INVSENSOR00011 Clinical Performance Study
Conditions: Healthy
Sponsor: Masimo Corporation

 
 
 
 
 
 
 
Official Title: INVSENSOR00011 Clinical 
Performance Study 
 
Date of Protocol: December 5, 2017 
 
NCT Number:  NCT03641937 
 
 
 
 
 
 

PROTOCOL/TEST PROCEDURE 
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Protocol/Test Procedure Title 
INVSENSOR00011 Clinical Performance Study  
Lead Investigator 
Ahmed Alghazi, MD 
Other Investigators 
 
Expected Start Date 
 
Expected End Date 
 
IRB 
E&I West Coast Board – IRB00007807 
 
 
Protocol Test Abstract: 
This study assesses the investigational sensor’s (INVSENSOR00011) performance for detection of subjects’ 
position and posture in bed, along with heart rate and respiratory rate.  
 
 
APPROVALS 
Author 
Date 
Engineering 
Date 
Ahmed Alghazi, 
Amy Kirkpatrick  
11/14/2017 
 
 
Quality Assurance 
Date 
Manufacturing 
Date 
 
 
 
 
 

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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, 21 CFR Part 50, 21 
CFR Part 56, 21 CFR Part 812, ISO-14155, and International Conference on Harmonisation E6 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.   
1. 
PURPOSE  
 
The objective of this study is to assess INVSENSOR00011’s clinical performance for detection of a subject’s 
position and posture in bed, subject’s activity (sitting, standing, etc.) along with heart rate and respiratory rate. 
Only noninvasive sensors and corresponding devices will be employed to collect data from healthy volunteers 
in this study. 
 
This is a nonrandomized single arm study where all of the subjects are enrolled into the experimental arm and 
will receive the INVSENSOR00011 device on their chest or back, along with a RAM (Rainbow Acoustic 
Monitoring) sensor on their neck, a pulse oximeter on their finger, and a nasal cannula which will be attached 
to the capnography device.   
 
Outcome Measure: Assess the clinical performance of the detection of position, posture and activity through 
comparing INVSENSOR00011 measurements to observer’s notes. Assess INVSENSOR00011’s heart rate 
and respiratory rate measurements through comparison with those from Masimo SET pulse oximeter and 
RAM.  
 
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.  
2.1. 
Background and Rationale     
People with the most risk of developing bedsores are those with a medical condition that limits their 
ability to change positions, requires them to use a wheelchair or confines them to a bed for a long 
time. 
Bedsores can develop quickly and are often difficult to treat. Automated detection of patients’ 
position can help medical staff monitor position to time and optimize interventions.  Masimo has 
developed a new noninvasive sensor named INVSENSOR00011 as a device to aid in preventing 
hospital-acquired pressure injury or worsening of existing pressure injury by monitoring patient 
movement, position, and orientation. The sensor is also able to detect falls through the same 
monitoring features. This type of monitoring may be effective in reducing the debilitating conditions 
for patients and their duration of stay in hospitals, especially in the patient population vulnerable to 
pressure and/or fall related injuries.  

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Each year over 2.5 million individuals in the U.S. develop a pressure injury [1]. Pressure injuries are 
painful, debilitating and are usually avoidable. Routine repositioning relieves and redistributes 
pressure over bony prominences; it is a recommended procedure to help mitigate the risks for 
developing a pressure injury [2]. The INVSENSOR00011 device, through detection of patient 
position, is a modality to ensure repositioning occurs routinely.  
As many as 1 million Americans fall in the hospital every year. Falls result in fractures, lacerations, 
bleeding and even death. Current practices to prevent falls include assessment of patient risk, 
scheduled rounding practices and patient specific interventions to prevent falls [3]. The 
INVSENSOR00011 device is proposed to supplement current practices with a unique modality to 
assess risk for fall based on patient position. 
The INVSENSOR00011 system consists of a wearable, battery-operated, adhesive sensor and a 
back-end user interface and display at the patient bedside as well as a central location (e.g., nursing 
station). The sensor contains sensing elements (accelerometers, gyroscopes), processor, and a blue-
tooth communication chip (BTLE 2.4 GHz). An algorithm processes three-dimensional acceleration 
and rotation information and calculates the patient’s relative position and fall, heart rate and 
respiration rate as its key parameters. Position related parameters are then combined over a given 
time period to compute trend and potential risk for pressure injury. The system can generate alarms 
configured for adverse events related to patient posture, stress level for pressure injury and detected 
fall events. 
 
Literature Review: 
 
1. Berlowitz, et al. (2014). Preventing pressure ulcers in hospitals: A toolkit for improving quality of 
care. Retrieved http://www.ahrq.gov/sites/default/files/publications/files/putoolkit.pdf 
2. National Pressure Ulcer Advisory Panel, European Pressure Ulcer Advisory Panel and Pan Pacific 
Pressure Ulcer Injury Alliance. Prevention and treatment of pressure ulcers: Quick reference 
guide. Emily Haesler (Ed.). Cambridge Media: Perth, Australia; 2014 
3. Ganz, DA, Huang, C, Saliba D, et al. Preventing falls in hospitals: A toolkit for improving quality 
of care. (Prepared by RAND corporation, Boston University School of Public Health, and ECRI 
Institute under Contract No. HHSA2902010000171 TO#1). Rockville, MD: Agency for 
Healthcare Research and Quality; January 2013. AHRQ Publication No. 13-0015-EF. 
 
2.2. 
Study Devices  
2.2.1. Investigational Devices and Sensors:   
2.2.1.1. INVSENSOR00011 sensor is an investigational, non-invasive sensor that 
measures signals regarding patient’s movement and posture, pulse rate, and 
respiratory rate. This sensor has undergone a risk assessment prior to use in 
human subjects to safeguard their safety and well-being. Refer to IB-00116B.  
2.2.1.2. Root® is a noninvasive monitoring platform. The version of the device used in 
this study, as compared to the FDA cleared device, contains a software 
modification to allow for Bluetooth connection to the INVSENSOR00011 sensor. 
The software update has undergone a risk assessment prior to use in human 
subjects to safeguard their safety and well-being. Refer to IB-00129A.  
 

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2.2.2. FDA cleared Sensors and Devices: 
 
Masimo FDA-cleared Radical-7 
 
Masimo FDA-cleared RAM cloth sensor 
 
Masimo FDA-cleared pulse oximeter sensor 
 
Masimo FDA-cleared RAM dual cable 
 
FDA-cleared Capnostream20 Capnography device with nasal cannula  
3. 
REFERENCE 
3.1.1. FRM-4121 Rev. A 
Consent 18 years and greater 
3.1.2. FRM-4122 Rev. A 
Recruitment Script 
3.1.3. FRM-4123 Rev. A 
Web Ad 
3.1.4. FRM-4124 Rev. A 
Health Questionnaire  
3.1.5. FRM-4125 Rev. A 
Gender and Ethnicity Questionnaire 
3.1.6. FRM-3124 Rev. A 
Confidentiality Agreement 
3.1.7. FRM-4126 Rev. A 
Case Report Form 
3.1.8. FRM-3336  
 
Device Accountability Log 
3.1.9. FRM-2706 
 
Protocol Deviation Report 
3.1.10. FRM-3280 
 
Adverse Event Form 
3.1.11. FRM-2336 
 
Clinical Study Request Form 
4. 
LOCATION 
Masimo Corporation 
Clinical Laboratory  
 
52 Discovery 
 
Irvine, CA 92618 
 
The Masimo Clinical Laboratory facility is designed as a Phase 1 clinical study research center. All personnel 
undergo routine required training on GCP and human subject research protections. The laboratory is equipped 
with standard FDA-approved medical monitoring equipment. Hospitals and urgent care facilities are within 
three miles of Masimo Clinical Laboratory.  
 
5. 
STUDY POPULATION   
5.1. 
Inclusion Criteria 
 
18 to 80 years old  
 
Physical status of ASA I or II 
 
Subjects must be able to read and communicate in English 
 
Has signed all necessary related documents, e.g. written informed consent, health assessment 
questionnaire, gender and ethnicity form, confidentiality agreement  
 
Passed Health Assessment Screening 
5.2. 
Exclusion Criteria  

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 
Subject has any medical condition which in the judgment of the investigator, renders them 
inappropriate for participation in this study 
 
Inability to tolerate sitting still or minimal movement for at least 30 minutes 
 
Nursing female volunteers 
 
Excluded at the Principal Investigator’s discretion 
 
Refusal to take the pregnancy test (for female subjects) 
 
Positive pregnancy test for female subjects of child bearing potential. This is done for the 
safety of this population.  
 
Refusal to shave hair (neck, chest) off areas where sensors will be applied (male subjects) 
5.3. 
Withdrawal of Subjects 
Subjects must be withdrawn under the following circumstances: 
 
The subject withdraws consent  
 
Non-verbal consent withdrawal 
 
Serious adverse event 
 
Discretion of investigator 
 
Malfunction of the device for greater than 10 minutes 
 
6. 
EQUIPMENTAND MATERIALS   
Equipment and Materials: All lab equipment will be maintained per manufacturer specifications and all study 
personnel will be trained on the use of relevant equipment. 
Test Devices:  
 
INVSENSOR00011 
 
Root with modified software to allow for communication with INVSENSOR00011 
Control Devices:  
 
Masimo Radical-7 
 
Masimo pulse oximeter sensor 
 
Masimo RAM sensor 
 
Capnostream20 Capnography device 
Research Equipment:  
 
Data Collection Laptop, software and other equipment as necessary to record the data 
 
7. 
PROCEDURES 
7.1. 
Advertisement and Recruitment  
7.1.1. Our Web Ad (FRM-4123A) will be posted publically on craigslist or similar websites.  
7.2. 
Phone Screening 

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7.2.1. Once the potential subject sees the recruitment material (i.e. Web Ad), they contact 
our clinical schedulers to elicit more details about the screening. The phone screening 
is handled by designated clinical staff that is trained for screening/scheduling. 
7.2.2. Appointments are made once the phone screening process is completed and the person 
screening the subject determines they qualify for screening based on the Recruitment 
Script (FRM-4122A).  
7.2.3. If the person does not qualify at this time their information will not be kept.  
7.3. 
Consent Process.  
7.3.1. Have each volunteer read and sign the correct forms which include the consent form 
(FRM-4121A), Gender and Ethnicity Questionnaire (FRM-4125A) and 
Confidentiality Agreement (FRM-3124A). The consent form must be stamped with 
current IRB approval. No study related activities will be conducted until consent is 
signed.  
7.3.2. Subject demographic information including age, gender, height, weight, and ethnicity 
may be collected. In addition, a brief medical history and vital signs may be recorded.   
7.4. 
 Screening: 
7.4.1. Have each subject complete FRM-4124A – Health Assessment Questionnaire.   
7.4.2. 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.  
7.4.3. If the subject does not pass screening, he/she will be compensated $25 for travel.  
 
7.5. 
Study Procedure  
7.5.1. Apply sensors. INVSENSOR00011 sensors will be placed on the subject’s chest 
and/or back. A RAM sensor will be placed on their neck, a pulse oximeter sensor on 
their finger, and a nasal cannula in their nose. In some cases it may be required for 
subjects to shave their neck, chest and/or back for the purpose of applying the 
adhesive sensors with their consent. The study starts once the first sensor is placed.   
7.5.2. Photos may be taken of sensor placement and the subject’s position in bed. Photos 
may only be taken with the subject’s consent. All photos will be de-identified and will 
not show the subject’s face or any other identifying features.   
7.5.3. Have the subject lay down on the bed. Subjects will be asked to follow the instructions 
below. The start time will correspond to the beginning of each instruction.  
Step 1 
Lie flat on back 
2 minutes 
Step 2 
Lie on right side  
2 minutes 
Step 3 
Lie flat on back 
2 minutes 
Step 4 
Lie on left side 
2 minutes 
Step 5 
Lie flat on back 
2 minutes 
Step 6 
Lie on back with head-of-bed 
angle at 30 degrees 
2 minutes 
Step 7 
Lie on back with head-of-bed 
angle at 60 degrees 
2 minutes 

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Step 8 
Lie flat on back  
2 minutes 
Step 9 
Subject sitting on the bedside 
ready to stand  
2 minutes 
Step 10 
Subject stands and starts a 
slow walk 
2 minutes 
7.5.4. The study is expected to last no more than 30 minutes. All enrolled subjects will be 
paid $50 after the completion of the study with no additional compensation for travel. 
Subjects who do not complete the study will be paid $25 with no additional 
compensation for travel.    
7.5.5. In case of an error in following the instruction set, subject can repeat the missed steps. 
7.5.6. Subjects may stop the study at any time. 
7.5.7. Data collected in this study may be used in the future for product development, 
publications, and/or submissions to the FDA or other regulatory agencies.  
7.6. 
Discontinuation  
7.6.1. 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, refer to Section 7.5.4. 
7.7. 
Protocol Deviation 
7.7.1. If there is a protocol deviation it shall be recorded on the Case Report Form. The 
Protocol Deviation Report (FRM-2706) shall also be completed.  
8. 
ACCEPTANCE CRITERIA (IF APPLICABLE) 
There are no acceptance criteria. The study is to report the results of the evaluations: sensitivity and 
specificity for position and posture detection, mean and standard deviation of differences for heart rate and 
respiratory rate.  
9. 
SAMPLE SIZE JUSTIFICATION AND DATA ANALYSIS PROCEDURE TO BE USED 
9.1. 
Sample Size Determination   
In each subject, the protocol induces at least five position changes during the study. To assess 
INVSENSOR00011’s detection capability, the device output will be compared against observer’s 
notes for each change. Assuming a sample size N = 30, there will be at least 150 independent data 
points collected, which will be used for validation. This data will be enough for calculating 
sensitivity and specificity of the position detection algorithm.  
 
9.2. 
For heart rate and respiration rate comparison, the study does not have an accuracy requirement to 
meet. However, INVSENSOR00011’s heart rate and respiration rate measurements will be 
compared against reference measurements for an assessment. N=30 is deemed sufficient for a 
qualitative assessment of performance.  
9.3. 
Statistical Analysis   

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9.3.1. For each subject’s position detection, INVSENSOR00011 output will be compared against 
observer’s notes at each turn of the subject. 
9.3.2. Correctly detected position changes will be marked as True Positive.  
9.3.3. Missed detections (if any) will be counted. 
9.3.4. Combining the two, sensitivity of INVSENSOR00011’s posture change detection will be 
computed as 
Sensitivity = True Positive/(True Positive + Missed Detection) 
9.3.5. From the INVSENSOR00011’s output, all false positives will be counted, i.e., when a turn is 
indicated by INVSENSOR00011 but the observer’s notes do not agree with that. These will 
present a measure of specificity of the device. 
9.3.6. Heart rate readings from INVSENSOR00011 will be compared against reference pulse-rates 
to compute mean and standard deviation of the differences. 
9.3.7. Respiration rate readings from INVSENSOR00011 will be compared against reference 
respiration rate to compute mean and standard deviation of the differences. 
9.4. 
Expected Dropout Rates 
Subjects may not complete the study for various reasons, such as a clinical screening test failure, at 
the Principal Investigator’s discretion, or because the subject does not want to continue the study. 
Expected dropout rate for this study is approximately 0% of the total number of subjects enrolled.  
10. 
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. 
If there is a device deficiency during the study, it will be documented on the Case Report Form, FRM-
4126A and it will be reported according to department procedures.  
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. 
10.1  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. 

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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 or redness from the adhesive are anticipated adverse events. 
10.2 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 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. 
10.3 Unanticipated Problems 
Any unanticipated problems involving subjects will be reported to the IRB, such as protocol violations or 
deviations as required by the IRB reporting procedures.  
11. 
SUPPORTING DOCUMENTATION AND OPERATIONAL CONSIDERATIONS 
11.1. 
Measures Taken to Protect the Rights and Welfare of Subjects 
11.1.1 All subjects will be monitored closely throughout the study.   
11.1.2 The following measures will be taken to insure the privacy of the subjects:  
11.1.2.1 Information about the patients will be kept confidential. 
11.1.2.2 An identification number (code) for each subject will be kept on file. 
11.1.2.3 The study documents will only contain the subject’s corresponding identification number except 
in the Informed Consent Document. 
11.1.2.4 Access to identifying documents and data will only be granted to the investigators in the study. 
11.1.2.5 Study data that will be released to Masimo and other regulatory authorities will be de-identified 
and will only pertain to study data collection, demographics, sensor placement locations and 
recordings from devices. 
11.1.2.6 The confidentiality and retention of these documents will be protected to the extent provided 
and required by the law. 
11.2 Vulnerable Populations   
11.2.1 Employees are considered to be a vulnerable population. 
11.2.1.1 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. 
11.2.1.2 Neither supervisors nor superiors will be involved in the recruitment of employees for 
participation in the study.  
11.2.2 Economically disadvantaged or unemployed and educationally disadvantaged. 
11.2.2.1 Reasonable compensation will be provided for economically disadvantaged subjects to 
eliminate the possibility of undue influence due to financial incentive. 

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11.2.2.2 Educationally disadvantaged subjects will be provided ample time to ask questions and 
comprehend information.   
11.3 Documents and Database  
11.3.1 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. 
11.3.2 Documents and information stored electronically will be protected using a multi-faceted procedures 
included, but not limited to, the following steps: 
11.3.2.1 Endpoint: 2 layers of endpoint security and one layer of DLP (Data loss prevention) running on 
all company machines. 
11.3.2.2 Premier firewalls/Network monitoring appliances and log collection systems (SIEM) protecting 
the network 
11.3.2.3 4 layers of email security systems for protecting against phishing attacks 
11.3.2.4 Security policies to limit access to specific folders 
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 FRM-3336 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.   
12.2. 
Use of Study Device  
Use of devices and sensors will be documented on Case Report Forms for each subject. 
13. 
RISKS AND BENEFITS  
13.1. 
Benefits 
There would be no other benefit to the subject. Other possible benefits would be to society as a 
whole. 
13.2. 
Device Risks 
 
See LAB-4063, Radical-7 Operator’s Manual  
 
See IB-00116B, INVSENSOR00011Position and Fall Monitoring 
 
See IB-00129A, Root with Modified Software  
Risks of skin irritation or redness to adhesives. Additionally any adhesive may leave a temporary 
mark on the subject’s skin.  
13.3. 
Risks associated with disclosure of confidential information 
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.  
13.4. 
Risks associated with study procedures  

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There is minimal risk. The study procedures involve the subject changing their position in and 
getting out of bed.  
14. 
EMERGENCY RESPONSE PLAN FOR MEDICAL EMERGENCIES 
 A crash cart is on site and emergency services are available within a 3 mile radius of the facility.  
15. 
MONITORING PLAN 
A separate document for the study monitoring plan will be developed and followed to ensure subject safety 
and GCP compliance. 
16. 
PROTOCOL DEVIATIONS AND AMENDMENTS 
Deviations from the protocol will be documented on the Case Report Form or a separate document.  Protocol 
deviations will be reported to the sponsor and IRB per IRB reporting guidelines. 
Modifications to the protocol, informed consent materials, recruitment materials, or any other materials 
provided to subjects must be reviewed and approved by the IRB.