Validation of the Performance of the Electrocardiogram (ECG) Function in the Masimo INVSENSOR00057
Phase: NA
Conditions: Healthy, Atrial Fibrillation
Sponsor: Masimo Corporation

 
 
Official Title: Validation of the performance of 
the electrocardiogram (ECG) function of the 
INVSENSOR00057 
 
Date of Protocol: 16Apr2024 
 
NCT Number: NCT06071754  

 
CLINICAL INVESTIGATION PLAN 
CIP-1085 
Study Title: Validation of the performance of the electrocardiogram (ECG) 
function of the Masimo INVSENSOR00057 
ECGV0001 
Revision: E  
 
CONFIDENTIAL AND PROPRIETARY 
Page 1 of 25 
© 2025 Masimo Corporation (Unpublished) 
DOT-1225 Rev. A 
All Rights Reserved 
CO-072624 
 
 
 
 
                     Clinical Investigation Title: 
Validation of the performance of the electrocardiogram (ECG) 
function of the INVSENSOR00057 
 
 Clinical Investigation Number, Version:  CIP-1085B, Version 5.0 
 
Other Study Identifier: ECGV0001 
 
Study Device(s): Masimo INVSENSOR00057 – Investigational  
 
 Sponsor: 
 
Masimo Corporation 
52 Discovery 
Irvine, California 92618 USA 
 
 
 
 
 

 
CLINICAL INVESTIGATION PLAN 
CIP-1085 
Study Title: Validation of the performance of the electrocardiogram (ECG) 
function of the Masimo INVSENSOR00057 
ECGV0001 
Revision: E  
 
CONFIDENTIAL AND PROPRIETARY 
Page 2 of 25 
© 2025 Masimo Corporation (Unpublished) 
DOT-1225 Rev. A 
All Rights Reserved 
CO-072624 
 
 
Table of Contents 
1. 
Investigator Page ........................................................................................................................................................................ 4 
2. 
Overall synopsis of the clinical investigation ............................................................................................................................. 6 
3. 
Description of the study device ................................................................................................................................................... 7 
4. 
Justification for clinical investigation design plan ...................................................................................................................... 9 
5. 
Benefits and risks of the study devices, clinical procedure, and clinical investigation ............................................................. 10 
5.1. 
Anticipated Clinical Benefits .......................................................................................................................................... 10 
5.2. 
Anticipated Adverse Events ............................................................................................................................................ 10 
5.2.1. 
Risks Associated with the Study Devices ................................................................................................................... 10 
5.2.2. 
Risks Associated with Participation in the Clinical Investigation ............................................................................... 10 
5.2.3. 
Risks Associated with Placement of FDA-cleared 12-lead ECG Electrodes .............................................................. 10 
5.2.4. 
Risks from Inflicted Knowledge ................................................................................................................................. 10 
5.2.5. 
Risks Associated with Study Data .............................................................................................................................. 10 
6. 
Objectives of the clinical investigation ..................................................................................................................................... 11 
7. 
Design of the clinical investigation ........................................................................................................................................... 11 
7.1. 
General ............................................................................................................................................................................ 11 
7.2. 
Investigation Site(s)......................................................................................................................................................... 11 
7.3. 
Definition of Completion of the Clinical Investigation ................................................................................................... 12 
7.4. 
Study Device(s) ............................................................................................................................................................... 12 
7.5. 
Subjects ........................................................................................................................................................................... 12 
7.5.1. 
Inclusion Criteria ........................................................................................................................................................ 12 
7.5.2. 
Exclusion Criteria ....................................................................................................................................................... 12 
7.5.3. 
Number of Subjects..................................................................................................................................................... 13 
7.5.4. 
Subject Classifications ................................................................................................................................................ 13 
7.5.5. 
Study Duration ............................................................................................................................................................ 13 
7.6. 
Study Procedures ............................................................................................................................................................. 13 
7.6.1. 
Subject Recruitment and Pre-screening ...................................................................................................................... 13 
7.6.2. 
Informed Consent and Screening ................................................................................................................................ 13 
7.6.3. 
Study Procedures ........................................................................................................................................................ 14 
7.7. 
Monitoring Plan .............................................................................................................................................................. 14 
8. 
Statistical design and analysis ................................................................................................................................................... 15 
8.1. 
Classification Accuracy Calculations .............................................................................................................................. 16 
8.1.1. 
Data Analysis .............................................................................................................................................................. 16 
8.1.2. 
Sample Size Justification ............................................................................................................................................ 16 
8.1.3. 
Acceptance Criteria ..................................................................................................................................................... 16 
8.2. 
Waveform Comparison Analysis .................................................................................................................................... 16 
8.2.1. 
Data Analysis .............................................................................................................................................................. 16 
8.2.2. 
Sample Size Justification ............................................................................................................................................ 17 
8.2.3. 
Acceptance Criteria ..................................................................................................................................................... 17 
8.3. 
Methodology for evaluating the accuracy of heart rate measurements ........................................................................... 17 
8.3.1. 
Data Analysis .............................................................................................................................................................. 17 
8.3.2. 
Sample size ................................................................................................................................................................. 17 
8.3.3. 
Acceptance Criteria ..................................................................................................................................................... 17 
9. 
Data management ..................................................................................................................................................................... 18 
9.1. 
Data Management and Confidentiality ............................................................................................................................ 18 

 
CLINICAL INVESTIGATION PLAN 
CIP-1085 
Study Title: Validation of the performance of the electrocardiogram (ECG) 
function of the Masimo INVSENSOR00057 
ECGV0001 
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9.2. 
Source Documents........................................................................................................................................................... 18 
9.3. 
Case Report Forms .......................................................................................................................................................... 18 
9.4. 
Data Transfer and Storage ............................................................................................................................................... 18 
9.5. 
Record Retention ............................................................................................................................................................. 19 
10. Amendments to the Clinical Investigation Plan ........................................................................................................................ 19 
11. Deviations from clinical investigation plan .............................................................................................................................. 19 
12. Device accountability ............................................................................................................................................................... 19 
12.1. 
Receipt of Study Device .................................................................................................................................................. 19 
12.2. 
Use of Study Device ........................................................................................................................................................ 20 
12.3. 
Return or Destruction of Study Device ........................................................................................................................... 20 
13. Statements of compliance ......................................................................................................................................................... 20 
14. Informed consent process ......................................................................................................................................................... 20 
15. Adverse events, adverse device effects, and device deficiencies .............................................................................................. 20 
15.1. 
Definitions ....................................................................................................................................................................... 20 
15.2. 
List of Anticipated Adverse Events ................................................................................................................................. 21 
15.2.1. Anticipated Device-Related Adverse Events .............................................................................................................. 21 
15.2.2. List of Non-Reportable Adverse Events ..................................................................................................................... 22 
15.3. 
Adverse Event Reporting ................................................................................................................................................ 22 
15.4. 
Device Deficiencies Reporting ........................................................................................................................................ 22 
16. Vulnerable population............................................................................................................................................................... 22 
16.1. 
Definition ........................................................................................................................................................................ 22 
16.2. 
Protection of Vulnerable Subjects ................................................................................................................................... 22 
16.3. 
Responsible Parties ......................................................................................................................................................... 22 
17. Suspension or premature termination of the clinical investigation ........................................................................................... 23 
17.1. 
Suspension or Termination of Study Site ........................................................................................................................ 23 
17.2. 
Termination of Clinical Investigation/Study due to UADE ............................................................................................ 23 
18. Publication policy ..................................................................................................................................................................... 23 
19. Bibliography ............................................................................................................................................................................. 23 
20. Revision history ........................................................................................................................................................................ 24 
21. Appendices ............................................................................................................................................................................... 25 
21.1. 
Appendix I: Study Workflow .......................................................................................................................................... 25 
21.2. 
Appendix II: Schedule of Events ..................................................................................................................................... 25 
 
 
 

 
CLINICAL INVESTIGATION PLAN 
CIP-1085 
Study Title: Validation of the performance of the electrocardiogram (ECG) 
function of the Masimo INVSENSOR00057 
ECGV0001 
Revision: E  
 
CONFIDENTIAL AND PROPRIETARY 
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1. 
INVESTIGATOR PAGE 
Principal Investigator: 
  
Site 01: Ahmed Alghazi, MD 
Site 02: Jagadeesh Ganji, MD 
Site 03: Paul Drury, MD 
Site 04: Cameron Lambert, MD 
 
Investigation Site(s): 
Address: 
Multicenter study at the following sites:  
Site 01: Masimo Clinical Lab 
52 Discovery 
Irvine, CA 92618 
Site 02: Medication Management 
1910-A North Church Street 
Greensboro, NC 27405 
Site 03: PCA Cardiology 
24022 Calle de la Plata, Suite 500 
Laguna Hills, CA 92653 
 
Site 04: Cone Health 
1200 North Elm Street 
Greensboro, NC 27401 
 
IRB: 
Address: 
WCG IRB 
1019 39th Avenue SE, Suite 120 
Puyallup, Washington 98374 
 
Agreement between Investigator and Sponsor Regarding Responsibilities for Good Clinical Practice 
Sponsor and investigator agree to comply with International Conference of Harmonization (ICH) E6 Good Clinical Practice guidance. International 
Conference of Harmonization (ICH) E6 Good Clinical Practice guidance is an international ethical and scientific quality standard for designing, 
conducting, recording, and reporting trials that involve the participation of human subjects. 
It specifies general requirements intended to: 
x 
Protect the rights, safety and well-being of human subjects, 
x 
Ensure the scientific conduct of the clinical investigation and the credibility of the clinical investigation results, 
x 
Assist sponsors, monitors, investigators, ethics committees, regulatory authorities and other bodies involved in the conformity 
assessment of medical devices. 
The Principal Investigator of the clinical investigation shall: 
x 
Obtain and maintain IRB approval of the study. 
x 
Ensure all subjects are consented prior to enrollment, per FDA Code of Federal Regulations titled 21 CFR 50, unless the investigation 
is granted a waiver of consent by the IRB of record. 
x 
Ensure only appropriately trained personnel will be involved in clinical investigation. 
x 
Maintain study records mentioned in the Clinical Investigation Plan. 
x 
Maintain logs for study team delegation, site visit/monitoring, equipment disposition, study team training, subject recruitment and 
enrollment. 
x 
Evaluate all adverse events and adverse device effects and determine whether the study is safe to continue. 
x 
Allow the sponsor to conduct periodic monitoring of study activities to ensure GCP compliance. 
x 
Not promote non-FDA cleared devices prior to clearance by FDA for commercial distribution, except for academic purposes and 
scientific presentations.  

 
CLINICAL INVESTIGATION PLAN 
CIP-1085 
Study Title: Validation of the performance of the electrocardiogram (ECG) 
function of the Masimo INVSENSOR00057 
ECGV0001 
Revision: E  
 
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The sponsor shall ensure the existence and record of all necessary compliance documents and will conduct monitoring visits to ensure appropriate 
conduct of the study. 
 
The principal investigator’s signature on this page constitutes the investigator’s affirmation that he or she is qualified to conduct the clinical 
investigation, agreement to adhere to all stipulations of this clinical investigation plan, the conditions of the Institutional Review Board (IRB) or 
Research Ethics Committee (REC) approval, federal and local regulatory requirements, 21 CFR 812, ISO 14155, and International Conference on 
Harmonization Good Clinical Practice (ICH GCP) guidance. 
 
 
 
Principal Investigator: 
Title: 
Signature: 
Date: 
 
Principal Investigator 
 
 
Sponsor Representative: 
Title: 
Signature: 
Date: 
William Wilson, MD, MA 
 EVP, Clinical Operations 
 
 

 
CLINICAL INVESTIGATION PLAN 
CIP-1085 
Study Title: Validation of the performance of the electrocardiogram (ECG) 
function of the Masimo INVSENSOR00057 
ECGV0001 
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2. 
OVERALL SYNOPSIS OF THE CLINICAL INVESTIGATION 
Clinical investigation 
title: 
Validation of the performance of the electrocardiogram (ECG) function of the 
INVSENSOR00057 
Study objective(s): 
The objective of this study is to validate the performance of the electrocardiogram (ECG) 
function of the Masimo INVSENSOR00057 against contemporaneous measurements 
from reference 12-lead ECG gold standard.  
Study device(s): 
Masimo devices: 
x 
Masimo INVSENSOR00057 – Investigational  
Comparators: 
x 
FDA-approved 12-lead electrocardiogram (ECG) electrodes and monitors 
Research Equipment: 
x 
Data collection research equipment (e.g., laptops, automated data collection 
software, data collection application, or comparable) 
Number of subjects: 
 Up to 550 subjects (~275 in each group).   
Inclusion criteria: 
x 
Subject is 22 years of age or older. 
x 
Subject is comfortable to read and communicate in English*.  
x 
Subject belongs to one of the two groups:  
o Subjects without prior arrhythmia diagnosis presenting in normal sinus 
rhythm (Group 1) 
o Subjects with history of paroxysmal or persistent atrial fibrillation 
presenting in atrial fibrillation (Group 2). 
*This is to ensure the subject can provide informed consent (as Masimo INVSENSOR00057 ECG study 
materials are currently available in English only) and can comply with study procedures.  
Exclusion criteria: 
x 
Subjects who are physically unable to wear a wristwatch.  
x 
Subjects whose skin is not intact (e.g., has open wounds, has inflamed tattoos or 
piercings, has visible healing wounds) in or at the vicinity of the device 
placement site. 
x 
Subjects with an implantable defibrillator or cardiac pacing device.  
x 
Subjects with a skin condition which would preclude proper ECG electrode 
placement.   
x 
Subjects with known allergic reactions to adhesive tapes or ECG gel.  
x 
Subjects previously diagnosed with lethal cardiac arrhythmia, determined by the 
investigator. 
x 
Subjects not suitable for the investigation at the discretion of the investigator or 
the clinical team.  

 
CLINICAL INVESTIGATION PLAN 
CIP-1085 
Study Title: Validation of the performance of the electrocardiogram (ECG) 
function of the Masimo INVSENSOR00057 
ECGV0001 
Revision: E  
 
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Groups and 
Randomization: 
Two groups of normal sinus rhythm and atrial fibrillation, where subjects are assigned to 
each group based on the clinical interpretation of the reference 12-lead ECG results. To 
ensure equal representation of two groups, a targeted enrollment approach will be taken 
at enrollment sites, where subjects with no known arrythmia (normal sinus rhythm) will 
be recruited at Masimo Clinical Laboratory and subjects with known diagnosis of atrial 
fibrillation will be recruited at external sites.   
x 
NSR - Subjects with no arrhythmia (normal sinus rhythm) based on the clinical 
interpretation of the reference 12-lead ECG results.  
x 
AFib - Subjects with known diagnosis of atrial fibrillation based on the clinical 
interpretation of the reference 12-lead ECG results. 
Duration of the clinical 
investigation: 
The study is anticipated to require ~ 3 months to complete. Subject participation in the 
study will be approximately 30 minutes.  
Study endpoint(s): 
Primary: Evaluate the diagnostic performance of ECG rhythm classification and waveform 
characteristics. 
x 
Sensitivity and specificity of the automatic classification of atrial fibrillation 
(AFib) and normal sinus rhythm (NSR) by the single-lead ECG module of 
INVSENSOR00057 against clinical interpretation of a reference 12-lead ECG. 
x 
Clinician interpretation of ECG waveform characteristics of INVSENSOR00057 
against Lead I ECG of the reference 12-lead ECG, through visual assessment of 
morphology of the INVSENSOR00057 PQRST waveform in comparison to the 
reference 12-lead ECG. 
  
3. 
DESCRIPTION OF THE STUDY DEVICE 
As a leader in hospital pulse oximetry, Masimo brings over 30 years of innovation and breakthrough advances in 
noninvasive blood parameter monitoring to miniaturize its monitoring technology and integrate it into a wristwatch. 
Masimo INVSENSOR00057 (aka Masimo W1™ watch, see Figure 1) offers accurate, continuous health data and 
actionable health insights in a personal, lifestyle-friendly wristwatch. Masimo INVSENSOR00057 provides a variety 
of physiological data for consumers wanting to make better informed health and lifestyle decisions, improve their 
fitness, or track their health data. These parameters include hydration index (Hi), oxygen saturation level (SpO2), pulse 
rate (PR), pulse rate variability (PRV), respiration rate (RRp®), pleth variability index (PVi), perfusion index (Pi). 
Additionally, Masimo INVSENSOR00057 is equipped with an ECG module, which captures the electrical signals of 
the heartbeat and informs user of potential atrial fibrillation (AFib) and their heart rate (HR). This validation study 
pertains to the ECG module of the Masimo INVSENSOR00057. 

CLINICAL INVESTIGATION PLAN
CIP-1085
Study Title: Validation of the performance of the electrocardiogram (ECG)
function of the Masimo INVSENSOR00057
ECGV0001 
Revision: E  
CONFIDENTIAL AND PROPRIETARY
Page 8 of 25
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DOT-1225 Rev. A
All Rights Reserved
CO-072624
As shown in Figure 1, the Masimo INVSENSOR00057 ECG module includes a bottom ECG electrode that is in direct 
contact with the skin at the wrist and a top ECG electrode; a closed electrical circuit is created with the placement of 
fingers (thumb and index) of the opposite hand on the bezel, which allows for an ECG spot check measurement (see
Figure 2). 
With each ECG spot check, Masimo INVSENSOR00057 provides the average heart rate, rhythm classification, and a 
description of the classification as detailed below. 
INVSENSOR00057 Rhythm Classification:
x
Normal Sinus Rhythm 
A Normal Sinus Rhythm ECG classification will indicate that ECG shows signs of a normal regular heartbeat 
with heart rates of 50 to 100 bpm. The ECG output of normal sinus rhythm only applies to the duration of the 
spot-check measurement and does not fully exclude cardiac arrhythmias. Subjects who are not feeling well 
should follow up with their healthcare provider. 
x
Atrial Fibrillation
An atrial fibrillation ECG classification will indicate that ECG shows signs of irregular heartbeat. Atrial 
fibrillation is the most common pathologic cardiac arrhythmia. Masimo INVSENSOR00057 can detect signs 
of atrial fibrillation between heart rates of 50 to 150 bpm. Atrial fibrillation can often be accompanied by a 
rapid heart rate. Subjects who have not been previously diagnosed with atrial fibrillation and consistently 
receive this result or subjects who are not feeling well should consult with their healthcare provider. The 
resulting output does not guarantee the presence or absence of atrial fibrillation or other arrhythmias.  
x
Inconclusive 
An Inconclusive ECG classification indicates that the ECG recording could not be classified, which may be due 
to a number of reasons such as other arrhythmias, pacing, or heart conditions that Masimo INVSENSOR00057
Figure 1. Overview of Masimo INVSENSOR00057. A. Front and Back view of Masimo INVSENSOR00057 B. Masimo 
Health App. Masimo INVSENSOR00057 can be paired with the free Masimo Health App on Android and iOS devices to 
provide users with important health data.
A.
B.
Bottom ECG 
electrode  
Top ECG 
electrode  

 
CLINICAL INVESTIGATION PLAN 
CIP-1085 
Study Title: Validation of the performance of the electrocardiogram (ECG) 
function of the Masimo INVSENSOR00057 
ECGV0001 
Revision: E  
 
CONFIDENTIAL AND PROPRIETARY 
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DOT-1225 Rev. A 
All Rights Reserved 
CO-072624 
 
 
is not designed to detect. It is recommended to repeat the measurement in a few minutes for subjects who get 
this result. An inconclusive classification does not indicate the presence or absence of any arrhythmias 
(including AFib) or other heart conditions. Subjects who consistently receive this result should follow up with 
their healthcare provider, particularly if they are feeling unwell.  
x 
Noise 
This classification of the ECG means the ECG waveform quality and performance were compromised and the 
device cannot report any measurements from the ECG. 
INVSENSOR00057 Heart Rate Classification: 
x 
Low Heart Rate  
A low heart rate ECG classification will indicate a heart rate lower than 50 bpm, which can be commonly due 
to benign causes such as certain medication effects, or a normal finding during rest in particular among well-
conditioned athletes or other cardiovascularly-fit individuals. However, subjects who are not feeling well should 
follow up with their healthcare provider as sometimes very low heart rates can indicate an underlying 
cardiovascular condition. 
x 
High Heart Rate 
A high heart rate ECG classification will indicate heart rates greater than 100 bpm, which can be due to exercise, 
stress, the presence of cardiac arrhythmia, or consumption of alcohol, stimulants or caffeinated drinks. Subjects 
who are not feeling well should follow up with their healthcare provider.  
4. 
JUSTIFICATION FOR CLINICAL INVESTIGATION DESIGN PLAN 
Approximately 60 million individuals worldwide suffer from atrial fibrillation, which is the most common type of 
cardiac arrhythmia.(1) Patients with atrial fibrillation have approximately a 4-fold increased risk of mortality compared 
to the general population.(3) In addition to increased risk of death, atrial fibrillation also increases the risk of heart failure 
and stroke. The imminent risks of stroke can be mitigated with prompt administration of anticoagulants, which relies 
on timely diagnosis of atrial fibrillation.(4, 5)  
Certain populations are more vulnerable to atrial fibrillation than others; studies have indicated that risk factors for 
increased risk include older age, sedentary lifestyle, obesity, diabetes mellitus, thyroid disease, obstructive sleep apnea, 
hypertension, myocardial infarction, heart failure, smoking, and alcohol. (2, 6) Detecting atrial fibrillation in its early 
stages can significantly reduce the high disability and mortality rate. A study reviewing the prevalence of atrial 
fibrillation in 2009 estimated that 700,000 cases were undetected, comprising 13.1% of all cases; half of these projected 
cases of undiagnosed atrial fibrillation were at increased susceptibility to stroke.(7)  
The standard for diagnosis of atrial fibrillation is use of an electrocardiogram (ECG); advancement of this technology, 
especially via wearable technology, for early detection can improve the prognosis for patients and enable them to seek 
medical care before the arrhythmia progresses into more adverse complications. Prior studies have demonstrated 
usability and performance of wrist-wearable ECG spot check devices in the detection of atrial fibrillation.(8) This study 
is designed to validate the performance of Masimo INVSENSOR00057 ECG module in detecting atrial fibrillation in 
adults with persistent or paroxysmal atrial fibrillation who are in atrial fibrillation. 

 
CLINICAL INVESTIGATION PLAN 
CIP-1085 
Study Title: Validation of the performance of the electrocardiogram (ECG) 
function of the Masimo INVSENSOR00057 
ECGV0001 
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5. 
BENEFITS AND RISKS OF THE STUDY DEVICES, CLINICAL PROCEDURE, AND CLINICAL 
INVESTIGATION 
5.1. 
Anticipated Clinical Benefits 
There will be no direct benefit to the enrolled subjects. This is a validation study to support regulatory submission for a 
new wrist-wearable ECG technology, which may enable users to identify potential life-threatening conditions more 
appropriately. 
5.2. 
Anticipated Adverse Events 
The following adverse events are anticipated: 
5.2.1. Risks Associated with the Study Devices 
The noninvasive devices used in this study are similar in technology and design to commercially available FDA-cleared 
devices and hence pose minimal risk to subjects. There is a risk of temporary discomfort to subjects at placement 
locations, including temporary skin irritation. If the device is worn too tight around the wrist, there is potential for a 
pressure injury. In the absence of intact skin (e.g., cuts or abrasions) at or near the application site, the subject will be 
disqualified from the study to avoid potential discomfort.  
5.2.2. Risks Associated with Participation in the Clinical Investigation 
5.2.3. Risks Associated with Placement of FDA-cleared 12-lead ECG Electrodes 
Subjects may be asked to use an alcohol pad or fingertip abrasive pad on application sites of the FDA-cleared 12-lead 
ECG electrodes to allow the electrodes to adhere to the skin. Risks associated with skin preparation include cuts and/or 
abrasions, rash, itching skin, flushing or redness of the skin, unusually warm skin, skin inflammation, and/or skin 
irritation. Each of these discomforts are temporary and should fade over time. 
Subjects may also be asked to shave the site of application of the FDA-cleared 12-lead ECG electrodes application to 
allow the sensors to adhere to the skin. Risks associated with shaving include cuts and/or abrasions, bleeding, infection, 
razor burn, rash, itching skin, flushing or redness of the skin, unusually warm skin, skin inflammation, skin irritation, 
ingrown hairs, and/or inflamed hair follicles. While some of these symptoms may last up to several days after shaving, 
discomforts are temporary and should fade over time. Subjects have the option to decline shaving the electrode 
application sites in the informed consent. Moreover, subjects can stop these measures at any time if they feel 
uncomfortable. 
5.2.4. Risks from Inflicted Knowledge  
The risk of inflicted knowledge will be reduced by assuring the subjects that device readings are for research use only. 
In the case that a subject becomes aware of a condition (arrhythmia, etc.) during the study, study staff will recommend 
that they contact their primary care physician, and will document this recommendation.  
5.2.5. Risks Associated with Study Data 
The other main risk associated with the study is a potential breach of confidentiality which will be minimized by 
limiting the collection of protected health information (PHI) and through secure data storage practices. 

 
CLINICAL INVESTIGATION PLAN 
CIP-1085 
Study Title: Validation of the performance of the electrocardiogram (ECG) 
function of the Masimo INVSENSOR00057 
ECGV0001 
Revision: E  
 
CONFIDENTIAL AND PROPRIETARY 
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DOT-1225 Rev. A 
All Rights Reserved 
CO-072624 
 
 
6. 
OBJECTIVES OF THE CLINICAL INVESTIGATION 
The objective of this study is to validate the performance of the ECG function of the Masimo INVSENSOR00057 
against contemporaneous measurements from reference 12-lead ECG gold standard. Study endpoints are as follows:  
Primary: Evaluate the performance of ECG rhythm classification and waveform characteristics. 
x 
Sensitivity and specificity of the automatic classification of atrial fibrillation (AFib) and normal sinus rhythm 
(NSR) by the single-lead ECG module of INVSENSOR00057 against clinical interpretation of reference 12-
lead ECG. 
x 
Clinician interpretation of ECG waveform characteristics of INVSENSOR00057 against Lead I ECG of the 
reference 12-lead ECG, through visual assessment of the rhythm and morphology of the INVSENSOR00057 
PQRST waveform in comparison to reference 12-lead ECG. (e.g., presence of physiologically interpretable 
waveforms, QRS width, QRS morphology, T morphology, and P presence). 
7. 
DESIGN OF THE CLINICAL INVESTIGATION 
7.1. 
General 
This is a prospective validation study of Masimo INVSENSOR00057 ECG function (see Appendix I for a study 
workflow) in a mix of subjects with and without a diagnosis of AFib. Enrolled subjects will receive training on how to 
take a spot check ECG measurement on Masimo INVSENSOR00057. Subsequently, subjects will wear Masimo 
INVSENSOR00057 and reference 12-lead ECG concurrently for a simultaneous measurement. Clinician interpretation 
of  reference 12-lead ECG classification will be used in classifying subjects to rhythm cohorts and establish the basis 
for analysis of subject data with respect to study endpoints.  
7.2. 
Investigation Site(s) 
This is a multicenter study that will be completed at the sites listed below. 
Site PI 
Site Name and Address 
Target Enrollment 
01 
Ahmed Alghazi, MD 
 
Masimo Clinical Laboratory** 
52 Discovery 
Irvine, CA 92618 
approximately 275 NSR subjects  
02 
Jagadeesh Ganji, MD 
 
Medication Management 
1910-A North Church Street 
Greensboro, NC 27405 
~ 94 AFib subjects (up to 275 
subjects total across the sites where 
AFib subjects will be enrolled) 
03 
Paul Drury, MD 
 
PCA Cardiology 
24022 Calle de la Plata, Suite 500 
Laguna Hills, CA 92653 
~ 94 AFib subjects (up to 275 
subjects total across the sites where 
AFib subjects will be enrolled) 
04 
Cameron Lambert, MD 
Cone Health 
1200 North Elm Street 
Greensboro, NC 27401 
~ 94 AFib subjects (up to 275 
subjects total across the sites where 
AFib subjects will be enrolled) 
** Masimo Clinical Laboratory facility, which is a Phase 1 clinical study research center, is staffed by physicians, anesthesiologists, certified 
registered nurse anesthetists, registered nurses, medical assistants, and clinical research staff. All personnel undergo routine required training on 

 
CLINICAL INVESTIGATION PLAN 
CIP-1085 
Study Title: Validation of the performance of the electrocardiogram (ECG) 
function of the Masimo INVSENSOR00057 
ECGV0001 
Revision: E  
 
CONFIDENTIAL AND PROPRIETARY 
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DOT-1225 Rev. A 
All Rights Reserved 
CO-072624 
 
 
GCP and human research subject protections. The laboratory is equipped with standard FDA-approved medical monitoring equipment including 
ECG monitors, blood pressure monitors, pulse oximeters, standard hematology analyzers, and has emergency crash carts available. Hospitals and 
urgent care facilities are within three miles of the Masimo Clinical Laboratory, in case of an emergency. 
7.3. 
Definition of Completion of the Clinical Investigation 
The study will be considered complete when quality data from approximately 550 subjects have been collected and 
evaluated.  
7.4. 
Study Device(s)  
Masimo devices: 
x 
Masimo INVSENSOR00057 – Investigational  
Comparators: 
x 
FDA-approved 12-lead electrocardiogram (ECG) electrodes and monitors 
Research Equipment: 
Data collection research equipment (e.g., laptops, automated data collection software, data collection application, or 
comparable) 
7.5. 
Subjects 
7.5.1. Inclusion Criteria 
x 
Subject is 22 years of age or older. 
x 
Subject is comfortable to read and communicate in English*.  
x 
Subject belongs to one of the two groups:  
o Subjects without prior arrhythmia diagnosis presenting in normal sinus rhythm (Group 1) 
o Subjections with history of paroxysmal or persistent atrial fibrillation presenting in atrial fibrillation 
(Group 2). 
*This is to ensure the subject can provide informed consent (as Masimo INVSENSOR00057 ECG study materials are currently available in 
English only) and can comply with study procedures. 
7.5.2. Exclusion Criteria 
x 
Subjects who are physically unable to wear a wristwatch.  
x 
Subjects whose skin is not intact (e.g., has open wounds, has inflamed tattoos or piercings, has visible healing 
wounds) in or at the vicinity of the device placement site. 
x 
Subjects with an implantable defibrillator or cardiac pacing device. 
x 
Subjects with a skin condition which would preclude proper ECG electrode placement.   
x 
Subjects with known allergic reactions to adhesive tapes or ECG gel.  
x 
Subjects previously diagnosed with lethal cardiac arrhythmia, determined by the investigator. 
x 
Subjects not suitable for the investigation at the discretion of the investigator or the clinical team. 

 
CLINICAL INVESTIGATION PLAN 
CIP-1085 
Study Title: Validation of the performance of the electrocardiogram (ECG) 
function of the Masimo INVSENSOR00057 
ECGV0001 
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7.5.3. Number of Subjects  
Up to 550 subjects (~ 275 in each group).   
7.5.4. Subject Classifications 
Subjects will be classified according to the criteria below: 
x 
Screened – Subjects who are assessed for study eligibility. 
x 
Enrolled – Subjects who have met all the inclusion criteria, do not meet any exclusion criteria, and have been 
assigned a subject identification number. 
x 
Screen Failure – Subjects who do not meet all the eligibility criteria. (Reason for the subject’s ineligibility will 
be documented on a Screening and Enrollment Log). 
x 
Withdrawn – Subjects who do not complete the study due to reasons listed below: 
ż 
Subject voluntarily opts not to participate. 
ż 
Subject was discontinued from study at the discretion of the clinical team. 
x 
Completed – Subjects with a completed simultaneous ECG measurement using Masimo INVSENSOR00057 
and interpretable 12-lead reference ECG.  
7.5.5. Study Duration 
The study is anticipated to require ~ 3 months to complete. Subject participation in the study will be approximately 30 
minutes. 
7.6. 
Study Procedures 
7.6.1. Subject Recruitment and Pre-screening  
Subjects with no known arrythmia (normal sinus rhythm) will be recruited at Masimo Clinical Laboratory and subjects 
with known diagnosis of atrial fibrillation will be recruited at external sites from medical clinics or cardiology offices.  
Subjects in the AFib cohort may have paroxysmal, persistent, or permanent forms of AFib, and will be determined by 
the referring cardiologist to be in atrial fibrillation at the time of routine office visit.  
7.6.2. Informed Consent and Screening 
Following the identification of a potential eligible subject as defined by the inclusion and exclusion criteria, the subject 
will be informed about the purpose of the study and given an overview of the study procedures. Study staff will explain 
the potential risks and benefits, and discuss the subject’s rights and privacy information. Subjects will be provided with 
ample time to review the consent form and ask questions. The research team will emphasize that participation is 
voluntary and declining participation in the study will not result in any penalty or loss of benefits that the subject is 
otherwise entitled. 
Once the subject’s questions have been answered and the consent documents are signed and dated, the Principal 
Investigator or delegate will also sign the informed consent documents, approving the subject to be enrolled in the study. 
The investigator shall retain the original copy of the signed informed consent documents in each subject’s records and 
provide a copy to the subject. No study related activities shall be conducted until the consent form is signed. 

 
CLINICAL INVESTIGATION PLAN 
CIP-1085 
Study Title: Validation of the performance of the electrocardiogram (ECG) 
function of the Masimo INVSENSOR00057 
ECGV0001 
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Subjects will be screened to determine eligibility for study enrollment. Subjects must meet all inclusion criteria and 
none of the exclusion criteria to participate in the study. All subjects screened will be documented on the Screening 
and Enrollment Log. Subjects who do not meet the eligibility criteria will be considered screen failures and the reason 
for the status of screen failure will be documented on the Screening and Enrollment Log. 
Information on subject demographics, medical history including comorbidities and concurrent medications will be 
collected (see Appendix II). 
7.6.3. Study Procedures 
7.6.3.1. ECG Measurements 
The Masimo INVSENSOR00057 placed on the wrist according to the Investigator Brochure (IB). Site staff will check 
proper application of wrist strap. Next, the reference 12-lead ECG electrodes will be placed. INVSENSOR00057 will 
be paired via Bluetooth connection to the Masimo data collection software on a laptop or Masimo smartphone 
application. Subjects will be asked to rest the arm on which they have worn INVSENSOR00057 on a flat surface during 
the duration of ECG measurement, to minimize movement.  
The subjects will be provided with assistance with INVSENSOR00057placement according to the user manual and 
allowed to practice taking ECG measurements. Once the subject is familiarized with the device, study measurement 
commences.  
A 12-lead ECG reading to classify rhythm cohorts may precede the simultaneous measurement. For the concurrent 
measurement, measurements on the reference 12-lead ECG test will be initiated. During the initiation of reference ECG, 
subjects will be asked to hold the INVSENSOR00057 bezel with their thumb and index fingers for 30 seconds. Study 
personnel will record their observations (e.g., timing and duration of the normal measurement, etc.) on eCRF form.  
The on-site trained research personnel will confirm the ECG recordings are of diagnostic quality prior to removing the 
electrodes.  At the conclusion of the procedure, the 12-lead ECG electrodes and INVSENSOR00057 will be removed. 
7.6.3.2. Data Analysis 
The digital pdf ECG data will be downloaded and provided to Masimo. Three independent board-certified cardiologists 
will be tasked with rhythm classification and evaluating the Masimo INVSENSOR00057 ECG waveform characteristic 
with the Lead I of the corresponding 12-lead reference ECG. PQRST complexes will be identified and used for 
morphology assessment. The paired Masimo INVSENSOR00057 ECG data and the reference 12-lead ECG data will 
be used to determine if Masimo INVSENSOR00057 meets acceptable accuracy and efficacy standards.   
7.7. 
Monitoring Plan 
Oversight for this clinical trial is provided by the sponsor, investigators, and IRB. 
As the sponsor of this clinical investigation, Masimo Corporation is required by 21 CFR Part 812, of the Food and Drug 
Administration regulations to monitor and oversee the progress of the investigation. The monitor(s) assigned by Masimo 
Corporation to this task will be trained on departmental Standard Operating Procedures (SOPs) on conduct and 
monitoring of sponsored studies. 

 
CLINICAL INVESTIGATION PLAN 
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Study Title: Validation of the performance of the electrocardiogram (ECG) 
function of the Masimo INVSENSOR00057 
ECGV0001 
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In accordance with good clinical practices guidelines, there will be at least three scheduled monitoring visits to ensure 
overall regulatory compliance of the study: 
x 
An initiation visit, prior to any subject enrollment to confirm site readiness, and to document training on the 
study protocol and procedures, and use of equipment, 
x 
At least one monitoring visit during initial enrollment, and/or every 2-3 months thereafter. 
x 
A final close out visit after the last subject had finished the study. 
The monitor will contact and visit the investigator and will be allowed, on request, to have access to all source 
documents needed to verify the entries in the CRFs and other GCP-related documents (IRB approvals, IRB 
correspondences, and ICFs), provided that subject confidentiality is maintained in agreement with HIPAA regulations. 
The Investigator will provide the monitor access to all necessary records to ensure the integrity of the data (21 CFR 
812). 
It will be the monitor's responsibility to inspect the CRFs at regular intervals throughout the study, to verify the 
adherence to the CIP and the completeness, consistency and accuracy of the data being entered on them.  
During each visit, the monitor will also verify adherence to the inclusion/exclusion criteria, and documentation of 
SAEs/SADEs and protocol deviations/violations and check the CRF against source documentation. 
After each visit, the monitor will provide a monitoring letter to the Investigator within four weeks of visit completion. 
The monitoring letter will detail the findings and open action items observed during the visit. It is the responsibility of 
the PI and study coordinator(s) to respond to the findings of the monitoring letter and complete any open action items 
as soon as possible but no later than 60 days of receiving the monitoring letter. Any open action items not completed 
within the time allowed may be sufficient grounds for study site suspension or termination; it will be up to the sponsor 
to determine whether any incomplete action items are sufficient grounds for suspension or termination.  
Depending on the quality of the data and/or changes to factors affecting subject safety, additional monitoring visits may 
be necessary at the sponsor’s discretion. 
8. 
STATISTICAL DESIGN AND ANALYSIS 
The study objective is to evaluate the performance of the INVSENSOR00057 rhythm classification and waveform 
characteristics relative to a 12-lead ECG. The INVSENSOR00057 evaluates a 30 second duration, single lead, ECG 
waveform measurement. One of four possible outcomes for each measurement per Table 8a. 
Outcome 
Description 
AFib 
Waveform is classified as atrial fibrillation 
NSR 
Waveform is classified as Normal Sinus Rhythm 
Inconclusive 
INVSENSOR00057 cannot determine the rhythm 
classification 
Noise 
INVSENSOR00057 has determined that the waveform is too 
noisy and does not represent a physiological signal 
 

 
CLINICAL INVESTIGATION PLAN 
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Study Title: Validation of the performance of the electrocardiogram (ECG) 
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Data from subjects where reference 12-lead ECG did not provide readable ECG waveforms (as assessed by medical 
personnel) will be excluded from the primary analysis.  
8.1. 
Classification Accuracy Calculations  
8.1.1. Data Analysis 
Classification accuracy will be measured on all measurements where both the INVSENSOR00057 and the 12-lead 
reference ECG provided a classification of either AFib or NSR. (This incidence rate of Inconclusive and Noise 
outcomes on the INVSENSOR00057 will be evaluated separately.) Sensitivity is the probability that the diagnostic 
test is positive for the disease, given that the subject actually has AFib, while specificity is the probability that the 
diagnostic test is negative, given that the subject does not have AFib (or conversely, has NSR). 
8.1.2. Sample Size Justification 
Sample size was determined to meet simultaneous requirements for both sensitivity and specificity analysis. The 
PASS 20191 software package was used to calculate the appropriate sample size using the “Confidence Intervals for 
One-Sample Sensitivity and Specificity” module.  The Exact Clopper-Pearson formula was used to provide a 95%, 
two-sided, confidence interval with a width no greater than 0.10. (9) This calculation assumed the approximate 
sensitivity and specificity observed in the trial would be 0.95.  Since subjects will be recruited into one of two groups, 
the expected prevalence of AFIB in this sample population was set to 50%.   
Calculations indicate a minimum of 94 subjects with interpretable results are required in each group (total of 188 
subjects in the study) after which a primary analysis will be performed. This number may be increased to 275 in each 
group to match sample sizes reported in predicate device studies (K201168). 
8.1.3. Acceptance Criteria  
6HQVLWLYLW\ 
6SHFLILFLW\ 
339 
Subject Inconclusive UDWH 
8.2. 
Waveform Comparison Analysis  
8.2.1. Data Analysis 
The study will use board certified cardiologists to evaluate both the reference 12 Lead ECG and the 
INVSENSOR00057 single lead ECG. The cardiologists will visually evaluate both waveforms and provide an 
Afib/NSR/Inconclusive/Noise classification for each.  
Similar to the Classification analysis (Section 8.1), the waveform comparison will be measured on all measurements 
where both the INVSENSOR00057 and the 12-lead reference ECG provided a classification of either Afib or NSR. 
(This incidence rate of Inconclusive and Noise outcomes on the INVSENSOR00057 will be evaluated separately.)  
The Area under the ROC curve (AUC) will be used as the agreement metric.  
 
1 PASS 2019 Power Analysis and Sample Size Software (2019). NCSS, LLC. Kaysville, Utah, USA, ncss.com/software/pass. 

 
CLINICAL INVESTIGATION PLAN 
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Study Title: Validation of the performance of the electrocardiogram (ECG) 
function of the Masimo INVSENSOR00057 
ECGV0001 
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8.2.2. Sample Size Justification 
The PASS 20191 software package was used to calculate the appropriate sample size using the “Tests for One ROC 
Curve” module.  This assumes the measured AUC =0.95 with a detection difference of 0.05.  This provides sufficient 
power to detect an AUC below the acceptance criteria of 0.90. 
Calculations indicate the number of subjects in each group should be at least 90 (Total of 180 subjects in the study). 
Since this value will be satisfied by the sample size discussed in Section 8.1, the waveform comparison study will also 
be adequately powered.  
8.2.3. Acceptance Criteria  
$),%YV165$UHD8QGHUWKH&XUYH 90% 
8.3. 
Methodology for evaluating the accuracy of heart rate measurements  
8.3.1. Data Analysis 
Statistical analysis will be used to estimate the agreement between INVSENSOR00057 heart rate output and the 
reference 12-lead ECG. Bias, precision, and accuracy (ARMS) will be calculated per equations 8-10 below. 
 
(8)         ܤ݅ܽݏ (݉݁ܽ݊ ݂݂݀݅݁ݎ݁݊ܿ݁) =
ଵ
ேσ
ܶ݁ݏݐܪܴ௜
ே
௜ୀଵ
െܴ݂݁ܪܴ௜ 
(9)         ܲݎ݁ܿ݅ݏ݅݋݊= ට෌
((்௘௦௧ுோ೔
ಿ
೔సభ
ିோ௘௙ுோ೔)ି஻௜௔௦)మ
ே
 
(10)         ܣݎ݉ݏ (ܽܿܿݑݎܽܿݕ) = ට෌
(்௘௦௧ுோ೔
ಿ
೔సభ
ିோ௘௙ுோ೔)మ
ே
 , ܣݎ݉ݏ= ξܤ݅ܽݏଶ+ ܲݎ݁ܿ݅ݏ݅݋݊ଶ 
 
ݓ݄݁ݎ݁ ܰ ݅ݏ ݐ݄݁ ݐ݋ݐ݈ܽ ݊ݑܾ݉݁ݎ ݋݂ ݉݁ܽݏݑݎ݁݉݁݊ݐݏ ܽ݊݀ ݅ ݅ݏ ܽ ݏ݈݅݊݃݁ ݉݁ܽݏݑݎ݁݉݁݊ݐ 
 
8.3.1.1. Data Exclusion Criteria 
Points where the reference 12-lead ECG does not provide any HR measurements will be excluded. Rate of data 
exclusion for reference and test ECG will be reported.  
8.3.2. Sample size  
It is not possible to control the subject heart rate during this study, so it is not possible to validate the entire range of 
heart rate (25-240 BPM).  Further, the heart rate of Afib patients is ill defined, so a comparison in this cohort is not 
possible. 
Therefore, the data collected in this study for the NSR cohort only will be used as a convenience sample of the 
INVSENSOR00057 heart rate output. 
8.3.3. Acceptance Criteria 
ARMSE 5 bpm over the clinical range found in the normal sinus rhythm cohort.   
The INVSENSOR00057 full range of 25-240 BPM is validated separately using ECG simulators.  

 
CLINICAL INVESTIGATION PLAN 
CIP-1085 
Study Title: Validation of the performance of the electrocardiogram (ECG) 
function of the Masimo INVSENSOR00057 
ECGV0001 
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9. 
DATA MANAGEMENT 
9.1. 
Data Management and Confidentiality 
All documents associated with this protocol will be securely stored in a physical location or on password-protected 
computers. The confidentiality and retention of these documents will be protected to the extent provided and required 
by the law. All data will be de-identified before any statistical analysis. Only de-identified data will be shared with 
Masimo for research purposes stated in this protocol. Data collected by the eCRF data capture software will be shared 
with Masimo via a secure, password-protected server that only study staff and Masimo study team members will have 
access to. Data will be retained for a minimum of two years following completion of the final analysis. 
9.2. 
Source Documents 
Source data is all information, original records of clinical findings, observations, or other activities in a clinical trial 
necessary for the reconstruction and evaluation of the trial. Source data are contained in source documents. Examples 
of these original documents and data records include hospital records, clinical and office charts, laboratory notes, 
memoranda, recorded data from automated instruments, and copies or transcriptions certified after verification as being 
accurate and complete. 
9.3. 
Case Report Forms 
The site shall capture study data in case report forms (CRFs) for each subject enrolled, to be provided to the sponsor. 
CRFs may be in paper or electronic format through electronic data capture (EDC) software. Masimo shall ensure that 
systems used for electronic CRFs are compliant with the requirements of 21 CFR Part 11 and ISO / IEC 27001 
certification. The CRFs will be completed and signed by the PI or delegate. This also applies to those subjects who fail 
to complete the study. 
If a subject withdraws from the study, the reason must be noted on the CRF. The CRFs are to be completed on an 
ongoing (weekly) basis. CRF entries and corrections will only be performed by study site staff, authorized by the 
investigator. For paper CRFs, entries and corrections to the CRF will be made following good documentation practices 
(GDP). 
The CRF may include the following information, including but not limited to: inclusion/exclusion criteria, demographic 
information, co-morbidities, device readings, occurrence of any adverse events and protocol deviation, and device 
deficiencies, if any. The CRFs will be signed by the PI or delegate to attest that the data are complete and accurate.  
CRF entries will be checked by the study monitor and any errors or inconsistencies will be queried to the site on an 
ongoing basis. Any changes made within an electronic CRF will be tracked by audit trail. Any changes on a paper CRF 
will be made directly on the CRF and will be initialed and dated by the person making the change. Query resolution 
will be assessed and confirmed by study monitor during site visit.  
9.4. 
Data Transfer and Storage 
Original paper CRFs will be stored in a secure location at the site. Copy of the original paper CRFs may be scanned and 
sent to sponsor. If using electronic CRFs, the site staff will be assigned unique usernames and passwords for data 
security. Final copies of the electronic CRFs in EDC are stored on a secure server. 

 
CLINICAL INVESTIGATION PLAN 
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Only authorized sponsor personnel will have access to study data and will move it to a secure and backed-up drive at 
Masimo.  
CRFs will be checked for completeness and if there are inconsistent or missing data points, queries will be generated. 
If delegated study staff are to correct the paper CRF, they shall follow GDP practices to strike through old entry, add in 
new entry, initial and date it, and provide the corrected information to sponsor. Corrections made to electronic CRFs 
will be tracked by audit trail and require PI or delegate sign-off.   
9.5. 
Record Retention 
Study data will be retained for the necessary period of time as required by regulations. Study records shall be retained 
for a minimum of two years after study closure.  
10. 
AMENDMENTS TO THE CLINICAL INVESTIGATION PLAN 
Any changes made to the clinical investigational plan/study protocol will be documented by way of an amendment. 
Before submitting a protocol amendment to the IRB, the protocol amendment must be agreed upon and signed by both 
the PI and the sponsor. The protocol amendment will be submitted to the IRB for approval. At a minimum, a redline 
version and a clean version of the new protocol amendment will be kept on file by the PI and the sponsor. Protocol 
amendments will need to be version controlled. Both PI and sponsor will retain the IRB approval letter as confirmation 
that the protocol amendment was approved. 
11. 
DEVIATIONS FROM CLINICAL INVESTIGATION PLAN 
Deviations from the protocol must receive both sponsor and the investigator’s IRB/ethics committee approval before 
they are initiated, with the exception that under emergency circumstances, deviations from the Clinical Investigation 
Plan to protect the rights, safety and well-being of human subjects may proceed without prior approval of the sponsor 
or the IRB/ethics committee.   
Any protocol deviations initiated without sponsor and the investigator’s IRB/ethics committee approval that may affect 
the scientific soundness of the study, or affect the rights, safety, or welfare of study subjects, must be documented and 
reported to the sponsor and to the investigator’s IRB/ethics committee as soon as a possible, but no later than 5 working 
days after the occurrence of the protocol deviation. In addition to documenting deviations on the CRF, the Protocol 
Deviation Form may also be used. If protocol deviations continue to occur frequently at a study site, a corrective and 
preventive action (CAPA) may be opened by the sponsor.  
Withdrawal of IRB approval: An investigator shall report to the sponsor a withdrawal of approval by the investigator’s 
reviewing IRB as soon as possible, but no later than five working days of the IRB notification of withdrawal of approval. 
12. 
DEVICE ACCOUNTABILITY 
12.1. 
Receipt of Study Device 
Upon receipt of the study device supplies, an inventory must be performed and the device accountability log filled out 
and signed by the person accepting the shipment. It is important that the designated study staff counts and verifies that 
the shipment contains all the items noted in the shipment inventory. Any damaged or unusable study devices in a given 
shipment will be documented in the study files. The investigator must notify the study sponsor of any damaged or 
unusable study devices that were supplied to the investigator’s site. 

 
CLINICAL INVESTIGATION PLAN 
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Study Title: Validation of the performance of the electrocardiogram (ECG) 
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12.2. 
Use of Study Device 
Use of device will be documented in the CRF for each subject. Any unused devices must be returned to the sponsor at 
the end of the study or before product expiration date. 
12.3. 
Return or Destruction of Study Device 
At the completion of the study, there will be a final reconciliation of study devices shipped, devices used, and devices 
remaining.  This reconciliation will be logged on the device accountability log. Any discrepancies noted will be 
investigated, resolved, and documented prior to return or destruction of unused study devices. Devices destroyed onsite 
will only be upon written instruction from the sponsor and will be documented in the study files. When a Masimo device 
deficiency is observed, every effort should be made to return the device and its packaging to the sponsor in a timely 
manner. 
13. 
STATEMENTS OF COMPLIANCE 
This document is a clinical investigational plan for a human research study sponsored by Masimo Corporation. The 
study will be conducted in accordance with the ethical principles that have their origin in the Declaration of Helsinki. 
By participating in the study, the Investigator agrees to adhere to all stipulations of this protocol, the conditions of the 
IRB or Research Ethics Committee approval, federal and local regulatory requirements, 21 CFR 812, ISO-14155, ICH 
GCP guidance. 
The protocol, ICFs, recruitment materials, and all subject materials will be submitted to the IRB for review and approval. 
Approval of both the protocol and the consent form must be obtained before any subject is enrolled. Any amendment 
to the protocol will require review and approval by the IRB before the changes are implemented to the study. 
14. 
INFORMED CONSENT PROCESS 
See subsection on Informed Consent under Study Procedures. 
15. 
ADVERSE EVENTS, ADVERSE DEVICE EFFECTS, AND DEVICE DEFICIENCIES 
15.1. 
Definitions 
The definitions for adverse event, adverse device effect, serious adverse event, serious health threat, serious adverse 
device effect, and unanticipated adverse device effect, device deficiencies are provided below (ISO 14155, 21 CFR 
812.3(s)). 
x 
adverse event: untoward medical occurrence, unintended disease or injury, or untoward clinical signs (including 
abnormal laboratory findings) in subjects, users or other persons, whether or not related to the investigational 
medical device and whether anticipated or unanticipated (ISO 14155) 
x 
adverse device effect: adverse event related to the use of an investigational medical device 
x 
serious adverse event: adverse event that led to any of the following:  
ż 
a) death 
ż 
b) serious deterioration in the health of the subject, users, or other persons as defined by one or more 
of the following: 

 
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 
1) a life-threatening illness or injury, or 
 
2) a permanent impairment of a body structure or a body function including chronic diseases, 
or 
 
3) in-subject or prolonged hospitalization, or 
 
4) medical or surgical intervention to prevent life-threatening illness or injury, or permanent 
impairment to a body structure or a body function, 
o c) fetal distress, fetal death, a congenital abnormality, or birth defect including physical or mental 
impairment 
Note: Planned hospitalization for a pre-existing condition, or a procedure required by the Clinical Investigation 
Plan, without serious deterioration in health, is not considered a serious adverse event. 
x 
serious health threat: signal from any adverse event or device deficiency that indicates an imminent risk of death 
or a serious deterioration in the health of subjects, users or other persons, and that requires prompt remedial 
action for other subjects, users or other persons. 
Note: This would include events that are of significant and unexpected nature such that they become alarming 
as a potential serious health hazard or possibility of multiple deaths occurring at short intervals. 
x 
serious adverse device effect: adverse device effect that has resulted in any of the consequences characteristic 
of a serious adverse event 
x 
unanticipated serious adverse device effect: serious adverse device effect which by its nature, incidence, 
severity or outcome has not been identified in the current risk assessment 
Note: Anticipated serious adverse device effect (ASADE) is an effect which by its nature, incidence, severity 
or outcome has been identified in the risk assessment. 
x 
device deficiency: inadequacy of a medical device with respect to its identity, quality, durability, reliability, 
usability, safety or performance 
Note 1: Device deficiencies include malfunctions, use errors, and inadequacy in the information supplied by 
the manufacturer including labeling. 
Note 2: This definition includes device deficiencies related to the investigational medical device or the 
comparator. 
15.2. 
List of Anticipated Adverse Events 
15.2.1. Anticipated Device-Related Adverse Events 
The investigational device used in this study is similar to commercially available wearables and is considered to have 
minimal risk.  
Refer to section 5.2. for the description of anticipated events.  

 
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15.2.2. List of Non-Reportable Adverse Events 
All adverse events will be reported and documented as described below.  
15.3. 
Adverse Event Reporting  
x 
All adverse events, both anticipated and unanticipated, must be recorded in the CRF and in the Adverse Event 
Report Form. 
x 
All adverse events must be promptly reported to the sponsor.  
x 
All unanticipated adverse device effects will be also reported to both the sponsor and the IRB.   
x 
Both serious adverse events and unanticipated adverse device effects must be reported to the sponsor within 48 
hours. All other adverse events should be reported to the sponsor within five business days.  
x 
All serious adverse events will be also reported to the IRB per IRB reporting requirements.  These reports may 
include, but will not be limited to: date of onset, brief description of the events, their treatment, whether they 
resulted in death, subject hospitalization, severe or permanent disability or were life threatening, their 
relationship to the study device, and resolution. 
15.4. 
Device Deficiencies Reporting 
All Masimo device-related deficiencies should be reported to the sponsor and must be recorded in the CRF in a timely 
manner. When a Masimo device deficiency is observed, every effort should be made to return the device and its 
packaging to the sponsor in a timely manner. 
16. 
VULNERABLE POPULATION 
16.1. 
Definition 
Vulnerable population are research subjects, such as children, prisoners, pregnant women, handicapped, or mentally 
disable persons, or economically or educationally disadvantaged persons, who are likely to be vulnerable to coercion 
and undue influence. This study is not targeting these populations. 
The federal regulations that govern the protection of human subjects require additional protection for the vulnerable 
population. 
16.2. 
Protection of Vulnerable Subjects 
x 
Not applicable as study follows standard of care procedures.  
16.3. 
Responsible Parties  
x 
The IRB will review research with vulnerable populations and evaluate consent, level of risk, coercion, and the 
reason for choosing this particular subject population. The IRB will be responsible for determining what 
practices will include continuing review for compliance while monitoring these studies.  
x 
The Investigator holds the ultimate responsibility for protecting the rights, safety, and welfare of research 
subjects by ensuring that all regulations and proper documentation of consent are handled in a compliant and 
timely manner. 

 
CLINICAL INVESTIGATION PLAN 
CIP-1085 
Study Title: Validation of the performance of the electrocardiogram (ECG) 
function of the Masimo INVSENSOR00057 
ECGV0001 
Revision: E  
 
CONFIDENTIAL AND PROPRIETARY 
Page 23 of 25 
© 2025 Masimo Corporation (Unpublished) 
DOT-1225 Rev. A 
All Rights Reserved 
CO-072624 
 
 
17. 
SUSPENSION OR PREMATURE TERMINATION OF THE CLINICAL INVESTIGATION 
17.1. 
Suspension or Termination of Study Site 
The sponsor can suspend or prematurely terminate the PI’s and study site’s participation in the study, particularly if 
sponsor finds serious non-compliance by the PI or site, and if such non-compliance was not resolved in a timely manner. 
The sponsor will document the decision to suspend or terminate the investigation in writing. A suspended study site 
cannot enroll new subjects.  
If the sponsor determines that the study site’s compliance to be inadequate at any point during the study, and the sponsor 
moves to suspend or terminate the study site, the sponsor will provide notification in writing to the PI and IRB as 
necessary. The study site is eligible for reinstatement upon correction of any findings and any open action items prior 
to the suspension, and provides a written guarantee that the same non-compliance will not reoccur in the future. Site 
can only resume subject enrollment upon receiving written notification of reinstatement from the sponsor.  
If for any GCP and Regulatory non-compliance reasons the study site is prematurely terminated by the sponsor, then 
the study site is not eligible for reinstatement under the same Clinical Investigational Plan/Study Protocol. 
17.2. 
Termination of Clinical Investigation/Study due to UADE 
The clinical investigation may be terminated if the sponsor determines that an unanticipated adverse device effect 
presents an unreasonable risk to the subjects. Termination shall occur no later than five working days after the sponsor 
makes this determination, and not later than 15 working days after the sponsor first received notice of the effect.  
The sponsor may resume the terminated clinical investigation with prior IRB approval if the device is non-significant 
risk. 
18. 
PUBLICATION POLICY 
In compliance with 42 CFR Part 11, a study that meets the definition of an Applicable Clinical Trial (ACT) and that is 
initiated after September 27, 2007 must be registered on ClinicalTrials.gov. Results of this clinical investigation will be 
made publicly available on the ClinicalTrials.gov website. 
19. 
BIBLIOGRAPHY 
1. 
Elliott AD, Middeldorp ME, Van Gelder IC, Albert CM, Sanders P. Epidemiology and modifiable risk factors 
for atrial fibrillation. Nature Reviews Cardiology. 2023;20(6):404-17. 
2. 
Kornej J, Börschel CS, Benjamin EJ, Schnabel RB. Epidemiology of Atrial Fibrillation in the 21st Century. 
Circulation Research. 2020;127(1):4-20. 
3. 
Lee E, Choi E-K, Han K-D, Lee H, Choe W-S, Lee S-R, et al. Mortality and causes of death in patients with 
atrial fibrillation: A nationwide population-based study. PLOS ONE. 2018;13(12):e0209687. 
4. 
Manning W, Singer D, Lip G. Atrial fibrillation in adults: Use of oral anticoagulants. UpToDate Inc. 
5. 
Katritsis DG, Gersh BJ, Camm AJ. Anticoagulation in Atrial Fibrillation - Current Concepts. Arrhythm 
Electrophysiol Rev. 2015;4(2):100-7. 
6. 
Staerk L, Sherer JA, Ko D, Benjamin EJ, Helm RH. Atrial Fibrillation: Epidemiology, Pathophysiology, and 
Clinical Outcomes. Circ Res. 2017;120(9):1501-17. 
7. 
Turakhia MP, Shafrin J, Bognar K, Trocio J, Abdulsattar Y, Wiederkehr D, et al. Estimated prevalence of 
undiagnosed atrial fibrillation in the United States. PLOS ONE. 2018;13(4):e0195088. 

 
CLINICAL INVESTIGATION PLAN 
CIP-1085 
Study Title: Validation of the performance of the electrocardiogram (ECG) 
function of the Masimo INVSENSOR00057 
ECGV0001 
Revision: E  
 
CONFIDENTIAL AND PROPRIETARY 
Page 24 of 25 
© 2025 Masimo Corporation (Unpublished) 
DOT-1225 Rev. A 
All Rights Reserved 
CO-072624 
 
 
8. 
Mannhart D, Lischer M, Knecht S, du Fay de Lavallaz J, Strebel I, Serban T, et al. Clinical Validation of 
5 Direct-to-Consumer Wearable Smart Devices to Detect Atrial Fibrillation: BASEL Wearable Study. JACC: Clinical 
Electrophysiology. 2023;9(2):232-42. 
9. 
Campo D, Elie V, de Gallard T, Bartet P, Morichau-Beauchant T, Genain N, et al. Atrial Fibrillation 
Detection With an Analog Smartwatch: Prospective Clinical Study and Algorithm Validation. JMIR Form Res. 
2022;6(11):e37280. 
 
 
20. 
REVISION HISTORY 
Version Number 
Version Date 
Summary of Revisions Made 
1.0 
11 July 2023 
Original version 
2.0 
21 August 2023 
Added Site 03 PCA Cardiology. 
3.0 
18Sep2023 
Updated Exclusion Criteria 
4.0 
15Nov2023 
Added site 04 Cone Health 
5.0 
01Apr2024 
Clarification 
to 
exclusion 
criteria 
and 
allowance 
of 
sequential 
12 
lead 
ECG 
reference acquisition 

CLINICAL INVESTIGATION PLAN
CIP-1085
Study Title: Validation of the performance of the electrocardiogram (ECG)
function of the Masimo INVSENSOR00057
ECGV0001 
Revision: E  
CONFIDENTIAL AND PROPRIETARY
Page 25 of 25
© 2025 Masimo Corporation (Unpublished)
DOT-1225 Rev. A
All Rights Reserved
CO-072624
21.
APPENDICES
21.1.
Appendix I: Study Workflow  
21.2.
Appendix II: Schedule of Events  
At enrollment
After enrollment
Recruitment & Screening
Informed Consent
x
Demographic & Medical History 
x 
Device Education
Device Demo by a study personnel 
x 
Subject Practice 
x 
Study-Related Measurements
12-lead Reference ECG  
x 
30-second contemporaneous measurement from IINVSENSOR00057 and 12-lead reference ECG.
x