purposes only. The only alternative is to not participate in 
this study. 
 

Mindset Medical, LLC / Protocol Number IVC-400-006 
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«PiFullName» 
Advarra IRB Approved Version 9 May 2023 
Revised «PIApprovalDate» 
 
COMPENSATION FOR PARTICIPATION  
«Compensation» 
 
You will be paid up to a total of $75.00 if you complete this study. If you have any questions 
regarding your compensation for participation, please contact the study staff.   
 
CONFIDENTIALITY   
Records of your participation in this study will be held confidential except when sharing the 
information is required by law or as described in this informed consent. The Investigator, the 
sponsor or persons working on behalf of the sponsor, and under certain circumstances, the 
United States Food and Drug Administration (FDA) and the Institutional Review Board (IRB) will 
be able to inspect and copy confidential study-related records which identify you by name. This 
means that absolute confidentiality cannot be guaranteed. If the results of this study are 
published or presented at meetings, you will not be identified. 
 
A description of this clinical trial will be available on http://www.ClinicalTrials.gov, as required 
by U.S. Law. This Web site will not include information that can identify you. At most, the Web 
site will include a summary of the results. You can search this Web site at any time. 
 
To make sure that the health information collected in this study is accurate, it will need to be 
checked from time to time against your medical records. Some persons may need to see these 
records in order to monitor the research and verify the accuracy of the study data, including: 
• A limited number of representatives from the study sponsoring company (namely its 
monitors and auditors),  
• The institutional review board – Advarra IRB (an independent committee that reviewed 
the aspects of this study to help protect the rights and welfare of study subjects),  
• Government regulatory authorities including, the US Food and Drug Administration 
(FDA) and other foreign regulatory agencies. 
 
Your study records including confidential information about you collected during the study will 
be kept at a secure location. 
 
While every effort will be made to protect the privacy of your information, absolute 
confidentiality cannot be guaranteed. This does not limit the duty of the researchers and others 
to protect your privacy. 
 
By signing this information and consent form, you consent to the collection, access, use and 
disclosure of your information as described above. 
 
COMPENSATION FOR INJURY  
If you become ill or are injured while you are in the study, get the medical care that you need 
right away. You should inform the healthcare professional treating you that you are 

Mindset Medical, LLC / Protocol Number IVC-400-006 
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«PiFullName» 
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Revised «PIApprovalDate» 
 
participating in this study. If you tell the study staff that you think you have been injured, then 
they will help you get the care you need.  
 
If you are injured as a result from procedures done for the purpose of this study, the sponsor 
will pay for those medical expenses necessary to treat your injury that are not covered by your 
medical insurance or any other third-party coverage. By signing this document, you will not lose 
any of your legal rights or release anyone involved in the research from responsibility for 
mistakes. 
 
To pay medical expenses, the sponsor will need to know some information about you like your 
name, date of birth, and Medicare Beneficiary Identifier (MBI). This is because the sponsor has 
to check to see if you receive Medicare and if you do, report the payment it makes to Medicare.  
 
COSTS  
There will be no charge to you for your participation in this study. The study device, study-
related procedures, and study visit will be provided at no charge to you or your insurance 
company. 
 
WHOM TO CONTACT ABOUT THIS STUDY 
During the study, if you experience any medical problems, suffer a research-related injury, or 
have questions, concerns, or complaints about the study such as: 
 
• Whom to contact in the case of a research-related injury or illness; 
• Payment or compensation for being in the study, if any; 
• Your responsibilities as a research subject; 
• Eligibility to participate in the study; 
• The Investigator’s or study site’s decision to withdraw you from participation; 
• Results of tests and/or procedures; 
 
Please contact the Investigator at the telephone number listed on the first page of this 
consent document.  
 
If you seek emergency care, or hospitalization is required, alert the treating physician that you 
are participating in this research study.  
 
An institutional review board (IRB) is an independent committee established to help protect the 
rights of research subjects. If you have any questions about your rights as a research subject, 
contact: 
 
• By mail: 
Study Subject Adviser 
Advarra IRB 
6100 Merriweather Dr., Suite 600 

Mindset Medical, LLC / Protocol Number IVC-400-006 
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«PiFullName» 
Advarra IRB Approved Version 9 May 2023 
Revised «PIApprovalDate» 
 
Columbia, MD 21044 
• or call toll free:    877-992-4724 
• or by email:          adviser@advarra.com 
 
Please reference the following number when contacting the Study Subject Adviser: 
Pro00070500. 
 
PRIMARY HEALTH CARE PROVIDER NOTIFICATION OPTION  
I consent to having my family doctor or primary health care provider notified by the study site 
of my participation in this study and/or any significant findings related to my health (please 
check yes or no). 
 
YES (If yes, please complete the information below) 
NO  
 
Name and address of family 
doctor or primary health care 
provider: 
Name: 
Address: 
 
Telephone and Fax Number: 
Tel: 
Fax: 
 
 
 

Mindset Medical, LLC / Protocol Number IVC-400-006 
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«PiFullName» 
Advarra IRB Approved Version 9 May 2023 
Revised «PIApprovalDate» 
 
CONSENT  
I have read and understand the information in this informed consent document. I have had an 
opportunity to ask questions and all of my questions have been answered to my satisfaction. I 
voluntarily agree to participate in this study until I decide otherwise. I do not give up any of my 
legal rights by signing this consent document. I will receive a copy of this signed consent 
document. 
 
 
________________________________________ 
 
 
Subject’s Printed Name  
 
 
________________________________________ 
 
___________  
Subject’s Signature 
 
 
 
 
 
Date 
 
 
________________________________________ 
 
 
Printed Name of the Person Conducting the  
 
 
Consent Discussion   
 
 
________________________________________ 
 
___________ 
Signature of the Person Conducting the  
 
 
Date 
 
Consent Discussion   
 
 
 
 
 
 
 
 
 

Mindset Medical, LLC / Protocol Number IVC-400-006 
Page 9 of 13 
 
 
«PiFullName» 
Advarra IRB Approved Version 9 May 2023 
Revised «PIApprovalDate» 
 
CONSENT FOR OPTIONAL SUBSTUDY  
You are also being asked to participate in an optional substudy.  
 
“Informed Vital Core, Data Collection Protocol (Respiratory Rate, Pulse Oxygen Saturation, and 
Blood Pressure)” is the substudy. 
 
If you leave the substudy for any reason, the Investigator may ask you to have some end-of-
study tests for your safety (for example, if you have experienced any adverse or serious adverse 
events while participating in the substudy.   
 
WHY IS THE CLINICAL SUBSTUDY BEING CONDUCTED? 
The scope of this substudy is to gather data from an FDA approved device called the Masimo 
MightySat Rx Fingertip Pulse Oximeter and/or Caretaker Vital Stream continuous blood 
pressure device) while gathering real-time environmental images to improve the measurement 
of pulse rate (PR), respiratory rate (RR), blood oxygen saturation (SpO2), and blood pressure 
(BP) for the purpose of training the algorithms of the IVC App.  
 
You will be asked to provide four measurements of either SpO2 or blood pressure.  You may be 
asked to do four measurements of one or the other, or a combination of two sessions of each, 
etc. 
 
You will be asked to sit for 120 seconds while the IVC App takes continuous photos of your face 
and/or fingertip while you wear the reference device. 
 
WHAT INFORMATION WILL BE COLLECTED AND USED FOR THIS SUBSTUDY? 
• Sex 
• Race 
• Ethnicity 
• Skin Tone as rated by the Fitzpatrick Scale 
• Age 
• Height/Weight 
• Facial variables (glasses, facial hear, facial tattoos, and/ or makeup) 
• Permission to collect photos. You will be asked to sit for 120 seconds while the IVC APP 
takes continuous photos of your face and/ or fingertip.  
• Pulse Rate, Respiratory rate, SpO2, and Blood Pressure 
 
RISKS 
You will have photographs of your face taken for this substudy.  It is possible that your face may 
be recognizable and your identity may be known. 
 
There may be other risks that are unknown. 
 

Mindset Medical, LLC / Protocol Number IVC-400-006 
Page 10 of 13 
 
 
«PiFullName» 
Advarra IRB Approved Version 9 May 2023 
Revised «PIApprovalDate» 
 
BENEFITS 
This substudy is for research purposes only. There is no direct benefit to you from your 
participation in the substudy. Information learned from the substudy may help other people in 
the future. 
 
ALTERNATIVES 
This research substudy is for research purposes only. The only alternative is to not participate in 
this substudy. 
 
CONFIDENTIALITY 
Records of your participation in this study will be held confidential except when sharing the 
information is required by law or as described in this informed consent. The Investigator, the 
sponsor or persons working on behalf of the sponsor, and under certain circumstances, the 
United States Food and Drug Administration (FDA) and the Institutional Review Board (IRB) will 
be able to inspect and copy confidential study-related records which identify you by name. This 
means that absolute confidentiality cannot be guaranteed. If the results of this study are 
published or presented at meetings, you will not be identified. 
 
COMPENSATION FOR INJURY 
If you become ill or are injured while you are in the substudy, get the medical care that you 
need right away. You should inform the healthcare professional treating you that you are 
participating in this substudy. If you tell the study staff that you think you have been injured 
then they will help you get the care you need.  
 
If you are injured as a result of procedures done for the purpose of this substudy, the sponsor 
will pay for those medical expenses necessary to treat your injury that are not covered by your 
medical insurance or any other third-party coverage. By signing this document, you will not lose 
any of your legal rights or release anyone involved in the research from responsibility for 
mistakes. 
 
To pay medical expenses, the sponsor will need to know some information about you like your 
name, date of birth, and Medicare Beneficiary Identifier (MBI). This is because the sponsor has 
to check to see if you receive Medicare and if you do, report the payment it makes to Medicare. 
 
COMPENSATION FOR PARTICIPATION  
«Compensation» 
 
You will be paid up to a total of $75.00 for 4 data collection sessions if you complete this 
substudy.  
 
If you have any questions regarding your compensation for participation, please contact the 
study staff.   
 
There will be no charge to you for your participation in this substudy. 

Mindset Medical, LLC / Protocol Number IVC-400-006 
Page 11 of 13 
 
 
«PiFullName» 
Advarra IRB Approved Version 9 May 2023 
Revised «PIApprovalDate» 
 
 
You may decide not to participate in the optional substudy or you may choose to withdraw 
from the substudy for any reason. If you decide not to participate in the substudy, your decision 
will have no impact on your ability to participate in the initial study and will have no impact on 
any other benefits to which you would otherwise be entitled.  
 
The Investigator or the sponsor can stop your participation at any time without your consent 
for the following reasons: 
 
• If you fail to follow directions for participating in the study; 
• If it is discovered that you do not meet the study requirements; 
• If the study is canceled; or  
• For administrative reasons. 
 
Please indicate your preference below: 
 
YES _____ (initials) I agree to participate in the substudy described above. 
 
NO _____ (initials) I do not agree to participate in the substudy described above. 
 
 
________________________________________ 
 
 
Subject’s Printed Name  
 
 
________________________________________ 
 
___________  
Subject’s Signature 
 
 
 
 
 
Date 
 
 
________________________________________ 
 
 
Printed Name of the Person Conducting the  
 
 
Consent Discussion   
 
 
________________________________________ 
 
___________ 
Signature of the Person Conducting the  
 
 
Date 
 
Consent Discussion   
 
 
 
 
 
 
 
 

Mindset Medical, LLC / Protocol Number IVC-400-006 
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«PiFullName» 
Advarra IRB Approved Version 9 May 2023 
Revised «PIApprovalDate» 
 
AUTHORIZATION TO USE AND DISCLOSE PROTECTED HEALTH INFORMATION 
 
If you decide to be in this study, the Investigator and study staff will use and share 
health data about you to conduct the study. Health data may include: 
• Your name 
• Address 
• Phone number 
• Date of birth 
• Medical history 
• Information from your study visits, including all test results 
 
Health data may come from your study records or from existing records kept by 
your doctor or other health care workers.  
 
For this study, the study staff may share health data about you with authorized 
users. Authorized users may include: 
• Representatives of Mindset Medical, LLC 
• Representatives of Total Clinical Trial Management (TOTAL CRO) 
• Representatives of Advarra IRB (an Institutional Review Board that reviews 
this study) 
• The Food and Drug Administration (FDA) and other US federal and state 
agencies 
• Government agencies to whom certain diseases (like HIV, hepatitis, and 
STDs) must be reported 
• Governmental agencies of other countries 
• Outside individuals and companies, such as laboratories and data storage 
companies, that work with the researchers and sponsor and need to access 
your information to conduct this study 
• Other research doctors and medical centers participating in this study, if 
applicable 
 
Your health data will be used to conduct and oversee the research, including for 
instance: 
• To see if the study device/Software works and is safe 
• To compare the study device/Software to other devices/Software 
• For other research activities related to the study device/Software 
 

Mindset Medical, LLC / Protocol Number IVC-400-006 
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«PiFullName» 
Advarra IRB Approved Version 9 May 2023 
Revised «PIApprovalDate» 
 
Once your health data has been shared with authorized users, it may no longer be 
protected by federal privacy law and could possibly be used or disclosed in ways 
other than those listed here.  
 
Your permission to use and share health data about you will end in 50 years 
unless you revoke it (take it back) sooner.  
 
You may revoke (take back) your permission to use and share health data about 
you at any time by writing to the Investigator at the address listed on the first 
page of this form. If you do this, you will not be able to stay in this study. No new 
health data that identifies you will be gathered after your written request is 
received. However, health data about you that has already been gathered may 
still be used and given to others as described in this form.  
 
Your right to access your health data in the study records will be suspended 
during the study to keep from changing the study results. When the study is over, 
you can access your study health data from your doctor. 
 
If you decide not to sign this form, you will not be able to take part in the study. 
 
STATEMENT OF AUTHORIZATION 
I have read this form and its contents were explained. My questions have been 
answered. I voluntarily agree to allow study staff to collect, use and share my 
health data as specified in this form. I will receive a signed and dated copy of this 
form for my records. I am not giving up any of my legal rights by signing this form.  
 
 
__________________________________ 
Printed Name of Subject 
 
 
__________________________________ 
 
 
__________ 
Signature of Subject 
 
 
 
 
 
Date 
 

No.
Site Name
PI Name
Staff
Credentials
Phone #
Role
Address
City
State
Zip Code
301
Velocity Clinical Research
Gregg Lucksinger
Victor Haas
BS, GCP, IATA
512-506-8287
Coordinator 
1900 Cypress Creek, Suite 200
Cedar Park 
Texas
78613
301
Velocity Clinical Research
Gregg Lucksinger
Valencia Smith
MA, GCP, IATA
512-506-8287
Coordinator 
1900 Cypress Creek, Suite 200
Cedar Park 
Texas
78613
301
Velocity Clinical Research
Gregg Lucksinger
Amy Vester
BS, GCP, IATA, BLS
512-506-8287
Coordinator 
1900 Cypress Creek, Suite 200
Cedar Park 
Texas
78613
301
Velocity Clinical Research
Gregg Lucksinger
Angel Cervantes
GCP, IATA
512-506-8287
Coordinator 
1900 Cypress Creek, Suite 200
Cedar Park 
Texas
78613
301
Velocity Clinical Research
Gregg Lucksinger
Tambra Dora
Certified Medical Assistant, Phlebotomy, CPR, GCP, 
512-506-8287
Coordinator 
1900 Cypress Creek, Suite 200
Cedar Park 
Texas
78613
301
Velocity Clinical Research
Gregg Lucksinger
Therese Spalding
RN, IATA, BLS, GCP, CPR
512-506-8287
Coordinator 
1900 Cypress Creek, Suite 200
Cedar Park 
Texas
78613
301
Velocity Clinical Research
Gregg Lucksinger
Yasmin Mota
NRCMA, CPR, BCLS, IATA, GCP
512-506-8287
Coordinator 
1900 Cypress Creek, Suite 200
Cedar Park 
Texas
78613
302
Velocity Clinical Research
Marian Shaw
Kate Lyon
CPR, GCP
208-377-8653
Coordinator 
2950 E. Magic View Dr., Suite 182
Meridian
Idaho
83642
302
Velocity Clinical Research
Marian Shaw
Paula Dockstader
CPhT, CPR, GCP
208-377-8653
Coordinator 
2950 E. Magic View Dr., Suite 182
Meridian
Idaho
83642
302
Velocity Clinical Research
Marian Shaw
Audra Weslowski 
GCP, IATA
208-377-8653
Coordinator 
2950 E. Magic View Dr., Suite 182
Meridian
Idaho
83642
302
Velocity Clinical Research
Marian Shaw
Erika Calhoun 
AS, GCP
208-377-8653
Coordinator 
2950 E. Magic View Dr., Suite 182
Meridian
Idaho
83642
302
Velocity Clinical Research
Marian Shaw
Westin Payne 
BA, GCP
208-377-8653
Coordinator 
2950 E. Magic View Dr., Suite 182
Meridian
Idaho
83642
302
Velocity Clinical Research
Marian Shaw
Cecelia Pena  
BS, IATA, GCP
208-377-8653
Coordinator 
2950 E. Magic View Dr., Suite 182
Meridian
Idaho
83642
302
Velocity Clinical Research
Marian Shaw
Ronnie Moore
AS, GCP
208-377-8653
Research Assistant
2950 E. Magic View Dr., Suite 182
Meridian
Idaho
83642
302
Velocity Clinical Research
Marian Shaw
Tyler Scoggins
BA, GCP
208-377-8653
Research Assistant
2950 E. Magic View Dr., Suite 182
Meridian
Idaho
83642
304
Velocity Clinical Research
Margaret Rhee
Alanna Billups
BA, CITI Protection of Human Services, CITI GCP for 
216-682-0320
Coordinator
3619 Park East Dr., Suite 300 
Cleveland 
Ohio 
44122
304
Velocity Clinical Research
Margaret Rhee
Maggie Jedlinsky
MSW, BSW (Bach. of Social Work), ACRP GCP cert. 
216-682-0320
Coordinator
3619 Park East Dr., Suite 300 
Cleveland 
Ohio 
44122
304
Velocity Clinical Research
Margaret Rhee
Cameron Robinson
BS, ACRP GCP 
216-682-0320
Coordinator
3619 Park East Dr., Suite 300 
Cleveland 
Ohio 
44122
304
Velocity Clinical Research
Margaret Rhee
Casssie Uminski
Community College, Health Carreers Program 
216-682-0320
Data Entry Coordinator
3619 Park East Dr., Suite 300 
Cleveland 
Ohio 
44122
304
Velocity Clinical Research
Margaret Rhee
Jane Boggan
CITI GCP (health info privacy/security for clinical), 
216-682-0320
Data Entry Coordinator
3619 Park East Dr., Suite 300 
Cleveland 
Ohio 
44122
304
Velocity Clinical Research
Margaret Rhee
Lisle Merriman
BA, CITI human subjects research GCP & HIPS, GCP for 216-682-0320
Data Entry Coordinator
3619 Park East Dr., Suite 300 
Cleveland 
Ohio 
44122
305
Velocity Clinical Research
Greg Feldman, MD, CPI
Keith Cullum
Associate degree (x2), BLS, IATA, ACRP intro to GCP
803-766-2680
Site Operations Manager
1655 Bernardin Ave. Suite 300 
Columbia 
South Carolina
29204
305
Velocity Clinical Research
Greg Feldman, MD, CPI
Laura Weier
BS
803-766-2680
Coordinator
1655 Bernardin Ave. Suite 300 
Columbia 
South Carolina
29204
305
Velocity Clinical Research
Greg Feldman, MD, CPI
Brandon Harp
MHA, BS (x2)
803-766-2680
Coordinator
1655 Bernardin Ave. Suite 300 
Columbia 
South Carolina
29204
305
Velocity Clinical Research
Greg Feldman, MD, CPI
Sharon Williams
Phlebotomy certification
803-766-2680
Research Assistant
1655 Bernardin Ave. Suite 300 
Columbia 
South Carolina
29204
305
Velocity Clinical Research
Greg Feldman, MD, CPI
Catherine Mann
Technical college (3 areas), CPR, ACRP GCP Simulation, 803-766-2680
Research Assistant
1655 Bernardin Ave. Suite 300 
Columbia 
South Carolina
29204
305
Velocity Clinical Research
Greg Feldman, MD, CPI
DeAnn Tucker
BBA, Associate of Arts, foster care courses
803-766-2680
Regualtory Coordinator
1655 Bernardin Ave. Suite 300 
Columbia 
South Carolina
29204
306
Velocity Clinical Research
Lawrence J. Sindel, MD
Jessica Miller, RN
RN
251-263-5669
Coordinator
3715 Dauphin St, Bldg 2, Ste 503B
Mobile
Alabama
36608
306
Velocity Clinical Research
Lawrence J. Sindel, MD
Myia McMillian, B.S., Assistant CRC
BS, Assistant CRC, 
251-263-5669
Coordinator
3715 Dauphin St, Bldg 2, Ste 503B
Mobile
Alabama
36608
306
Velocity Clinical Research
Lawrence J. Sindel, MD
Laura Hill
BS, CCRC
251-263-5669
Coordinator
3715 Dauphin St, Bldg 2, Ste 503B
Mobile
Alabama
36608
306
Velocity Clinical Research
Lawrence J. Sindel, MD
Mike Weichman
N/A
251-263-5669
Research Assistant
3715 Dauphin St, Bldg 2, Ste 503B
Mobile
Alabama
36608
306
Velocity Clinical Research
Lawrence J. Sindel, MD
Robyn Robertson
Administrative Clinical Assistant, CITI GCP, IATA, OSHA B251-263-5669
Regulatory Coordinator
3715 Dauphin St, Bldg 2, Ste 503B
Mobile
Alabama
36608
306
Velocity Clinical Research
Lawrence J. Sindel, MD
Danny Kakish
GCP
251-263-5669
Coordinator 
3715 Dauphin St, Bldg 2, Ste 503B
Mobile
Alabama
36608
307
Velocity Clinical Research
J. Scott Overcash, MD
Lakeyla Bates
BA, AA, ACPR Intro to GCP, CITI IRB Chair, ACRP 
619-567-1550
Senior Regulatory Specialist
5565 Grossmont Center Dr, Bldg 2, Suite 1
La Mesa 
California
91942
307
Velocity Clinical Research
J. Scott Overcash, MD
Angela Anorve
BS, ACRP GCP, OSHA Bloodborne Pathogen
(619) 567-1550
Coordinator
5565 Grossmont Center Dr, Bldg 2, Suite 1
La Mesa 
California
91942
307
Velocity Clinical Research
J. Scott Overcash, MD
Ashliegh Lindsay
CPT I, Phlebotomy program, college (current), CA 
(619) 567-1550
Coordinator
5565 Grossmont Center Dr, Bldg 2, Suite 1
La Mesa 
California
91942
307
Velocity Clinical Research
J. Scott Overcash, MD
Audrey Sanchez
Clinical Research Coordinator, BA, 
(619) 567-1550
Coordinator
5565 Grossmont Center Dr, Bldg 2, Suite 1
La Mesa 
California
91942
307
Velocity Clinical Research
J. Scott Overcash, MD
Hunter  Asmann
BBA (bachelor's of business administration), GCP for 
(619) 567-1550
Coordinator
5565 Grossmont Center Dr, Bldg 2, Suite 1
La Mesa 
California
91942
307
Velocity Clinical Research
J. Scott Overcash, MD
Keji Kubari
BS
(619) 567-1550
Coordinator
5565 Grossmont Center Dr, Bldg 2, Suite 1
La Mesa 
California
91942
307
Velocity Clinical Research
J. Scott Overcash, MD
Kevin Fong
BA, Teaching english as a foregin language, GCP (intro (619) 567-1550
Data Entry Coordinator
5565 Grossmont Center Dr, Bldg 2, Suite 1
La Mesa 
California
91942
307
Velocity Clinical Research
J. Scott Overcash, MD
Stephanie Esquer-Soto
Phlebotomy, Certified Phlebotomy Tech
(619) 567-1550
Data Entry Coordinator
5565 Grossmont Center Dr, Bldg 2, Suite 1
La Mesa 
California
91942
307
Velocity Clinical Research
J. Scott Overcash, MD
Sylvia Lindholm
CPR, CITI HIPS, NIH Protecting Human Research Particip (619) 567-1550
Coordinator
5565 Grossmont Center Dr, Bldg 2, Suite 1
La Mesa 
California
91942
307
Velocity Clinical Research
J. Scott Overcash, MD
Pat Kappen, CCRP
CCRP, Edu. in Clinical Trials Design/Management, Certif (619) 567-1550
Regulatory Coordinator
5565 Grossmont Center Dr, Bldg 2, Suite 1
La Mesa 
California
91942

Mindset Medical, LLC 
IVC-400-006 
Page 1 of 5 
Listing 16.2.1.1 
Subject Disposition 
All-Enrolled Population 
 
 
ITC = Intent-to-Capture, PP = Per-Protocol 
 
Program name: l_16_2_1_1.sas 
Run Date: 21NOV2023 
Subject 
ID 
Date of 
Informed 
Consent 
Completion or 
Discontinuation 
Date 
Status 
Reason for 
Discontinuation 
ITC 
Population 
PP 
Population 
Reason ITC 
subject is 
excluded 
from PP 
population 
301-001 
02JUN2023 
02JUN2023 
COMPLETED 
 
Yes 
No 
Rhythm strip not uploaded 
301-002 
02JUN2023 
02JUN2023 
COMPLETED 
 
Yes 
Yes 
 
301-003 
09JUN2023 
09JUN2023 
COMPLETED 
 
Yes 
No 
Rhythm strip not uploaded 
301-004 
12JUN2023 
12JUN2023 
COMPLETED 
 
Yes 
Yes 
 
301-005 
13JUN2023 
13JUN2023 
COMPLETED 
 
Yes 
Yes 
 
301-006 
13JUN2023 
13JUN2023 
COMPLETED 
 
Yes 
Yes 
 
301-007 
14JUN2023 
14JUN2023 
DISCONTINUED SCREEN FAILURE No 
No 
 
301-008 
14JUN2023 
14JUN2023 
COMPLETED 
 
Yes 
Yes 
 
301-009 
15JUN2023 
15JUN2023 
COMPLETED 
 
Yes 
Yes 
 
301-010 
16JUN2023 
16JUN2023 
COMPLETED 
 
Yes 
Yes 
 
301-011 
16JUN2023 
16JUN2023 
COMPLETED 
 
Yes 
Yes 
 
301-012 
16JUN2023 
16JUN2023 
COMPLETED 
 
Yes 
Yes 
 
301-013 
20JUN2023 
20JUN2023 
COMPLETED 
 
Yes 
Yes 
 
301-014 
20JUN2023 
20JUN2023 
COMPLETED 
 
Yes 
Yes 
 
301-015 
21JUN2023 
21JUN2023 
COMPLETED 
 
Yes 
Yes 
 
301-016 
21JUN2023 
21JUN2023 
COMPLETED 
 
Yes 
Yes 
 
301-017 
22JUN2023 
22JUN2023 
COMPLETED 
 
Yes 
Yes 
 
301-018 
22JUN2023 
22JUN2023 
COMPLETED 
 
Yes 
Yes 
 
301-019 
22JUN2023 
22JUN2023 
COMPLETED 
 
Yes 
Yes 
 

Mindset Medical, LLC 
IVC-400-006 
Page 2 of 5 
Listing 16.2.1.1 
Subject Disposition 
All-Enrolled Population 
 
 
ITC = Intent-to-Capture, PP = Per-Protocol 
 
Program name: l_16_2_1_1.sas 
Run Date: 21NOV2023 
Subject 
ID 
Date of 
Informed 
Consent 
Completion or 
Discontinuation 
Date 
Status 
Reason for 
Discontinuation 
ITC 
Population 
PP 
Population 
Reason ITC 
subject is 
excluded 
from PP 
population 
301-020 
23JUN2023 
23JUN2023 
COMPLETED 
 
Yes 
No 
Rhythm strip not uploaded 
301-021 
26JUN2023 
26JUN2023 
COMPLETED 
 
Yes 
Yes 
 
301-022 
27JUN2023 
27JUN2023 
COMPLETED 
 
Yes 
Yes 
 
302-001 
02JUN2023 
02JUN2023 
COMPLETED 
 
Yes 
Yes 
 
302-002 
05JUN2023 
05JUN2023 
COMPLETED 
 
Yes 
Yes 
 
302-003 
06JUN2023 
06JUN2023 
COMPLETED 
 
Yes 
Yes 
 
302-004 
07JUN2023 
07JUN2023 
COMPLETED 
 
Yes 
Yes 
 
302-005 
07JUN2023 
07JUN2023 
COMPLETED 
 
Yes 
Yes 
 
302-006 
13JUN2023 
13JUN2023 
COMPLETED 
 
Yes 
Yes 
 
302-007 
14JUN2023 
14JUN2023 
COMPLETED 
 
Yes 
Yes 
 
302-008 
14JUN2023 
14JUN2023 
COMPLETED 
 
Yes 
Yes 
 
302-009 
15JUN2023 
15JUN2023 
COMPLETED 
 
Yes 
Yes 
 
302-010 
15JUN2023 
15JUN2023 
COMPLETED 
 
Yes 
Yes 
 
302-011 
16JUN2023 
16JUN2023 
COMPLETED 
 
Yes 
Yes 
 
302-012 
16JUN2023 
16JUN2023 
COMPLETED 
 
Yes 
Yes 
 
302-013 
20JUN2023 
20JUN2023 
COMPLETED 
 
Yes 
Yes 
 
302-014 
21JUN2023 
21JUN2023 
COMPLETED 
 
Yes 
Yes 
 
302-015 
21JUN2023 
21JUN2023 
COMPLETED 
 
Yes 
No 
Rhythm strip not uploaded 
302-016 
22JUN2023 
22JUN2023 
COMPLETED 
 
Yes 
Yes 
 
302-017 
22JUN2023 
22JUN2023 
COMPLETED 
 
Yes 
Yes 
 

Mindset Medical, LLC 
IVC-400-006 
Page 3 of 5 
Listing 16.2.1.1 
Subject Disposition 
All-Enrolled Population 
 
 
ITC = Intent-to-Capture, PP = Per-Protocol 
 
Program name: l_16_2_1_1.sas 
Run Date: 21NOV2023 
Subject 
ID 
Date of 
Informed 
Consent 
Completion or 
Discontinuation 
Date 
Status 
Reason for 
Discontinuation 
ITC 
Population 
PP 
Population 
Reason ITC 
subject is 
excluded 
from PP 
population 
302-018 
22JUN2023 
22JUN2023 
COMPLETED 
 
Yes 
Yes 
 
302-019 
23JUN2023 
23JUN2023 
COMPLETED 
 
Yes 
Yes 
 
302-020 
27JUN2023 
27JUN2023 
COMPLETED 
 
Yes 
Yes 
 
302-021 
28JUN2023 
28JUN2023 
COMPLETED 
 
Yes 
Yes 
 
304-001 
20JUN2023 
20JUN2023 
COMPLETED 
 
Yes 
Yes 
 
304-002 
20JUN2023 
20JUN2023 
DISCONTINUED PROTOCOL 
DEVIATION 
No 
No 
Rhythm strip not uploaded 
304-003 
21JUN2023 
21JUN2023 
COMPLETED 
 
Yes 
Yes 
 
304-004 
21JUN2023 
21JUN2023 
COMPLETED 
 
Yes 
Yes 
 
304-005 
22JUN2023 
22JUN2023 
COMPLETED 
 
Yes 
Yes 
 
304-006 
22JUN2023 
22JUN2023 
COMPLETED 
 
Yes 
Yes 
 
304-007 
27JUN2023 
27JUN2023 
COMPLETED 
 
Yes 
Yes 
 
304-008 
27JUN2023 
27JUN2023 
COMPLETED 
 
Yes 
Yes 
 
304-009 
27JUN2023 
27JUN2023 
COMPLETED 
 
Yes 
Yes 
 
304-010 
28JUN2023 
28JUN2023 
COMPLETED 
 
Yes 
Yes 
 
304-011 
28JUN2023 
28JUN2023 
COMPLETED 
 
Yes 
Yes 
 
304-012 
28JUN2023 
28JUN2023 
COMPLETED 
 
Yes 
Yes 
 
304-013 
29JUN2023 
29JUN2023 
COMPLETED 
 
Yes 
Yes 
 
305-001 
06JUN2023 
06JUN2023 
COMPLETED 
 
Yes 
No 
Rhythm strip not uploaded 
305-002 
06JUN2023 
06JUN2023 
COMPLETED 
 
Yes 
No 
Rhythm strip not uploaded 
305-003 
08JUN2023 
08JUN2023 
COMPLETED 
 
Yes 
No 
Rhythm strip not uploaded 

Mindset Medical, LLC 
IVC-400-006 
Page 4 of 5 
Listing 16.2.1.1 
Subject Disposition 
All-Enrolled Population 
 
 
ITC = Intent-to-Capture, PP = Per-Protocol 
 
Program name: l_16_2_1_1.sas 
Run Date: 21NOV2023 
Subject 
ID 
Date of 
Informed 
Consent 
Completion or 
Discontinuation 
Date 
Status 
Reason for 
Discontinuation 
ITC 
Population 
PP 
Population 
Reason ITC 
subject is 
excluded 
from PP 
population 
305-004 
09JUN2023 
09JUN2023 
COMPLETED 
 
Yes 
Yes 
 
305-005 
23JUN2023 
23JUN2023 
COMPLETED 
 
Yes 
Yes 
 
305-006 
23JUN2023 
23JUN2023 
COMPLETED 
 
Yes 
No 
Rhythm strip not uploaded 
305-007 
26JUN2023 
26JUN2023 
COMPLETED 
 
Yes 
No 
Rhythm strip not uploaded 
305-008 
26JUN2023 
26JUN2023 
COMPLETED 
 
Yes 
No 
Rhythm strip not uploaded 
305-009 
28JUN2023 
28JUN2023 
COMPLETED 
 
Yes 
Yes 
 
305-010 
29JUN2023 
29JUN2023 
COMPLETED 
 
Yes 
Yes 
 
305-011 
29JUN2023 
29JUN2023 
DISCONTINUED OTHER 
No 
No 
Study closed prior to 
assessment. 
305-012 
29JUN2023 
29JUN2023 
COMPLETED 
 
Yes 
Yes 
 
306-001 
22JUN2023 
22JUN2023 
COMPLETED 
 
Yes 
No 
Rhythm strip not uploaded 
306-002 
22JUN2023 
22JUN2023 
COMPLETED 
 
Yes 
No 
Rhythm strip not uploaded 
306-003 
26JUN2023 
26JUN2023 
COMPLETED 
 
Yes 
Yes 
 
306-004 
26JUN2023 
26JUN2023 
COMPLETED 
 
Yes 
No 
The reference device does not 
collect data 
306-005 
28JUN2023 
28JUN2023 
COMPLETED 
 
Yes 
Yes 
 
306-006 
28JUN2023 
28JUN2023 
COMPLETED 
 
Yes 
Yes 
 
306-007 
29JUN2023 
29JUN2023 
COMPLETED 
 
Yes 
Yes 
 
307-001 
14JUN2023 
14JUN2023 
COMPLETED 
 
Yes 
Yes 
 
307-002 
14JUN2023 
14JUN2023 
COMPLETED 
 
Yes 
Yes 
 
307-003 
22JUN2023 
22JUN2023 
COMPLETED 
 
Yes 
Yes 
 
307-004 
22JUN2023 
22JUN2023 
COMPLETED 
 
Yes 
Yes 
 

Mindset Medical, LLC 
IVC-400-006 
Page 5 of 5 
Listing 16.2.1.1 
Subject Disposition 
All-Enrolled Population 
 
 
ITC = Intent-to-Capture, PP = Per-Protocol 
 
Program name: l_16_2_1_1.sas 
Run Date: 21NOV2023 
Subject 
ID 
Date of 
Informed 
Consent 
Completion or 
Discontinuation 
Date 
Status 
Reason for 
Discontinuation 
ITC 
Population 
PP 
Population 
Reason ITC 
subject is 
excluded 
from PP 
population 
307-005 
22JUN2023 
22JUN2023 
COMPLETED 
 
Yes 
No 
The reference device does not 
collect data 
307-006 
23JUN2023 
23JUN2023 
COMPLETED 
 
Yes 
Yes 
 
307-007 
23JUN2023 
23JUN2023 
DISCONTINUED SCREEN FAILURE No 
No 
 
307-008 
23JUN2023 
23JUN2023 
COMPLETED 
 
Yes 
Yes 
 
307-009 
26JUN2023 
26JUN2023 
COMPLETED 
 
Yes 
Yes 
 
307-010 
26JUN2023 
26JUN2023 
COMPLETED 
 
Yes 
No 
Thumb drive not recognized by 
pixel phone. USB was sent back 
to sponsor for review on 7/20/23 
307-011 
28JUN2023 
28JUN2023 
COMPLETED 
 
Yes 
Yes 
 
 

DOCUMENT VERSION: 3 
THIS DOCUMENT SUPERSEDES VERSION: 2 
PAGE: 
1 OF 15 
STATUS: 
 
Active  
TITLE: 
 
Informed Vital Core - Statistical Analysis Plan 
IDENTIFICATION: 
 
IVC-400-006d 
EFFECTIVE DATE: 
 
June 22, 2023 
AUTHOR: 
 
Chris Joslin 
APPROVED BY: 
 
Mark Whitehouse 
 
 
Confidential – Mindset Medical, LLC 
Do not distribute without permission.  
 
Protocol Number: IVC-400-006 
Informed Vital Core Application (IVC App) 
Statistical Analysis Plan 
 
 
 
 
 
A Multi-Center Prospective Open Label Study of a Web-based 
 Application for Pulse Rate in Adult Patients 
 
 
 
 
Mindset Medical, LLC 
Version 3 
Date: June 22, 2023 
 

DOCUMENT VERSION: 3 
THIS DOCUMENT SUPERSEDES VERSION: 2 
PAGE: 
5 OF 15 
STATUS: 
 
Active  
TITLE: 
 
Informed Vital Core - Statistical Analysis Plan 
IDENTIFICATION: 
 
IVC-400-006d 
EFFECTIVE DATE: 
 
June 22, 2023 
AUTHOR: 
 
Chris Joslin 
APPROVED BY: 
 
Mark Whitehouse 
 
 
Confidential – Mindset Medical, LLC 
Do not distribute without permission.  
 
Contents 
LIST OF ABBREVIATIONS .......................................................................................................................................................... 6 
1.0 
INTRODUCTION ........................................................................................................................................................... 7 
2.0 
STUDY OBJECTIVES AND ENDPOINTS ........................................................................................................................... 7 
2.1 
STUDY OBJECTIVE ................................................................................................................................................................... 7 
2.1.1 
Primary Endpoint .......................................................................................................................................................... 7 
3.0 
STUDY HYPOTHESIS ..................................................................................................................................................... 7 
4.0 
STATISTICAL AND ANALYTICAL PROCEDURES ............................................................................................................... 7 
4.1 
ANALYSIS POPULATIONS AND COLLECTION GROUPS ...................................................................................................................... 7 
4.1.1 
All-Enrolled Population .................................................................................................................................................. 7 
4.1.2 
Intent-to-Capture Population (ITC) ................................................................................................................................ 8 
4.1.3 
Per-Protocol Population (PP) ......................................................................................................................................... 8 
4.1.4 
Successful Data Collection ............................................................................................................................................. 8 
4.1.5 
Data Collection Groups ................................................................................................................................................. 9 
4.2 
ANALYSIS VARIABLES ............................................................................................................................................................... 9 
4.2.1 
Subject’s Disposition and Analysis Sets ......................................................................................................................... 9 
4.2.2 
Demographics and Baseline Characteristics ................................................................................................................. 9 
4.2.3 
Health Conditions and Concomitant Medications ....................................................................................................... 10 
4.2.4 
Endpoint Variables ...................................................................................................................................................... 10 
4.2.5 
Subgroup Analysis ....................................................................................................................................................... 10 
4.2.6 
Adverse Events (AE) ..................................................................................................................................................... 10 
5.0 
STATISTICAL METHODS ............................................................................................................................................. 11 
5.1 
SOFTWARE .......................................................................................................................................................................... 11 
5.2 
GENERAL CONSIDERATIONS .................................................................................................................................................... 11 
5.2.1 
Listings ........................................................................................................................................................................ 11 
5.2.2 
Descriptive Statistics and Summary Tables ................................................................................................................. 11 
5.3 
ENDPOINT DATA ANALYSIS METHODS ...................................................................................................................................... 11 
5.3.1 
Primary Endpoint ........................................................................................................................................................ 11 
5.3.2 
IVC App PR Reporting Rate .......................................................................................................................................... 12 
6.0 
BACKGROUND, SAMPLE SIZE ..................................................................................................................................... 12 
6.1 
POWER ANALYSIS METHODOLOGY ........................................................................................................................................... 12 
6.2 
POWER ANALYSIS FOR SAMPLE SIZE ......................................................................................................................................... 13 
6.3 
SAFETY ANALYSIS.................................................................................................................................................................. 15 
6.4 
EXPLORATORY ANALYSES ....................................................................................................................................................... 15 
7.0 
REFERENCES .............................................................................................................................................................. 15 
 

DOCUMENT VERSION: 3 
THIS DOCUMENT SUPERSEDES VERSION: 2 
PAGE: 
7 OF 15 
STATUS: 
 
Active  
TITLE: 
 
Informed Vital Core - Statistical Analysis Plan 
IDENTIFICATION: 
 
IVC-400-006d 
EFFECTIVE DATE: 
 
June 22, 2023 
AUTHOR: 
 
Chris Joslin 
APPROVED BY: 
 
Mark Whitehouse 
 
 
Confidential – Mindset Medical, LLC 
Do not distribute without permission.  
 
1.0 Introduction 
This documentation describes the planned data analyses for clinical study IVC-400-006 sponsored by 
Mindset Medical, LLC.  
 
This SAP supersedes the statistical considerations identified in the protocol; where considerations are 
substantially different, and these differences will be identified. If additional analyses are required to 
supplement objectives described in the SAP, they may be performed and will be identified in the Clinical 
Study Report (CSR) or through an SAP addendum (as warranted). 
 
Analyses described in the current SAP version is based on the protocol version 1 IVC-400-006 dated March 
31, 2023. 
 
 
2.0 Study Objectives and Endpoints 
2.1 Study Objective 
The primary objective of the study is to establish that pulse rate (PR) measured with the IVC App are accurate 
to within +/- 3 BPM ARMS (average root mean square) of Heart Rate (HR) measured with the reference ECG 
device.  
 
2.1.1 Primary Endpoint 
The primary endpoint is a non-inferiority comparison to an FDA approved reference device to establish that 
PR measured with the IVC App are accurate to an ARMS of +/- 3 BPM. In accordance with ISO 80601-2-
61:2017(E) accuracy will be calculated as the RMS difference between the IVC App and the heart rate 
measured by the ECG reference device. 
 
3.0 Study Hypothesis 
The IVC App can measure pulse rate between 50 and 130 BPM to an accuracy of +/-3 BPM average RMS. The 
hypothesis will be tested in a non-inferiority design. PR will be collected simultaneously with the IVC App 
and HR with an ECG reference device, and the ARMS and its 95% confidence interval calculated. If the upper 
limit of the 95% confidence interval of the ARMS is < 3.0, the IVC App will be determined to be non-inferior 
and the hypothesis that it is accurate to an ARMS of +/- 3.0 accepted. 
 
4.0 Statistical and Analytical Procedures 
4.1 Analysis Populations and Collection Groups 
The following populations will be considered for the study: 
 
4.1.1 All-Enrolled Population 
The All-Enrolled population will be defined as all subjects who signed the ICF. The number of screen failures 
and the reasons for failure will be tabulated and reported. Subjects who consent but withdraw before data 
collection will be tabulated and reported. 
 

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Informed Vital Core - Statistical Analysis Plan 
IDENTIFICATION: 
 
IVC-400-006d 
EFFECTIVE DATE: 
 
June 22, 2023 
AUTHOR: 
 
Chris Joslin 
APPROVED BY: 
 
Mark Whitehouse 
 
 
Confidential – Mindset Medical, LLC 
Do not distribute without permission.  
 
4.1.2 Intent-to-Capture Population (ITC) 
The Intent-to-Capture (ITC) population will be defined as all consented subjects who passed screening and 
completed at least one data collection session without withdrawing.  
 
4.1.3 Per-Protocol Population (PP) 
In order to compare devices, subjects must have a simultaneous PR measurement from the IVC App and an 
HR measurement from the reference ECG device. Therefore, the Per Protocol analysis group for the primary 
endpoint will consist of subjects from whom PR measurement from the IVC App and a successful HR data 
collection from the ECG reference device were collected during the same window.   
 
In preliminary testing of the ECG reference device, not all collections produced a rhythm strip suitable for 
analysis. The ECG data are processed after the subject’s participation in the study ends, so there is no way 
to detect an unusable ECG collection during the study. In order to increase the likelihood of collecting usable 
ECG data, two sessions will be collected from each subject. 
 
Subjects will be asked to collect up to 3 additional sessions as technical fallbacks if a collection failure occurs 
from the reference device or if conditions at the study site interfere with the functionality of the IVC App. 
Examples of technical difficulties include, but are not limited to, frozen or stuttering video during data 
capture, failure of the reference device to produce a rhythm strip, connection issues with the reference 
device,  interruptions during data collection that require the subject to leave the camera frame, or upload 
failures. 
 
4.1.4 Successful Data Collection 
ECG rhythm analysis will be performed and calculated using a synchronized moving average across 12-RR 
intervals as described in IVC-400-006i – Informed Vital Core Heart Rate Rhythm Analysis Procedure. A 
successful data collection is defined as a session that produces a measurement from the IVC App and the 
ECG reference device where the moving average of the HR measurement from the reference device does 
not vary by more than 15 BPM during the 1 minute of measurement. A 15 BPM threshold is applied to the 
ECG data because variability in contact with the electrodes, subject movement, or atypical ECG waveforms 
can result in processing artifacts that appear as unrealistically large jumps or fluctuations in HR during the 
session. In instances where the reference HR is found to vary by more than 15 BPM, the second data 
collection session will be used for analysis.  
 
The second session will not be treated as a fallback for the IVC App. The study is designed to represent a 
patient encounter with the IVC App.  Under the intended use, if the IVC App cannot collect video from which 
a PR can be determined after prompts to stop moving or improve lighting, patients are instructed to retry 
up to twice.  If the HR collection with the ECG reference device is successful but the IVC App does not produce 
a PR, the subject will be excluded from the PP analysis group and considered to be an IVC App collection 
failure.  
 
All subjects in the ITC group who were not included in the PP group will be listed with the reason they were 
excluded from the analysis. Subjects will be excluded if the reference device does not collect data, the ECG 

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Informed Vital Core - Statistical Analysis Plan 
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IVC-400-006d 
EFFECTIVE DATE: 
 
June 22, 2023 
AUTHOR: 
 
Chris Joslin 
APPROVED BY: 
 
Mark Whitehouse 
 
 
Confidential – Mindset Medical, LLC 
Do not distribute without permission.  
 
from both reference device collections is not suitable for rhythm analysis as defined above, or the IVC App 
does not report a PR during the first session where the ECG collection is successful.  
 
A subject could withdraw before all data collection attempts and technical fallbacks are completed. If the 
subject has a successful collection, they will still be included in the PP group. Otherwise, they will be excluded 
from the PP group. If they completed an IVC App collection without a reference HR, that collection will be 
included when calculating the IVC App success rate as described in section 5.3.2. 
 
4.1.5 Data Collection Groups 
Simultaneous data collection from the ECG reference device and IVC App device will be performed on all 
subjects so there is only one data collection group. 
 
4.2 Analysis Variables 
4.2.1 Subject’s Disposition and Analysis Sets 
Disposition will be summarized descriptively with counts and percentages using the All-Enrolled population 
for both devices (IVC App and reference device) data collection and all Intent to Collect and all Per Protocol 
subjects. The number and percentage of subjects who prematurely discontinued from the study along with 
reasons for study discontinuation will be summarized as well. 
 
A subject’s eligibility with inclusion/exclusion criteria failed/met will be listed, along with the list of protocol 
deviations.  
 
4.2.2 Demographics and Baseline Characteristics 
Demographic data and baseline characteristics will include: 
• Sex 
• Ethnicity 
• Race 
• Fitzpatrick scale- Fitzpatrick scale skin tones will be grouped into light (Fitzpatrick 1 and 2), medium 
(Fitzpatrick 3 and 4) and dark (Fitzpatrick 5 and 6). 
• Age (years) 
• Height (cm) 
• Weight (kg) 
• BMI (kg/m2) 
 
Demographics and baseline characteristics will be tabulated and summarized as described in section 5.2.2.   
 
The summary results will be based on the ITC population. 
 
4.2.3 Health Conditions and Concomitant Medications 
Self-reported health conditions will be coded using MedDRA,  tabulated and reported. 
 
Concomitant medications will be coded with WHODrug, tabulated, and reported. 

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TITLE: 
 
Informed Vital Core - Statistical Analysis Plan 
IDENTIFICATION: 
 
IVC-400-006d 
EFFECTIVE DATE: 
 
June 22, 2023 
AUTHOR: 
 
Chris Joslin 
APPROVED BY: 
 
Mark Whitehouse 
 
 
Confidential – Mindset Medical, LLC 
Do not distribute without permission.  
 
 
The summary results will be based on the ITC population. 
 
4.2.4 Endpoint Variables 
The endpoint variables are the IVC App PR and ECG reference device HR. 
 
Summary statistics of the HR and PR measured for each device within the PP group will be tabulated and 
reported as described in section 5.2.2. 
 
Subjects in the PP group will be tabulated by IVC App PR in groups of 10 bpm and the number of subjects 
and percentages in each pulse rate group reported. 
 
4.2.5 Subgroup Analysis  
No subgroup analyses will be performed, since the study is not powered or sized for subgroup analysis. 
 
4.2.6 Adverse Events (AE) 
While adverse events are not anticipated in this clinical study, if the reason for removal of a subject from the 
study is an adverse event, the event will be recorded on the appropriate eCRF(s) and will be reported to 
Mindset Medical per the AE reporting guidelines (Required Reporting Timelines per Regulatory Guidance). 
All efforts will be made to follow the subject until the condition resolves, or the Investigator determines that 
the subject's health has returned to an acceptable state.   
 
All verbatim AE terms will be coded using the Medical Dictionary for Regulatory Activities (MedDRA) of the 
latest version and summarized by system organ class (SOC) and preferred term (PT).  
 
An Unanticipated Adverse Device Effect (UADE) is "any serious" adverse effect on health or safety or any life-
threatening problem or death caused by, or associated with, a device, if that effect, problem, or death was 
not previously identified in any nature, severity, or degree of incidence in the investigational plan or any 
other unanticipated serious problem associated with a device that relates to the rights, safety, and welfare 
of subjects.  
 
All Life-Threatening AEs will be considered as Severe. 
 
All AEs will be classified in one of two types of relation to device: 
• Not Related 
• Related (Definitely Related and Possibly Related) 
 
AEs in the ITC population will be tabulated and summarized by type, severity, and MedDRA codes as 
described in section 5.2.2.  
 

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TITLE: 
 
Informed Vital Core - Statistical Analysis Plan 
IDENTIFICATION: 
 
IVC-400-006d 
EFFECTIVE DATE: 
 
June 22, 2023 
AUTHOR: 
 
Chris Joslin 
APPROVED BY: 
 
Mark Whitehouse 
 
 
Confidential – Mindset Medical, LLC 
Do not distribute without permission.  
 
5.0 Statistical Methods 
5.1 Software 
The primary endpoint analyses will be performed using CRAN R Version 4.3.0 or higher using the boot 
package version 1.3-28.1 or above. Tables and listings will be produced using R and SAS version 9.4 (SAS 
Institute Inc.) 
 
5.2 General Considerations  
 
5.2.1 Listings 
All study data will be included in the study data listings. Both the captured data and the MedDRA and 
WHODrug codes will be provided. Listings will be displayed by subject in chronological order, if not stated 
otherwise. 
Study data will be provided in electronic format, either as SAS XPT V5 files or CSV files. 
 
5.2.2 Descriptive Statistics and Summary Tables 
The total number of subjects in the study group (N) under the stated population will be displayed in the 
header of summary tables. 
 
For age, height, weight, and BMI, the mean, standard deviation, minimum and maximum will be presented 
along with the n size from which the statistics were calculated.  
 
PR and HR data will be presented as median, lower, and upper quartiles, min, max, and n size because they 
were not normally distributed in product development data (5.1.4). 
 
For categorical variables, count, and percentage of subjects/counts in each device group and/or category 
will be presented. Percentages will be based on number of subjects with non-missing values, if not specified 
otherwise. 
 
5.3 Endpoint Data Analysis Methods 
5.3.1 Primary Endpoint  
For the primary endpoint analysis, the ARMS will be calculated as the square root of the mean difference 
between the devices, as described in ISO 80601-2-61:2017(E). All PP subjects will be included in the primary 
endpoint analysis. The 95% CI for the primary endpoint analysis will be determined by jackknifing 100,000 
samples with replacement and calculating a 95% CI from the distribution of ARMS among the jackknifed 
samples. If the ARMS and its upper 95% confidence interval are below the target of 3.0, the device will be 
determined to be non-inferior.  

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TITLE: 
 
Informed Vital Core - Statistical Analysis Plan 
IDENTIFICATION: 
 
IVC-400-006d 
EFFECTIVE DATE: 
 
June 22, 2023 
AUTHOR: 
 
Chris Joslin 
APPROVED BY: 
 
Mark Whitehouse 
 
 
Confidential – Mindset Medical, LLC 
Do not distribute without permission.  
 
 
A Bland-Altman plot will be constructed from the differences vs. the average measured PRs and HRs for all 
PP subjects to assist in visualizing the differences between devices and the full range of PR and HR 
measurements. Since the differences were not normally distributed due to the “white coat” effect on PR in 
the product development data, upper and lower 95th percentiles will be drawn on the graph to aid in 
visualization rather than two standard deviations. Visible outliers with greater than +/- 6.0 BPM difference 
from the reference device will be tabulated. A threshold of +/- 6.0 BPM will be considered outlying because 
under a labelled ARMS of +/- 3.0, 95% of the differences should fall in the range of +/- 6.0 BPM against the 
reference.    
 
5.3.2 IVC App PR Reporting Rate 
The overall PR reporting rate of the IVC App will be calculated from the ITC population. All subjects with an 
IVC App PR from the first non-fallback session will be counted as IVC App collections. The total count of 
subjects with IVC App collections will be divided by the count of subjects in the ITC group to calculate the 
overall PR reporting rate for the IVC App. 
 
A second rate will be calculated as above, only excluding subjects who had no IVC App sessions collected due 
to repeated technical failures. The second rate reflects the proportion of subjects who were able to use the 
IVC App and is more reflective of proportion of sessions where a reliable PR can be determined from the 
analyzed video frames. The number of subjects excluded due to technical failures will also be reported. 
6.0 BACKGROUND, SAMPLE SIZE  
6.1 Power Analysis Methodology 
Power analysis and enrollment percentages for the PR measures were based on data collected from 571 
consented subjects who attempted one or more simultaneous data collections from a Masimo MightySat 
fingertip PPG device (reference device) and the IVC App. The data collection rate across the 571 subjects was 
used to determine how many subjects to enroll in order to meet the target n size for the non-inferiority 
analysis. Collection success defined as a successful data collection from the IVC App was 80.5% (95% CI of 
79% - 82%). 
 
The measured PRs from both the reference device and the IVC App had a high kurtosis, as did the differences 
between devices. Data were also not Box-Cox normal, so they were treated as nonparametric. Deviation from 
a normal distribution has previously been observed in measured PR during studies and is attributed to a 
“white coat” phenomenon, with people who have higher 24-hour resting heart rates showing a more 
pronounced increase (1). 
 
Under the assumption that the IVC App is non-inferior to the reference device, at 90% power the upper 
bound of the bootstrapped 95% CI should fall below 3.0, 90% of the time. Subsampling the differences 
between the devices at systematically varied n sizes and calculating an ARMS and its 95% CI on each 
subsample gives a distribution of 95% confidence intervals for each n size. The distribution of confidence 

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TITLE: 
 
Informed Vital Core - Statistical Analysis Plan 
IDENTIFICATION: 
 
IVC-400-006d 
EFFECTIVE DATE: 
 
June 22, 2023 
AUTHOR: 
 
Chris Joslin 
APPROVED BY: 
 
Mark Whitehouse 
 
 
Confidential – Mindset Medical, LLC 
Do not distribute without permission.  
 
intervals is used to determine power at that n size. Since the distribution of differences was nonparametric, 
95% CI distributions were bagged (bootstrap aggregated). The bagging procedure was performed as follows: 
1. A cohort of 475 or 484 subjects with one paired PR measurement each was established as described 
later. 
2. Random subsamples with replacement were selected from the cohort at n sizes from 20 to 100 in 
intervals of 5. For each n size, 4,000 subsamples were generated. 
3. The 95% confidence interval on the Arms was bootstrapped on each subsample by jackknifing with 
replacement 2,000 times. 
4. The 95% confidence interval upper bounds were aggregated for each n size to produce a distribution 
of upper 95% confidence intervals. 
5. 90th and 95th percentiles were calculated to find the power at each n size.  
 
6.2 Power Analysis for Sample Size 
A total of 85 subjects (n = 85) will be enrolled.   
 
Figure 1. Power analysis workflow. The first sessions were selected as representative of the study design for the initial power 
analysis (left). A second set of sessions with the largest difference from the reference device were used in a conservative scenario 
(right). 
 
A total of 475 subjects out of the 571 in the product development cohort had data collected the IVC App in 
from the first PR collection and were included in the initial power analysis. Only the first PR sessions were 
used in order to accurately model the clinical study design, where subjects will have only one IVC App 
collection.  The overall ARMS was 0.9 BPM. The bagging procedure was performed on n sizes ranging from 
20 to 100 subjects (Figure 2). At all n sizes in the analysis, the 95th percentile of the confidence intervals was 
below the target ARMS of 3.0. Thus, n sizes of 20 or greater are powered at 95%.  
 

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STATUS: 
 
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TITLE: 
 
Informed Vital Core - Statistical Analysis Plan 
IDENTIFICATION: 
 
IVC-400-006d 
EFFECTIVE DATE: 
 
June 22, 2023 
AUTHOR: 
 
Chris Joslin 
APPROVED BY: 
 
Mark Whitehouse 
 
 
Confidential – Mindset Medical, LLC 
Do not distribute without permission.  
 
 
 
Figure 2.  Bagging results for sample sizes ranging from 20 to 100. The filled-in squares show the 95th percentile and the open 
circles show the 90th percentile of the upper bound of the confidence intervals. The x-axis shows the sample size of the subsamples 
and the y-axis is the RMS. All 95th percentiles are below the target ARMS of 3.0. 
 
As well as the first IVC App collection attempt used in the power analysis above, some of the subjects 
provided additional data collection sessions under varied conditions for product development. To perform 
a more conservative power analysis, the session with the largest absolute difference from the reference 
device was selected for each subject. The same bagging analysis over 484 “worst case” collections with an 
ARMS of 1.5 BPM showed 90% power with 40 subjects and 95% power with 45 subjects. The conservative 
power analysis was used to establish a PP group goal of 55 subjects to ensure that power is at or above 95%. 
Additionally, a sample size greater than 50 subjects ensures that the sample is likely to be representative of 
the IVC App performance under the Central Limit Theorem. Since the IVC App is designed to report only 
reliable results and inform the user that a PR could not be collected otherwise, not all sessions result in a 
successful PR measurement. As mentioned above, the PR collection rate for the IVC app was 80%, so the 
study will be overenrolled to reach the target PP group size. A total of 85 subjects will be enrolled, allowing 
for screening failures, withdrawals, technical failures, and sessions where the IVC App does not report a PR.  
 
In order to ensure a diverse PP group, the enrollment target for the PP group is 15% in the dark (Fitzpatrick 
5-6) skin tone group. Initially enrollment will be random, but targeted enrollment may be used to meet skin 
tone goals if the dark skin tone PP group is projected to fall below the 15% goal. 
 

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TITLE: 
 
Informed Vital Core - Statistical Analysis Plan 
IDENTIFICATION: 
 
IVC-400-006d 
EFFECTIVE DATE: 
 
June 22, 2023 
AUTHOR: 
 
Chris Joslin 
APPROVED BY: 
 
Mark Whitehouse 
 
 
Confidential – Mindset Medical, LLC 
Do not distribute without permission.  
 
6.3 Safety Analysis 
No safety analysis is planned. The IVC App is a remote device so no device related AEs are anticipated. 
 
6.4 Exploratory Analyses 
All exploratory analyses will be based on ITC and PP populations. 
 
7.0 References 
1) Paolo Palatini, Edoardo Casiglia, Paolo Pauletto, Jan Staessen, Niko Kaciroti and Stevo Julius. Relationship 
of Tachycardia With High Blood Pressure and Metabolic Abnormalities. A Study With Mixture Analysis in 
Three Populations. Hypertension 30:1267–1273 (1997). https://doi.org/10.1161/01.HYP.30.5.1267 

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TITLE: 
 
Rhythm Strip Analysis Procedure for 
IVC-400-006 
IDENTIFICATION: 
 
IVC-400-006i 
EFFECTIVE DATE: 
 
May 30, 2023 
AUTHOR: 
 
Chris Joslin 
APPROVED BY: 
 
Mark Whitehouse 
 
 
Confidential – Mindset Medical, LLC 
Do not distribute without permission. 
 
 
 
 
 
 
 
 
 
Informed Vital Core 
Rhythm Strip Analysis Procedure for IVC-400-006 
 
IVC-400-006i 
Rev. 1 
 
Mindset Medical, LLC 
 
 
 

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Rhythm Strip Analysis Procedure for 
IVC-400-006 
IDENTIFICATION: 
 
IVC-400-006i 
EFFECTIVE DATE: 
 
May 30, 2023 
AUTHOR: 
 
Chris Joslin 
APPROVED BY: 
 
Mark Whitehouse 
 
 
Confidential – Mindset Medical, LLC 
Do not distribute without permission. 
 
Table of Contents 
Contents 
1. 
INTRODUCTION ........................................................................................................................................... 3 
2. 
SCOPE .......................................................................................................................................................... 3 
3. 
REFERENCES ................................................................................................................................................ 3 
4. 
PROCEDURE ................................................................................................................................................. 3 
4.1. 
GENERAL PROCEDURE FOR COLLECTING ECG RHYTHM STRIP XML FILE ..................................................................... 4 
4.2. 
RHYTHM STRIP ANALYSIS OF ELECTROCARDIOGRAM SIGNAL FOR REFERENCE HEART RATE ............................................. 4 
5. 
REFERENCES ................................................................................................................................................ 6 
APPENDIX A – README ....................................................................................................................................... 7 
APPENDIX B – RHYTHM STRIP ANALYSIS VALIDATION.......................................................................................... 8 
 
 
 
 
 

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Rhythm Strip Analysis Procedure for 
IVC-400-006 
IDENTIFICATION: 
 
IVC-400-006i 
EFFECTIVE DATE: 
 
May 30, 2023 
AUTHOR: 
 
Chris Joslin 
APPROVED BY: 
 
Mark Whitehouse 
 
 
Confidential – Mindset Medical, LLC 
Do not distribute without permission. 
 
The Python script has been validated on stable releases of standard publicly available libraries 
and runs in a virtual environment configured from a requirements text file that lists the specific 
packages and versions (Xie, et. al., 2023). Heart rate analysis is performed using the WFDB 
package described in Waveform Database Software Package (WFDB) for Python (version 4.1.0).  
The SHA # will be documented on the Rhythm Strip Analysis Report (RSAR).  Validation of the 
procedure in Section 4.1 and 4.2 will be outlined in Appendix B. 
 
4.1. General Procedure for Collecting ECG Rhythm Strip XML File 
  
1. After the ECG measurement has been collected from the subject per the clinical study 
protocol, the clinical site staff will upload the ECG Rhythm Strip XML File to a shared drive 
per the IVC-400-006g Pulse Rate Clinical Study Site Instruction Guide.  
2. The subject ID will be on the ECG Rhythm Strip XML file and the file will be copied by 
Mindset Medical staff to a file folder on SharePoint. 
3. The Rhythm Strip Analysis Report will be stored on SharePoint.  
4. The ECG Rhythm Strip XML files and Heart Rate Analysis Reports will be stored per 21 CFR 
812.140 (b), (d), and (e) when the trial is complete.   
 
4.2. Rhythm Strip Analysis of Electrocardiogram Signal for Reference Heart Rate 
Steps involved for the Mindset Medical staff in generating the reference heart rate are listed 
below: 
1. Access the ECG Rhythm Strip XML file from the SharePoint folder. 
2. Download the metadata file produced by the IVC App. 
3. Run the Python Script on the XML file and the IVC App metadata file. The script can be 
run from the command line in a Python virtual environment that enforces the version 
control with arguments that point to the ECG XML Rhythm Strip file and the IVC App 
metadata file. The Python script performs the following steps: 
a. Read the ECG Rhythms Strip XML file and return the lead-I signal in millivolts at a 
1 kHz sample rate. 
b. Adjust for the 2.3 second buffer delay added by the Edan SE-301 to synchronize 
timing with the reference device clock. 
c. Apply the WFDB XQRS peak detection algorithm. 
d. Plot and save the ECG signal with peak markers for visual validation.  
e. Compute the moving average heart rate (HR-MA) by using a sliding window of 12 
RR-intervals.  Boundary values are imputed using expanding windows. 
f. Sample the HR-MA at the solution times reported by IVC App metadata and 
average. 

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Rhythm Strip Analysis Procedure for 
IVC-400-006 
IDENTIFICATION: 
 
IVC-400-006i 
EFFECTIVE DATE: 
 
May 30, 2023 
AUTHOR: 
 
Chris Joslin 
APPROVED BY: 
 
Mark Whitehouse 
 
 
Confidential – Mindset Medical, LLC 
Do not distribute without permission. 
 
4. Visual validation of the Rhythm Strip Analysis Report is performed by two Mindset 
Medical reviewers. The first review is the primary reviewer and the second reviewer will 
perform a quality control review.  
a. Discrepancies identified will be documented and reviewed by management for 
inclusion or exclusion in the final analysis.  
5. The result is a single integer value for reference heart rate that is entered into the study 
electronic data capture system. 
Note: The script will warn if there is a timing discrepancy or if the reference range violates the 
study protocol which can be included in the notes field.  
 

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Rhythm Strip Analysis Procedure for 
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IVC-400-006i 
EFFECTIVE DATE: 
 
May 30, 2023 
AUTHOR: 
 
Chris Joslin 
APPROVED BY: 
 
Mark Whitehouse 
 
 
Confidential – Mindset Medical, LLC 
Do not distribute without permission. 
 
5. References 
Xie, C., McCullum, L., Johnson, A., Pollard, T., Gow, B., & Moody, B. (2023). Waveform Database 
Software Package (WFDB) for Python (version 4.1.0). PhysioNet. https://doi.org/10.13026/9njx-
6322 
 
 
 
 
 
 

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Rhythm Strip Analysis Procedure for 
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IDENTIFICATION: 
IVC-400-006i 
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AUTHOR: 
Chris Joslin 
APPROVED BY: 
Mark Whitehouse 
Confidential – Mindset Medical, LLC 
Do not distribute without permission. 
Appendix A – Readme 
•
Create venv with Python 3.9.16
•
pip install -r requirements.txt
•
Run using command below
python edan_se301_ra.py file_name_ecg file_name_ivc timezone_name 
where timezone_name is US/Pacific or US/Mountain etc. Output prints hr reference value and saves ecg 
with annotations as pdf 

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AUTHOR: 
Chris Joslin 
APPROVED BY: 
Mark Whitehouse 
Confidential – Mindset Medical, LLC 
Do not distribute without permission. 
Appendix B – Rhythm Strip Analysis Validation 
To validate the heart rate Rhythm Analysis Procedure for IVC-400-600 using the ECG XML Rhythm 
Strip, ten (10) trial sessions simulating the conditions of the clinical protocol were conducted. 
Validation included following the procedure in Sections 4.1 and 4.2 with 100% accuracy in 
automated peak detection.  
Demonstrated accuracy is evaluated by visual inspection of two reviewers using the annotated 
report generated by the standard script. Though the official implementation allows for 
documented human correction, the validation standard is zero false positive or false negative 
automated classifications.    
Each of these criteria has been successfully met as can be verified in the annotated figures 
included in the appendix. The black signal line reproducing the cardiograph confirms the first 
requirement. Red crosses indicate automated peak detections. If there are corrected false 
positives they would be overlaid with large gray x’s; false negatives corrected by a reviewer would 
be indicated with large blue crosses. The absence of such annotations indicates automated 
accuracy of 100% for this sample. The bottom plot shows the instantaneous heart rate and its 10 
second moving average; blue dots on that MA line show the IVC sample timestamps synchronized 
with ECG demonstrate completion of criteria two.  

Mindset Medical, LLC 
IVC-400-006 
Page 1 of 5 
Listing 16.2.1.1 
Subject Disposition 
All-Enrolled Population 
 
 
ITC = Intent-to-Capture, PP = Per-Protocol 
 
Program name: l_16_2_1_1.sas 
Run Date: 21NOV2023 
Subject 
ID 
Date of 
Informed 
Consent 
Completion or 
Discontinuation 
Date 
Status 
Reason for 
Discontinuation 
ITC 
Population 
PP 
Population 
Reason ITC 
subject is 
excluded 
from PP 
population 
301-001 
02JUN2023 
02JUN2023 
COMPLETED 
 
Yes 
No 
Rhythm strip not uploaded 
301-002 
02JUN2023 
02JUN2023 
COMPLETED 
 
Yes 
Yes 
 
301-003 
09JUN2023 
09JUN2023 
COMPLETED 
 
Yes 
No 
Rhythm strip not uploaded 
301-004 
12JUN2023 
12JUN2023 
COMPLETED 
 
Yes 
Yes 
 
301-005 
13JUN2023 
13JUN2023 
COMPLETED 
 
Yes 
Yes 
 
301-006 
13JUN2023 
13JUN2023 
COMPLETED 
 
Yes 
Yes 
 
301-007 
14JUN2023 
14JUN2023 
DISCONTINUED SCREEN FAILURE No 
No 
 
301-008 
14JUN2023 
14JUN2023 
COMPLETED 
 
Yes 
Yes 
 
301-009 
15JUN2023 
15JUN2023 
COMPLETED 
 
Yes 
Yes 
 
301-010 
16JUN2023 
16JUN2023 
COMPLETED 
 
Yes 
Yes 
 
301-011 
16JUN2023 
16JUN2023 
COMPLETED 
 
Yes 
Yes 
 
301-012 
16JUN2023 
16JUN2023 
COMPLETED 
 
Yes 
Yes 
 
301-013 
20JUN2023 
20JUN2023 
COMPLETED 
 
Yes 
Yes 
 
301-014 
20JUN2023 
20JUN2023 
COMPLETED 
 
Yes 
Yes 
 
301-015 
21JUN2023 
21JUN2023 
COMPLETED 
 
Yes 
Yes 
 
301-016 
21JUN2023 
21JUN2023 
COMPLETED 
 
Yes 
Yes 
 
301-017 
22JUN2023 
22JUN2023 
COMPLETED 
 
Yes 
Yes 
 
301-018 
22JUN2023 
22JUN2023 
COMPLETED 
 
Yes 
Yes 
 
301-019 
22JUN2023 
22JUN2023 
COMPLETED 
 
Yes 
Yes 
 

Mindset Medical, LLC 
IVC-400-006 
Page 2 of 5 
Listing 16.2.1.1 
Subject Disposition 
All-Enrolled Population 
 
 
ITC = Intent-to-Capture, PP = Per-Protocol 
 
Program name: l_16_2_1_1.sas 
Run Date: 21NOV2023 
Subject 
ID 
Date of 
Informed 
Consent 
Completion or 
Discontinuation 
Date 
Status 
Reason for 
Discontinuation 
ITC 
Population 
PP 
Population 
Reason ITC 
subject is 
excluded 
from PP 
population 
301-020 
23JUN2023 
23JUN2023 
COMPLETED 
 
Yes 
No 
Rhythm strip not uploaded 
301-021 
26JUN2023 
26JUN2023 
COMPLETED 
 
Yes 
Yes 
 
301-022 
27JUN2023 
27JUN2023 
COMPLETED 
 
Yes 
Yes 
 
302-001 
02JUN2023 
02JUN2023 
COMPLETED 
 
Yes 
Yes 
 
302-002 
05JUN2023 
05JUN2023 
COMPLETED 
 
Yes 
Yes 
 
302-003 
06JUN2023 
06JUN2023 
COMPLETED 
 
Yes 
Yes 
 
302-004 
07JUN2023 
07JUN2023 
COMPLETED 
 
Yes 
Yes 
 
302-005 
07JUN2023 
07JUN2023 
COMPLETED 
 
Yes 
Yes 
 
302-006 
13JUN2023 
13JUN2023 
COMPLETED 
 
Yes 
Yes 
 
302-007 
14JUN2023 
14JUN2023 
COMPLETED 
 
Yes 
Yes 
 
302-008 
14JUN2023 
14JUN2023 
COMPLETED 
 
Yes 
Yes 
 
302-009 
15JUN2023 
15JUN2023 
COMPLETED 
 
Yes 
Yes 
 
302-010 
15JUN2023 
15JUN2023 
COMPLETED 
 
Yes 
Yes 
 
302-011 
16JUN2023 
16JUN2023 
COMPLETED 
 
Yes 
Yes 
 
302-012 
16JUN2023 
16JUN2023 
COMPLETED 
 
Yes 
Yes 
 
302-013 
20JUN2023 
20JUN2023 
COMPLETED 
 
Yes 
Yes 
 
302-014 
21JUN2023 
21JUN2023 
COMPLETED 
 
Yes 
Yes 
 
302-015 
21JUN2023 
21JUN2023 
COMPLETED 
 
Yes 
No 
Rhythm strip not uploaded 
302-016 
22JUN2023 
22JUN2023 
COMPLETED 
 
Yes 
Yes 
 
302-017 
22JUN2023 
22JUN2023 
COMPLETED 
 
Yes 
Yes 
 

Mindset Medical, LLC 
IVC-400-006 
Page 3 of 5 
Listing 16.2.1.1 
Subject Disposition 
All-Enrolled Population 
 
 
ITC = Intent-to-Capture, PP = Per-Protocol 
 
Program name: l_16_2_1_1.sas 
Run Date: 21NOV2023 
Subject 
ID 
Date of 
Informed 
Consent 
Completion or 
Discontinuation 
Date 
Status 
Reason for 
Discontinuation 
ITC 
Population 
PP 
Population 
Reason ITC 
subject is 
excluded 
from PP 
population 
302-018 
22JUN2023 
22JUN2023 
COMPLETED 
 
Yes 
Yes 
 
302-019 
23JUN2023 
23JUN2023 
COMPLETED 
 
Yes 
Yes 
 
302-020 
27JUN2023 
27JUN2023 
COMPLETED 
 
Yes 
Yes 
 
302-021 
28JUN2023 
28JUN2023 
COMPLETED 
 
Yes 
Yes 
 
304-001 
20JUN2023 
20JUN2023 
COMPLETED 
 
Yes 
Yes 
 
304-002 
20JUN2023 
20JUN2023 
DISCONTINUED PROTOCOL 
DEVIATION 
No 
No 
Rhythm strip not uploaded 
304-003 
21JUN2023 
21JUN2023 
COMPLETED 
 
Yes 
Yes 
 
304-004 
21JUN2023 
21JUN2023 
COMPLETED 
 
Yes 
Yes 
 
304-005 
22JUN2023 
22JUN2023 
COMPLETED 
 
Yes 
Yes 
 
304-006 
22JUN2023 
22JUN2023 
COMPLETED 
 
Yes 
Yes 
 
304-007 
27JUN2023 
27JUN2023 
COMPLETED 
 
Yes 
Yes 
 
304-008 
27JUN2023 
27JUN2023 
COMPLETED 
 
Yes 
Yes 
 
304-009 
27JUN2023 
27JUN2023 
COMPLETED 
 
Yes 
Yes 
 
304-010 
28JUN2023 
28JUN2023 
COMPLETED 
 
Yes 
Yes 
 
304-011 
28JUN2023 
28JUN2023 
COMPLETED 
 
Yes 
Yes 
 
304-012 
28JUN2023 
28JUN2023 
COMPLETED 
 
Yes 
Yes 
 
304-013 
29JUN2023 
29JUN2023 
COMPLETED 
 
Yes 
Yes 
 
305-001 
06JUN2023 
06JUN2023 
COMPLETED 
 
Yes 
No 
Rhythm strip not uploaded 
305-002 
06JUN2023 
06JUN2023 
COMPLETED 
 
Yes 
No 
Rhythm strip not uploaded 
305-003 
08JUN2023 
08JUN2023 
COMPLETED 
 
Yes 
No 
Rhythm strip not uploaded 

Mindset Medical, LLC 
IVC-400-006 
Page 4 of 5 
Listing 16.2.1.1 
Subject Disposition 
All-Enrolled Population 
 
 
ITC = Intent-to-Capture, PP = Per-Protocol 
 
Program name: l_16_2_1_1.sas 
Run Date: 21NOV2023 
Subject 
ID 
Date of 
Informed 
Consent 
Completion or 
Discontinuation 
Date 
Status 
Reason for 
Discontinuation 
ITC 
Population 
PP 
Population 
Reason ITC 
subject is 
excluded 
from PP 
population 
305-004 
09JUN2023 
09JUN2023 
COMPLETED 
 
Yes 
Yes 
 
305-005 
23JUN2023 
23JUN2023 
COMPLETED 
 
Yes 
Yes 
 
305-006 
23JUN2023 
23JUN2023 
COMPLETED 
 
Yes 
No 
Rhythm strip not uploaded 
305-007 
26JUN2023 
26JUN2023 
COMPLETED 
 
Yes 
No 
Rhythm strip not uploaded 
305-008 
26JUN2023 
26JUN2023 
COMPLETED 
 
Yes 
No 
Rhythm strip not uploaded 
305-009 
28JUN2023 
28JUN2023 
COMPLETED 
 
Yes 
Yes 
 
305-010 
29JUN2023 
29JUN2023 
COMPLETED 
 
Yes 
Yes 
 
305-011 
29JUN2023 
29JUN2023 
DISCONTINUED OTHER 
No 
No 
Study closed prior to 
assessment. 
305-012 
29JUN2023 
29JUN2023 
COMPLETED 
 
Yes 
Yes 
 
306-001 
22JUN2023 
22JUN2023 
COMPLETED 
 
Yes 
No 
Rhythm strip not uploaded 
306-002 
22JUN2023 
22JUN2023 
COMPLETED 
 
Yes 
No 
Rhythm strip not uploaded 
306-003 
26JUN2023 
26JUN2023 
COMPLETED 
 
Yes 
Yes 
 
306-004 
26JUN2023 
26JUN2023 
COMPLETED 
 
Yes 
No 
The reference device does not 
collect data 
306-005 
28JUN2023 
28JUN2023 
COMPLETED 
 
Yes 
Yes 
 
306-006 
28JUN2023 
28JUN2023 
COMPLETED 
 
Yes 
Yes 
 
306-007 
29JUN2023 
29JUN2023 
COMPLETED 
 
Yes 
Yes 
 
307-001 
14JUN2023 
14JUN2023 
COMPLETED 
 
Yes 
Yes 
 
307-002 
14JUN2023 
14JUN2023 
COMPLETED 
 
Yes 
Yes 
 
307-003 
22JUN2023 
22JUN2023 
COMPLETED 
 
Yes 
Yes 
 
307-004 
22JUN2023 
22JUN2023 
COMPLETED 
 
Yes 
Yes 
 

Mindset Medical, LLC 
IVC-400-006 
Page 5 of 5 
Listing 16.2.1.1 
Subject Disposition 
All-Enrolled Population 
 
 
ITC = Intent-to-Capture, PP = Per-Protocol 
 
Program name: l_16_2_1_1.sas 
Run Date: 21NOV2023 
Subject 
ID 
Date of 
Informed 
Consent 
Completion or 
Discontinuation 
Date 
Status 
Reason for 
Discontinuation 
ITC 
Population 
PP 
Population 
Reason ITC 
subject is 
excluded 
from PP 
population 
307-005 
22JUN2023 
22JUN2023 
COMPLETED 
 
Yes 
No 
The reference device does not 
collect data 
307-006 
23JUN2023 
23JUN2023 
COMPLETED 
 
Yes 
Yes 
 
307-007 
23JUN2023 
23JUN2023 
DISCONTINUED SCREEN FAILURE No 
No 
 
307-008 
23JUN2023 
23JUN2023 
COMPLETED 
 
Yes 
Yes 
 
307-009 
26JUN2023 
26JUN2023 
COMPLETED 
 
Yes 
Yes 
 
307-010 
26JUN2023 
26JUN2023 
COMPLETED 
 
Yes 
No 
Thumb drive not recognized by 
pixel phone. USB was sent back 
to sponsor for review on 7/20/23 
307-011 
28JUN2023 
28JUN2023 
COMPLETED 
 
Yes 
Yes 
 
 

Mindset Medical, LLC 
IVC-400-006 
Page 1 of 1 
Listing 16.2.1.3 
Protocol Deviation 
All-Enrolled Subjects 
 
 
Program name: l_16_2_1_3.sas 
Run Date: 21NOV2023 
Subject 
ID 
Date of Deviation Type of Deviation Specification for Other 
Brief Description of Deviation 
301-015 
21JUN2023 
Other 
The ECG was conducted but not 
uploaded to the drive 
The first ECG that I performed on the subject was not saved 
due to the disk drive was not in the ecg 
 
302-019 
23JUN2023 
Deviation From 
Protocol Defined 
Procedure 
 
ECG limb leads were inadvertently reversed. 
 
304-002 
20JUN2023 
Deviation From 
Protocol Defined 
Procedure 
 
PR PRO's were not completed per protocol. 
 
305-001 
06JUN2023 
Deviation From 
Protocol Defined 
Procedure 
 
PRO HR data not captured despite multiple attempts and 
2nd visit attempts per PM instructions. 
 
305-002 
06JUN2023 
Deviation From 
Protocol Defined 
Procedure 
 
The second PRO assessment was not completed per protocol 
per PM instruction. 
 
306-001 
22JUN2023 
Deviation From 
Protocol Defined 
Procedure 
 
Leads on ECG were reversed 
 
 
 
 
Less than 2 PROs collected in the mainstudy. 
 
 

Mindset Medical, LLC 
IVC-400-006 
Page 1 of 5 
Listing 16.2.1.2 
Eligibility Criteria 
All-Enrolled Population 
 
 
Program name: l_16_2_1_2.sas 
Run Date: 21NOV2023 
Subject 
ID 
Did the subject meet all the 
inclusion and none of the 
exclusion criteria? 
Criterion Type 
Description 
301-001 
Yes 
 
 
301-002 
Yes 
 
 
301-003 
Yes 
 
 
301-004 
Yes 
 
 
301-005 
Yes 
 
 
301-006 
Yes 
 
 
301-007 
No 
EXCLUSION 
SUBJECTS WITH CARDIAC ARRHYTHMIA 
301-008 
Yes 
 
 
301-009 
Yes 
 
 
301-010 
Yes 
 
 
301-011 
Yes 
 
 
301-012 
Yes 
 
 
301-013 
Yes 
 
 
301-014 
Yes 
 
 
301-015 
Yes 
 
 
301-016 
Yes 
 
 
301-017 
Yes 
 
 
301-018 
Yes 
 
 
301-019 
Yes 
 
 

Mindset Medical, LLC 
IVC-400-006 
Page 2 of 5 
Listing 16.2.1.2 
Eligibility Criteria 
All-Enrolled Population 
 
 
Program name: l_16_2_1_2.sas 
Run Date: 21NOV2023 
Subject 
ID 
Did the subject meet all the 
inclusion and none of the 
exclusion criteria? 
Criterion Type 
Description 
301-020 
Yes 
 
 
301-021 
Yes 
 
 
301-022 
Yes 
 
 
302-001 
Yes 
 
 
302-002 
Yes 
 
 
302-003 
Yes 
 
 
302-004 
Yes 
 
 
302-005 
Yes 
 
 
302-006 
Yes 
 
 
302-007 
Yes 
 
 
302-008 
Yes 
 
 
302-009 
Yes 
 
 
302-010 
Yes 
 
 
302-011 
Yes 
 
 
302-012 
Yes 
 
 
302-013 
Yes 
 
 
302-014 
Yes 
 
 
302-015 
Yes 
 
 
302-016 
Yes 
 
 
302-017 
Yes 
 
 

Mindset Medical, LLC 
IVC-400-006 
Page 3 of 5 
Listing 16.2.1.2 
Eligibility Criteria 
All-Enrolled Population 
 
 
Program name: l_16_2_1_2.sas 
Run Date: 21NOV2023 
Subject 
ID 
Did the subject meet all the 
inclusion and none of the 
exclusion criteria? 
Criterion Type 
Description 
302-018 
Yes 
 
 
302-019 
Yes 
 
 
302-020 
Yes 
 
 
302-021 
Yes 
 
 
304-001 
Yes 
 
 
304-002 
Yes 
 
 
304-003 
Yes 
 
 
304-004 
Yes 
 
 
304-005 
Yes 
 
 
304-006 
Yes 
 
 
304-007 
Yes 
 
 
304-008 
Yes 
 
 
304-009 
Yes 
 
 
304-010 
Yes 
 
 
304-011 
Yes 
 
 
304-012 
Yes 
 
 
304-013 
Yes 
 
 
305-001 
Yes 
 
 
305-002 
Yes 
 
 
305-003 
Yes 
 
 

Mindset Medical, LLC 
IVC-400-006 
Page 4 of 5 
Listing 16.2.1.2 
Eligibility Criteria 
All-Enrolled Population 
 
 
Program name: l_16_2_1_2.sas 
Run Date: 21NOV2023 
Subject 
ID 
Did the subject meet all the 
inclusion and none of the 
exclusion criteria? 
Criterion Type 
Description 
305-004 
Yes 
 
 
305-005 
Yes 
 
 
305-006 
Yes 
 
 
305-007 
Yes 
 
 
305-008 
Yes 
 
 
305-009 
Yes 
 
 
305-010 
Yes 
 
 
305-011 
Yes 
 
 
305-012 
Yes 
 
 
306-001 
Yes 
 
 
306-002 
Yes 
 
 
306-003 
Yes 
 
 
306-004 
Yes 
 
 
306-005 
Yes 
 
 
306-006 
Yes 
 
 
306-007 
Yes 
 
 
307-001 
Yes 
 
 
307-002 
Yes 
 
 
307-003 
Yes 
 
 
307-004 
Yes 
 
 

Mindset Medical, LLC 
IVC-400-006 
Page 5 of 5 
Listing 16.2.1.2 
Eligibility Criteria 
All-Enrolled Population 
 
 
Program name: l_16_2_1_2.sas 
Run Date: 21NOV2023 
Subject 
ID 
Did the subject meet all the 
inclusion and none of the 
exclusion criteria? 
Criterion Type 
Description 
307-005 
Yes 
 
 
307-006 
Yes 
 
 
307-007 
No 
EXCLUSION 
SUBJECTS WITH CARDIAC ARRHYTHMIA 
307-008 
Yes 
 
 
307-009 
Yes 
 
 
307-010 
Yes 
 
 
307-011 
Yes 
 
 
 

Mindset Medical, LLC 
IVC-400-006 
Page 1 of 13 
Listing 16.2.6.1 
IVC App Pulse Rate and ECG Reference Device Heart Rate 
ITC Population 
 
 
ITC = Intent-to-Capture. 
 
Program name: l_16_2_6_1.sas 
Run Date: 21NOV2023 
Subject 
ID 
Session 
Was the 
pulse 
rate taken 
by IVC? 
Reason Pulse 
was Not Taken 
Was ECG 
performed? 
Reason ECG 
was Not 
performed 
Was ECG 
Strip 
Uploaded? 
Reason ECG 
Strip Was 
Not Uploaded 
Reason not 
able to 
Analyze 
Pulse 
Rate (BPM) 
by IVC app 
ECG 
Reference 
Device 
Heart 
Rate (BPM) 
301-001 
1 
No 
App not able 
to measure 
vitals 
Yes 
 
Yes 
 
Null IVC 
solution 
 
 
 
2 
No 
App not able 
to measure 
vitals 
Yes 
 
Yes 
 
Null IVC 
solution 
 
 
301-002 
1 
Yes 
 
Yes 
 
Yes 
 
 
60 
60 
 
2 
Yes 
 
Yes 
 
Yes 
 
 
66 
62 
301-003 
1 
No 
App was not 
able to 
measure 
vitals 
No 
 
Yes 
 
 
 
 
 
2 
No 
App was not 
able to 
measure 
vitals 
No 
 
Yes 
 
 
 
 
301-004 
1 
Yes 
 
Yes 
 
Yes 
 
 
69 
69 
 
2 
Yes 
 
Yes 
 
Yes 
 
 
67 
68 
301-005 
1 
Yes 
 
Yes 
 
Yes 
 
 
57 
58 
 
2 
Yes 
 
Yes 
 
Yes 
 
 
57 
57 
301-006 
1 
Yes 
 
Yes 
 
Yes 
 
 
69 
69 
 
2 
Yes 
 
Yes 
 
Yes 
 
 
66 
66 

Mindset Medical, LLC 
IVC-400-006 
Page 2 of 13 
Listing 16.2.6.1 
IVC App Pulse Rate and ECG Reference Device Heart Rate 
ITC Population 
 
 
ITC = Intent-to-Capture. 
 
Program name: l_16_2_6_1.sas 
Run Date: 21NOV2023 
Subject 
ID 
Session 
Was the 
pulse 
rate taken 
by IVC? 
Reason Pulse 
was Not Taken 
Was ECG 
performed? 
Reason ECG 
was Not 
performed 
Was ECG 
Strip 
Uploaded? 
Reason ECG 
Strip Was 
Not Uploaded 
Reason not 
able to 
Analyze 
Pulse 
Rate (BPM) 
by IVC app 
ECG 
Reference 
Device 
Heart 
Rate (BPM) 
301-008 
1 
Yes 
 
Yes 
 
Yes 
 
 
67 
67 
 
2 
Yes 
 
Yes 
 
Yes 
 
 
68 
69 
301-009 
1 
Yes 
 
Yes 
 
Yes 
 
 
71 
70 
 
2 
Yes 
 
Yes 
 
Yes 
 
 
71 
71 
301-010 
1 
Yes 
 
Yes 
 
Yes 
 
 
81 
81 
 
2 
Yes 
 
Yes 
 
Yes 
 
 
79 
78 
301-011 
1 
Yes 
 
Yes 
 
Yes 
 
 
64 
65 
 
2 
Yes 
 
Yes 
 
Yes 
 
 
60 
61 
301-012 
1 
Yes 
 
Yes 
 
Yes 
 
 
76 
77 
 
2 
Yes 
 
Yes 
 
Yes 
 
 
78 
78 
301-013 
1 
Yes 
 
Yes 
 
Yes 
 
 
72 
72 
 
2 
Yes 
 
Yes 
 
Yes 
 
 
73 
74 
301-014 
1 
Yes 
 
Yes 
 
Yes 
 
 
67 
67 

Mindset Medical, LLC 
IVC-400-006 
Page 3 of 13 
Listing 16.2.6.1 
IVC App Pulse Rate and ECG Reference Device Heart Rate 
ITC Population 
 
 
ITC = Intent-to-Capture. 
 
Program name: l_16_2_6_1.sas 
Run Date: 21NOV2023 
Subject 
ID 
Session 
Was the 
pulse 
rate taken 
by IVC? 
Reason Pulse 
was Not Taken 
Was ECG 
performed? 
Reason ECG 
was Not 
performed 
Was ECG 
Strip 
Uploaded? 
Reason ECG 
Strip Was 
Not Uploaded 
Reason not 
able to 
Analyze 
Pulse 
Rate (BPM) 
by IVC app 
ECG 
Reference 
Device 
Heart 
Rate (BPM) 
301-014 
2 
Yes 
 
Yes 
 
Yes 
 
 
68 
69 
301-015 
1 
Yes 
 
No 
 
Yes 
 
 
70 
 
 
2 
Yes 
 
Yes 
 
Yes 
 
 
67 
66 
301-016 
1 
Yes 
 
Yes 
 
Yes 
 
 
73 
73 
 
2 
Yes 
 
Yes 
 
Yes 
 
 
73 
73 
301-017 
1 
Yes 
 
Yes 
 
Yes 
 
 
84 
83 
 
2 
Yes 
 
Yes 
 
Yes 
 
 
83 
83 
301-018 
1 
Yes 
 
Yes 
 
Yes 
 
 
67 
67 
 
2 
Yes 
 
Yes 
 
Yes 
 
 
67 
67 
301-019 
1 
Yes 
 
Yes 
 
Yes 
 
 
60 
60 
 
2 
Yes 
 
Yes 
 
Yes 
 
 
60 
60 
301-020 
1 
No 
App not able 
to measure 
vitals 
Yes 
 
Yes 
 
Null IVC 
solution 
 
 
 
2 
No 
App not able 
to measure 
vitals 
Yes 
 
Yes 
 
Null IVC 
solution 
 
 
301-021 
1 
Yes 
 
Yes 
 
Yes 
 
 
54 
53 

Mindset Medical, LLC 
IVC-400-006 
Page 4 of 13 
Listing 16.2.6.1 
IVC App Pulse Rate and ECG Reference Device Heart Rate 
ITC Population 
 
 
ITC = Intent-to-Capture. 
 
Program name: l_16_2_6_1.sas 
Run Date: 21NOV2023 
Subject 
ID 
Session 
Was the 
pulse 
rate taken 
by IVC? 
Reason Pulse 
was Not Taken 
Was ECG 
performed? 
Reason ECG 
was Not 
performed 
Was ECG 
Strip 
Uploaded? 
Reason ECG 
Strip Was 
Not Uploaded 
Reason not 
able to 
Analyze 
Pulse 
Rate (BPM) 
by IVC app 
ECG 
Reference 
Device 
Heart 
Rate (BPM) 
301-021 
2 
Yes 
 
Yes 
 
Yes 
 
 
53 
53 
301-022 
1 
Yes 
 
Yes 
 
Yes 
 
 
61 
61 
 
2 
Yes 
 
Yes 
 
Yes 
 
 
64 
63 
302-001 
1 
Yes 
 
Yes 
 
Yes 
 
 
80 
80 
 
2 
Yes 
 
Yes 
 
Yes 
 
 
79 
79 
302-002 
1 
Yes 
 
Yes 
 
Yes 
 
 
81 
80 
 
2 
Yes 
 
Yes 
 
Yes 
 
 
80 
79 
302-003 
1 
Yes 
 
Yes 
 
Yes 
 
 
65 
67 
 
2 
Yes 
 
Yes 
 
Yes 
 
 
68 
68 
302-004 
1 
Yes 
 
Yes 
 
Yes 
 
 
60 
61 
 
2 
Yes 
 
Yes 
 
Yes 
 
 
61 
62 
302-005 
1 
Yes 
 
Yes 
 
Yes 
 
 
69 
69 
 
2 
Yes 
 
Yes 
 
Yes 
 
 
69 
69 
302-006 
1 
Yes 
 
Yes 
 
Yes 
 
 
78 
79 

Mindset Medical, LLC 
IVC-400-006 
Page 5 of 13 
Listing 16.2.6.1 
IVC App Pulse Rate and ECG Reference Device Heart Rate 
ITC Population 
 
 
ITC = Intent-to-Capture. 
 
Program name: l_16_2_6_1.sas 
Run Date: 21NOV2023 
Subject 
ID 
Session 
Was the 
pulse 
rate taken 
by IVC? 
Reason Pulse 
was Not Taken 
Was ECG 
performed? 
Reason ECG 
was Not 
performed 
Was ECG 
Strip 
Uploaded? 
Reason ECG 
Strip Was 
Not Uploaded 
Reason not 
able to 
Analyze 
Pulse 
Rate (BPM) 
by IVC app 
ECG 
Reference 
Device 
Heart 
Rate (BPM) 
302-006 
2 
Yes 
 
Yes 
 
Yes 
 
 
78 
78 
302-007 
1 
Yes 
 
Yes 
 
Yes 
 
 
64 
64 
 
2 
Yes 
 
Yes 
 
Yes 
 
 
64 
64 
302-008 
1 
Yes 
 
Yes 
 
Yes 
 
 
53 
54 
 
2 
Yes 
 
Yes 
 
Yes 
 
 
55 
55 
302-009 
1 
Yes 
 
Yes 
 
Yes 
 
 
53 
53 
 
2 
Yes 
 
Yes 
 
Yes 
 
 
53 
53 
302-010 
1 
Yes 
 
Yes 
 
Yes 
 
 
57 
57 
 
2 
Yes 
 
Yes 
 
Yes 
 
 
54 
55 
302-011 
1 
Yes 
 
Yes 
 
Yes 
 
 
67 
68 
 
2 
Yes 
 
Yes 
 
Yes 
 
 
71 
70 
302-012 
1 
Yes 
 
Yes 
 
Yes 
 
 
64 
64 
 
2 
Yes 
 
Yes 
 
Yes 
 
 
64 
64 
302-013 
1 
Yes 
 
Yes 
 
Yes 
 
 
75 
75 

Mindset Medical, LLC 
IVC-400-006 
Page 6 of 13 
Listing 16.2.6.1 
IVC App Pulse Rate and ECG Reference Device Heart Rate 
ITC Population 
 
 
ITC = Intent-to-Capture. 
 
Program name: l_16_2_6_1.sas 
Run Date: 21NOV2023 
Subject 
ID 
Session 
Was the 
pulse 
rate taken 
by IVC? 
Reason Pulse 
was Not Taken 
Was ECG 
performed? 
Reason ECG 
was Not 
performed 
Was ECG 
Strip 
Uploaded? 
Reason ECG 
Strip Was 
Not Uploaded 
Reason not 
able to 
Analyze 
Pulse 
Rate (BPM) 
by IVC app 
ECG 
Reference 
Device 
Heart 
Rate (BPM) 
302-013 
2 
Yes 
 
Yes 
 
Yes 
 
 
75 
75 
302-014 
1 
Yes 
 
Yes 
 
Yes 
 
 
76 
76 
 
2 
Yes 
 
Yes 
 
Yes 
 
 
78 
78 
302-015 
1 
No 
App not able 
to measure 
vitals 
Yes 
 
Yes 
 
null IVC 
solution 
 
 
 
2 
No 
App not able 
to measure 
vitals 
Yes 
 
Yes 
 
null IVC 
solution 
 
 
302-016 
1 
Yes 
 
Yes 
 
Yes 
 
 
60 
60 
 
2 
Yes 
 
Yes 
 
Yes 
 
 
61 
61 
302-017 
1 
Yes 
 
Yes 
 
Yes 
 
 
86 
87 
 
2 
Yes 
 
Yes 
 
Yes 
 
 
87 
87 
302-018 
1 
Yes 
 
Yes 
 
Yes 
 
 
103 
103 
 
2 
Yes 
 
No 
 
Yes 
 
 
105 
 
302-019 
1 
Yes 
 
Yes 
 
Yes 
 
 
50 
50 
 
2 
Yes 
 
Yes 
 
Yes 
 
 
50 
50 
302-020 
1 
Yes 
 
Yes 
 
Yes 
 
 
85 
84 

Mindset Medical, LLC 
IVC-400-006 
Page 7 of 13 
Listing 16.2.6.1 
IVC App Pulse Rate and ECG Reference Device Heart Rate 
ITC Population 
 
 
ITC = Intent-to-Capture. 
 
Program name: l_16_2_6_1.sas 
Run Date: 21NOV2023 
Subject 
ID 
Session 
Was the 
pulse 
rate taken 
by IVC? 
Reason Pulse 
was Not Taken 
Was ECG 
performed? 
Reason ECG 
was Not 
performed 
Was ECG 
Strip 
Uploaded? 
Reason ECG 
Strip Was 
Not Uploaded 
Reason not 
able to 
Analyze 
Pulse 
Rate (BPM) 
by IVC app 
ECG 
Reference 
Device 
Heart 
Rate (BPM) 
302-020 
2 
Yes 
 
Yes 
 
Yes 
 
 
82 
83 
302-021 
1 
Yes 
 
Yes 
 
Yes 
 
 
74 
75 
 
2 
Yes 
 
Yes 
 
Yes 
 
 
78 
79 
304-001 
1 
Yes 
 
Yes 
 
Yes 
 
 
67 
68 
 
2 
Yes 
 
Yes 
 
Yes 
 
 
71 
70 
304-003 
1 
Yes 
 
Yes 
 
Yes 
 
 
53 
53 
 
2 
Yes 
 
Yes 
 
Yes 
 
 
53 
52 
304-004 
1 
Yes 
 
Yes 
 
Yes 
 
 
96 
95 
 
2 
Yes 
 
Yes 
 
Yes 
 
 
96 
96 
304-005 
1 
Yes 
 
Yes 
 
Yes 
 
 
71 
70 
 
2 
Yes 
 
Yes 
 
Yes 
 
 
71 
70 
304-006 
1 
Yes 
 
Yes 
 
Yes 
 
 
78 
79 

Mindset Medical, LLC 
IVC-400-006 
Page 8 of 13 
Listing 16.2.6.1 
IVC App Pulse Rate and ECG Reference Device Heart Rate 
ITC Population 
 
 
ITC = Intent-to-Capture. 
 
Program name: l_16_2_6_1.sas 
Run Date: 21NOV2023 
Subject 
ID 
Session 
Was the 
pulse 
rate taken 
by IVC? 
Reason Pulse 
was Not Taken 
Was ECG 
performed? 
Reason ECG 
was Not 
performed 
Was ECG 
Strip 
Uploaded? 
Reason ECG 
Strip Was 
Not Uploaded 
Reason not 
able to 
Analyze 
Pulse 
Rate (BPM) 
by IVC app 
ECG 
Reference 
Device 
Heart 
Rate (BPM) 
304-006 
2 
Yes 
 
Yes 
 
Yes 
 
 
78 
78 
304-007 
1 
Yes 
 
Yes 
 
Yes 
 
 
68 
69 
 
2 
Yes 
 
Yes 
 
Yes 
 
 
74 
73 
304-008 
1 
Yes 
 
Yes 
 
Yes 
 
 
74 
73 
 
2 
Yes 
 
Yes 
 
Yes 
 
 
75 
75 
304-009 
1 
Yes 
 
Yes 
 
Yes 
 
 
78 
79 
 
2 
Yes 
 
Yes 
 
Yes 
 
 
78 
77 
304-010 
1 
Yes 
 
Yes 
 
Yes 
 
 
67 
67 
 
2 
Yes 
 
Yes 
 
Yes 
 
 
67 
67 
304-011 
1 
Yes 
 
Yes 
 
Yes 
 
 
75 
74 
 
2 
Yes 
 
Yes 
 
Yes 
 
 
74 
74 
304-012 
1 
Yes 
 
Yes 
 
Yes 
 
 
71 
70 
 
2 
Yes 
 
Yes 
 
Yes 
 
 
68 
69 
304-013 
1 
Yes 
 
Yes 
 
Yes 
 
 
71 
70 

Mindset Medical, LLC 
IVC-400-006 
Page 9 of 13 
Listing 16.2.6.1 
IVC App Pulse Rate and ECG Reference Device Heart Rate 
ITC Population 
 
 
ITC = Intent-to-Capture. 
 
Program name: l_16_2_6_1.sas 
Run Date: 21NOV2023 
Subject 
ID 
Session 
Was the 
pulse 
rate taken 
by IVC? 
Reason Pulse 
was Not Taken 
Was ECG 
performed? 
Reason ECG 
was Not 
performed 
Was ECG 
Strip 
Uploaded? 
Reason ECG 
Strip Was 
Not Uploaded 
Reason not 
able to 
Analyze 
Pulse 
Rate (BPM) 
by IVC app 
ECG 
Reference 
Device 
Heart 
Rate (BPM) 
304-013 
2 
Yes 
 
Yes 
 
Yes 
 
 
73 
72 
305-001 
1 
No 
app unable to 
measure 
Yes 
 
Yes 
 
Null IVC 
solution 
 
 
 
2 
No 
app unable to 
measure 
No 
 
Yes 
 
 
 
 
305-002 
1 
No 
app not able 
to measure 
Yes 
 
Yes 
 
Null IVC 
solution 
 
 
 
2 
No 
The second PRO 
assessment 
was not 
completed per 
protocol per 
PM 
instruction. 
No 
 
Yes 
 
 
 
 
305-003 
1 
No 
App not able 
to measure 
vitals. 
No 
 
Yes 
 
 
 
 
 
2 
No 
App not able 
to measure 
vitals. 
No 
 
Yes 
 
 
 
 

Mindset Medical, LLC 
IVC-400-006 
Page 10 of 13 
Listing 16.2.6.1 
IVC App Pulse Rate and ECG Reference Device Heart Rate 
ITC Population 
 
 
ITC = Intent-to-Capture. 
 
Program name: l_16_2_6_1.sas 
Run Date: 21NOV2023 
Subject 
ID 
Session 
Was the 
pulse 
rate taken 
by IVC? 
Reason Pulse 
was Not Taken 
Was ECG 
performed? 
Reason ECG 
was Not 
performed 
Was ECG 
Strip 
Uploaded? 
Reason ECG 
Strip Was 
Not Uploaded 
Reason not 
able to 
Analyze 
Pulse 
Rate (BPM) 
by IVC app 
ECG 
Reference 
Device 
Heart 
Rate (BPM) 
305-004 
1 
Yes 
 
Yes 
 
Yes 
 
 
64 
65 
 
2 
Yes 
 
Yes 
 
Yes 
 
 
64 
64 
305-005 
1 
Yes 
 
Yes 
 
Yes 
 
 
50 
49 
 
2 
Yes 
 
Yes 
 
Yes 
 
 
50 
49 
305-006 
1 
No 
App unable to 
measure 
Yes 
 
Yes 
 
Null IVC 
solution 
 
 
 
2 
No 
App unable to 
measure 
Yes 
 
Yes 
 
Null IVC 
solution 
 
 
305-007 
1 
No 
App unable to 
measure 
Yes 
 
Yes 
 
Null IVC 
solution 
 
 
 
2 
No 
App unable to 
measure 
Yes 
 
Yes 
 
Null IVC 
solution 
 
 
305-008 
1 
No 
App unable to 
measure 
Yes 
 
Yes 
 
Null IVC 
solution 
 
 
 
2 
No 
App unable to 
measure 
Yes 
 
Yes 
 
Null IVC 
solution 
 
 
305-009 
1 
Yes 
 
Yes 
 
Yes 
 
 
71 
71 
 
2 
Yes 
 
Yes 
 
Yes 
 
 
73 
73 
305-010 
1 
Yes 
 
Yes 
 
Yes 
 
 
53 
53 
 
2 
Yes 
 
Yes 
 
Yes 
 
 
52 
53 
305-012 
1 
Yes 
 
Yes 
 
Yes 
 
 
68 
68 
 
2 
Yes 
 
Yes 
 
Yes 
 
 
73 
72 
306-001 
1 
No 
App not able 
to measure 
vitals 
Yes 
 
Yes 
 
Null IVC 
solution 
 
 
 
2 
No 
App not able 
to measure 
vitals 
No 
 
Yes 
 
 
 
 
306-002 
1 
No 
App not able 
to measure 
vitals 
No 
 
Yes 
 
 
 
 

Mindset Medical, LLC 
IVC-400-006 
Page 11 of 13 
Listing 16.2.6.1 
IVC App Pulse Rate and ECG Reference Device Heart Rate 
ITC Population 
 
 
ITC = Intent-to-Capture. 
 
Program name: l_16_2_6_1.sas 
Run Date: 21NOV2023 
Subject 
ID 
Session 
Was the 
pulse 
rate taken 
by IVC? 
Reason Pulse 
was Not Taken 
Was ECG 
performed? 
Reason ECG 
was Not 
performed 
Was ECG 
Strip 
Uploaded? 
Reason ECG 
Strip Was 
Not Uploaded 
Reason not 
able to 
Analyze 
Pulse 
Rate (BPM) 
by IVC app 
ECG 
Reference 
Device 
Heart 
Rate (BPM) 
306-002 
2 
No 
App not able 
to measure 
vitals 
No 
 
Yes 
 
 
 
 
306-003 
1 
Yes 
 
No 
 
Yes 
 
 
95 
 
 
2 
Yes 
 
Yes 
 
Yes 
 
 
93 
94 
306-004 
1 
No 
app not able 
to measure 
vitals 
Yes 
 
Yes 
 
Null IVC 
solution 
 
 
 
2 
Yes 
 
No 
 
Yes 
 
 
60 
 
306-005 
1 
Yes 
 
Yes 
 
Yes 
 
 
63 
62 
 
2 
Yes 
 
Yes 
 
Yes 
 
 
60 
61 
306-006 
1 
Yes 
 
Yes 
 
Yes 
 
 
87 
88 
 
2 
Yes 
 
Yes 
 
Yes 
 
 
87 
87 
306-007 
1 
Yes 
 
Yes 
 
Yes 
 
 
77 
77 
 
2 
Yes 
 
Yes 
 
Yes 
 
 
75 
75 
307-001 
1 
Yes 
 
Yes 
 
Yes 
 
 
73 
73 
 
2 
Yes 
 
Yes 
 
Yes 
 
 
75 
74 
307-002 
1 
Yes 
 
Yes 
 
Yes 
 
 
84 
83 

Mindset Medical, LLC 
IVC-400-006 
Page 12 of 13 
Listing 16.2.6.1 
IVC App Pulse Rate and ECG Reference Device Heart Rate 
ITC Population 
 
 
ITC = Intent-to-Capture. 
 
Program name: l_16_2_6_1.sas 
Run Date: 21NOV2023 
Subject 
ID 
Session 
Was the 
pulse 
rate taken 
by IVC? 
Reason Pulse 
was Not Taken 
Was ECG 
performed? 
Reason ECG 
was Not 
performed 
Was ECG 
Strip 
Uploaded? 
Reason ECG 
Strip Was 
Not Uploaded 
Reason not 
able to 
Analyze 
Pulse 
Rate (BPM) 
by IVC app 
ECG 
Reference 
Device 
Heart 
Rate (BPM) 
307-002 
2 
Yes 
 
Yes 
 
Yes 
 
 
82 
83 
307-003 
1 
Yes 
 
Yes 
 
Yes 
 
 
62 
63 
 
2 
Yes 
 
Yes 
 
Yes 
 
 
62 
62 
307-004 
1 
Yes 
 
Yes 
 
Yes 
 
 
64 
65 
 
2 
Yes 
 
Yes 
 
Yes 
 
 
61 
61 
307-005 
1 
Yes 
 
No 
 
Yes 
 
 
92 
 
 
2 
Yes 
 
No 
 
Yes 
 
 
92 
 
307-006 
1 
Yes 
 
Yes 
 
Yes 
 
 
77 
76 
 
2 
Yes 
 
Yes 
 
Yes 
 
 
80 
80 
307-008 
1 
No 
app unable to 
measure 
Yes 
 
Yes 
 
Null IVC 
solution 
 
 
 
2 
Yes 
 
Yes 
 
Yes 
 
 
79 
79 
307-009 
1 
No 
unable to 
measure 
vitals 
Yes 
 
Yes 
 
Null IVC 
solution 
 
 

Mindset Medical, LLC 
IVC-400-006 
Page 13 of 13 
Listing 16.2.6.1 
IVC App Pulse Rate and ECG Reference Device Heart Rate 
ITC Population 
 
 
ITC = Intent-to-Capture. 
 
Program name: l_16_2_6_1.sas 
Run Date: 21NOV2023 
Subject 
ID 
Session 
Was the 
pulse 
rate taken 
by IVC? 
Reason Pulse 
was Not Taken 
Was ECG 
performed? 
Reason ECG 
was Not 
performed 
Was ECG 
Strip 
Uploaded? 
Reason ECG 
Strip Was 
Not Uploaded 
Reason not 
able to 
Analyze 
Pulse 
Rate (BPM) 
by IVC app 
ECG 
Reference 
Device 
Heart 
Rate (BPM) 
307-009 
2 
Yes 
 
Yes 
 
Yes 
 
 
75 
74 
307-010 
1 
No 
no Pulse Rate 
obtained- App 
not able to 
measure 
vitals 
No 
 
No 
Thumb drive 
not 
recognized by 
pixel phone. 
USB was sent 
back to 
sponsor for 
review on 
7/20/23 
 
 
 
 
2 
No 
no Pulse Rate 
obtained- App 
not able to 
measure 
vitals 
No 
 
No 
Thumb drive 
not 
recognized by 
pixel phone. 
USB was sent 
back to 
sponsor for 
review on 
7/20/23 
 
 
 
307-011 
1 
Yes 
 
Yes 
 
Yes 
 
 
60 
59 
 
2 
Yes 
 
Yes 
 
Yes 
 
 
57 
58 
 

Mindset Medical, LLC 
IVC-400-006 
Page 1 of 5 
Listing 16.2.4.1 
Demographic and Other Baseline Characteristics 
ITC Population 
 
 
ITC = Intent-to-Capture. 
 
Program name: l_16_2_4_1.sas 
Run Date: 21NOV2023 
Subject 
ID 
Age 
(years) Sex 
Race 
Ethnicity 
Fitzpatrick Scale 
Assignment 
Is the 
subject 
wearing 
Glasses
? 
Does the 
subject 
have 
facial 
hair? 
301-001 
29 
Female 
BLACK OR AFRICAN AMERICAN NOT HISPANIC OR LATINO 
6 - Deeply Pigmented Dark Brown to 
Black Skin 
Yes 
No 
301-002 
36 
Female 
BLACK OR AFRICAN AMERICAN NOT HISPANIC OR LATINO 
5 - Dark Brown Skin 
No 
No 
301-003 
43 
Male 
BLACK OR AFRICAN AMERICAN NOT HISPANIC OR LATINO 
5 - Dark Brown Skin 
No 
Yes 
301-004 
51 
Male 
WHITE 
NOT HISPANIC OR LATINO 
2 - White Skin 
Yes 
Yes 
301-005 
56 
Male 
WHITE 
HISPANIC OR LATINO 
3 - Light Brown Skin 
Yes 
No 
301-006 
27 
Female 
WHITE 
NOT HISPANIC OR LATINO 
2 - White Skin 
No 
No 
301-008 
70 
Female 
WHITE 
NOT HISPANIC OR LATINO 
1 - Pale White Skin 
No 
No 
301-009 
69 
Female 
WHITE 
NOT HISPANIC OR LATINO 
2 - White Skin 
Yes 
No 
301-010 
62 
Female 
ASIAN 
NOT HISPANIC OR LATINO 
4 - Moderate Brown Skin 
No 
No 
301-011 
53 
Female 
BLACK OR AFRICAN AMERICAN NOT HISPANIC OR LATINO 
5 - Dark Brown Skin 
Yes 
No 
301-012 
40 
Female 
BLACK OR AFRICAN AMERICAN NOT HISPANIC OR LATINO 
3 - Light Brown Skin 
No 
No 
301-013 
60 
Female 
WHITE 
NOT HISPANIC OR LATINO 
1 - Pale White Skin 
Yes 
No 
301-014 
35 
Male 
WHITE 
NOT HISPANIC OR LATINO 
3 - Light Brown Skin 
No 
No 
301-015 
45 
Female 
WHITE 
NOT HISPANIC OR LATINO 
2 - White Skin 
Yes 
No 
301-016 
37 
Female 
WHITE 
NOT HISPANIC OR LATINO 
1 - Pale White Skin 
No 
No 
301-017 
67 
Female 
WHITE 
NOT HISPANIC OR LATINO 
2 - White Skin 
Yes 
No 
301-018 
62 
Male 
BLACK OR AFRICAN AMERICAN NOT HISPANIC OR LATINO 
6 - Deeply Pigmented Dark Brown to 
Black Skin 
No 
Yes 

Mindset Medical, LLC 
IVC-400-006 
Page 2 of 5 
Listing 16.2.4.1 
Demographic and Other Baseline Characteristics 
ITC Population 
 
 
ITC = Intent-to-Capture. 
 
Program name: l_16_2_4_1.sas 
Run Date: 21NOV2023 
Subject 
ID 
Age 
(years) Sex 
Race 
Ethnicity 
Fitzpatrick Scale 
Assignment 
Is the 
subject 
wearing 
Glasses
? 
Does the 
subject 
have 
facial 
hair? 
301-019 
66 
Female 
WHITE 
NOT HISPANIC OR LATINO 
2 - White Skin 
Yes 
No 
301-020 
33 
Female 
BLACK OR AFRICAN AMERICAN NOT HISPANIC OR LATINO 
6 - Deeply Pigmented Dark Brown to 
Black Skin 
No 
No 
301-021 
30 
Male 
BLACK OR AFRICAN AMERICAN NOT HISPANIC OR LATINO 
5 - Dark Brown Skin 
No 
Yes 
301-022 
62 
Male 
WHITE 
NOT HISPANIC OR LATINO 
3 - Light Brown Skin 
Yes 
No 
302-001 
48 
Male 
WHITE 
HISPANIC OR LATINO 
5 - Dark Brown Skin 
No 
Yes 
302-002 
76 
Female 
WHITE 
NOT HISPANIC OR LATINO 
2 - White Skin 
Yes 
No 
302-003 
32 
Male 
BLACK OR AFRICAN AMERICAN NOT HISPANIC OR LATINO 
6 - Deeply Pigmented Dark Brown to 
Black Skin 
No 
Yes 
302-004 
55 
Female 
WHITE 
NOT HISPANIC OR LATINO 
3 - Light Brown Skin 
No 
No 
302-005 
53 
Female 
WHITE 
NOT HISPANIC OR LATINO 
1 - Pale White Skin 
Yes 
No 
302-006 
61 
Male 
ASIAN 
NOT HISPANIC OR LATINO 
3 - Light Brown Skin 
Yes 
Yes 
302-007 
65 
Female 
WHITE 
NOT HISPANIC OR LATINO 
2 - White Skin 
No 
No 
302-008 
52 
Female 
WHITE 
HISPANIC OR LATINO 
3 - Light Brown Skin 
No 
No 
302-009 
39 
Male 
BLACK OR AFRICAN AMERICAN NOT HISPANIC OR LATINO 
6 - Deeply Pigmented Dark Brown to 
Black Skin 
No 
Yes 
302-010 
43 
Male 
NATIVE HAWAIIAN OR OTHER 
PACIFIC ISLANDER 
NOT HISPANIC OR LATINO 
6 - Deeply Pigmented Dark Brown to 
Black Skin 
Yes 
Yes 
302-011 
22 
Female 
BLACK OR AFRICAN AMERICAN NOT HISPANIC OR LATINO 
5 - Dark Brown Skin 
No 
No 
302-012 
44 
Male 
WHITE 
NOT HISPANIC OR LATINO 
2 - White Skin 
No 
Yes 
302-013 
68 
Female 
WHITE 
NOT HISPANIC OR LATINO 
1 - Pale White Skin 
No 
No 
302-014 
48 
Female 
WHITE 
NOT HISPANIC OR LATINO 
2 - White Skin 
No 
No 

Mindset Medical, LLC 
IVC-400-006 
Page 3 of 5 
Listing 16.2.4.1 
Demographic and Other Baseline Characteristics 
ITC Population 
 
 
ITC = Intent-to-Capture. 
 
Program name: l_16_2_4_1.sas 
Run Date: 21NOV2023 
Subject 
ID 
Age 
(years) Sex 
Race 
Ethnicity 
Fitzpatrick Scale 
Assignment 
Is the 
subject 
wearing 
Glasses
? 
Does the 
subject 
have 
facial 
hair? 
302-015 
44 
Male 
BLACK OR AFRICAN AMERICAN NOT HISPANIC OR LATINO 
5 - Dark Brown Skin 
No 
Yes 
302-016 
22 
Male 
BLACK OR AFRICAN AMERICAN NOT HISPANIC OR LATINO 
6 - Deeply Pigmented Dark Brown to 
Black Skin 
No 
No 
302-017 
57 
Male 
WHITE 
NOT HISPANIC OR LATINO 
2 - White Skin 
No 
Yes 
302-018 
32 
Female 
ASIAN 
NOT HISPANIC OR LATINO 
3 - Light Brown Skin 
No 
No 
302-019 
42 
Male 
WHITE 
NOT HISPANIC OR LATINO 
2 - White Skin 
No 
Yes 
302-020 
62 
Male 
WHITE 
NOT HISPANIC OR LATINO 
2 - White Skin 
No 
Yes 
302-021 
44 
Female 
WHITE 
NOT HISPANIC OR LATINO 
2 - White Skin 
No 
No 
304-001 
60 
Male 
BLACK OR AFRICAN AMERICAN NOT HISPANIC OR LATINO 
5 - Dark Brown Skin 
No 
Yes 
304-003 
38 
Female 
BLACK OR AFRICAN AMERICAN NOT HISPANIC OR LATINO 
5 - Dark Brown Skin 
No 
No 
304-004 
33 
Female 
BLACK OR AFRICAN AMERICAN NOT HISPANIC OR LATINO 
5 - Dark Brown Skin 
No 
No 
304-005 
61 
Male 
WHITE 
NOT HISPANIC OR LATINO 
2 - White Skin 
Yes 
No 
304-006 
69 
Female 
WHITE 
NOT HISPANIC OR LATINO 
2 - White Skin 
No 
No 
304-007 
77 
Female 
WHITE 
NOT HISPANIC OR LATINO 
1 - Pale White Skin 
Yes 
No 
304-008 
63 
Male 
BLACK OR AFRICAN AMERICAN NOT HISPANIC OR LATINO 
4 - Moderate Brown Skin 
No 
No 
304-009 
55 
Male 
WHITE 
NOT HISPANIC OR LATINO 
2 - White Skin 
No 
Yes 
304-010 
33 
Male 
ASIAN 
NOT HISPANIC OR LATINO 
2 - White Skin 
No 
No 
304-011 
34 
Female 
WHITE 
NOT HISPANIC OR LATINO 
2 - White Skin 
No 
No 
304-012 
53 
Female 
WHITE 
NOT HISPANIC OR LATINO 
3 - Light Brown Skin 
No 
No 

Mindset Medical, LLC 
IVC-400-006 
Page 4 of 5 
Listing 16.2.4.1 
Demographic and Other Baseline Characteristics 
ITC Population 
 
 
ITC = Intent-to-Capture. 
 
Program name: l_16_2_4_1.sas 
Run Date: 21NOV2023 
Subject 
ID 
Age 
(years) Sex 
Race 
Ethnicity 
Fitzpatrick Scale 
Assignment 
Is the 
subject 
wearing 
Glasses
? 
Does the 
subject 
have 
facial 
hair? 
304-013 
27 
Male 
WHITE 
NOT HISPANIC OR LATINO 
2 - White Skin 
No 
Yes 
305-001 
49 
Male 
BLACK OR AFRICAN AMERICAN NOT HISPANIC OR LATINO 
6 - Deeply Pigmented Dark Brown to 
Black Skin 
No 
Yes 
305-002 
51 
Female 
BLACK OR AFRICAN AMERICAN NOT HISPANIC OR LATINO 
6 - Deeply Pigmented Dark Brown to 
Black Skin 
No 
No 
305-003 
69 
Female 
BLACK OR AFRICAN AMERICAN NOT HISPANIC OR LATINO 
6 - Deeply Pigmented Dark Brown to 
Black Skin 
No 
No 
305-004 
31 
Female 
OTHER 
HISPANIC OR LATINO 
2 - White Skin 
No 
No 
305-005 
74 
Female 
BLACK OR AFRICAN AMERICAN NOT HISPANIC OR LATINO 
5 - Dark Brown Skin 
No 
No 
305-006 
52 
Male 
BLACK OR AFRICAN AMERICAN NOT HISPANIC OR LATINO 
6 - Deeply Pigmented Dark Brown to 
Black Skin 
No 
Yes 
305-007 
46 
Female 
BLACK OR AFRICAN AMERICAN NOT HISPANIC OR LATINO 
5 - Dark Brown Skin 
No 
No 
305-008 
38 
Male 
BLACK OR AFRICAN AMERICAN NOT HISPANIC OR LATINO 
5 - Dark Brown Skin 
No 
Yes 
305-009 
62 
Female 
WHITE 
NOT HISPANIC OR LATINO 
2 - White Skin 
Yes 
No 
305-010 
73 
Male 
BLACK OR AFRICAN AMERICAN NOT HISPANIC OR LATINO 
5 - Dark Brown Skin 
Yes 
Yes 
305-012 
69 
Female 
ASIAN 
NOT HISPANIC OR LATINO 
3 - Light Brown Skin 
Yes 
No 
306-001 
22 
Male 
BLACK OR AFRICAN AMERICAN NOT HISPANIC OR LATINO 
5 - Dark Brown Skin 
No 
Yes 
306-002 
23 
Male 
BLACK OR AFRICAN AMERICAN NOT HISPANIC OR LATINO 
5 - Dark Brown Skin 
No 
Yes 
306-003 
37 
Female 
BLACK OR AFRICAN AMERICAN NOT HISPANIC OR LATINO 
4 - Moderate Brown Skin 
No 
No 
306-004 
38 
Male 
BLACK OR AFRICAN AMERICAN NOT HISPANIC OR LATINO 
6 - Deeply Pigmented Dark Brown to 
Black Skin 
No 
Yes 
306-005 
70 
Female 
BLACK OR AFRICAN AMERICAN NOT HISPANIC OR LATINO 
5 - Dark Brown Skin 
No 
No 
306-006 
30 
Female 
WHITE 
NOT HISPANIC OR LATINO 
2 - White Skin 
No 
No 

Mindset Medical, LLC 
IVC-400-006 
Page 5 of 5 
Listing 16.2.4.1 
Demographic and Other Baseline Characteristics 
ITC Population 
 
 
ITC = Intent-to-Capture. 
 
Program name: l_16_2_4_1.sas 
Run Date: 21NOV2023 
Subject 
ID 
Age 
(years) Sex 
Race 
Ethnicity 
Fitzpatrick Scale 
Assignment 
Is the 
subject 
wearing 
Glasses
? 
Does the 
subject 
have 
facial 
hair? 
306-007 
36 
Female 
WHITE 
NOT HISPANIC OR LATINO 
2 - White Skin 
No 
No 
307-001 
66 
Female 
WHITE 
NOT HISPANIC OR LATINO 
3 - Light Brown Skin 
No 
No 
307-002 
66 
Male 
AMERICAN INDIAN OR ALASKA 
NATIVE/BLACK OR AFRICAN 
AMERICAN 
NOT HISPANIC OR LATINO 
5 - Dark Brown Skin 
No 
Yes 
307-003 
24 
Male 
WHITE 
HISPANIC OR LATINO 
4 - Moderate Brown Skin 
No 
No 
307-004 
34 
Male 
WHITE 
NOT HISPANIC OR LATINO 
3 - Light Brown Skin 
No 
Yes 
307-005 
59 
Male 
WHITE 
NOT HISPANIC OR LATINO 
2 - White Skin 
No 
Yes 
307-006 
23 
Male 
AMERICAN INDIAN OR ALASKA 
NATIVE 
HISPANIC OR LATINO 
3 - Light Brown Skin 
No 
Yes 
307-008 
44 
Male 
WHITE 
HISPANIC OR LATINO 
4 - Moderate Brown Skin 
No 
Yes 
307-009 
63 
Male 
BLACK OR AFRICAN AMERICAN NOT HISPANIC OR LATINO 
5 - Dark Brown Skin 
No 
No 
307-010 
44 
Male 
BLACK OR AFRICAN AMERICAN NOT HISPANIC OR LATINO 
5 - Dark Brown Skin 
No 
Yes 
307-011 
58 
Male 
WHITE 
NOT HISPANIC OR LATINO 
2 - White Skin 
No 
Yes 
 

Mindset Medical, LLC 
IVC-400-006 
Page 1 of 2 
Table 14.1.2.1 
Summary of Subject Demographic and Other Baseline Characteristics 
ITC Population 
 
 
% = 100 x n/N. ITC = Intent-to-Capture. 
[a] Fitzpatrick scale skin tones are grouped into light (Fitzpatrick 1 and 2), medium (Fitzpatrick 3 and 4) and dark (Fitzpatrick 5 and 
6). 
See Listing 16.2.4.1 
 
Program name: t_14_1_2_1.sas 
Run Date: 21NOV2023 
Characteristic 
Statistic or Category 
Total 
(N=82) 
n   (%) 
 
Sex, n (%) 
Male 
40 (48.8) 
 
Female 
42 (51.2) 
 
Ethnic Group, n (%) 
Hispanic or Latino 
 7 ( 8.5) 
 
Not Hispanic or Latino 
75 (91.5) 
 
Race, n (%) 
American Indian or Alaska Native/Black or African American 
 1 ( 1.2) 
 
American Indian or Alaska Native 
 1 ( 1.2) 
 
Asian 
 5 ( 6.1) 
 
Black or African American 
32 (39.0) 
 
Native Hawaiian or Other Pacific Islander 
 1 ( 1.2) 
 
White 
41 (50.0) 
 
Other 
 1 ( 1.2) 
 
Fitzpatrick Scale, n (%) 
1 - Pale White Skin 
 6 ( 7.3) 
 
2 - White Skin 
26 (31.7) 
 
3 - Light Brown Skin 
13 (15.9) 
 
4 - Moderate Brown Skin 
 5 ( 6.1) 
 
5 - Dark Brown Skin 
20 (24.4) 
 
6 - Deeply Pigmented Dark Brown to Black Skin 
12 (14.6) 
 
Fitzpatrick Scale Group, n (%) [a] 
Light 
32 (39.0) 
 
Medium 
18 (22.0) 
 
Dark 
32 (39.0) 

Mindset Medical, LLC 
IVC-400-006 
Page 2 of 2 
Table 14.1.2.1 
Summary of Subject Demographic and Other Baseline Characteristics 
ITC Population 
 
 
% = 100 x n/N. ITC = Intent-to-Capture. 
[a] Fitzpatrick scale skin tones are grouped into light (Fitzpatrick 1 and 2), medium (Fitzpatrick 3 and 4) and dark (Fitzpatrick 5 and 
6). 
See Listing 16.2.4.1 
 
Program name: t_14_1_2_1.sas 
Run Date: 21NOV2023 
Characteristic 
Statistic or Category 
Total 
(N=82) 
n   (%) 
 
Age (years) 
n 
82 
 
Mean 
48.7 
 
Standard deviation 
15.40 
 
Median 
48.5 
 
Minimum 
22 
 
Maximum 
77 
 

Mindset Medical, LLC 
IVC-400-006 
Page 1 of 13 
Listing 16.2.6.1 
IVC App Pulse Rate and ECG Reference Device Heart Rate 
ITC Population 
 
 
ITC = Intent-to-Capture. 
 
Program name: l_16_2_6_1.sas 
Run Date: 21NOV2023 
Subject 
ID 
Session 
Was the 
pulse 
rate taken 
by IVC? 
Reason Pulse 
was Not Taken 
Was ECG 
performed? 
Reason ECG 
was Not 
performed 
Was ECG 
Strip 
Uploaded? 
Reason ECG 
Strip Was 
Not Uploaded 
Reason not 
able to 
Analyze 
Pulse 
Rate (BPM) 
by IVC app 
ECG 
Reference 
Device 
Heart 
Rate (BPM) 
301-001 
1 
No 
App not able 
to measure 
vitals 
Yes 
 
Yes 
 
Null IVC 
solution 
 
 
 
2 
No 
App not able 
to measure 
vitals 
Yes 
 
Yes 
 
Null IVC 
solution 
 
 
301-002 
1 
Yes 
 
Yes 
 
Yes 
 
 
60 
60 
 
2 
Yes 
 
Yes 
 
Yes 
 
 
66 
62 
301-003 
1 
No 
App was not 
able to 
measure 
vitals 
No 
 
Yes 
 
 
 
 
 
2 
No 
App was not 
able to 
measure 
vitals 
No 
 
Yes 
 
 
 
 
301-004 
1 
Yes 
 
Yes 
 
Yes 
 
 
69 
69 
 
2 
Yes 
 
Yes 
 
Yes 
 
 
67 
68 
301-005 
1 
Yes 
 
Yes 
 
Yes 
 
 
57 
58 
 
2 
Yes 
 
Yes 
 
Yes 
 
 
57 
57 
301-006 
1 
Yes 
 
Yes 
 
Yes 
 
 
69 
69 
 
2 
Yes 
 
Yes 
 
Yes 
 
 
66 
66 

Mindset Medical, LLC 
IVC-400-006 
Page 2 of 13 
Listing 16.2.6.1 
IVC App Pulse Rate and ECG Reference Device Heart Rate 
ITC Population 
 
 
ITC = Intent-to-Capture. 
 
Program name: l_16_2_6_1.sas 
Run Date: 21NOV2023 
Subject 
ID 
Session 
Was the 
pulse 
rate taken 
by IVC? 
Reason Pulse 
was Not Taken 
Was ECG 
performed? 
Reason ECG 
was Not 
performed 
Was ECG 
Strip 
Uploaded? 
Reason ECG 
Strip Was 
Not Uploaded 
Reason not 
able to 
Analyze 
Pulse 
Rate (BPM) 
by IVC app 
ECG 
Reference 
Device 
Heart 
Rate (BPM) 
301-008 
1 
Yes 
 
Yes 
 
Yes 
 
 
67 
67 
 
2 
Yes 
 
Yes 
 
Yes 
 
 
68 
69 
301-009 
1 
Yes 
 
Yes 
 
Yes 
 
 
71 
70 
 
2 
Yes 
 
Yes 
 
Yes 
 
 
71 
71 
301-010 
1 
Yes 
 
Yes 
 
Yes 
 
 
81 
81 
 
2 
Yes 
 
Yes 
 
Yes 
 
 
79 
78 
301-011 
1 
Yes 
 
Yes 
 
Yes 
 
 
64 
65 
 
2 
Yes 
 
Yes 
 
Yes 
 
 
60 
61 
301-012 
1 
Yes 
 
Yes 
 
Yes 
 
 
76 
77 
 
2 
Yes 
 
Yes 
 
Yes 
 
 
78 
78 
301-013 
1 
Yes 
 
Yes 
 
Yes 
 
 
72 
72 
 
2 
Yes 
 
Yes 
 
Yes 
 
 
73 
74 
301-014 
1 
Yes 
 
Yes 
 
Yes 
 
 
67 
67 

Mindset Medical, LLC 
IVC-400-006 
Page 3 of 13 
Listing 16.2.6.1 
IVC App Pulse Rate and ECG Reference Device Heart Rate 
ITC Population 
 
 
ITC = Intent-to-Capture. 
 
Program name: l_16_2_6_1.sas 
Run Date: 21NOV2023 
Subject 
ID 
Session 
Was the 
pulse 
rate taken 
by IVC? 
Reason Pulse 
was Not Taken 
Was ECG 
performed? 
Reason ECG 
was Not 
performed 
Was ECG 
Strip 
Uploaded? 
Reason ECG 
Strip Was 
Not Uploaded 
Reason not 
able to 
Analyze 
Pulse 
Rate (BPM) 
by IVC app 
ECG 
Reference 
Device 
Heart 
Rate (BPM) 
301-014 
2 
Yes 
 
Yes 
 
Yes 
 
 
68 
69 
301-015 
1 
Yes 
 
No 
 
Yes 
 
 
70 
 
 
2 
Yes 
 
Yes 
 
Yes 
 
 
67 
66 
301-016 
1 
Yes 
 
Yes 
 
Yes 
 
 
73 
73 
 
2 
Yes 
 
Yes 
 
Yes 
 
 
73 
73 
301-017 
1 
Yes 
 
Yes 
 
Yes 
 
 
84 
83 
 
2 
Yes 
 
Yes 
 
Yes 
 
 
83 
83 
301-018 
1 
Yes 
 
Yes 
 
Yes 
 
 
67 
67 
 
2 
Yes 
 
Yes 
 
Yes 
 
 
67 
67 
301-019 
1 
Yes 
 
Yes 
 
Yes 
 
 
60 
60 
 
2 
Yes 
 
Yes 
 
Yes 
 
 
60 
60 
301-020 
1 
No 
App not able 
to measure 
vitals 
Yes 
 
Yes 
 
Null IVC 
solution 
 
 
 
2 
No 
App not able 
to measure 
vitals 
Yes 
 
Yes 
 
Null IVC 
solution 
 
 
301-021 
1 
Yes 
 
Yes 
 
Yes 
 
 
54 
53 

Mindset Medical, LLC 
IVC-400-006 
Page 4 of 13 
Listing 16.2.6.1 
IVC App Pulse Rate and ECG Reference Device Heart Rate 
ITC Population 
 
 
ITC = Intent-to-Capture. 
 
Program name: l_16_2_6_1.sas 
Run Date: 21NOV2023 
Subject 
ID 
Session 
Was the 
pulse 
rate taken 
by IVC? 
Reason Pulse 
was Not Taken 
Was ECG 
performed? 
Reason ECG 
was Not 
performed 
Was ECG 
Strip 
Uploaded? 
Reason ECG 
Strip Was 
Not Uploaded 
Reason not 
able to 
Analyze 
Pulse 
Rate (BPM) 
by IVC app 
ECG 
Reference 
Device 
Heart 
Rate (BPM) 
301-021 
2 
Yes 
 
Yes 
 
Yes 
 
 
53 
53 
301-022 
1 
Yes 
 
Yes 
 
Yes 
 
 
61 
61 
 
2 
Yes 
 
Yes 
 
Yes 
 
 
64 
63 
302-001 
1 
Yes 
 
Yes 
 
Yes 
 
 
80 
80 
 
2 
Yes 
 
Yes 
 
Yes 
 
 
79 
79 
302-002 
1 
Yes 
 
Yes 
 
Yes 
 
 
81 
80 
 
2 
Yes 
 
Yes 
 
Yes 
 
 
80 
79 
302-003 
1 
Yes 
 
Yes 
 
Yes 
 
 
65 
67 
 
2 
Yes 
 
Yes 
 
Yes 
 
 
68 
68 
302-004 
1 
Yes 
 
Yes 
 
Yes 
 
 
60 
61 
 
2 
Yes 
 
Yes 
 
Yes 
 
 
61 
62 
302-005 
1 
Yes 
 
Yes 
 
Yes 
 
 
69 
69 
 
2 
Yes 
 
Yes 
 
Yes 
 
 
69 
69 
302-006 
1 
Yes 
 
Yes 
 
Yes 
 
 
78 
79 

Mindset Medical, LLC 
IVC-400-006 
Page 5 of 13 
Listing 16.2.6.1 
IVC App Pulse Rate and ECG Reference Device Heart Rate 
ITC Population 
 
 
ITC = Intent-to-Capture. 
 
Program name: l_16_2_6_1.sas 
Run Date: 21NOV2023 
Subject 
ID 
Session 
Was the 
pulse 
rate taken 
by IVC? 
Reason Pulse 
was Not Taken 
Was ECG 
performed? 
Reason ECG 
was Not 
performed 
Was ECG 
Strip 
Uploaded? 
Reason ECG 
Strip Was 
Not Uploaded 
Reason not 
able to 
Analyze 
Pulse 
Rate (BPM) 
by IVC app 
ECG 
Reference 
Device 
Heart 
Rate (BPM) 
302-006 
2 
Yes 
 
Yes 
 
Yes 
 
 
78 
78 
302-007 
1 
Yes 
 
Yes 
 
Yes 
 
 
64 
64 
 
2 
Yes 
 
Yes 
 
Yes 
 
 
64 
64 
302-008 
1 
Yes 
 
Yes 
 
Yes 
 
 
53 
54 
 
2 
Yes 
 
Yes 
 
Yes 
 
 
55 
55 
302-009 
1 
Yes 
 
Yes 
 
Yes 
 
 
53 
53 
 
2 
Yes 
 
Yes 
 
Yes 
 
 
53 
53 
302-010 
1 
Yes 
 
Yes 
 
Yes 
 
 
57 
57 
 
2 
Yes 
 
Yes 
 
Yes 
 
 
54 
55 
302-011 
1 
Yes 
 
Yes 
 
Yes 
 
 
67 
68 
 
2 
Yes 
 
Yes 
 
Yes 
 
 
71 
70 
302-012 
1 
Yes 
 
Yes 
 
Yes 
 
 
64 
64 
 
2 
Yes 
 
Yes 
 
Yes 
 
 
64 
64 
302-013 
1 
Yes 
 
Yes 
 
Yes 
 
 
75 
75 

Mindset Medical, LLC 
IVC-400-006 
Page 6 of 13 
Listing 16.2.6.1 
IVC App Pulse Rate and ECG Reference Device Heart Rate 
ITC Population 
 
 
ITC = Intent-to-Capture. 
 
Program name: l_16_2_6_1.sas 
Run Date: 21NOV2023 
Subject 
ID 
Session 
Was the 
pulse 
rate taken 
by IVC? 
Reason Pulse 
was Not Taken 
Was ECG 
performed? 
Reason ECG 
was Not 
performed 
Was ECG 
Strip 
Uploaded? 
Reason ECG 
Strip Was 
Not Uploaded 
Reason not 
able to 
Analyze 
Pulse 
Rate (BPM) 
by IVC app 
ECG 
Reference 
Device 
Heart 
Rate (BPM) 
302-013 
2 
Yes 
 
Yes 
 
Yes 
 
 
75 
75 
302-014 
1 
Yes 
 
Yes 
 
Yes 
 
 
76 
76 
 
2 
Yes 
 
Yes 
 
Yes 
 
 
78 
78 
302-015 
1 
No 
App not able 
to measure 
vitals 
Yes 
 
Yes 
 
null IVC 
solution 
 
 
 
2 
No 
App not able 
to measure 
vitals 
Yes 
 
Yes 
 
null IVC 
solution 
 
 
302-016 
1 
Yes 
 
Yes 
 
Yes 
 
 
60 
60 
 
2 
Yes 
 
Yes 
 
Yes 
 
 
61 
61 
302-017 
1 
Yes 
 
Yes 
 
Yes 
 
 
86 
87 
 
2 
Yes 
 
Yes 
 
Yes 
 
 
87 
87 
302-018 
1 
Yes 
 
Yes 
 
Yes 
 
 
103 
103 
 
2 
Yes 
 
No 
 
Yes 
 
 
105 
 
302-019 
1 
Yes 
 
Yes 
 
Yes 
 
 
50 
50 
 
2 
Yes 
 
Yes 
 
Yes 
 
 
50 
50 
302-020 
1 
Yes 
 
Yes 
 
Yes 
 
 
85 
84 

Mindset Medical, LLC 
IVC-400-006 
Page 7 of 13 
Listing 16.2.6.1 
IVC App Pulse Rate and ECG Reference Device Heart Rate 
ITC Population 
 
 
ITC = Intent-to-Capture. 
 
Program name: l_16_2_6_1.sas 
Run Date: 21NOV2023 
Subject 
ID 
Session 
Was the 
pulse 
rate taken 
by IVC? 
Reason Pulse 
was Not Taken 
Was ECG 
performed? 
Reason ECG 
was Not 
performed 
Was ECG 
Strip 
Uploaded? 
Reason ECG 
Strip Was 
Not Uploaded 
Reason not 
able to 
Analyze 
Pulse 
Rate (BPM) 
by IVC app 
ECG 
Reference 
Device 
Heart 
Rate (BPM) 
302-020 
2 
Yes 
 
Yes 
 
Yes 
 
 
82 
83 
302-021 
1 
Yes 
 
Yes 
 
Yes 
 
 
74 
75 
 
2 
Yes 
 
Yes 
 
Yes 
 
 
78 
79 
304-001 
1 
Yes 
 
Yes 
 
Yes 
 
 
67 
68 
 
2 
Yes 
 
Yes 
 
Yes 
 
 
71 
70 
304-003 
1 
Yes 
 
Yes 
 
Yes 
 
 
53 
53 
 
2 
Yes 
 
Yes 
 
Yes 
 
 
53 
52 
304-004 
1 
Yes 
 
Yes 
 
Yes 
 
 
96 
95 
 
2 
Yes 
 
Yes 
 
Yes 
 
 
96 
96 
304-005 
1 
Yes 
 
Yes 
 
Yes 
 
 
71 
70 
 
2 
Yes 
 
Yes 
 
Yes 
 
 
71 
70 
304-006 
1 
Yes 
 
Yes 
 
Yes 
 
 
78 
79 

Mindset Medical, LLC 
IVC-400-006 
Page 8 of 13 
Listing 16.2.6.1 
IVC App Pulse Rate and ECG Reference Device Heart Rate 
ITC Population 
 
 
ITC = Intent-to-Capture. 
 
Program name: l_16_2_6_1.sas 
Run Date: 21NOV2023 
Subject 
ID 
Session 
Was the 
pulse 
rate taken 
by IVC? 
Reason Pulse 
was Not Taken 
Was ECG 
performed? 
Reason ECG 
was Not 
performed 
Was ECG 
Strip 
Uploaded? 
Reason ECG 
Strip Was 
Not Uploaded 
Reason not 
able to 
Analyze 
Pulse 
Rate (BPM) 
by IVC app 
ECG 
Reference 
Device 
Heart 
Rate (BPM) 
304-006 
2 
Yes 
 
Yes 
 
Yes 
 
 
78 
78 
304-007 
1 
Yes 
 
Yes 
 
Yes 
 
 
68 
69 
 
2 
Yes 
 
Yes 
 
Yes 
 
 
74 
73 
304-008 
1 
Yes 
 
Yes 
 
Yes 
 
 
74 
73 
 
2 
Yes 
 
Yes 
 
Yes 
 
 
75 
75 
304-009 
1 
Yes 
 
Yes 
 
Yes 
 
 
78 
79 
 
2 
Yes 
 
Yes 
 
Yes 
 
 
78 
77 
304-010 
1 
Yes 
 
Yes 
 
Yes 
 
 
67 
67 
 
2 
Yes 
 
Yes 
 
Yes 
 
 
67 
67 
304-011 
1 
Yes 
 
Yes 
 
Yes 
 
 
75 
74 
 
2 
Yes 
 
Yes 
 
Yes 
 
 
74 
74 
304-012 
1 
Yes 
 
Yes 
 
Yes 
 
 
71 
70 
 
2 
Yes 
 
Yes 
 
Yes 
 
 
68 
69 
304-013 
1 
Yes 
 
Yes 
 
Yes 
 
 
71 
70 

Mindset Medical, LLC 
IVC-400-006 
Page 9 of 13 
Listing 16.2.6.1 
IVC App Pulse Rate and ECG Reference Device Heart Rate 
ITC Population 
 
 
ITC = Intent-to-Capture. 
 
Program name: l_16_2_6_1.sas 
Run Date: 21NOV2023 
Subject 
ID 
Session 
Was the 
pulse 
rate taken 
by IVC? 
Reason Pulse 
was Not Taken 
Was ECG 
performed? 
Reason ECG 
was Not 
performed 
Was ECG 
Strip 
Uploaded? 
Reason ECG 
Strip Was 
Not Uploaded 
Reason not 
able to 
Analyze 
Pulse 
Rate (BPM) 
by IVC app 
ECG 
Reference 
Device 
Heart 
Rate (BPM) 
304-013 
2 
Yes 
 
Yes 
 
Yes 
 
 
73 
72 
305-001 
1 
No 
app unable to 
measure 
Yes 
 
Yes 
 
Null IVC 
solution 
 
 
 
2 
No 
app unable to 
measure 
No 
 
Yes 
 
 
 
 
305-002 
1 
No 
app not able 
to measure 
Yes 
 
Yes 
 
Null IVC 
solution 
 
 
 
2 
No 
The second PRO 
assessment 
was not 
completed per 
protocol per 
PM 
instruction. 
No 
 
Yes 
 
 
 
 
305-003 
1 
No 
App not able 
to measure 
vitals. 
No 
 
Yes 
 
 
 
 
 
2 
No 
App not able 
to measure 
vitals. 
No 
 
Yes 
 
 
 
 

Mindset Medical, LLC 
IVC-400-006 
Page 10 of 13 
Listing 16.2.6.1 
IVC App Pulse Rate and ECG Reference Device Heart Rate 
ITC Population 
 
 
ITC = Intent-to-Capture. 
 
Program name: l_16_2_6_1.sas 
Run Date: 21NOV2023 
Subject 
ID 
Session 
Was the 
pulse 
rate taken 
by IVC? 
Reason Pulse 
was Not Taken 
Was ECG 
performed? 
Reason ECG 
was Not 
performed 
Was ECG 
Strip 
Uploaded? 
Reason ECG 
Strip Was 
Not Uploaded 
Reason not 
able to 
Analyze 
Pulse 
Rate (BPM) 
by IVC app 
ECG 
Reference 
Device 
Heart 
Rate (BPM) 
305-004 
1 
Yes 
 
Yes 
 
Yes 
 
 
64 
65 
 
2 
Yes 
 
Yes 
 
Yes 
 
 
64 
64 
305-005 
1 
Yes 
 
Yes 
 
Yes 
 
 
50 
49 
 
2 
Yes 
 
Yes 
 
Yes 
 
 
50 
49 
305-006 
1 
No 
App unable to 
measure 
Yes 
 
Yes 
 
Null IVC 
solution 
 
 
 
2 
No 
App unable to 
measure 
Yes 
 
Yes 
 
Null IVC 
solution 
 
 
305-007 
1 
No 
App unable to 
measure 
Yes 
 
Yes 
 
Null IVC 
solution 
 
 
 
2 
No 
App unable to 
measure 
Yes 
 
Yes 
 
Null IVC 
solution 
 
 
305-008 
1 
No 
App unable to 
measure 
Yes 
 
Yes 
 
Null IVC 
solution 
 
 
 
2 
No 
App unable to 
measure 
Yes 
 
Yes 
 
Null IVC 
solution 
 
 
305-009 
1 
Yes 
 
Yes 
 
Yes 
 
 
71 
71 
 
2 
Yes 
 
Yes 
 
Yes 
 
 
73 
73 
305-010 
1 
Yes 
 
Yes 
 
Yes 
 
 
53 
53 
 
2 
Yes 
 
Yes 
 
Yes 
 
 
52 
53 
305-012 
1 
Yes 
 
Yes 
 
Yes 
 
 
68 
68 
 
2 
Yes 
 
Yes 
 
Yes 
 
 
73 
72 
306-001 
1 
No 
App not able 
to measure 
vitals 
Yes 
 
Yes 
 
Null IVC 
solution 
 
 
 
2 
No 
App not able 
to measure 
vitals 
No 
 
Yes 
 
 
 
 
306-002 
1 
No 
App not able 
to measure 
vitals 
No 
 
Yes 
 
 
 
 

Mindset Medical, LLC 
IVC-400-006 
Page 11 of 13 
Listing 16.2.6.1 
IVC App Pulse Rate and ECG Reference Device Heart Rate 
ITC Population 
 
 
ITC = Intent-to-Capture. 
 
Program name: l_16_2_6_1.sas 
Run Date: 21NOV2023 
Subject 
ID 
Session 
Was the 
pulse 
rate taken 
by IVC? 
Reason Pulse 
was Not Taken 
Was ECG 
performed? 
Reason ECG 
was Not 
performed 
Was ECG 
Strip 
Uploaded? 
Reason ECG 
Strip Was 
Not Uploaded 
Reason not 
able to 
Analyze 
Pulse 
Rate (BPM) 
by IVC app 
ECG 
Reference 
Device 
Heart 
Rate (BPM) 
306-002 
2 
No 
App not able 
to measure 
vitals 
No 
 
Yes 
 
 
 
 
306-003 
1 
Yes 
 
No 
 
Yes 
 
 
95 
 
 
2 
Yes 
 
Yes 
 
Yes 
 
 
93 
94 
306-004 
1 
No 
app not able 
to measure 
vitals 
Yes 
 
Yes 
 
Null IVC 
solution 
 
 
 
2 
Yes 
 
No 
 
Yes 
 
 
60 
 
306-005 
1 
Yes 
 
Yes 
 
Yes 
 
 
63 
62 
 
2 
Yes 
 
Yes 
 
Yes 
 
 
60 
61 
306-006 
1 
Yes 
 
Yes 
 
Yes 
 
 
87 
88 
 
2 
Yes 
 
Yes 
 
Yes 
 
 
87 
87 
306-007 
1 
Yes 
 
Yes 
 
Yes 
 
 
77 
77 
 
2 
Yes 
 
Yes 
 
Yes 
 
 
75 
75 
307-001 
1 
Yes 
 
Yes 
 
Yes 
 
 
73 
73 
 
2 
Yes 
 
Yes 
 
Yes 
 
 
75 
74 
307-002 
1 
Yes 
 
Yes 
 
Yes 
 
 
84 
83 

Mindset Medical, LLC 
IVC-400-006 
Page 12 of 13 
Listing 16.2.6.1 
IVC App Pulse Rate and ECG Reference Device Heart Rate 
ITC Population 
 
 
ITC = Intent-to-Capture. 
 
Program name: l_16_2_6_1.sas 
Run Date: 21NOV2023 
Subject 
ID 
Session 
Was the 
pulse 
rate taken 
by IVC? 
Reason Pulse 
was Not Taken 
Was ECG 
performed? 
Reason ECG 
was Not 
performed 
Was ECG 
Strip 
Uploaded? 
Reason ECG 
Strip Was 
Not Uploaded 
Reason not 
able to 
Analyze 
Pulse 
Rate (BPM) 
by IVC app 
ECG 
Reference 
Device 
Heart 
Rate (BPM) 
307-002 
2 
Yes 
 
Yes 
 
Yes 
 
 
82 
83 
307-003 
1 
Yes 
 
Yes 
 
Yes 
 
 
62 
63 
 
2 
Yes 
 
Yes 
 
Yes 
 
 
62 
62 
307-004 
1 
Yes 
 
Yes 
 
Yes 
 
 
64 
65 
 
2 
Yes 
 
Yes 
 
Yes 
 
 
61 
61 
307-005 
1 
Yes 
 
No 
 
Yes 
 
 
92 
 
 
2 
Yes 
 
No 
 
Yes 
 
 
92 
 
307-006 
1 
Yes 
 
Yes 
 
Yes 
 
 
77 
76 
 
2 
Yes 
 
Yes 
 
Yes 
 
 
80 
80 
307-008 
1 
No 
app unable to 
measure 
Yes 
 
Yes 
 
Null IVC 
solution 
 
 
 
2 
Yes 
 
Yes 
 
Yes 
 
 
79 
79 
307-009 
1 
No 
unable to 
measure 
vitals 
Yes 
 
Yes 
 
Null IVC 
solution 
 
 

Mindset Medical, LLC 
IVC-400-006 
Page 13 of 13 
Listing 16.2.6.1 
IVC App Pulse Rate and ECG Reference Device Heart Rate 
ITC Population 
 
 
ITC = Intent-to-Capture. 
 
Program name: l_16_2_6_1.sas 
Run Date: 21NOV2023 
Subject 
ID 
Session 
Was the 
pulse 
rate taken 
by IVC? 
Reason Pulse 
was Not Taken 
Was ECG 
performed? 
Reason ECG 
was Not 
performed 
Was ECG 
Strip 
Uploaded? 
Reason ECG 
Strip Was 
Not Uploaded 
Reason not 
able to 
Analyze 
Pulse 
Rate (BPM) 
by IVC app 
ECG 
Reference 
Device 
Heart 
Rate (BPM) 
307-009 
2 
Yes 
 
Yes 
 
Yes 
 
 
75 
74 
307-010 
1 
No 
no Pulse Rate 
obtained- App 
not able to 
measure 
vitals 
No 
 
No 
Thumb drive 
not 
recognized by 
pixel phone. 
USB was sent 
back to 
sponsor for 
review on 
7/20/23 
 
 
 
 
2 
No 
no Pulse Rate 
obtained- App 
not able to 
measure 
vitals 
No 
 
No 
Thumb drive 
not 
recognized by 
pixel phone. 
USB was sent 
back to 
sponsor for 
review on 
7/20/23 
 
 
 
307-011 
1 
Yes 
 
Yes 
 
Yes 
 
 
60 
59 
 
2 
Yes 
 
Yes 
 
Yes 
 
 
57 
58 
 

Mindset Medical, LLC 
IVC-400-006 
Page 1 of 1 
Listing 16.2.7.1 
Adverse Events 
ITC Population 
 
 
ITC = Intent-to-Capture. SAE = Serious Adverse Events. 
 
Program name: l_16_2_7_1.sas 
Run Date: 21NOV2023 
Subject 
ID 
MedDRA System Organ Class/ 
  Preferred Term/ 
    Investigator AE Term 
Start Date End Date 
Ongoing? SAE? 
SAE 
Criteria Severity 
Relatio 
nship 
to 
Study 
Process 
Any 
Unanticipated 
Adverse 
Device 
Effect 
Outcome 
Caused 
Study 
Discontinu 
ation 
 
 
 
 
 
 
 
 
 
 
 
 
No Data To Report