MightySat - Clinical Performance Comparison Study
Conditions: Healthy
Sponsor: Masimo Corporation

 
 
Official Title:  MightySat - Clinical Performance 
Comparison Study 
 
Date of Protocol: June 20, 2017 
 
NCT Number:   NCT03239574 

PROTOCOL/TEST PROCEDURE 
TP – 18810 
MightySat – Clinical Performance Comparison Study 
Revision:  A 
CO-035851 
 
CONFIDENTIAL AND PROPRIETARY 
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© 2020 Masimo Corporation (Unpublished) 
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CO-024597 
 
Protocol/Test Procedure Title 
MightySat – Clinical Performance Comparison Study 
Lead Investigator 
Ahmed Alghazi, MD 
Other Investigators 
 
Expected Start Date 
 
Expected End Date 
 
 
Protocol Test Abstract: 
This study compares the performance of Respiratory rate from pleth (RRp) measured prospectively with MightySat 
device against capnography, Rainbow Acoustic Monitoring (RAM) Respiratory rate (RR) and manual annotation in 
healthy adult subjects.   
 
APPROVALS 
Author 
Date 
Engineering 
Date 
Ahmed Alghazi, Amy Kirkpatrick  
05/31/2017 
 
 
Quality Assurance 
Date 
Manufacturing 
Date 
 
 
 
 
 
 
 

PROTOCOL/TEST PROCEDURE 
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MightySat – Clinical Performance Comparison Study 
Revision:  A 
CO-035851 
 
CONFIDENTIAL AND PROPRIETARY 
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1 
PURPOSE 
The objective of this study is to compare the noninvasive RRp performance of the Masimo MightySat device 
against the RR measured by capnography, Masimo’s RAM technology and the manual annotation. All of the 
devices are noninvasive and data will be collected from healthy volunteers.  
 
This is a nonrandomized single arm study where all of the subjects are enrolled into the experimental arm and 
receive the MightySat device on their index finger along with a RAM sensor on their neck, a pulse oximeter 
on their other index finger, and a nasal cannula which will be attached to the capnography device.   
 
Outcome Measure: Comparison of MightySat, capnography, rainbow acoustic monitoring and manual 
annotation of RR by ARMS calculation.  
 
2 
BACKGROUND 
Masimo Corporation develops non-invasive medical technologies. These devices have applications in the 
operating room, critical care unit, emergency room, emergency transport vehicles, as well as physician’s 
offices.  
 
Recording respiratory rate is considered standard for monitoring patients. However, measurement frequency 
and documentation of respiratory rate is often poor and inaccurate. Respiratory rate is difficult to assess and 
often is not even recorded in the patient record. This is in spite of the fact that elevated respiratory rate is one 
of the best predictors of respiratory deterioration, cardiac arrest, and admission to the intensive care unit 
(ICU). Our Masimo MightySat and RAM technologies allows for real-time, non-invasive monitoring of 
respiratory rate in patients and has the potential to improve clinical outcomes while reducing the cost of care 
and risks to patients. 
 
Respiratory rate can be determined by the plethysmographic waveform. This method measures respiration per 
minute (rpm) based on plethysmgraphic amplitude changes that correspond to the respiratory cycle.  
 
Literature Review: 
Accuracy of a Novel Bioacoustic Sensor in Adult Postoperative Patients. Macknet MR, Kimball-Jones PL, 
Applegate RL, Martin RD, Allard MW. Anesthesiology. 2007;107:A 83. 
 
Accuracy of a Novel Bioacoustic Sensor in Pediatric Postoperative Patients. Macknet M, Kimball-Jones P, 
Applegate R, Martin R, Allard M. Presented at the 17th Annual Meeting for Society for Technology in 
Anesthesia, January 17-20, 2007. 
 
Recording system and data fusion algorithm for enhancing the estimation of the respiratory rate from 
photoplethysmogram. Cernat RA, Ciorecan SI, Ungureanu C, Arends J, Strungaru R, Ungureanu GM. Conf 
Proc IEEE Eng Med Biol Soc. 2015;2015:5977-80. doi: 10.1109/EMBC.2015.7319753. PubMed PMID: 
26737653. 
 
3 
REFERENCE 
FRM-3958 Rev.A 
Consent 18 years and greater 
FRM-3953 Rev.A 
Recruitment Script 
FRM-3954 Rev. A 
Web Ad 
FRM-3957 Rev. A 
Health Questionnaire  
FRM-3124 Rev. A 
Confidentiality Agreement 
FRM-3955 Rev. A 
Case Report Form 
FRM-3956 Rev. A  
Gender and Ethnicity Questionnaire 

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FRM-3336  
 
Device Accountability Log 
FRM-2706 
 
Protocol Deviation Report 
FRM-3280 
 
Adverse Event Form 
DRV-7410 
             Non Significant Risk Assessment of a MightySat Modified For Data Collection 
IB00122 
 
Investigator’s Brochure for MightySat 
 
4 
LOCATION 
Masimo Corporation 
 
52 Discovery 
 
Irvine, CA 92618 
 
5 
EQUIPMENT, MATERIALS AND SAMPLE SIZE JUSTIFICATION   
5.1 
EQUIPMENT AND MATERIALS  
9500 
 
Radical7 2012 or equivalent 
3661  
 
RAM Dual Cable LNC-10 or equivalent 
3475 
 
Acoustic Respiration Monitoring (RAM) Sensor or equivalent 
 
 
     1859 
 
Pulse oximeter or equivalent 
 
 
     9909 
 
Investigational MightySat (modified per DRV-7410) 
NA 
Data Collection Laptop, Software and other equipment as necessary to record 
the data 
 
 
     NA  
 
Capnography device, Capnostream20 unit or equivalent  
     NA 
 
Nasal cannula (capnography accessory) 
5.2 
STUDY DEVICES 
Investigational Device: 
x 
MightySat pulse oximeter– this is a noninvasive, investigational device that is a modified 
version of the FDA cleared MightySat. It has been modified with the RRp software 
feature to allow measuring Respiratory rate from Pleth, and there has been a connected 
cable modification to allow for continuous data collection.  These modifications do not 
pose increased risk to study subjects. The device has undergone risk assessment prior to 
use in human subjects to safeguard subject safety and well-being. Refer to the DRV-7410 
and Investigator’s Brochure (IB00122) for more details on the investigational device.  
Control Devices:  
x 
Masimo FDA-cleared RAM cloth sensor 
x 
Masimo FDA-cleared Radical-7 pulse oximeter or equivalent 
x 
FDA-cleared Capnostream20 Capnography device 
 
5.3 
Inclusion/Exclusion Criteria 
Inclusion Criteria 
x 
18 to 45 years old  
x 
Physical status of ASA I or II 
x 
Must be able to read and communicate in English 
x 
Has signed all necessary related documents, e.g. written informed consent, confidentiality 
agreement. 
x 
Passed health assessment screening 

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x 
Negative pregnancy test for female subjects of child bearing potential.  
 
Exclusion Criteria 
x 
Age < 18 years old or > 45 years old 
x 
ASA physical status of III, IV, and V 
x 
Subject has any medical condition which in the judgment of the investigator, renders them 
inappropriate for participation in this study 
x 
Inability to tolerate sitting still or minimal movement for at least 30 minutes 
x 
Positive pregnancy test for female subjects 
x 
Refusal to take pregnancy test for women of child bearing potential 
x 
Nursing female subjects 
x 
Refusal of male subjects to agree to shave hair off areas where sensors will be applied (neck) 
when deemed necessary 
x 
Excluded at the Principal Investigator’s discretion 
 
Withdrawal and Replacement of Subjects 
Subjects must be withdrawn under the following circumstances: 
x 
The subject withdraws consent or assent 
x 
Serious adverse event 
x 
Discretion of investigator 
x 
Malfunction of the device for greater than 10 minutes 
In the case a subject is withdrawn from the study, another may be recruited. 
 
5.4 
Sample Size Justification 
Sample size for this study has been determined to be at least 32 subjects, based on previous 
experience with similar devices and Masimo internal procedures for sample size calculation.  
The study sample size is given by[1] ܰൌቀ
ሺ௭ഀȀమା௭ഁሻ൉ఙ
ఋ
ቁ
ଶ
 where  
zα/2 is the standard normal distribution z-score with tail area α/2 
zβ is the standard normal distribution z-score with tail area β 
δ is the limit of equivalence (Bias) 
σ is the a-priori estimate of standard deviation 
 
For Type I error rate or α = 5%, zα/2 = 1.96  
For Type II error rate or β = 20% or power = 80%, zβ = 0.85 
δ = 2.0 RPM  
σ = 4.0 RPM 
ܰൌ൬ሺͳǤͻ͸ ൅ͲǤͺͷሻ൉Ͷ
ʹ
൰
ଶ
ൌ͵ʹ 
6 
PROCEDURES 
6.1 
 Advertisement and Recruitment  
                                                          
[1] Sample Size Calculations, Practical Methods for Engineer and Scientists, Paul Mathews ISBN 978-0-615-32461-6 
 

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6.1.1 
Subjects will be recruited using IRB-approved advertisements. Our Web Ad (FRM-
3954) will be posted publically on craigslist or similar websites. Subjects may also be 
referred to the study by previous volunteers. 
6.2 
Phone Screening  
6.2.1 
Once the potential subject sees the recruitment material (i.e. Web Ad), they contact our 
clinical schedulers to inquire more about details about the screening. The recruitment 
process is taken care of by the designated clinical staff who are trained for 
screening/scheduling. 
6.2.2 
Appointments are made once the phone screening process is completed and the person 
screening the subject determines if they qualify or not for the screening based on the 
Recruitment Script (FRM-3953).  
6.2.3 
If the person does not qualify at this time their information will not be kept. 
6.3 
 Consent Process   
6.3.1 
Have each subject read and sign the correct forms set below. The consent form must be 
stamped with current IRB approval. No study related activities will be conducted until 
the correct document is signed. 
6.3.2 
Have each subject complete FRM-3124- Confidentiality Agreement 
6.4 
Screening  
6.4.1 
 Have each subject complete FRM-3957 – Health Assessment Questionnaire. 
6.4.2 
Female volunteers of child bearing potential will be required to take a pregnancy test as 
part of screening. A positive pregnancy test will disqualify them from the study. A 
negative pregnancy test qualifies them for the study.  
6.5 
Study Procedure 
6.5.1 
  Have each subject complete FRM-3956 – Gender and Ethnicity Questionnaire 
6.5.2 
Have subject at rest, sitting in a dental chair.    
6.5.3 
Apply the MightySat device onto the subject’s index finger. Apply the RAM sensor 
onto the subject’s neck and a pulse oximeter onto the subject’s other index finger. A 
flexible tube called a nasal cannula will be put in their nose. In some cases, it may be 
required for subjects to shave their neck hair for the purpose of applying an adhesive 
sensor with their consent. The study starts once the first sensor is placed.  
6.5.4 
Photos may be taken of sensor placement. Photos may only be taken with the subject’s 
consent. All photos will be de-identified and will not show the subject’s face. 
6.5.5 
Subjects will be asked to breathe at nominal rates described below. 
Breathe normally 
2 minutes 
Breathe at 5 breaths per minute 
3 minutes 
Breathe normally 
2 minutes 
Breathe at 10 breaths per minute 
3 minutes 
Breathe normally 
2 minutes 
Breathe at 15 breaths per minute 
3 minutes 
Breathe normally 
2 minutes 

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Breathe at 20 breaths per minute 
3 minutes 
Breathe normally 
2 minutes 
Breathe at 25 breaths per minute 
3 minutes 
Breathe normally 
2 minutes 
Breathe at 30 breaths per minute 
3 minutes 
6.5.6 
 Subjects may stop the study at any time.  
6.5.7 
Non-disposable devices will be sanitized after each subject completes the study. 
6.5.8 
Data collected in this study may be used in the future for product development and/or 
applications to the FDA or other regulatory agencies.  
6.6 
Discontinuation  
In the event that a study is discontinued prior to completion, whether it is due to the investigator’s 
discretion or the subject’s request, the subject will be paid for their time according to the Financial 
Compensation chart below in the Appendix H – Financial Compensation. 
6.7 
Protocol Deviation  
If there is a protocol deviation it shall be recorded on the Case Report Form (FRM-3955). The 
Protocol Deviation Report (FRM-2706) shall also be completed.  
7 
ACCEPTANCE CRITERIA (IF APPLICABLE)      
The MightySat device will be determined to have comparable performance and should meet the acceptable 
limit of ≤ 2.0 RPM ARMS.         
8 
DATA ANALYSIS PROCEDURE TO BE USED    
Statistical Analysis: 
Accuracy will be reported as the ARMS using the following equation: 
ܤ݅ܽݏൌͳ
݊෍ሺܴܴ݌െܴܴሻ
௡
௜ୀଵ
 
 ൌඨσ
ሺሺܴܴ݌െܴܴሻെܤ݅ܽݏሻଶ
௡
௜ୀଵ
݊
 
ܣோெௌൌඨσ
ሺܴܴ݌െܴܴሻଶ
௡
௜ୀଵ
݊
 
 
 
    *RR is the manual annotation  
 
 
 
 
 

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Revision:  A 
CO-035851 
 
CONFIDENTIAL AND PROPRIETARY 
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All Rights Reserved 
CO-024597 
 
APPENDICES 
A. 
DEVICE ACCOUNTABILITY 
Device accountability will be logged on the Device Accountability Log FRM-3336. Devices shall also be 
recorded on the Case Report Form (FRM-3955) for each subject.  
B. 
DEVICE DEFICIENCY 
If there is a device deficiency during the study, it will be documented on the Case Report Form  
C. 
AMENDMENTS TO THE PROTOCOL 
Clinical Lab and Engineering departments may collaborate to amend the protocol. The amended protocol 
shall be submitted through Masimo’s documentation process. IRB approval is necessary prior to 
implementation of the amended protocol.  
D. 
ADVERSE EVENTS 
Definitions: 
Adverse event:  Any untoward medical occurrence in a subjects, users or other persons, whether or not 
related to the medical device under study. 
Device-related adverse event:  Adverse event related to, associated with, or caused by, the use of a medical 
device under study, including but not limited to events that may have been attributed to the device because of 
device failure or malfunction, improper or inadequate design, manufacture or user error. 
Device deficiency: Inadequacy of a medical device with respect to its identity, quality, durability, reliability, 
safety or performance.  Device deficiencies include malfunctions, use errors and inadequate labeling. 
Serious adverse event:  Adverse event that: a) led to death, b) led to serious deterioration in the health of the 
subject, that resulted in: (i) a life-threatening illness or injury,  (ii) a persistent or significant impairment of a 
body structure or a body function, (iii) in-patient or prolonged hospitalization, or (iv) medical or surgical 
intervention to prevent life-threatening illness or injury or permanent impairment to a body structure or a 
body function, or c) led to fetal distress, fetal death or a congenital abnormality or birth defect.  NOTE:  
Planned hospitalization for a pre-existing condition, or a procedure required by the clinical investigational 
plan, without serious deterioration in health, is not considered a serious adverse event. 
D.1 
Adverse Events   
All devices used in the study are non-significant risk devices. All study procedures are 
noninvasive.  In the unlikely event that an adverse event should occur, it will be reported and 
documented as described below. 
All adverse events that occur during the study shall be recorded on the Case Report Form. The 
Adverse Event Form (FRM-3280) shall also be completed.  
Skin irritation/redness from the adhesive is an anticipated adverse event. 
D.2 
Serious and Unanticipated Adverse Events 
The investigator shall promptly report to the IRB within 24 hours any serious and unanticipated 
adverse event involving subjects. 
At the time of discharge from the study, an unresolved serious and unanticipated adverse event(s) 
will be followed up by the investigator until the event(s) are resolved, stabilized, or the patient is 
unable to follow-up or the adverse event is otherwise explained. The investigator will also instruct 
the subject to report any subsequent events occurring in the next 30 days, which the subject or the 

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subject’s physician believes might reasonably be regarded as caused by or have a reasonable 
possibility of being caused by the test device or procedures involved in the study. 
E. 
MEASURES TAKEN TO PROTECT THE RIGHTS AND WELFARE OF SUBJECTS  
E.1 
All subjects will be monitored closely throughout the study. 
E.2 
The following measures will be taken to insure the privacy of the subjects:  
E.2.1 
An identification number (code) for each subject will be kept on file. 
E.2.2 
Only their corresponding number will identify subjects.   
E.2.3 
Access to identifying documents and data will only be made to the investigators in the 
study. 
E.2.4 
The confidentiality and retention of these documents will be protected to the extent 
provided and required by the law. 
E.3 
Documents and Database:    
E.3.1 
Documents will be kept a minimum of 5 years after the specific product/tested for is no 
longer being made. If destroyed, these documents will be shredded and done by a 
certified company used for destroying medical and clinical data.   
E.3.2 
 Documents and information stored electronically will be protected using a multi-
faceted procedure included, but not limited to, the following steps: 
E.3.2.1 Endpoint: 2 layers of endpoint security and one layer of DLP (Data loss 
prevention) running on all company machines. 
E.3.2.2 Premier firewalls/Networking monitoring appliances and log collection 
systems (SIEM) protecting the network. 
E.3.2.3 4 layers of email security systems for protecting against phishing attacks. 
E.3.2.4 Security policies to limit access to specific folders.  
E.4 
Vulnerable Population   
E.4.1 
Employees are considered to be a vulnerable population. 
E.4.1.1 Participation is not a condition of employment. There will be no 
repercussions in the workplace in the case that the employee refuses to 
participate in the study or withdraws at any point during the study  
E.4.1.2 Neither supervisors nor superiors will be involved in the recruitment of 
employees for participation in the study.  
E.4.2 
Economically disadvantaged or unemployed and educationally disadvantaged.   
E.4.2.1 Reasonable compensation will be provided for economically disadvantaged 
subjects to eliminate the possibility of undue influence due to financial 
incentive.  
E.4.2.2 Educationally disadvantaged subjects will be provided ample time to ask 
questions and comprehend information. 
F. 
RISKS/DISCOMFORT  
F.1 
   Risks can be categorized into the following categories:  
 

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x 
Risks associated with the devices and sensors 
x 
Risks associated with disclosure of confidential information  
  F.2 
       Device Risks: “Devices and Sensors”  
x 
See LAB-4063, Radical-7 Operator’s Manual 
x 
See LAB-8722, MightySat Fingertip Pulse Oximeter Operator’s Manual  
x 
DRV-7410, Non-Significant Risk Assessment of a MightySat modified for Data Collection 
x 
IB00122,  MightySat Investigator’s Brochure 
x 
Risks of skin irritation from the adhesives.  Additionally any adhesive may leave a temporary 
mark on the subject’s skin.  
F.3 
      Risk of disclosure of Confidential Information: 
x 
There is minimal risk to the privacy of the subject because access to study data will be kept in 
a secure location and limited to study personnel and to others legally authorized to view it. 
G. 
BENEFITS 
There would be no other benefit to the subject. Other possible benefits would be to society as a whole. 
 
H. 
FINANCIAL COMPENSATION 
Subjects will be compensated for the time and discomfort involved in study participation according to the 
chart below. 
Study Duration 
(Minutes) 
Compensation 
(US$) 
0 to 29  
$25 
30 to 59 
$75 
  
I. 
STATEMENT OF COMPLIANCE 
This document is a protocol for a clinical research study sponsored by Masimo Corporation. The study will be 
conducted in compliance with all stipulations of this protocol, the conditions of IRB approval, 45 CFR Part 
46, 21 CFR Part 50, 21 CFR Part 56, 21 CFR Part 812,  ISO-14155, and International Conference on 
Harmonization Good Clinical Practice (ICH GCP). 
The protocol, informed consent form(s), recruitment materials, and all participant materials will be submitted 
to the Institutional Review Board (IRB) for review and approval. Approval of both the protocol and the 
consent form must be obtained before any participant is enrolled. Any amendment to the protocol will require 
review and approval by the IRB before the changes are implemented to the study.  In addition, all changes to 
the consent form will be IRB-approved; a determination will be made regarding whether a new consent needs 
to be obtained from participants who provided consent, using a previously approved consent form.