Respiratory Rate Validation Study - Mindset Medical Informed Vital Core Application
Conditions: Vital Sign Evaluation
Sponsor: Mindset Medical

 
 
Element Boulder 
80 Health Park Drive, Suite 20 
Louisville, Colorado 80027, USA 
TITLE: Respiratory Rate Validation Study – Mindset Medical 
Informed Vital Core Application  
Study ID# PR 2024-593 
Principal Investigator: Monica Rabanal, NP     Site ID # 001 
DOCUMENT NUMBER 
PR# 2024-593 
SHEET   1   of   34 
REV 
1.0 
Confidential & Proprietary  
Clinical Investigation Plan  
Respiratory Rate Validation Study – Mindset Medical Informed Vital 
Core Application 
PR 2024-593 
 
Commercial Sponsor 
Mindset Medical 
12439 N 32 Street 
Phoenix, AZ 85032  
Document 
Ownership 
Document is in accordance with Code of Federal Regulations for Non-Significant Risk Investigations and 
ISO 14155:2020 where applicable 
 
Function, Title 
Name 
Signature 
Date 
 
Element Boulder, Study 
Manager 
Blair Holman, MS 
 
25 June 2024 
 
Document 
Approver 
The document approvers are listed below: 
 
Function, Title 
Name 
Signature 
Date 
 
Element Boulder, 
Medical Director & 
Principal Investigator 
Monica Rabanal, NP 
 
25 June 2024 
 
Element Boulder, 
Quality Assurance 
Manager 
Gil Monos 
25 June 2024 
 
Mindset Medical 
Representative, Senior 
Director, Clinical 
Operations 
Sarah Schermer 
 
 
 
Mindset Medical 
Representative, VP of 
Quality Assurance 
Shannon Gentry 
 
 
 
Revision 
History 
 
Revision 
Date 
Revision Description 
 
Version 1.0 
25 June 2024 
Initial Revision 
 
Author  
Blair Holman, MS 
Study Manager 
Element Boulder 
Avista Adventist Hospital Plaza 
80 Health Park Drive Suite 20 
Louisville, CO 80027 
 
 
 
06 / 25 / 2024
06 / 25 / 2024
Doc ID: 762726837fe7b9fed3cf0c4b481f8f8ec3f2a540

PR 2024-593 Protocol Signature
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Signed
06 / 25 / 2024
20:23:42 UTC
Sent for signature to Shannon Gentry
(shannon@mindsetmedical.com) and Sarah Schermer
(sarah@mindsetmedical.com) from sarah@mindsetmedical.com
IP: 68.186.2.255
06 / 25 / 2024
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06 / 25 / 2024
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Signed by Sarah Schermer (sarah@mindsetmedical.com)
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Viewed by Shannon Gentry (shannon@mindsetmedical.com)
IP: 98.165.175.49
06 / 25 / 2024
20:27:08 UTC
Signed by Shannon Gentry (shannon@mindsetmedical.com)
IP: 98.165.175.49
The document has been completed.
06 / 25 / 2024
20:27:08 UTC

 
 
Element Boulder 
80 Health Park Drive, Suite 20 
Louisville, Colorado 80027, USA 
TITLE: Respiratory Rate Validation Study – Mindset Medical 
Informed Vital Core Application  
Study ID# PR 2024-593 
Principal Investigator: Monica Rabanal, NP     Site ID # 001 
DOCUMENT NUMBER 
PR# 2024-593 
SHEET   1   of   34 
REV 
1.0 
Confidential & Proprietary  
Clinical Investigation Plan  
Respiratory Rate Validation Study – Mindset Medical Informed Vital 
Core Application 
PR 2024-593 
 
Commercial Sponsor 
Mindset Medical 
12439 N 32 Street 
Phoenix, AZ 85032  
Document 
Ownership 
Document is in accordance with Code of Federal Regulations for Non-Significant Risk Investigations and 
ISO 14155:2020 where applicable 
 
Function, Title 
Name 
Signature 
Date 
 
Element Boulder, Study 
Manager 
Blair Holman, MS 
 
25 June 2024 
 
Document 
Approver 
The document approvers are listed below: 
 
Function, Title 
Name 
Signature 
Date 
 
Element Boulder, 
Medical Director & 
Principal Investigator 
Monica Rabanal, NP 
 
25 June 2024 
 
Element Boulder, 
Quality Assurance 
Manager 
Gil Monos 
25 June 2024 
 
Mindset Medical 
Representative, Senior 
Director, Clinical 
Operations 
Sarah Schermer 
 
 
 
Mindset Medical 
Representative, VP of 
Quality Assurance 
Shannon Gentry 
 
 
 
Revision 
History 
 
Revision 
Date 
Revision Description 
 
Version 1.0 
25 June 2024 
Initial Revision 
 
Author  
Blair Holman, MS 
Study Manager 
Element Boulder 
Avista Adventist Hospital Plaza 
80 Health Park Drive Suite 20 
Louisville, CO 80027 
 
 
 

 
 
Element Boulder 
80 Health Park Drive, Suite 20 
Louisville, Colorado 80027, USA 
TITLE: Respiratory Rate Validation Study – Mindset Medical 
Informed Vital Core Application  
Study ID# PR 2024-593 
Principal Investigator: Monica Rabanal, NP     Site ID # 001 
DOCUMENT NUMBER 
PR# 2024-593 
SHEET   2   of   34 
REV 
1.0 
Confidential & Proprietary  
Clinical Investigation Plan  
Respiratory Rate Validation Study – Mindset Medical Informed Vital 
Core Application 
PR 2024-593 
 
Ethics Committee Review 
Salus Institutional Review Board  
2111 West Braker Lane, Suite 100 Austin, TX 78758 
 
Study Procedure 
Respiratory Rate Validation Study – Mindset Medical Informed Vital Core Application  
Study ID# PR 2024-593 
 
Sponsorship / Providing Funding for This Study 
Mindset Medical 
12439 N 32nd Street  
Phoenix, AZ 85032 
 
Principal Investigator & Medical Oversight  
Monica Rabanal, NP 
Medical Director  
80 Health Park Drive 
Louisville, CO 80027 
 
Sub-Investigators  
Blair Holman, MS 
Clinical Study Manager 
80 Health Park Drive 
Louisville, CO 80027 
 
Study Site 
Boulder Element (Formerly Clinimark), Site ID# 001 
Avista Adventist Hospital Plaza, Medical Office Building II 
80 Health Park Drive Suite 20 
Louisville, CO 80027 
 
 

 
 
Element Boulder 
80 Health Park Drive, Suite 20 
Louisville, Colorado 80027, USA 
TITLE: Respiratory Rate Validation Study – Mindset Medical 
Informed Vital Core Application  
Study ID# PR 2024-593 
Principal Investigator: Monica Rabanal, NP     Site ID # 001 
DOCUMENT NUMBER 
PR# 2024-593 
SHEET   3   of   34 
REV 
1.0 
Confidential & Proprietary  
Element Statements 
Confidentiality 
The information contained in this document is confidential and is intended for the use of clinical investigators. It 
will not be copied by or distributed to persons not involved in the clinical investigations of Mindset Medical unless 
such persons are bound by a confidentiality agreement with Element Boulder or Mindset Medical. 
 
Impartiality 
Element Boulder is committed to maintaining impartiality of laboratory and study activities. Personnel are trained 
on processes and protocols are followed to ensure conformity of the activities. Commercial, financial, and other 
pressures are not allowed to compromise the impartiality of laboratory activities. This includes those risks that 
arise from lab activities, lab relationships, or from the relationships of its personnel. 
 
The risk of Impartiality is mitigated by conducting this study according to the mutually agreed upon protocol, 
contractual arrangements, and standards or guidance documents if applicable. 
 
Sponsorship 
Sponsorship/funding of this study is provided by Mindset Medical. Mindset Medical has retained the services of 
Element Boulder to perform study conduct activities on paid participant volunteers as identified in the contractual 
agreement. 
 
Glossary 
● 
CIP - Clinical Investigation Plan  
● 
FDA – Food and Drug Administration 
● 
IRB – Independent Review Board  
● 
ISO – the International Organization for Standardization 
● 
NIST – National Institute of Standards and Technology, NIST is the federal technology agency that works 
with industry to develop and apply technology, measurements, and standards. 
● 
Reference – established accuracy used for clinical evaluations of other instruments 
● 
Device Under Test (DUT) – the device being clinically evaluated   
● 
ECG - Electrocardiogram. Electrical rhythm of the heart 
● 
NSR – Non-Significant Risk  
● 
PPG – Photoplethysmography, optical method used to detect blood volume changes in the microvascular 
bed of tissue 
● 
bpm – beats per minute, in regards to heart or pulse rate 
● 
BPM– Breaths per minute, in regards to respiratory rate 
● 
EtCO2 – End Tidal Carbon Dioxide 
● 
RR – Respiration/Respiratory Rate 
● 
PR – Pulse Rate 
● 
ROI – Region of Interest 
● 
ARMS - Accuracy Root Mean Square 
 
Where: 
o 
ARMS is the accuracy root mean square. 
o 
DUT is the test device during sample i. 
o 
Ref is the Reference Respiratory Rate (EtCO2) during sample i. 
o 
n is the number of points. 

 
 
Element Boulder 
80 Health Park Drive, Suite 20 
Louisville, Colorado 80027, USA 
TITLE: Respiratory Rate Validation Study – Mindset Medical 
Informed Vital Core Application  
Study ID# PR 2024-593 
Principal Investigator: Monica Rabanal, NP     Site ID # 001 
DOCUMENT NUMBER 
PR# 2024-593 
SHEET   4   of   34 
REV 
1.0 
Confidential & Proprietary  
Respiratory Rate Validation Study – Mindset Medical Informed Vital 
Core Application 
PR 2024-593 
Summary 
Objectives of the Clinical Investigation Plan 
The purpose of this study is to conduct a Respiratory Rate accuracy validation comparing the Mindset Medical 
Application to the Reference, an FDA cleared End Tidal Carbon Dioxide monitor (GE Datex-Ohmeda) by manually 
scoring the collected waveform for data analysis.   
 
The procedure, data collection methods, and data analysis follow: 
● 
ISO 14155:2020 Clinical investigation of medical devices for human subjects – Good clinical 
practice (as appropriate). 
● 
Code of Federal Regulations for Nonsignificant Risk Devices 
 
The testing will be conducted in order to obtain a full data set for validation on a minimum of 65 participants.  
Multiple developmental phases may be conducted and will be reviewed for readiness for continuation to 
validation. A first developmental phase of 5 participants will be performed. If modifications are warranted, the 
initial data sets will be used for algorithm development. The full validation set will be collected independent of 
developmental data sets.   
 
Background 
Respiratory Rate is an important physiological measurement in the healthcare setting. The gold standard in 
Respiratory Rate is based off of an airway measurement using end tidal carbon dioxide (EtCO2) respiratory rate. 
 
The medical device studied under this protocol will be the noninvasive and investigational Mindset Medical 
Informed Vital Core Application-RR (IVC App, IVC), a web-based application. All appropriate preliminary testing on 
the device has been successfully performed and demonstrates safety and efficacy for use in human studies prior to 
Element Boulder’s receipt of the devices. 
 
The Informed Vital Core Application is a web-based software application that utilizes existing optical camera 
technology embedded in a smartphone, tablet, laptop, desktop computer, or camera enabled device to capture an 
individual’s physiological parameters including respiration rate (RR). RR is measured using a non-contact method - 
no measurement device is physically connected to the patient. The patient looks directly into the  camera when it 
is active. The IVC-RR App software uses proprietary software algorithms to detect landmarks on the individual’s 
shoulders and chest and track the motion corresponding to each inhalation. The IVC-RR App’s Vital Core Algorithm 
additionally applies signal extraction (including image segmentation, shoulder location identification, shoulder 
movement extraction), signal estimation, and analysis to respiration and accurately estimate RR.  
 
In the proposed commercial application, the IVC Application is delivered to the patient through a unique, one- 
time-use URL. When the URL is clicked, the default web browser opens on the patient device to launch and run the 
IVC-RR App. The measured RR data is transmitted and saved into the Mindset Medical Cloud Database using 
Hypertext Transfer Protocol Secure (HTTPS) methods.  
 
Since the IVC App is a web-based application, it can easily be utilized at a patient’s home without the need for a 
trained clinician, or in hospitals (replacing vital signs carts), physician offices, or clinics. The IVC App will guide a 
user through the workflow of collecting the measurements. 
 

 
 
Element Boulder 
80 Health Park Drive, Suite 20 
Louisville, Colorado 80027, USA 
TITLE: Respiratory Rate Validation Study – Mindset Medical 
Informed Vital Core Application  
Study ID# PR 2024-593 
Principal Investigator: Monica Rabanal, NP     Site ID # 001 
DOCUMENT NUMBER 
PR# 2024-593 
SHEET   5   of   34 
REV 
1.0 
Confidential & Proprietary  
Protocol Overview 
After IRB approval, a minimum of 65 volunteer test participants will be enrolled for the final validation study 
population. A minimum of 5 volunteer test participants will be enrolled for the initial development study. A 
maximum of 120 participants will be enrolled. All participants will be ≥ 22 years of age. The study population will 
be diverse in race, age, gender, BMI, skin tone, and health conditions.  
 
The procedures will be explained to the volunteer test participant and an Informed Consent will be signed by the 
participant. A health form and health screen will be conducted prior to the start of the test. 
 
Participants will be seated to apply the devices and remain seated for the remainder of the study. Each participant 
will be connected to a commonly used End Tidal Carbon Dioxide monitor (GE Datex-Ohmeda). The Device Under 
Test will be set up according to the Instructions for Use and the URL delivery will be initiated by the study staff. The 
end tidal carbon dioxide (EtCO2) manually scored waveform will determine performance of breathing rate metrics 
(Reference). Each participant will be instrumented with a mouthpiece or a nasal cannula that allows for 
measurement of the EtCO2. Participants will also be connected to a 3-lead ECG (reference for pulse rate) and pulse 
oximeter in order to monitor the participant’s vital signs for safety purposes. 
 
The first data sets will be recorded at the participant’s natural breathing rate. The study will commence by 
equipping the patient with the reference device. Once a stable natural breathing rate is attained, the study staff 
will access the URL, and the IVC-RR App will be activated. After the data set at the participant’s natural breathing 
rate, guided breathing rates will be approximately 8, 10, 15, 20, 25, and 30 breaths per minute; with some natural 
variation from these exact numbers and tailored to the participant’s capabilities, such that the rates will increase 
or decrease by 5 from the natural breathing rate. A paced audible breathing app will be used for the volunteer 
participants to follow during inspiration and exhalation periods that result in specific breathing rates. 
 
The breathing pattern on the app will be set to begin near the natural breathing rate of the participant and 
continue to go down by 5 bpm intervals until reaching the breathing rate of 8 bpm. After that, data collection will 
pick back up at the rate above the participant’s normal breathing rate and continue upwards until reaching 30 bpm 
or as high as the participant can tolerate up to 30 bpm. 
 
It is expected that some of the participants may not be able to be evaluated over the entire range as some 
participants may not be able to breathe at the lower and higher breathing rates. In this case, additional data may 
be recorded at their natural breathing rate and/or other ranges that are comfortable for the participant. Once 
stable breathing at specified rate is achieved data will be collected for one to two minutes per breathing rate 
plateau. Between plateaus, the participants using a mouthpiece are allowed to take the mouthpiece out and relax. 
Participants with comorbidities will be monitored to ensure they return to their baseline EtCO2 value between 
data sets. 
 
The respiration rate will be measured simultaneously with the Reference and the Device Under Test (DUT). During 
the stable plateaus at each breathing rate, the DUT will be initiated by the study staff to take a measurement, 
which takes 60 seconds to calculate and report a breathing rate value. Multiple 60 second measurements may be 
taken per breathing rate plateau. The Reference device is recorded continuously. 
 
To ‘Pass’ this test, the Mindset Medical Application must demonstrate a respiratory rate Accuracy root-mean-
square (Arms) of ≤3 breaths per minute when compared to the Reference EtCO2 manually scored waveform. 
 
Study Population 
The study population will include a minimum of 65 adults, ages 22 years and older. A maximum of 120 subjects will 
be enrolled. A minimum of five participants will be enrolled in an initial development phase, with a minimum of 65 
participants completed for the validation phase. 

 
 
Element Boulder 
80 Health Park Drive, Suite 20 
Louisville, Colorado 80027, USA 
TITLE: Respiratory Rate Validation Study – Mindset Medical 
Informed Vital Core Application  
Study ID# PR 2024-593 
Principal Investigator: Monica Rabanal, NP     Site ID # 001 
DOCUMENT NUMBER 
PR# 2024-593 
SHEET   6   of   34 
REV 
1.0 
Confidential & Proprietary  
 
The study population is carefully designed to represent the intended population for the intended use. The study 
population will be diverse in race, age, gender, BMI, skin tone, and health conditions. The health conditions will 
constitute inclusion of healthy controls (to allow testing over the full range of breaths per minute) and disease 
comorbidities (to represent comorbidities such as COPD, CHF, Asthma, Diabetes, Hypertension, and Obesity).  
 
The participants must understand the study and consent to participate by signing the Informed Consent Form. 
Participant enrollment and participation in this clinical study is based on meeting the inclusion criteria and none of 
the exclusion criteria, a satisfactory health screen, and the participant and data demographics needed for the 
study. 
 
Inclusion Criteria 
● 
Participants must have the ability to understand and provide written informed consent or have legally 
authorized representative consent to participate 
● 
Participant must be ≥22 years of age 
● 
Participant must be willing and able to comply with study procedures and duration 
● 
Participants or legally authorized representative must be able to read or write in English 
 
Population Criteria to be Included 
Gender Goals 
● 
At least 30% of the participants will be male 
● 
At least 30% of the participants will be female 
 
Body Mass Index (BMI) Goals 
● 
At least 33% of the participants will be with BMI between 25.0 to 29.9 kg/m2 (overweight) 
● 
At least 33% of the participants will be with BMI > 30.0 kg/m2 (obese) 
 
Skin Tone (Fitzpatrick scale) Goals 
● 
At least 15% of participants will have a light skin tone (Fitzpatrick Scale 1 or 2) 
● 
At least 15% of participants will have a medium skin tone (Fitzpatrick Scale 3 or 4) 
● 
At least 15% of participants will have a dark skin tone (Fitzpatrick Scale 5 or 6) 
 
Race and Ethnicity Distribution Goal – The study will attempt to enroll a race/ethnicity distribution similar to 
population demographics consistent with the 2020 US Census Data 
 
Health Conditions / Disease Comorbidities 
● 
At least 5 participants will have a history of smoking 
● 
At least 2 participants each with the below chronic conditions (self-reported): 
o 
COPD 
o 
CHF 
o 
Asthma 
o 
Hypertension 
o 
Diabetes 
 
Exclusion Criteria 
Participants who meet any of the following criteria will be excluded from the study: 
● 
Participants who refuse or are unable to sign an informed written consent for study 
● 
Participants evaluated by the Investigator and Clinical Staff and found to be medically unsuitable or have 
self-reported health conditions that are currently unstable as identified in the Health Assessment Form 
and Health Screening 

 
 
Element Boulder 
80 Health Park Drive, Suite 20 
Louisville, Colorado 80027, USA 
TITLE: Respiratory Rate Validation Study – Mindset Medical 
Informed Vital Core Application  
Study ID# PR 2024-593 
Principal Investigator: Monica Rabanal, NP     Site ID # 001 
DOCUMENT NUMBER 
PR# 2024-593 
SHEET   7   of   34 
REV 
1.0 
Confidential & Proprietary  
● 
Compromised circulation, injury, or physical malformation of the sensor Region of Interest (ROI) which 
would limit the ability to test ROI needed for the study. (Note: Certain malformations may still allow 
participants to participate if the condition is noted and would not affect the particular areas utilized.)  
● 
Participants with severe contact allergies to standard adhesives, latex or other materials found in pulse 
oximetry sensors, ECG electrodes, or other medical sensors (self-reported) 
● 
Other known health condition, should be considered upon disclosure in health assessment form 
 
Each participant test is expected to take approximately 1-2 hours. It is expected that the data collection will take 2-
3 weeks for final validation. The development and validation phases may not be continuous. There is no additional 
follow-up required for the investigation. 
 
 

 
 
Element Boulder 
80 Health Park Drive, Suite 20 
Louisville, Colorado 80027, USA 
TITLE: Respiratory Rate Validation Study – Mindset Medical 
Informed Vital Core Application  
Study ID# PR 2024-593 
Principal Investigator: Monica Rabanal, NP     Site ID # 001 
DOCUMENT NUMBER 
PR# 2024-593 
SHEET   8   of   34 
REV 
1.0 
Confidential & Proprietary  
Respiratory Rate Validation Study – Mindset Medical Informed Vital 
Core Application 
PR 2024-593 
Table of Contents 
Element Statements 
 
Glossary 
3 
Summary 
4 
Objectives of the Clinical Investigation Plan .............................................................................................................. 4 
Background ................................................................................................................................................................ 4 
Protocol Overview ..................................................................................................................................................... 5 
Study Population ....................................................................................................................................................... 5 
Inclusion Criteria .................................................................................................................................................... 6 
Population Criteria to be Included ......................................................................................................................... 6 
Exclusion Criteria ................................................................................................................................................... 6 
Table of Contents 
8 
Objectives of the Clinical Investigation Plan 
11 
Identification and Description of the Investigational Device 
11 
Data Acquisition System for the Investigational Device .......................................................................................... 12 
Preliminary Investigations and Justifications of the Study ...................................................................................... 12 
Risks and Benefits of the Investigational Device and Clinical Investigation 
12 
ECG Electrodes ......................................................................................................................................................... 12 
Blood Pressure Cuff ................................................................................................................................................. 12 
Sensors..................................................................................................................................................................... 13 
Mouthpiece and Nose clip/Nasal Cannula............................................................................................................... 13 
General Electrical Hazards ....................................................................................................................................... 13 
Benefits .................................................................................................................................................................... 13 
Design of the Clinical Investigation 
13 
Method .................................................................................................................................................................... 13 
Video and/or Photos ................................................................................................................................................ 14 
Equipment ............................................................................................................................................................... 15 
Study Population ..................................................................................................................................................... 16 
Inclusion Criteria .................................................................................................................................................. 16 
Population Criteria to be Included ....................................................................................................................... 16 
Exclusion Criteria ................................................................................................................................................. 16 
Fitzpatrick Scale ................................................................................................................................................... 17 
Duration of Clinical Investigation............................................................................................................................. 18 

 
 
Element Boulder 
80 Health Park Drive, Suite 20 
Louisville, Colorado 80027, USA 
TITLE: Respiratory Rate Validation Study – Mindset Medical 
Informed Vital Core Application  
Study ID# PR 2024-593 
Principal Investigator: Monica Rabanal, NP     Site ID # 001 
DOCUMENT NUMBER 
PR# 2024-593 
SHEET   9   of   34 
REV 
1.0 
Confidential & Proprietary  
Criteria for Study Termination ................................................................................................................................. 18 
Procedure 
19 
Participant Enrollment ............................................................................................................................................. 19 
Setup ........................................................................................................................................................................ 19 
Data Collection ........................................................................................................................................................ 19 
Ending Data Collection ............................................................................................................................................. 20 
Statistical Analysis 
20 
Endpoint / Comparator ............................................................................................................................................ 20 
Sample Size Justification .......................................................................................................................................... 21 
Investigational Review Board (IRB)/Independent Ethics Committee (IEC) 
22 
Monitoring Arrangements ....................................................................................................................................... 22 
Monitoring Plan ....................................................................................................................................................... 23 
Data and Quality Management / Confidentiality .................................................................................................... 23 
Records - Study Documentation / Case Report Forms ............................................................................................ 24 
Subject Documents .................................................................................................................................................. 24 
Data Collection Forms / Case Report Forms ............................................................................................................ 24 
Trial Master Files ..................................................................................................................................................... 24 
Amendments to the Clinical Investigation Plan ....................................................................................................... 25 
Deviations from the Clinical Investigation Plan ....................................................................................................... 25 
Device Accountability .............................................................................................................................................. 25 
Device Deficiencies .................................................................................................................................................. 25 
Packaging and Labeling ............................................................................................................................................ 25 
Storage and Accountability ...................................................................................................................................... 26 
Statement of Compliance ........................................................................................................................................ 26 
Reference Documents ......................................................................................................................................... 26 
Informed Consent Process ....................................................................................................................................... 26 
Safety ....................................................................................................................................................................... 27 
Investigators ........................................................................................................................................................ 27 
Subject ................................................................................................................................................................. 27 
Adverse Event Definitions.................................................................................................................................... 27 
Management of Adverse Event Reporting .............................................................................................................. 28 
Reporting of Serious Adverse Events and / or UADE ............................................................................................... 28 
Sponsor Records and Reports .................................................................................................................................. 28 
Records 21 CFR 812.140 (b) 4,5 ........................................................................................................................... 28 
Reporting 21 CFR 812.150 (b) 1,2,3,5,6,7,8,9,10: ................................................................................................ 28 
Unanticipated Adverse Device Effect .................................................................................................................. 28 

 
 
Element Boulder 
80 Health Park Drive, Suite 20 
Louisville, Colorado 80027, USA 
TITLE: Respiratory Rate Validation Study – Mindset Medical 
Informed Vital Core Application  
Study ID# PR 2024-593 
Principal Investigator: Monica Rabanal, NP     Site ID # 001 
DOCUMENT NUMBER 
PR# 2024-593 
SHEET   10   of   34 
REV 
1.0 
Confidential & Proprietary  
Withdrawal of IRB approval ................................................................................................................................. 28 
Withdrawal of Regulatory Authorities approval .................................................................................................. 29 
Progress Reports .................................................................................................................................................. 29 
Recall and device ................................................................................................................................................. 29 
Final Report ......................................................................................................................................................... 29 
Informed consent ................................................................................................................................................ 29 
Significant risk device determinations – (does not apply to NSR studies) ........................................................... 29 
Other .................................................................................................................................................................... 29 
Investigators Records and Reporting ....................................................................................................................... 29 
Records 21 CFR 812.140 (a)(3)(i) ......................................................................................................................... 29 
Reports 21 CFR 812.150 (a) 1,2,5,7 ..................................................................................................................... 29 
Unanticipated adverse device effects ................................................................................................................. 29 
Withdrawal of IRB approval ................................................................................................................................. 29 
Informed consent ................................................................................................................................................ 30 
Other .................................................................................................................................................................... 30 
Withdrawal, Early Termination or Suspension of the Investigation ........................................................................ 30 
Publication Policy ..................................................................................................................................................... 31 
Appendix A - Protocol Signature Page 
32 
Appendix B: Sample Waveform Scoring Form 
33 
 
 
 
 
 

 
 
Element Boulder 
80 Health Park Drive, Suite 20 
Louisville, Colorado 80027, USA 
TITLE: Respiratory Rate Validation Study – Mindset Medical 
Informed Vital Core Application  
Study ID# PR 2024-593 
Principal Investigator: Monica Rabanal, NP     Site ID # 001 
DOCUMENT NUMBER 
PR# 2024-593 
SHEET   11   of   34 
REV 
1.0 
Confidential & Proprietary  
Respiratory Rate Validation Study – Mindset Medical Informed 
Vital Core Application 
PR 2024-593 
 
Objectives of the Clinical Investigation Plan 
The purpose of this study is to conduct a Respiratory Rate accuracy validation comparing the Mindset Medical 
Application to the Reference, an FDA cleared End Tidal Carbon Dioxide monitor (GE Datex-Ohmeda) by manually 
scoring the collected waveform for data analysis.   
 
The procedure, data collection methods, and data analysis follow: 
● 
ISO 14155:2020 Clinical investigation of medical devices for human subjects – Good clinical 
practice (as appropriate). 
● 
Code of Federal Regulations for Nonsignificant Risk Devices 
 
The testing will be conducted in order to obtain a full data set for validation on a minimum of 65 participants.  
Multiple developmental phases may be conducted and will be reviewed for readiness for continuation to 
validation. If modifications are warranted, the initial data sets will be used for algorithm development. The full 
validation set will be collected independent of developmental data sets.   
 
Identification and Description of the Investigational Device 
Informed Vital Core Application is a web-based software application that utilizes existing optical camera 
technology embedded in a smartphone, tablet, laptop, or desktop computer to capture an individual’s 
physiological parameters including respiration rate (RR). RR is measured using a non-contact method - no 
measurement device is physically connected to the patient. The patient looks directly into the camera while it is 
active. The IVC-RR App software uses proprietary software algorithms to detect landmarks on the individual’s 
shoulders and chest and track the motion corresponding to each inhalation. The IVC-RR App’s Vital Core Algorithm 
additionally applies signal extraction (including image segmentation, shoulder location identification, shoulder 
movement extraction), signal estimation, and analysis to respiration and accurately estimate RR.  
 
In the proposed commercial application, the IVC Application is delivered to the patient through a unique, one- 
time-use URL. When the URL is clicked, the default web browser opens on the patient device to launch and run the 
IVC App. The measured RR data is transmitted and saved into the Mindset Medical Cloud Database using Hypertext 
Transfer Protocol Secure (HTTPS) methods.  
 
 
Figure 1: The Mindset Medical Informed Vital Core Application – The Device Under Test 
 
The intended purpose of the Device Under Test is spot check, non-invasive monitoring on the adult population. 
The software application accompanying acquisition software will be provided by Mindset Medical.  
 
The Mindset Medical Application is for investigational use only and has not been cleared by the FDA.  

 
 
Element Boulder 
80 Health Park Drive, Suite 20 
Louisville, Colorado 80027, USA 
TITLE: Respiratory Rate Validation Study – Mindset Medical 
Informed Vital Core Application  
Study ID# PR 2024-593 
Principal Investigator: Monica Rabanal, NP     Site ID # 001 
DOCUMENT NUMBER 
PR# 2024-593 
SHEET   12   of   34 
REV 
1.0 
Confidential & Proprietary  
 
Instructions for use, storage and handling can be found in the Instructions for Use.. Device model numbers, 
software version, serial numbers, date(s) of use, and subject ID number(s) for the equipment used will be recorded 
on the Case Report Forms.   
 
The safety of the IVC App has been well determined during the recent testing of the PR indication and the 
corresponding documentation is stored in the DHF. The addition of the RR indication does not change the basic 
safety profile and can be considered safe for use in human studies prior to Element Boulder’s receipt of the device.  
The safety documentation may be requested at any time by the Element Boulder staff if it is required.  
Data Acquisition System for the Investigational Device 
The data from the investigational devices/smartphone will be collected by a trained member of Element Boulder, 
separate from the Element Boulder automated data collection system. 
 
Preliminary Investigations and Justifications of the Study 
Mindset Medical is dedicated to developing and applying innovative electronic medical solutions that improve 
patient care in multiple clinical settings. As part of the product development, Mindset Medical retained the 
services of Element Boulder to conduct a respiratory rate accuracy study. 
 
Risks and Benefits of the Investigational Device and Clinical Investigation 
The devices under test in this study are considered non-significant risk devices. The device and use of the device 
under test does not meet the definition of significant risk device under 21 CFR 812.3(m)  
 
For the purpose of this study: 
● 
It is not intended as an implant. 
o 
The Mindset Medical Application is a non-contact, non-invasive software. 
● 
It is not purported or represented to be for use in supporting or sustaining human life, nor does it present 
a potential for serious risk to the health, safety, or welfare of a subject.  
o 
Monitors are not used to support or sustain human life.  
● 
It is not for use of substantial importance in diagnosing, curing, mitigating, or treating disease, or 
otherwise preventing impairment of human health  
o 
Monitors are Class II devices used to measure respiratory rate. They are not used to diagnose, 
cure, mitigate, or treat disease. These devices are typically labeled with a general indication for 
non-invasive measurement of respiratory rate. 
● 
The device as used in this investigation does not present a serious risk to the health, safety, or welfare of 
a subject. 
o 
See below for discussion of risk associated with the device and use of the device. 
 
There are no anticipated risks or adverse device effects to be assessed. There are no contraindications for use 
in the proposed study / study population. There may be other risks to the subject associated with the device 
or procedure that are unforeseeable at this time.  
 
ECG Electrodes  
Materials (such as the adhesive and/or gel contact) used in the electrodes may cause some skin irritations in some 
subjects. Typical skin irritations present with redness of skin and in some cases of sensitivity is an allergic reaction. 
Biocompatibility testing for surface contact electrodes is a requirement of the International Organization of 
Standardization (ISO) 10993 – Biological Evaluation of Medical Devices. The risk in the use of ECG electrodes is 
believed to be minimal. 
 

 
 
Element Boulder 
80 Health Park Drive, Suite 20 
Louisville, Colorado 80027, USA 
TITLE: Respiratory Rate Validation Study – Mindset Medical 
Informed Vital Core Application  
Study ID# PR 2024-593 
Principal Investigator: Monica Rabanal, NP     Site ID # 001 
DOCUMENT NUMBER 
PR# 2024-593 
SHEET   13   of   34 
REV 
1.0 
Confidential & Proprietary  
Hair on the body may need to be shaved in order for the adhesives to work properly.  Shaving the electrode site(s) 
may cause skin irritation or cuts. 
 
Blood Pressure Cuff 
The reported risks associated with non-invasive Blood Pressure (NIBP) include A) slight discomfort upon inflation of 
the cuff, B) possible bruising, C) petechial rash and D) discoloration of the skin beneath the cuff. In rare instances 
the reported risks associated with NIBP include A) peripheral nerve injuries B) skin tear, and C) compartment 
syndrome (swelling of muscles in the limb causing the reduction of the blood supply to the muscle). 
 
Through literature searches of other studies, we found the complications of taking repeated blood pressures were 
temporary and involved either bruising/rash; for example, petechiae rash (less than 2.2%), skin redness/lines 
(0.8%), or tingling/discoloration in the extremity wearing the cuff while the cuff is inflated (0.1%). 
 
It is possible that the test subject may experience an allergic reaction to the material in the cuff.  However, cuffs 
used in this trial utilize standard material that has undergone skin sensitivity testing. The blood pressure cuff is 
used during the initial health screen and for any follow up as necessary. 
 
Sensors 
Sensor placement involves positioning sensors on volunteer subjects in the same manner that is used on 
hospitalized patients. The sensors may be warm to the touch. Under normal operating conditions, no fault 
conditions, the sensors are not expected to overheat. If the sensors are too warm, they will be removed 
immediately.  Clip on and soft reusable sensors exert a minimal amount of pressure. They should not cause 
discomfort. 
 
Adhesive sensors or tape may cause some irritations to the skin in some subjects. Hair on the body may need to be 
shaved in order for the adhesives to work properly.  Shaving the sensor site may cause skin irritation or cuts.  
 
Every effort will be made to minimize products with natural rubber or latex. Products containing natural rubber or 
latex will be identified.  The risk in the use of the sensor is believed to be minimal. 
 
Mouthpiece and Nose clip/Nasal Cannula 
The mouthpiece, nose clip, and nasal cannula are made of soft, flexible plastic so as to minimize the discomfort level 
as much as is reasonably possible. Materials may cause some skin irritations. Insertion and removal of a nasal cannula 
may cause nasal irritation, discomfort, or pain. 
 
General Electrical Hazards 
Electrical hazards are a potential risk with all electrical equipment. The equipment used in this study has been 
designed to meet applicable safety standards. The equipment will be safety and functionally tested prior to subject 
use. The possibility of any electrical hazard is extremely remote. 
 
Benefits 
The benefits to the study are to the advancement of non-invasive medical monitoring of patients by improving 
accuracy and performance of the monitors. There are no direct benefits to the subjects participating in this study 
other than being a paid volunteer. The only alternative to this study is to NOT participate. 

 
 
Element Boulder 
80 Health Park Drive, Suite 20 
Louisville, Colorado 80027, USA 
TITLE: Respiratory Rate Validation Study – Mindset Medical 
Informed Vital Core Application  
Study ID# PR 2024-593 
Principal Investigator: Monica Rabanal, NP     Site ID # 001 
DOCUMENT NUMBER 
PR# 2024-593 
SHEET   14   of   34 
REV 
1.0 
Confidential & Proprietary  
 
Design of the Clinical Investigation 
Method 
The purpose of this study is to conduct a Respiratory Rate accuracy validation comparing the Mindset Medical 
Application to the Reference, an FDA cleared End Tidal Carbon Dioxide monitor (GE Datex-Ohmeda).  
 
The testing will be conducted in order to obtain a full data set for validation on a minimum of 65 participants. 
Multiple developmental phases may be conducted and will be reviewed for readiness for continuation to 
validation. A first developmental phase of 5 participants will be performed. If modifications are warranted, the 
initial data sets will be used for algorithm development.  The full validation set will be collected independent of 
developmental data sets.   
 
This study is a comparative, single-center, non-randomized comparative study in a minimum of 65 participants for 
the final validation. Each participant test is expected to take approximately 1-2 hours. Typically, up to 6 to 8 
participants will be run per day. The overall study process is expected to be completed in 2-3 weeks for 65 
participants. The development and validation phases may not be continuous. 
 
The procedures will be explained to the volunteer test subject and an Informed Consent will be signed by the 
subject. A health form and health screen will be conducted prior to the start of the test. 
 
Participants will be seated to apply the devices and remain seated for the remainder of the study. Each participant 
will be connected to a commonly used End Tidal Carbon Dioxide monitor (GE Datex-Ohmeda). The Device Under 
Test will be set up according to the Instructions for Use and the URL will be initiated by the study staff. The end 
tidal carbon dioxide (EtCO2) manually scored waveform will determine performance of breathing rate metrics 
(Reference). Each participant will be instrumented with a mouthpiece or a nasal cannula that allows for 
measurement of the EtCO2. Participants will also be connected to a 3-lead ECG (reference for pulse rate) and pulse 
oximeter in order to monitor the participant’s vital signs for safety purposes. 
 
The first data sets will be recorded at the participant’s natural breathing rate. The study will commence by 
equipping the patient with the reference device. Once a stable natural breathing rate is attained, the study staff 
will access the URL, and the IVC app will be activated. After the data set at the participant’s natural breathing rate, 
guided breathing rates will be approximately 8, 10, 15, 20, 25, and 30 breaths per minute; with some natural 
variation from these exact numbers and tailored to the participant’s capabilities, such that the rates will increase 
or decrease by 5 from the natural breathing rate... A paced audible breathing app will be used for the volunteer 
participants to follow during inspiration and exhalation periods that result in specific breathing rates. 
 
The breathing pattern on the guided breathing app will be set to begin near the natural breathing rate of the 
participant and continue to go down by 5bpm intervals until reaching the breathing rate of 8 bpm. After that, data 
collection will pick back up at the rate above the participant’s normal breathing rate and continue upwards until 
reaching 30 bpm or as high as the participant can tolerate up to 30 bpm. 
 
It is expected that some of the participants may not be able to be evaluated over the entire range as some 
participants may not be able to breathe at the lower and higher breathing rates. In this case, additional data may 
be recorded at their natural breathing rate and/or other ranges that are comfortable for the participant. Once 
stable breathing at specified rate is achieved data will be collected for one to two minutes per breathing rate 
plateau. Between plateaus, the participants using a mouthpiece are allowed to take the mouthpiece out and relax. 
Participants with comorbidities will be monitored to ensure they return to their baseline EtCO2 value between 
data sets. 
 

 
 
Element Boulder 
80 Health Park Drive, Suite 20 
Louisville, Colorado 80027, USA 
TITLE: Respiratory Rate Validation Study – Mindset Medical 
Informed Vital Core Application  
Study ID# PR 2024-593 
Principal Investigator: Monica Rabanal, NP     Site ID # 001 
DOCUMENT NUMBER 
PR# 2024-593 
SHEET   15   of   34 
REV 
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The respiration rate will be measured simultaneously with the Reference and the Device Under Test (DUT). During 
the stable plateaus at each breathing rate, the DUT will be initiated by the study staff to take a measurement, 
which takes 60 seconds to calculate and report a breathing rate value. Multiple 60 second measurements may be 
taken per breathing rate plateau. The Reference device is recorded continuously. 
 
To ‘Pass’ this test, the Mindset Medical Application must demonstrate a respiratory rate Accuracy root-mean-
square (Arms) of ≤3 breaths per minute when compared to the Reference EtCO2 monitor. 
 
Video and/or Photos 
In this study photographs or video may be taken of the study set up during monitor set up for data collection 
purposes and the Study Sponsor’s internal research and development purposes only. This allows the sponsor to 
analyze the data and observe the monitor set up. Pictures may be taken of any site where we have placed 
equipment. The study equipment will be photographed, however, in some circumstances it may be unavoidable to 
not photograph the subject’s face.  In order to protect the subject’s identity, the name will be kept confidential at 
all times.   
 
A photograph of each patient will be taken will be taken by the IVC App prior to each session and stored in the 
secure Mindset Medical Cloud Database.  
 
Equipment  
Description of MediCollector 
The MediCollector software will be used to collect the reference data.  
● 
Computer with data collection software, able to stream data as it is recorded with the ability to add 
annotations 
● 
Direct cable connection with the Datex-Ohmeda S/5 Multi-parameter Monitor 
● 
Collects a variety of signals including values displayed by the S5 as well as the raw waveforms 
o 
Up to 8 signals can be collected 
 
MediCollector –Signal Channels Examples 
# 
Name 
Description 
Freq. of 
Collection (Hz) 
Units 
1 
SpO2 
Oxygen Saturation 
0.2 
% 
2 
SpO2_Pulse Pulse Rate from SpO2 
0.2 
beats/min 
3 
CO_RR 
Respiratory Rate 
0.2 
breaths/min 
4 
HR_ecg 
Heart Rate from ECG 
0.2 
beats/min 
5 
CO2 
CO2 Concentration (RR 
waveform) 
25 
% 
 
Safety Equipment 
● 
GE Healthcare Datex-Ohmeda S/5 Multi-parameter Monitor, M-NESTPR (K993608) or E-PRESTN 
(K031781) module with ECG and/or SpO2 
● 
GE Healthcare (Datex-Ohmeda) 3900 TruTrak+ (K021955), GE Healthcare S5 Compact Monitor with 
M-NESTPR (K993608) or E-PRESTN (K031781) module, and/or Nellcor N600x Pulse Oximeter 
(K123581) 
● 
Portable oxygen tank, mask, and ambu bag 
● 
Blood pressure cuff and stethoscope 
 
Other Equipment 
● 
Skin Pigmentation Assessment (optional) - The Mexameter MX 18, the Melanin Density meter 
Photonova, Konica Minolta CM-700d, or equivalent 
 

 
 
Element Boulder 
80 Health Park Drive, Suite 20 
Louisville, Colorado 80027, USA 
TITLE: Respiratory Rate Validation Study – Mindset Medical 
Informed Vital Core Application  
Study ID# PR 2024-593 
Principal Investigator: Monica Rabanal, NP     Site ID # 001 
DOCUMENT NUMBER 
PR# 2024-593 
SHEET   16   of   34 
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Supplies for Participant  
● 
Mouthpiece and nose clips or nasal cannula for EtCO2 measurement 
● 
Additional equipment for use with the mouthpiece: 
o 
Ventilation monitoring adaptor with EtCO2 sample line 
o 
EtCO2 sample line  
o 
Respiratory bacterial/viral filter (optional) 
 
Reference  
● 
GE Healthcare Datex-Ohmeda S/5 Multi-parameter Monitor, M-COVX (K001814) or E-CaiO (K051092) 
module (Reference EtCO2) 
 
Investigational Device 
● 
Mindset Medical Informed Vital Core Application with computer, tablet, or phone for data capture 
transfer  
Sponsor Equipment:  
● 
Mindset Medical Provider Platform and login credentials  
  
There are no deviations expected from this investigation plan. Should deviations be needed, discussions will be 
conducted with Mindset Medical, Principal investigator, and reported to the IRB per the reviewing IRB guidelines. 
 
Study Population 
The study population will include a minimum of 65 adults, ages 22 years and older. A maximum of 120 subjects will 
be enrolled. A minimum of five participants will be enrolled in an initial development phase, with a minimum of 65 
participants completed for the validation phase. 
 
The study population is carefully designed to represent the intended population for the intended use. The study 
population will be diverse in race, age, gender, BMI, skin tone, and health conditions. The health conditions will 
constitute inclusion of healthy controls (to allow testing over the full range of breaths per minute) and disease 
comorbidities (to represent comorbidities such as COPD, CHF, Asthma, Diabetes, Hypertension, and Obesity).  
 
The participants must understand the study and consent to participate by signing the Informed Consent Form. 
Participant enrollment and participation in this clinical study is based on meeting the inclusion criteria and none of 
the exclusion criteria, a satisfactory health screen, and the participant and data demographics needed for the 
study. 
 
Inclusion Criteria 
● 
Participants must have the ability to understand and provide written informed consent or have legally 
authorized representative consent to participate 
● 
Participant must be ≥22 years of age 
● 
Participant must be willing and able to comply with study procedures and duration 
● 
Participants or legally authorized representative must be able to read or write in English 
 
Population Criteria to be Included 
Gender Goals 
● 
At least 30% of the participants will be male 
● 
At least 30% of the participants will be female 
 
Body Mass Index (BMI) Goals 
● 
At least 33% of the participants will be with BMI between 25.0 to 29.9 kg/m2 (overweight) 
● 
At least 33% of the participants will be with BMI > 30.0 kg/m2 (obese) 

 
 
Element Boulder 
80 Health Park Drive, Suite 20 
Louisville, Colorado 80027, USA 
TITLE: Respiratory Rate Validation Study – Mindset Medical 
Informed Vital Core Application  
Study ID# PR 2024-593 
Principal Investigator: Monica Rabanal, NP     Site ID # 001 
DOCUMENT NUMBER 
PR# 2024-593 
SHEET   17   of   34 
REV 
1.0 
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Skin Tone (Fitzpatrick scale) Goals 
● 
At least 15% of participants will have a light skin tone (Fitzpatrick Scale 1 or 2) 
● 
At least 15% of participants will have a medium skin tone (Fitzpatrick Scale 3 or 4) 
● 
At least 15% of participants will have a dark skin tone (Fitzpatrick Scale 5 or 6) 
 
Race and Ethnicity Distribution Goal – The study will attempt to enroll a race/ethnicity distribution similar to 
population demographics consistent with the 2020 US Census Data 
 
Health Conditions / Disease Comorbidities 
● 
At least 5 participants will have a history of smoking 
● 
At least 2 participants each with the below chronic conditions (self-reported): 
o 
COPD 
o 
CHF 
o 
Asthma 
o 
Hypertension 
o 
Diabetes 
 
Exclusion Criteria 
Participants who meet any of the following criteria will be excluded from the study: 
● 
Participants who refuse or are unable to sign an informed written consent for study 
● 
Participants evaluated by the Investigator and Clinical Staff and found to be medically unsuitable or have 
self-reported health conditions that are currently unstable as identified in the Health Assessment Form 
and Health Screening 
● 
Compromised circulation, injury, or physical malformation the Region of Interest (ROI) which would limit 
the ability to test ROI needed for the study. (Note: Certain malformations may still allow participants to 
participate if the condition is noted and would not affect the particular areas utilized.)  
● 
Participants with severe contact allergies to standard adhesives, latex or other materials found in pulse 
oximetry sensors, ECG electrodes, or other medical sensors (self-reported) 
● 
Other known health condition, should be considered upon disclosure in health assessment form 
 
Fitzpatrick Scale 
The Fitzpatrick or Monk scale may be used to assess skin tone. The following chart(s) will be used: 
 
Figure 2: The Fitzpatrick Scale 

 
 
Element Boulder 
80 Health Park Drive, Suite 20 
Louisville, Colorado 80027, USA 
TITLE: Respiratory Rate Validation Study – Mindset Medical 
Informed Vital Core Application  
Study ID# PR 2024-593 
Principal Investigator: Monica Rabanal, NP     Site ID # 001 
DOCUMENT NUMBER 
PR# 2024-593 
SHEET   18   of   34 
REV 
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Confidential & Proprietary  
 
 
Figure 3: The Monk Scale (MST)1 
 
Skin Tone Bins 
Skin Tone 
Fitzpatrick Scale 
Monk Scale 
Light  
I and II 
1-4 
Medium  
II and IV 
5-7 
Dark 
V and VI 
8-10 
 
Mexameter Results Interpretation (Mexameter may be used as necessary) 
Meximeter to Fitzpatrick Interpretation 
of Average Melanin Results 
 
Type I 
0-100 
Type II 
101-150 
Type III 
151-250 
Type IV 
251-350 
Type V 
351-450 
Type VI 
451-999 
 
Konica Minolta Results Interpretation, If Used 
The Konica Minolta CM-700d may be used for additional skin pigmentation assessment, but its 
measurements will not be used to determine demographics of the study population. Three 
measurements will be taken at each of the following:  
1. Forehead 
2. Inner bicep 
3. Sensor Site(s) 
 
Each measurement yields a pair of L* and b* values (CIELAB color space). Each pair will be used 
to calculate an Individual Topology Angle (ITA) according to:  
ITAi=arctan(𝐿𝑖∗−50𝑏𝑖∗)180𝜋 
 
The average ITA=13ΣITAi3𝑖=1 of the three measurements at a site will be used to calculate an ITA 
for that measurement site. An average ITA will be calculated for each of the measurement sites. 
These ITA can then later be mapped to skin tone classification scales. 
 
 
1 “Developing the Monk Skin Tone Scale.” Skin Tone Research @ Google AI, Google, skintone.google/the-scale. 

 
 
Element Boulder 
80 Health Park Drive, Suite 20 
Louisville, Colorado 80027, USA 
TITLE: Respiratory Rate Validation Study – Mindset Medical 
Informed Vital Core Application  
Study ID# PR 2024-593 
Principal Investigator: Monica Rabanal, NP     Site ID # 001 
DOCUMENT NUMBER 
PR# 2024-593 
SHEET   19   of   34 
REV 
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Duration of Clinical Investigation 
Each participant test is expected to take approximately 1 – 2 hours. Typically, 6 to 8 participants will be run per 
day. It is expected that the data collection will take 2-3 weeks for final validation. The development and validation 
phases may not be continuous. There is no additional follow-up required for the investigation. 
 
Criteria for Study Termination 
The study will be terminated if any of the following conditions occurs: 
● 
Study is complete 
● 
Subject withdrew consent. The subject may stop the study for any reason without prejudice 
● 
Withdrawal by Sub-Investigator / Investigator 
● 
Study Stopped due to Technical Problems 
● 
Study may be stopped due to Protocol Deviation  
● 
Study Terminated by Sponsor 
● 
Study Stopped due to Adverse Event 
● 
Development of any cardiac arrhythmia 
o 
Except respiratory sinus arrhythmia  
● 
PVCs increasing from baseline at health screening or symptomatic 
 
Any data collected to the point of a decision to terminate the study will be reviewed for inclusion to the analysis 
prior to generation of the final results. Data excluded from the analysis will be documented with justifications for 
the Final validation of the product. During the development phase, usage and removal of the data is at the 
sponsor's discretion.  
 
Procedure 
Participant Enrollment 
1. Explain the procedure to the participant. Have them read the Informed Consent Form and review the 
information answering all questions. Once all questions have been answered, have the participant sign 
and date the ICF. Have the participant complete, sign, and date the Health Assessment Form.  
a. Each participant will be given a copy of the consent form prior to release.  
2. Study Staff will confirm appropriate signatures on the ICF. 
3. The clinician or PI will verbally question the participant about their health history.  
4. Apply Reference ECG leads to the participant. 
5. Record baseline vital signs (for example: SpO2, PR or Heart Rate, ECG rhythm, blood pressure, antecubital 
fossa check, and/or alcohol smell check).  
6. Based on the responses to the Health Assessment form and health assessment, record accepted or 
declined from the study. Continue if accepted into the study. 
 
Setup 
7. Complete equipment setup and checkout prior to starting study.  
8. Set and / or synchronize the computer clocks for the sponsor and Element Boulder data collection 
systems. 
9. Setup and verify communication between the devices and data collection / measurement systems. 
10. Record device information for tracking (manufacturer, model #, serial/lot, hardware/software control 
info).  
11. Record participant information, subject number, and demographics information. 
12. Set up Device Under Test and adjust the position of the cell phone camera as appropriate, ensuring the 
conditions are appropriate for the Device Under Test. 
a. Set up sponsor-provided platform (IVHP) to connect to the DUT for participant data collection. 
13. Apply the nasal cannula to the participant or instruct the participant on how to use the mouthpiece.  

 
 
Element Boulder 
80 Health Park Drive, Suite 20 
Louisville, Colorado 80027, USA 
TITLE: Respiratory Rate Validation Study – Mindset Medical 
Informed Vital Core Application  
Study ID# PR 2024-593 
Principal Investigator: Monica Rabanal, NP     Site ID # 001 
DOCUMENT NUMBER 
PR# 2024-593 
SHEET   20   of   34 
REV 
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Data Collection 
14. Start data recording for the Reference.  
15. Begin the Respiratory Rate evaluation.  
a. Participants will be seated. 
b. Data will be collected for one to two minutes per data set. There will be a sitting time of at least 
one minute before the marking of the start of each data set. Times will be recorded on the CRF 
for start and end of each data set. 
c. 
The data will be continuously recorded electronically from the reference. During the stable 
plateaus at each level, the DUT will be initiated to take a measurement. 
d. Between data sets, the participant may take out the mouthpiece if in use.  
e. Additional study notes that describe the conditions of the test as well as deviations, device 
issues, and any adverse events will be recorded in written documentation. 
16. The first data sets will be recorded at the participant’s natural rate.   
17. A range of stable respiratory rates will be elicited from each volunteer test participant. The rates will be 
approximately 8, 10, 15, 20, 25, and 30 breaths per minute; with some natural variation from these exact 
numbers and tailored to the participant’s capabilities as some participants may not be able to breathe at 
the lower and higher respiratory rates.  A paced breathing app will be used. Once a stable breathing at 
specified rate is achieved data will be collected for one minute. More than one dataset may be collected, 
per clinician discretion and assessment and participant capabilities. 
a. The breathing pattern on the app will be set to begin near the natural respiratory rate of the 
participant and continue to go down by intervals of five BPM until reaching the respiratory rate 
of 8 bpm. After that, data collection will pick back up at the rate above the participant’s normal 
Respiratory Rate and continue upwards until reaching 30 bpm or as high as the subject can 
tolerate up to 30 bpm. If the participant’s natural breathing rate is lower than 8 bpm, the rate of 
8 bpm will be included, and the next rate will be five above the natural rate. 
b. In the case the participant is unable to breathe at higher and lower rates, additional data may be 
recorded at their natural rate and/or other ranges that are comfortable for the participant. 
c. 
Study staff will follow the “IVC Clinical Study Instruction Guide – Respiration Rate” for specific 
device instructions. 
18. At the end of the Respiratory Rate evaluation, stop the Reference recording. Remove the nasal cannula or 
mouthpiece. 
 
Ending Data Collection 
19. Take all equipment off and end the data collection, according to sponsor’s device IFU. 
20. The clinician will review any final questions with the participant and ask if there were any effects from the 
study. The participant will be released with no further follow-up required. 
 
Statistical Analysis  
Element Boulder will perform the statistical analysis for the final validation phase.  
 
Multiple developmental phases may be conducted and will be reviewed for readiness for continuation to 
validation. If modifications are warranted, the initial data sets will be used for algorithm development. The full 
validation set will be collected independent of developmental data sets. An interim analysis may be done on a 
development dataset, following the same endpoint and comparators listed below. 
 
The respiratory rate will be measured simultaneously with the Reference and the Device Under Test (DUT). During 
the stable plateaus at each level, the DUT will be initiated to take a measurement, which takes 60 seconds to 
calculate and report a respiratory rate value. The reference EtCO2 waveform during the matching 60 interval will 

 
 
Element Boulder 
80 Health Park Drive, Suite 20 
Louisville, Colorado 80027, USA 
TITLE: Respiratory Rate Validation Study – Mindset Medical 
Informed Vital Core Application  
Study ID# PR 2024-593 
Principal Investigator: Monica Rabanal, NP     Site ID # 001 
DOCUMENT NUMBER 
PR# 2024-593 
SHEET   21   of   34 
REV 
1.0 
Confidential & Proprietary  
be scored by counting the respiratory peaks per minute. Multiple 60 second measurements may be taken per 
respiratory rate plateau, based on clinician assessment and determination. If multiple datasets are completed on a 
participant, the last one will be used in analysis 
 
The final pairing to be analyzed is Reference manually EtCO2 scored and counted waveforms with the average of 
the simultaneous 60 second period for the DUT. The Accuracy root-mean-square (Arms) will be the basis for 
evaluation and acceptance. 
 
Endpoint / Comparator 
The primary objective of this study is to compare the accuracy of the Device Under Test for the measurement of 
respiratory rate to the Reference, manually scored End Tidal Carbon Dioxide (EtCO2) waveforms. For final 
validation, the EtCO2 waveform will be scored by counting the respiratory peaks per minute. The clinicians 
counting the raw EtCO2 waveform will be blinded to the results from the test device. 
 
The endpoint of interest is accuracy as measured by the Accuracy root-mean-square (Arms) difference between the 
Device Under Test (DUT) and the Reference Respiratory Rate as counted by EtCO2 scored waveform (Ref) for all 
stable respiratory periods where:  
 
 
Mean bias will also be generated: 
 
 
Acceptance Criteria: Passing requires an Arms of ≤3.0 
 
Mean Absolute Difference (MAD), Deming Regression, and Bland-Altman statistics will also be calculated and 
reported. Additional analyses will be performed by demographic cohort 
1. Age (Participants ≤50 years of age, >50 years of age) 
2. Skin Tone (Fitzpatrick Scale 1-6) 
3. BMI (Normal Weight, Overweight, Obese) 
4. Comorbidity vs No Comorbidity reported 
5. Sex (Female and Male) 
 
Sample Size Justification 
This study will utilize a sample size of 65 subjects with 7 to 11 respiratory rate plateaus per participant, providing 
>200 data points over the specified breath per minute range.  
 
Success for this study is defined as ARMS ≤ 3.0. The ARMS statistic measures accuracy of a device under test (DUT) 
when compared to a reference device (REF) over a range of values. Accuracy, measured by the ARMS statistic, can 
be affected by both random and systematic components of error. Here we estimate power to obtain an ARMS ≤ 3.0 
for this study through simulation using parameters estimated from two previous studies conducted by Element 
Boulder. Respiratory rate study 1 composed of 894 data points from 18 study participants. Respiratory rate study 2 
composed of 913 data points from 20 study participants. Both studies had respiratory rate targets of 5, 10, 15, 20, 
25, 30, 35, 40 and 45 breaths per minute. The ARMS statistics are 2.8 and 1.2 for Study 1 and Study 2 respectively. 
For more information about the results and standard respiratory rate metrics please refer to ‘Summary of 
Respiratory Rate Data and Results from Element Boulder Studies’ dated May 1, 2019. These preliminary data 

 
 
Element Boulder 
80 Health Park Drive, Suite 20 
Louisville, Colorado 80027, USA 
TITLE: Respiratory Rate Validation Study – Mindset Medical 
Informed Vital Core Application  
Study ID# PR 2024-593 
Principal Investigator: Monica Rabanal, NP     Site ID # 001 
DOCUMENT NUMBER 
PR# 2024-593 
SHEET   22   of   34 
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contain the features of real data, such as within subject correlation that is present due to repeated measurements 
on the same study participants.  
 
Repeated measures within subjects is a common practice in the pulse oximetry field but is known to potentially 
lead to within subject correlation, which is accounted for in these power estimates. Linear mixed models (LMM) 
were used to estimate parameters for each study in order to take into account repeated measures within subjects. 
DUT was treated as the dependent variable. Subject was treated as a random effect, and REF was treated as a fixed 
effect. Parameter estimates from the mixed model were used as parameter estimates for simulations. The 
variance between subjects in the mixed model results were used to model within individual correlation. Residual 
variance was used to model variance within subjects. The estimated effect of REF was modeled as slope. The 
simulation model also incorporated mean bias. The simulation model was as follows: 
𝐷𝑈𝑇𝑖𝑗= 𝑚× 𝑅𝐸𝐹𝑖𝑗+  𝐵+  𝜎2
𝑏𝑒𝑡𝑤𝑒𝑒𝑛+  𝜎2
𝑤𝑖𝑡ℎ𝑖𝑛 
● 
𝑚 = slope; 𝐵 = mean bias; 𝜎2 = variance; 
● 
𝑖 = measure; 𝑗 = individual 
Simulations were performed for the studies with a range of 10 to 38 individuals and 1 to 5 measurements at each 
respiratory rate target of 5, 10, 15, 20, 25, 30, 35, 40 and 45 breaths per minute, for a total of 145 different study 
size combinations. For each study size, 10,000 simulations were performed and the percentage of simulated 
studies that passed was taken as the estimate of power for that study size combination. Parameter estimates from 
study 1 resulted in the most conservative power estimates, and are as follows: 
𝑚:0.97039 
𝐵: -0.08434 
𝜎2
𝑏𝑒𝑡𝑤𝑒𝑒𝑛: 0.4724 
𝜎2
𝑤𝑖𝑡ℎ𝑖𝑛: 7.04 
Based on parameter estimates from study 1 the following combinations study sizes would have >80% power to 
obtain ARMS ≤ 3: (Subjects x measurements) 27x9, 16x18, 11x27, 10x36. A study design with 30 subjects and 18 
measurements per subject has >80% power to obtain ARMS ≤ 3 given the expectation that the device performs the 
same as Study 1. Statistical modeling and simulations were performed using R (R 3.5.3 GUI El Capitan build, the R 
Foundation for Statistical Computing, 2016). 
 
 
Figure 3 – Plot of estimated power based on the number of subjects and measurements per respiratory rate 
 

 
 
Element Boulder 
80 Health Park Drive, Suite 20 
Louisville, Colorado 80027, USA 
TITLE: Respiratory Rate Validation Study – Mindset Medical 
Informed Vital Core Application  
Study ID# PR 2024-593 
Principal Investigator: Monica Rabanal, NP     Site ID # 001 
DOCUMENT NUMBER 
PR# 2024-593 
SHEET   23   of   34 
REV 
1.0 
Confidential & Proprietary  
Investigational Review Board (IRB)/Independent Ethics Committee (IEC) 
Prior to the start of participant enrollment, the primary investigator will be responsible for obtaining approval from 
the authorized IRB/IEC for the institution at which the proposed clinical investigation is to be conducted. Written 
approval from the IRB/IEC should specifically refer to the investigator, the protocol title and date, and subject 
informed consent date. Written IRB/IEC approval and any conditions of approval imposed by the IRB/IEC will be 
obtained by the primary investigator. 
 
Protocol amendments must also undergo IRB/IEC review and approval at each clinical site. The written approval 
from the IRB/IEC for the amendment should specifically refer to the investigator, the protocol version number and 
title, and any amendment numbers that are applicable. 
 
Monitoring Arrangements 
Element Boulder personnel (Louisville, CO, USA) will provide all monitoring. The Monitor shall be responsible for 
maintaining a record of the findings, conclusions, and actions taken for the results of monitoring the study 
ensuring that: 
 
The monitoring requirements for an NSR device study is identified in 21 CFR 812.2(b) Abbreviated requirements. 
For monitoring an NSR device investigation, the requirement is to comply with 21 CFR 812.46 with respect to 
monitoring investigations: (a) Securing Compliance, (b) Unanticipated adverse device effects, (c) Resumption of 
terminated studies 
● 
Compliance to the signed agreement between the Investigator and sponsor 
● 
The study follows the protocol and any amendments that apply 
● 
Compliance to any conditions of the approval imposed by the IRB or Regulatory Authorities 
 
Additionally:  
● 
The conditions for the study continue to be acceptable 
● 
Accurate, complete, and current records are maintained and required reports are written 
● 
Any adverse effects are documented and reported to the Sponsor and IRB as appropriate 
● 
Monitor activities may include for example:  performing source data verification and requesting 
corrections to feedback forms where potential inconsistencies or missing values are identified. 
● 
Findings of non-compliance or required modifications are reviewed with the investigator and the Sponsor, 
and is presented in a written report to both  
● 
Providing a Monitoring Report at the end of the Clinical Investigation 
 
Monitoring Plan 
1) Informed Consent 
● 
Verify that the consent form was signed prior to any study procedures being conducted  
● 
Verify that the staff conducting the consent is listed for approval on the Delegation of Authority Log 
● 
Ensure that the consent process is documented. 
2) Subject Eligibility 
● 
Verify that the subject meets the inclusion criteria and none of the exclusion criteria. 
3) Baseline Data 
● 
Verify demographic information with the health assessment form 
● 
Check that informed consent time and date is prior to start of the procedure 
4) Verify all CRFs are completed 
5) Adverse Events 
● 
Verify that Adverse Events and Serious Adverse Events / UADEs are being reported accordingly to the IRB 
and Sponsor in the required timeframe. 
6) Protocol Deviations 

 
 
Element Boulder 
80 Health Park Drive, Suite 20 
Louisville, Colorado 80027, USA 
TITLE: Respiratory Rate Validation Study – Mindset Medical 
Informed Vital Core Application  
Study ID# PR 2024-593 
Principal Investigator: Monica Rabanal, NP     Site ID # 001 
DOCUMENT NUMBER 
PR# 2024-593 
SHEET   24   of   34 
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Confidential & Proprietary  
● 
Verity that Protocol Deviations are being reported accordingly to the IRB and Sponsor in the required 
timeframe 
7) Electronic Data Review 
● 
Verify that the filename matches the filename entered on the CRF 
8) Ensure the Trial Master File is complete. 
 
Data and Quality Management / Confidentiality 
A checklist will be maintained identifying the contents of the Trial Master File / Project folder PFC# 2024-593. 
 
The participant’s name and signatures will be recorded on the Informed Consent and Health Assessment Form. The 
data collection form will only use a participant number for the day of the test along with participant demographics. 
A name will not be recorded on the case report form.  
 
Records identifying the participant’s name will be kept in a secured location with either a locked file or locked 
door. Access to these files will be on a limited basis. Potential reviewers of this information include: Element 
Boulder representatives collecting the information and conducting the study, Medical Director for Element 
Boulder, Regulatory Authorities, Department of Health and Human Services (DHHS) agencies, Governmental 
agencies in other countries, Salus Independent Review Board and representatives of the Sponsor. This group may 
use the information to conduct independent audits and reviews to verify compliance of the regulatory 
requirements for these studies but not copy the information.  
 
Data files stored electronically will be associated with a participant based off of participant #, date and by filename 
recorded on the data collection forms. The original device electronic data files will be preserved in its original form. 
Data analysis will be performed as a separate electronic file.   
 
Data files, data collection records with participant demographics and participant number may be additionally 
copied, (after de-identification, if applicable) reviewed and supplied to the commercial sponsor for the study or 
Contractors associated with Element Boulder for data analysis purposes. 
 
All study records will be stored for at least 2 years post the release of the product or project cancellation. The 
investigator will notify sponsor prior to destruction of study records.  Other storage arrangements may be 
executed per contractual agreement between the sponsor and the investigator.  
 
Records - Study Documentation / Case Report Forms 
Respiratory Rate Validation Study – Mindset Medical Informed Vital Core Application 
Element Boulder Study ID# PR 2024-593 
  
Subject Documents 
Provided as separate documents to this protocol: 
● 
Informed Consent form (IRB approved) 
● 
Health Assessment Form (Control # F2000-001-001 Rev 14 or current revision) 
 
Study Conduct Documents: 
● 
CRF 2024-593 – Case Report Forms 
● 
Electronic Files – electronic data collected from the systems 
 
Data Collection Forms / Case Report Forms 
To ensure the quality and integrity of the data, it is the responsibility of the Investigator(s) or designee to complete 
the Case Report Forms (CRFs) for each subject who is enrolled to participate in this study. In some cases, the data 

 
 
Element Boulder 
80 Health Park Drive, Suite 20 
Louisville, Colorado 80027, USA 
TITLE: Respiratory Rate Validation Study – Mindset Medical 
Informed Vital Core Application  
Study ID# PR 2024-593 
Principal Investigator: Monica Rabanal, NP     Site ID # 001 
DOCUMENT NUMBER 
PR# 2024-593 
SHEET   25   of   34 
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Confidential & Proprietary  
collection forms will also be the source document for some information that is not directly collected in the Health 
Assessment Form. The following information will be recorded on the site’s data collection forms (CRF): 
● 
Study date, Subject ID#, Relevant Subject Demographics, Associated Electronic Filename(s) 
● 
Evidence that informed consent was signed and dated prior to the subject participating in the study 
● 
Information for Subject Inclusion or Exclusion to the study 
● 
Equipment calibration and communication check out  
● 
Device usage / sensor placement on the subject 
● 
Baseline vital signs pertinent to the inclusion and exclusion criteria 
● 
Annotations on data point markers, stability, and other observations used in the data analysis 
● 
Protocol Deviation reporting (only if needed) 
● 
Adverse Events reporting (only if needed) 
● 
Device Deficiency reporting (only if needed) 
● 
Study termination  
 
A black or blue pen will be used to record data on the data collection forms. Recorded information should be 
legible and complete. Erroneous entries should be crossed out, corrected with the change, initialed and dated by 
the individual making the correction. The Investigator(s) or designee will sign and date at indicated places on each 
page of the data collection form. The Protocol Deviations Reporting can be signed and dated by the designee only 
if there are no deviations, otherwise the Investigator should review, sign and date. The Adverse Events Reporting 
should be signed and dated by the designee and Principal  Investigator. The Principal Investigator needs to review, 
sign and date all serious adverse events.  The Investigator or designee will provide a final signature indicating that 
a thorough inspection of all subject data has been performed and will thereby certify the contents of the forms. 
The Investigator’s Certification Statement will disclose the overall documentation, study oversight and certification 
of the study.   
  
Trial Master Files 
● 
Document # B3000-000-003 - Adverse Events and Protocol Deviation Reporting System  
● 
Document # F2000-001-029 - Device Deficiency Form 
● 
Document # F2000-001-016 - Device Accountability Form 
● 
Document # F2000-001-015 - Delegation of Authority  
● 
Document # F2000-001-017 - Investigator Financial Interest Disclosure 
● 
Document # F2000-001-022 - Investigator’s Certification Statement 
● 
Document # F2000-001-028 - Subject Enrollment Log 
● 
Document # F2000-001-027 - Site Personnel Training Log 
● 
Document # F2000-001-033 - Site Visit/ Monitoring Log 
● 
Document # F2000-001-034 - Data Clarification Form 
● 
Document # F2000-001-037 - Protocol Deviation Log 
● 
Document # F2000-001-038 - Adverse Events Log 
● 
Document # F2000-001-042 - Adverse Event CRF 
● 
Document # F2000-001-043 - Protocol Deviation Form 
● 
Document # F2000-001-044 - Subject Screening Log 
● 
Document # F2000-001-052 - Device Deficiency Log 
● 
Communications 
● 
Additional documents include: Investigator brochure if provided, PI CV, key staff CV or resumes, 
Correspondence with IRB, IRB voting list, signed contract (optional), insurance certificates, shipping 
records, SIV / Monitoring documentation, names and contacts for key staff & sponsor, relevant sponsor 
correspondence, customer provided documentation, Final report. 
Current revision of documents applies. 
 

 
 
Element Boulder 
80 Health Park Drive, Suite 20 
Louisville, Colorado 80027, USA 
TITLE: Respiratory Rate Validation Study – Mindset Medical 
Informed Vital Core Application  
Study ID# PR 2024-593 
Principal Investigator: Monica Rabanal, NP     Site ID # 001 
DOCUMENT NUMBER 
PR# 2024-593 
SHEET   26   of   34 
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Confidential & Proprietary  
Amendments to the Clinical Investigation Plan 
The sponsor or Element Boulder may need to make protocol changes during the study. Such amendments will be 
documented, reviewed and changes will be submitted to the sponsor for first approval, then to the IRB for 
approval. The sponsor and site will make a decision regarding the continuation of subject enrollment during this 
period. The site may proceed with the amendment upon receipt of IRB approval. 
 
Deviations from the Clinical Investigation Plan 
Investigators are not allowed to deviate from the Clinical Investigation Plan (CIP) except under emergency 
circumstances. Deviations from the CIP to protect the rights, safety and well-being of human subjects may proceed 
without prior approval of the sponsor and the IRB. Such deviations shall be documented and reported to the 
sponsor and the IRB as soon as possible but within 5 working days of the occurrence of such deviation. 
 
Deviations that significantly affect the safety, efficacy, integrity, or conduct of the study must be reported to the 
Sponsor within 5 working days from awareness of occurrence and reported to the IRB per the deviation reporting 
policy. 
 
Deviations that do not affect the safety, efficacy, integrity, or conduct of the study will be documented in the case 
report forms, regulatory binder Protocol Deviation Log as appropriate. 
  
Device Accountability 
A Device Accountability Log will be maintained for the sponsor’s equipment documenting date of receipt, 
description of device (including model#, lot#, serial number or unique code, and quantity) and date of return for 
used and unused product. Device usage will be recorded in the Case Report Form for each individual subject. 
 
Device Deficiencies 
A Device Deficiency Log will be maintained during the study. Upon a device deficiency, a Device Deficiencies Form 
will be filled out and is also marked on the subject’s CRF.  Any device deficiency regarding the operation of the 
device or software or any malfunctions are to be reported to the sponsor. The sponsor will provide a follow up 
investigation to the deficiency. 
 
Packaging and Labeling 
Research conducted for this study will utilize investigational devices and devices cleared through the 510k 
regulatory process. The Sponsor is responsible for packaging and labeling of the device for delivery to the study 
site. Investigational devices or its immediate package shall bear a label with the following information: name and 
place of the manufacturer, packager, or distributor, the quantity of contents, if appropriate, and the following 
statement per 21 CRF Part 812.5 Labeling of investigational devices:  
 
“CAUTION - Investigational device. Limited by Federal (or United States) law to investigational use.” 
 
The label or other labeling shall describe all relevant contraindications, hazards, adverse effects, interfering 
substances or devices, warnings, and precautions. 
 
It is the investigator’s responsibility to ensure the appropriate labelling is visible and remains intact throughout the 
life of the study. 
 
The User Manual / Instructions for Use (IFUs) are provided as separate documents from this protocol. 
 

 
 
Element Boulder 
80 Health Park Drive, Suite 20 
Louisville, Colorado 80027, USA 
TITLE: Respiratory Rate Validation Study – Mindset Medical 
Informed Vital Core Application  
Study ID# PR 2024-593 
Principal Investigator: Monica Rabanal, NP     Site ID # 001 
DOCUMENT NUMBER 
PR# 2024-593 
SHEET   27   of   34 
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Storage and Accountability 
The site will store the investigational product. The storage area should be locked/secure with access limited only to 
approved study staff.  
 
The site will record/track use of the investigational device by each participant. Documentation should verify that 
the device use was in accordance with the approved protocol. Equipment Document in the Case Report Form shall 
provide documentation of the devices used on the study participant(s). 
 
Statement of Compliance 
The study will be conducted in accordance with the Declaration of Helsinki, 21 CFR 50, and 21 CFR 812 for non-
significant risk device study investigations. The study will not commence until the approval has been received from 
the IRB. 
 
Reference Documents 
IRB Approved Informed Consent for Study Title: Respiratory Rate Validation Study – Mindset Medical Informed 
Vital Core Application 
Study ID# PR 2024-593 
● 
ISO 80601-2-61, first edition 2011-04-01, applicable sections, Clause 50 and Annex EE.3 Medical electrical 
equipment — Part 2-61: Particular requirements for basic safety and essential performance of pulse 
oximeter equipment 
● 
World Medical Association Declaration of Helsinki, Ethical Principles for Medical Research Involving 
Human Subjects 
● 
ISO 14155:2020 Clinical investigation of medical devices for human subjects — Good clinical practice 
 
Informed Consent Process 
● 
The Principal Investigator or his / her designee conducts the informed consent process 
● 
Verify that the subject acknowledges ability to read English 
● 
Instruct the subject to ask questions at any time during this process, especially about things they do not 
understand. 
● 
Allow subject sample time to read the entire form and ask questions. 
● 
Give a thorough description of the study and the subject’s involvement – especially explain that they may 
withdraw from the study at any time. 
● 
After the subject has read the form ask if they understand everything 
● 
Ask if they would like to take part in the study and if so explain that they may sign and date the form. 
● 
Once the subject has signed and dated the informed consent, the principal investigator or authorized 
designee will sign and date the form. 
● 
Give a copy of the informed consent to the subject. 
● 
No procedure may be performed before the informed consent is signed by the subject 
 
If an investigator uses a device without obtaining informed consent, the investigator shall report such use to the 
sponsor and the reviewing IRB within 5 working days after the use occurs.  
 
Safety 
Investigators 
All experimenters must review the protocol prior to testing and sign that they read and understood the 
contents. 
 
Subject 
Equipment is checked out for proper functionality prior to being placed on the subject.  

 
 
Element Boulder 
80 Health Park Drive, Suite 20 
Louisville, Colorado 80027, USA 
TITLE: Respiratory Rate Validation Study – Mindset Medical 
Informed Vital Core Application  
Study ID# PR 2024-593 
Principal Investigator: Monica Rabanal, NP     Site ID # 001 
DOCUMENT NUMBER 
PR# 2024-593 
SHEET   28   of   34 
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Confidential & Proprietary  
   
The subject or legal guardians of the subject will review and sign the informed consent following a discussion 
of the test procedure and when all questions regarding the study have been answered and prior to the start of 
any study procedures. The subject will complete the health assessment questionnaire and disclose any 
pertinent issues that may affect his/her health during the test. The subject or legal guardians of the subject 
may withdraw the subject from the study at any time. The subject may be withdrawn per the Procedure 
section. 
 
A clinician will be present to monitor the subject at all times. Safety monitoring includes, SpO2, pulse rate, 
respiratory rate, direct observation and communication with the subject. 
 
Adverse Event Definitions 
The definitions for adverse event, adverse device effect, serious adverse event, serious adverse device effect, 
unanticipated adverse device effect, and their classifications are provided below (ISO 14155, 21 CFR 812.3). 
● 
Adverse Device Effect (ADE): Adverse event related to the use of an investigational medical device 
resulting from insufficiencies or inadequacies in the instructions for use, the deployment, installation, 
the operation, or any malfunction of the investigational medical device or from error use. 
● 
Adverse Event (AE): Any untoward medical occurrence, unintended disease or injury or any untoward 
clinical signs (including an abnormal laboratory finding) in subjects, users or other persons whether or 
not related to the investigational medical device or investigational procedure. 
● 
Anticipated Serious Adverse Device Effects (ASADE): ASADE is an effect which by its nature, 
incidence, severity or outcome has been identified in the risk analysis report. 
● 
Mild: a mild adverse event is one in which the subject is aware of the event, but it is easily tolerated 
without intervention. 
● 
Moderate: a moderate adverse event is one that causes sufficient discomfort to interfere with usual 
activities. 
● 
Serious Adverse Device Effect (SADE): adverse device effect that has resulted in any of the 
consequences characteristic of a serious adverse event. 
● 
Serious Adverse Event (SAE): a serious adverse event is an adverse event that results in death, 
inpatient hospitalization, severe or permanent disability, a life-threatening illness or injury, fetal 
distress, fetal death, a congenital abnormality, a birth defect, or medical or surgical intervention to 
prevent permanent impairment to body or structure.  
● 
Severe: a severe adverse event is one that results in the inability to perform usual activities. 
● 
Unanticipated Adverse Device Effect (UADE): serious adverse device effect which by its nature, 
incidence, severity or outcome has not been identified in the current version of the risk analysis 
report. 
 
Management of Adverse Event Reporting 
Should the subject experience an adverse or non-typical event, assessment of the situation is first initiated, and a 
determination will be made of appropriate actions. The Medical Director and Principal Investigator will be 
contacted as appropriate. Adverse Events are reported through standard Element Boulder Procedures, IRB 
requirements and per Mindset Medical SOPs.   
 
Records of Adverse events will be recorded in the Case Report Form 
The following information will be obtained: 
● 
Type of effect (ADE, AE. ASADE, SADE, SAE, UADE) 
● 
Date of onset and resolution 
● 
Intensity (mild, moderate, severe) 
● 
Serious (yes/no) 

 
 
Element Boulder 
80 Health Park Drive, Suite 20 
Louisville, Colorado 80027, USA 
TITLE: Respiratory Rate Validation Study – Mindset Medical 
Informed Vital Core Application  
Study ID# PR 2024-593 
Principal Investigator: Monica Rabanal, NP     Site ID # 001 
DOCUMENT NUMBER 
PR# 2024-593 
SHEET   29   of   34 
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Confidential & Proprietary  
● 
Relationship to device (unknown, not related, possibly related, probably related, definitely related) 
● 
Anticipated (yes/no) 
● 
Treatment given and / or action taken (procedure stopped, withdrawn from study, no action) 
 
Reporting of Serious Adverse Events and / or UADE 
All SAE’s, SADE, ASADE, and UADE will be reported in writing to the Principal Investigator, Medical Director, 
Sponsor, and IRB as soon as possible and no later than 10 working days after the investigator first learns of the 
event.  
 
If the event resulted in death of a subject, the event shall be reported to the Principal Investigator, Medical 
Director, Sponsor and IRB within 24hrs of knowledge of the event. 
 
Sponsor Records and Reports 
Records 21 CFR 812.140 (b) 4,5 
The following records shall be consolidated in one location and available for inspection and copying by 
Regulatory Authorities:  
● 
The name and intended use of the device and the objectives of the investigation,  
● 
A brief explanation of why the device is not a significant risk device 
● 
The name and address of each investigator 
● 
The name and address of each IRB that has reviewed the investigation 
● 
A statement of the extent to which the good manufacturing practice regulation in part 820 will be 
followed in manufacturing the device  
● 
Any other information required by Regulatory Authorities  
● 
Records concerning adverse device effects (whether anticipated or unanticipated) and complaints   
 
Reporting 21 CFR 812.150 (b) 1,2,3,5,6,7,8,9,10: 
The sponsor shall prepare and submit the following complete, accurate, and timely reports. 
 
Unanticipated Adverse Device Effect 
A sponsor shall immediately conduct an evaluation of an unanticipated adverse device effect. The results of 
such evaluation shall be reported to the Regulatory Authorities, IRB and participating investigators as soon as 
possible and not later than 10 working days after the investigator first learns of the effect.  
 
Withdrawal of IRB approval 
Withdrawal of IRB approval shall be reported to the Regulatory Authorities, IRB and the investigator within 5 
working days after receipt of the withdrawal approval by the sponsor. 
 
Withdrawal of Regulatory Authorities approval 
Withdrawal of Regulatory Authorities approval of an investigation shall be reported by the sponsor to the IRB 
and the investigator within 5 working days after receipt of notice the withdrawal approval. 
 
Progress Reports 
The sponsor shall submit progress reports to the IRB at least yearly. 
 
Recall and device 
The sponsor shall notify Regulatory Authorities and all reviewing IRB's of any request that an investigator 
return, repair, or otherwise dispose of any units of a device. Such notice shall occur within 30 working days 
after the request is made and shall state why the request was made. 
 

 
 
Element Boulder 
80 Health Park Drive, Suite 20 
Louisville, Colorado 80027, USA 
TITLE: Respiratory Rate Validation Study – Mindset Medical 
Informed Vital Core Application  
Study ID# PR 2024-593 
Principal Investigator: Monica Rabanal, NP     Site ID # 001 
DOCUMENT NUMBER 
PR# 2024-593 
SHEET   30   of   34 
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Final Report 
The sponsor shall submit a final report to the IRB within 6 months after termination or completion of the 
investigation. 
 
Informed consent  
The sponsor shall submit to Regulatory Authorities a copy of any report by an investigator under paragraph 
(a)(5) of this section of use of a device without obtaining informed consent, within 5 working days of receipt of 
notice of such use.  
 
Significant risk device determinations – (does not apply to NSR studies) 
If an IRB determines that a device is a significant risk device, and the sponsor had proposed that the IRB 
consider the device not to be a significant risk device, the sponsor shall submit to Regulatory Authorities a 
report of the IRB's determination within 5 working days after the sponsor first learns of the IRB's 
determination.  
 
Other 
A sponsor shall, upon request by a reviewing IRB or Regulatory Authorities, provide accurate, complete, and 
current information about any aspect of the investigation.  
 
Investigators Records and Reporting  
Records 21 CFR 812.140 (a)(3)(i) 
The investigator maintains records of each subject’s case history and exposure to the device and supporting 
data including signed and dated consent forms, health assessment form, and progress notes during the study. 
Records should show evidence that informed consent was signed and dated prior to the subject participating 
in the study.  
 
Reports 21 CFR 812.150 (a) 1,2,5,7 
The investigator shall prepare and submit the following complete, accurate, and timely reports:  
 
Unanticipated adverse device effects 
The investigator shall submit to the sponsor and to the reviewing IRB a report of any unanticipated adverse 
device effect occurring during an investigation as soon as possible, but in no event later than 10 working days 
after the investigator first learns of the effect.  
 
Withdrawal of IRB approval 
The investigator shall report to the sponsor, within 5 working days, a withdrawal of approval by the reviewing 
IRB of the investigator's part of an investigation.  
 
Informed consent 
If an investigator uses a device without obtaining informed consent, the investigator shall report such use to 
the sponsor and the reviewing IRB within 5 working days after the use occurs.  
 
Other 
The investigator shall, upon request by a reviewing IRB or Regulatory Authorities, provide accurate, complete, 
and current information about any aspect of the investigation.  
 

 
 
Element Boulder 
80 Health Park Drive, Suite 20 
Louisville, Colorado 80027, USA 
TITLE: Respiratory Rate Validation Study – Mindset Medical 
Informed Vital Core Application  
Study ID# PR 2024-593 
Principal Investigator: Monica Rabanal, NP     Site ID # 001 
DOCUMENT NUMBER 
PR# 2024-593 
SHEET   31   of   34 
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Confidential & Proprietary  
Withdrawal, Early Termination or Suspension of the Investigation 
Participation in the study is voluntary. The subject may choose to withdraw the subject from the study at any 
point. If a subject officially withdraws from the study, the laboratory staff will document the reason for withdrawal 
in the case report. 
  
Participation in the study may also be stopped at any time by the principal investigator or by the sub-investigators 
or sponsor. 
● 
The subject’s failure to cooperate fully (as determined by the investigator in his or her sole discretion) 
with the required conduct of this study. 
● 
The subject’s development of an illness as determined by the investigator in his or her sole discretion. 
● 
A determination by an Element Boulder representative (in his or her sole discretion), for whatever cause, 
that the study should be discontinued. 
● 
A determination by the sponsor (in his or her sole discretion), for whatever cause, that the study should 
be discontinued 
 
The collection of data for study subjects will cease in the following cases:  
● 
Subject completes all study requirements 
● 
Subject withdraw consent 
● 
Investigator’s decision that it is in subject’s best interest to be discontinued from the study 
● 
Subject death  
● 
Adverse event other than death requiring withdrawal of the subject from the study 
● 
Determination that the subject was ineligible for the study. 
 
There will not be any follow-up procedures for withdrawn or discontinued subjects required, unless a follow-up is 
required at the Investigator’s discretion. 
 
Consideration for early termination or suspension of the investigation is tied to unanticipated equipment failure or 
a decision by the sponsor or the site. Both Mindset Medical and Element Boulder reserve the right to discontinue 
the study at any time for administrative or other reasons. Written notice of study termination will be submitted to 
the investigator in advance of such termination. Termination of a specific site can occur because of, but not limited 
to, inadequate data collection, low subject enrollment, or non-compliance with the protocol or other research 
requirements. 
 
Early termination results when the study is closed prior to the end of the study. A study suspension is a temporary 
postponement of the study activities related to enrollment. Both are possible for the study. If the study is 
terminated or suspended, no additional enrollment will be allowed unless otherwise informed by the sponsor. The 
current subjects will be followed according to the protocol. 
 
If the study is terminated prematurely or suspended by the sponsor/investigator, the sponsor /investigator will 
promptly inform the regulatory authorities (if required) of the termination and the reason(s). IRB/IECs will also be 
promptly informed and provided with the reason(s) for termination or suspension by the sponsor/ investigator. 
The investigator will promptly inform the subjects and assure appropriate follow-up for the subject. 
 
If the investigator (or IRB/IEC) terminates or suspends the investigation the investigator will promptly inform the 
institution (if required) and the IRB/IEC, and provide a detailed written explanation of the termination or 
suspension. The investigator will promptly inform the subjects and assure appropriate therapy and follow-up for 
the subjects. The sponsor will inform the regulatory authorities (if required). 
 
 
Withdrawal of IRB approval shall be reported to the sponsor by the investigator within 2 working days. 
 

 
 
Element Boulder 
80 Health Park Drive, Suite 20 
Louisville, Colorado 80027, USA 
TITLE: Respiratory Rate Validation Study – Mindset Medical 
Informed Vital Core Application  
Study ID# PR 2024-593 
Principal Investigator: Monica Rabanal, NP     Site ID # 001 
DOCUMENT NUMBER 
PR# 2024-593 
SHEET   32   of   34 
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1.0 
Confidential & Proprietary  
In case of early termination of the study, all study subjects should be followed until the resolution of any pending 
adverse event(s). 
 
Publication Policy 
The results of this investigation may be submitted for publication. 

 
 
Element Boulder 
80 Health Park Drive, Suite 20 
Louisville, Colorado 80027, USA 
TITLE: Respiratory Rate Validation Study – Mindset Medical 
Informed Vital Core Application  
Study ID# PR 2024-593 
Principal Investigator: Monica Rabanal, NP     Site ID # 001 
DOCUMENT NUMBER 
PR# 2024-593 
SHEET   33   of   34 
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1.0 
Confidential & Proprietary  
Appendix A - Protocol Signature Page 
 
Protocol No. PR 2024-593 
As the Principal Investigator, I confirm that I have read this protocol, I understand it, and I will work according to 
this protocol and to the ethical principles stated in accordance with the Declaration of Helsinki, 21 CFR 50, 54, 56, 
and 21 CFR 812: or the applicable laws and regulations of the country of the study site for which I am responsible, 
whichever provides the greater protection of the individual. 
● 
Ensuring informed consent of each subject is obtained prior to the start of any study procedure 
● 
Ensuring the investigation is conducted according to the Clinical Investigation Plan, 
● 
Personally conducting or supervising the investigation, 
● 
Protecting the rights, safety, and welfare of participants, 
● 
Preparing and maintaining adequate, current, and complete case histories or records, 
● 
Retaining records for two years following the date the marketing application is approved or withdrawn, 
● 
Furnishing the required reports to the sponsor, including reports of adverse events and study completion, 
● 
Providing timely reports to the IRB, including reports of changes in the research activity needed to avoid 
immediate hazards to participants, unanticipated problems involving risks to participants or others, 
including adverse events to the extent required by the IRB, 
● 
Ensuring that changes are not implemented without prospective IRB approval, unless required to 
eliminate immediate hazard to participants, 
● 
Complying with all FDA or Regulatory Authorities test article requirements, 
● 
Adequately maintaining control of test articles, including appropriate tracking documentation for test 
articles to the extent that such control and documentation are not centrally administered, 
● 
Supervising the use and disposition of the test article, 
● 
Disclosing relevant financial information, and 
● 
Ensuring that all associates, colleagues, and employees assisting in the conduct of the investigation(s) are 
informed about their obligations in meeting the above commitments. 
● 
An investigator shall, upon request by a reviewing IRB, FDA, or other Regulatory Authorities provide 
accurate, complete, and current information about any aspect of the investigation. 
 
 
25 June 2024 
Signature of Investigator 
 
Date 
Monica Rabanal, NP 
 
 
Investigator Name (print or type) 
 
 
Principal Investigator 
 
 
Investigator Title 
 
 
Element Boulder 
 
 
Name of Facility 
 
 
Louisville, CO USA 
 
 
Location of Facility (City, State, Country) 
 
 
 
 
 

 
 
Element Boulder 
80 Health Park Drive, Suite 20 
Louisville, Colorado 80027, USA 
TITLE: Respiratory Rate Validation Study – Mindset Medical 
Informed Vital Core Application  
Study ID# PR 2024-593 
Principal Investigator: Monica Rabanal, NP     Site ID # 001 
DOCUMENT NUMBER 
PR# 2024-593 
SHEET   34   of   34 
REV 
1.0 
Confidential & Proprietary  
Appendix B: Sample Waveform Scoring Form 
Below is an example of the waveform scoring form.  The reviewers counting the raw EtCO2 waveform will be 
blinded to the results from the test device. 
 
 
 
 
Respiratory Rate ________________________________ 
 
 
Scorer Name ________________________________  Date ________________________________ 
 
 
 
Checked by ______________________________________________________ 
 
 
Date ____________________________________________________________