A Study to Evaluate the Performance, Usability, and Reliability of a Novel Device for Continuous Collection of Physiological Data in Healthcare and Remote Settings
Phase: NA
Conditions: Healthy Normals
Sponsor: MC10 Inc.

Protocol: MC10-PTL-103, Revision 00 
1 
Confidential 
A Study to Evaluate the Performance, Usability, and Reliability of a Novel Device 
for Continuous Collection of Physiological Data in Healthcare and Remote 
Settings 
Protocol Number: MC10-PTL-103 
Revision 00 
Date:  June 21, 2017 
Investigational Product: BioStamp nPoint 
Regulatory Status: 
Limited to investigational use only 
Sponsor: 
MC10, Inc.  
10 Maguire Rd, Bldg. 3 
Lexington, MA 02421 
This study will be conducted in compliance with the ethical principles of the Declaration of 
Helsinki (64th WMA General Assembly, Fortaleza, Brazil October 2013), ISO 14155:2011, 
and ICH-GCP Guidelines. 
CONFIDENTIALITY STATEMENT 
This study is confidential in nature. All information related to this study is considered 
proprietary and should not be made available to anyone not directly involved in this 
study. Authorized recipients of this information include investigators and co-
investigators, other health care personnel necessary to conduct the study, and the 
presiding Institutional Review Boards and governing regulatory agencies. The personnel 
provided with data from this study are hereby informed of its confidential and proprietary 
nature. Release of these data to individuals other than those listed above requires the 
prior written permission of MC10, Inc. 
NCT03257189

 
 
 
 
 
Protocol: MC10-PTL-103, Revision 00 
 
4 
Confidential 
PROTOCOL SYNOPSIS 
Title 
A Study to Evaluate the Performance, Usability, and Reliability of a Novel System 
for Continuous Collection of Physiological Data in Healthcare and Remote 
Settings  
Investigational Device 
BioStamp nPoint™ 
Indications for Use 
The BioStamp nPoint system is a wireless remote monitoring system intended for 
use by researchers and healthcare professionals for continuous collection of 
physiological data in home and healthcare settings. These physiological data 
include heart rate, heart rate variability, respiration rate, activity (including step 
count and activity classification), and posture (body position relative to gravity). 
The system is also intended for measurement of surface electromyography and 
to monitor limb or body movements during daily living and sleep. Data are 
transmitted wirelessly from the Sensors for storage and analysis. 
The device is intended for use on general care patients who are 18 years of age 
or older as a general patient monitor to provide physiological information. The 
data from the BioStamp nPoint system are intended for use by researchers and 
healthcare professionals for research applications or, at the discretion of a 
qualified healthcare professional, as an aid to diagnosis and treatment. The 
device is not intended for use on critical care patients. 
Study Type 
Interventional 
Study Phase 
Pivotal study for FDA 510(k) submission 
Study Objective 
The primary objective of the clinical investigation is to: 
• 
Evaluate the accuracy of BioStamp nPoint system algorithm 
measurements and to evaluate the adhesion (reliability) of BioStamp 
nPoint Sensors. 
 
Study Design 
A single-site, non-significant risk, open-label, prospective non-randomized clinical 
investigation designed to validate the accuracy of the various physiological 
parameters that the Wearable Sensor Patches acquire and the system processes 
as well as to validate the performance of the skin adhesive  
Enrollment Size 
Twenty-five (25) subjects minimally will be enrolled in the study. 
Number of Sites 
One site in the United States. 
Subject Population 
Healthy adult subjects will be recruited to participate in this study.   
Effectiveness 
Endpoints  
The effectiveness endpoints for this study are the various types of measurements 
made by the BioStamp nPoint system.  All effectiveness endpoints to be 
statistically summarized will be collected using the BioStamp nPoint and are as 
follows: 
 
• 
Heart Rate (bpm) 
• 
Heart Rate Variability (RMSSD1 (msec) and LF/HF Ratio2) 
                                                 
 
1 RMSSD: root-mean-square of successive difference of the time intervals between successive heartbeats. 

 
 
 
 
 
Protocol: MC10-PTL-103, Revision 00 
 
5 
Confidential 
• 
Respiration (average respiration rate) 
• 
Activity Classification (activities – sleep, standing, sitting, lying, walking 
and other)  
• 
Activity Parameters - total step counts in a 6 minute walk test 
• 
Sleep (sleep onset time (hours, minutes, and seconds), sleep wake time 
(hours, minutes, and seconds)) 
• 
Posture Classification (sleep posture, stationary posture standing, 
stationary posture sitting) 
 
For each endpoint, the BioStamp nPoint measurements will be compared to a 
similar FDA approved measurement device, other simplistic measurement 
devices, or to independent observer measurements.  The FDA approved 
measurement devices for this study are the Actiheart heart rate reference device 
and the Capnostream™ portable respiratory monitor.  
 
Endpoint Variable Group 
Measurement Comparator 
Heart Rate 
Actiheart Device 
Heart Rate Variability 
Actiheart Device 
Respiration 
Capnostream Device 
Activity Classification 
Independent Observer 
Activity Parameters 
Manual Step Counting Device 
Sleep Parameters 
Independent Observer 
Posture 
Independent Observer 
Data Management 
MC10 sensor and system data to be uploaded to the MC10 cloud by subject and 
clinical site.  MC10 system and reference device to be returned to the clinical site 
by the subject after completion of protocol activities.   
All clinical study source documents to be retained at the site.  Copies, where 
applicable, to be provided to MC10.  Reference device data to be downloaded on 
site and both retained on site and provided to MC10. Any external electronic 
storage (e.g. DVD) to be retained by the site as source documents.  
Safety 
All adverse events (AEs) reported during the evaluation period will be collected 
and summarized. Serious AEs (SAEs) will be reported in accordance with US 
Code of Federal Regulation requirements. 
Inclusion Criteria 
 
Subjects must meet all of the following criteria to be eligible for participation in the 
study: 
Inclusion Criteria 
1. Male or female volunteers, at least 18 years of age at the time of 
screening visit; 
2. Fluent in English; 
3. The subject is willing to comply with the protocol specified evaluations; 
4. Subject is willing and cognitively able to sign informed consent 
Exclusion Criteria 
Subjects must be excluded from participation in this study if any of the following 
criteria are met: 
Exclusion Criteria 
1. Pregnancy; 
                                                                                                                                                              
 
2 LF/HF ratio: the ratio of power in the low-frequency (LF, 0.04-0.15 Hz) and high-frequency (HF, 0.15-0.4 Hz) bands of heart rate 
variability in the frequency domain. 

 
 
 
 
 
Protocol: MC10-PTL-103, Revision 00 
 
6 
Confidential 
2. Positive urine drug screen 
3. History of active (clinically significant) skin disorders; 
4. History of allergic response to silicones or adhesives; 
5. Subjects with electronic implants of any kind (e.g. pacemaker) 
6. History of sleep disorders or self-reported insomnia or other sleep 
conditions; 
7. Broken, damaged or irritated skin or rashes near the sensor application 
sites; 
8. Subjects that are MC10 employees or shareholders, or a spouse or child 
of an MC10 employee or shareholder; 
9. Subjects who are physically or cognitively unable to normally perform 
activities of daily living, assessed at the discretion of the investigator. 
Remuneration 
Subjects will receive $50 for on-site screening that results in screen fail or 
enrollment, and a subsequent $1050 for successfully completing the study, where 
completion is defined as completing the baseline clinic visit, wearing the sensors 
for two days, returning the sensors to the coordinators, and completing the 
usability survey.   
Study Duration / 
Follow-up Period 
A supervised session which includes one awake and two night-time sleep periods 
with observation periods throughout; thus a total evaluation duration of 
approximately 48 hours.  
One safety and tolerability follow-up call will occur within three to five days post-
sensor removal. 
Data Analysis Plan 
 
The following analysis populations will be defined for the study: 
 
• 
Intent-to-Measure (ITM) Population – The ITM population will consist of 
all subjects who are enrolled in the study and for which the ability of each 
measurement device to measure the subject has been established. 
 
• 
Safety Population – The safety population will consist of all subjects who 
are enrolled in the study. 
 
The ITM population will be the primary analysis set for all effectiveness analyses.  
The safety population will be used for the analysis of all safety variables and 
baseline characteristics. 
 
For each effectiveness endpoint, the BioStamp nPoint measurements will be 
compared to the noted comparator device or to independent observer 
measurements. 
 
For pairs of measurements collected on the continuous scale (quantitative to 
quantitative comparisons), scatter plots with the 45 degree line of agreement 
superimposed will be constructed from paired observations from the two sources 
(BioStamp nPoint vs comparator) along with Bland-Altman plots of the data.  The 
mean absolute error (MAE) and the root-mean-square error (RMSE) estimates of 
agreement will be calculated for each comparison.  The standard deviations of 
each of the agreement measures will also be computed.   
 
For pairs of measurements collected on a categorical scale (qualitative to 
qualitative comparisons), two-way tables of agreement will be constructed for 
each comparison.  The agreement percentage will be computed for each table. 
 
The number and percentage of sensor patches in each category of the adhesion 

 
 
 
 
 
Protocol: MC10-PTL-103, Revision 00 
 
7 
Confidential 
scoring scale will be tabulated. 
 
ClinicalTrials.gov 
Sponsor responsible for study registration per 42 CFR Part 11.  
Principal Investigator 
 
 
Sponsor 
MC10, Inc. 
10 Maguire Rd, Bldg. 3, First Floor 
Lexington, MA 02421 
Sponsor Contact 
 
MC10, Inc. 
10 Maguire Rd. Bldg. 3, First Floor 
Lexington, MA 02421 
 
 
 

 
 
 
 
 
Protocol: MC10-PTL-103, Revision 00 
 
8 
Confidential 
Table of Contents 
CONFIDENTIALITY STATEMENT .......................................................................................................... 1 
PROTOCOL SYNOPSIS .......................................................................................................................... 4 
LIST OF ABBREVIATIONS .................................................................................................................... 12 
1.0 BACKGROUND AND RATIONALE ................................................................................................ 13 
2.0 DEVICE DESCRIPTION ................................................................................................................ 13 
2.1 
Principles of Operation ........................................................................................................ 14 
2.2 
Indications for Use .............................................................................................................. 14 
3.0 STUDY PURPOSE AND OBJECTIVES......................................................................................... 15 
4.0 STUDY ENDPOINTS ..................................................................................................................... 15 
4.1 
Effectiveness Endpoints ...................................................................................................... 15 
4.2 
Safety .................................................................................................................................. 17 
5.0 STUDY DEVICES ........................................................................................................................... 17 
6.0 STUDY DESIGN ............................................................................................................................. 19 
6.1 
Study Duration .................................................................................................................... 19 
6.2 
Schedule of Events ............................................................................................................. 20 
7.0 STUDY POPULATION ................................................................................................................... 22 
7.1 
Number of Subjects............................................................................................................. 22 
8.0 STUDY PROCEDURES & ASSESSMENTS ................................................................................. 22 
8.1 
Device and System Configuration ....................................................................................... 22 
8.2 
Subject Identification ........................................................................................................... 23 
8.3 
Recruitment ......................................................................................................................... 23 
8.4 
Subject Eligibility, Pre-Screening and Exclusions ............................................................... 23 
8.5 
Written Informed Consent ................................................................................................... 23 
8.6 
Screening and Baseline (Day 0) Evaluation ....................................................................... 23 
8.7 
Subject Enrollment .............................................................................................................. 23 
8.8 
Study Assessments – In Clinic – Visit 1 (Supervised) ........................................................ 24 
8.9 
Study Assessments – Remote (Unobserved) ..................................................................... 27 

 
 
 
 
 
Protocol: MC10-PTL-103, Revision 00 
 
9 
Confidential 
8.10 
Study Assessments – In Clinic – Visit 2 (Supervised) ........................................................ 28 
8.11 
Data Download .................................................................................................................... 28 
8.12 
Subject Follow-up ................................................................................................................ 28 
9.0 Completion or Early Withdrawal of Subjects .................................................................................. 29 
9.1 
Subject Completion ............................................................................................................. 29 
9.2 
Subject Early Discontinuation / Withdrawal of Subjects ..................................................... 29 
10.0 Risk / Benefit Analysis .................................................................................................................... 29 
10.1 
Benefits ............................................................................................................................... 29 
10.2 
Risks ................................................................................................................................... 29 
10.3 
Minimization of Risk and Monitoring Procedures ................................................................ 30 
11.0 STATISTICAL METHODS .............................................................................................................. 30 
11.1 
Introduction ......................................................................................................................... 30 
11.2 
Sample Size ........................................................................................................................ 30 
11.3 
Effectiveness Variables ....................................................................................................... 30 
11.4 
Analysis Populations ........................................................................................................... 32 
11.5 
Analysis Subgroups ............................................................................................................ 32 
11.6 
Statistical and Analytical Plans ........................................................................................... 32 
11.7 
Handling Missing Data ........................................................................................................ 33 
11.8 
Interim Analysis ................................................................................................................... 33 
12.0 DATA MANAGEMENT ................................................................................................................... 33 
12.1 
Data Flow ............................................................................................................................ 33 
12.2 
Data Collection .................................................................................................................... 34 
12.3 
Data Processing .................................................................................................................. 34 
13.0 MONITORING AND QUALITY CONTROL PROCEDURES .......................................................... 34 
13.1 
Monitoring and Auditing ...................................................................................................... 34 
13.2 
Device Labeling ................................................................................................................... 35 
13.3 
Device Accountability .......................................................................................................... 35 
14.0 ADVERSE EVENTS ....................................................................................................................... 35 

 
 
 
 
 
Protocol: MC10-PTL-103, Revision 00 
 
10 
Confidential 
14.1 
Definitions ........................................................................................................................... 35 
14.2 
Adverse Event Reporting .................................................................................................... 36 
14.3 
Adverse Event Reporting .................................................................................................... 37 
14.4 
Device Deficiency ................................................................................................................ 38 
14.5 
Anticipated Device Related Effects ..................................................................................... 38 
15.0 MEDICAL MONITORING ............................................................................................................... 38 
16.0 STUDY ADMINISTRATION ........................................................................................................... 38 
16.1 
Statement of Compliance .................................................................................................... 38 
16.2 
IRB Approval ....................................................................................................................... 39 
16.3 
Informed Consent ................................................................................................................ 39 
16.4 
Amending the Protocol ........................................................................................................ 39 
16.5 
Protocol Deviations/Violations and Medical Emergencies .................................................. 40 
16.6 
Pre-Study Documentation Requirements ........................................................................... 40 
16.7 
Record Retention ................................................................................................................ 40 
16.8 
Criteria for Terminating Study ............................................................................................. 41 
16.9 
Criteria for Suspending/Terminating an Investigational Site ............................................... 41 
16.10 
Sponsor Responsibilities ..................................................................................................... 41 
16.11 
Investigator Responsibilities ............................................................................................... 41 
17.0 REVISION HISTORY ..................................................................................................................... 43 
18.0 BIBLIOGRAPHY ............................................................................................................................. 44 
 
 
 

 
 
 
 
 
Protocol: MC10-PTL-103, Revision 00 
 
11 
Confidential 
 
List of Figures 
Figure 1: Illustration of BioStamp nPoint Sensor ........................................................................................ 14 
Figure 2: Anatomical Locations for Investigational and Reference Devices ............................................... 18 
Figure 3: Study Design Flow Chart ............................................................................................................. 19 
 
List of Tables 
Table 1: Endpoint Variable Group and Measurement Comparator ............................................................. 15 
Table 2: Posture Variable and Classification .............................................................................................. 16 
Table 3: Sensor Adhesion Rating Scale ..................................................................................................... 16 
Table 4: Devices for Study Activities ........................................................................................................... 18 
Table 5: Schedule of Events ....................................................................................................................... 21 
Table 6: Application Activities ...................................................................................................................... 24 
Table 7: Activity Classification Activities ..................................................................................................... 25 
Table 8: Heart Rate Activities ...................................................................................................................... 26 
Table 9: Irritation Rating Scale .................................................................................................................... 27 
Table 10: Endpoint Variable Group and Measurement Comparator ........................................................... 31 
Table 11: Posture Variable vs Classification ............................................................................................... 32 
Table 12: Adverse Event Definitions ........................................................................................................... 35 
 
 
 

 
 
 
 
 
Protocol: MC10-PTL-103, Revision 00 
 
12 
Confidential 
LIST OF ABBREVIATIONS 
AE 
Adverse Event 
ADE 
Adverse Device Effect 
App 
Application - Software 
CDER 
Center for Drug Evaluation and Research 
CRF 
Case Report Form 
CFR 
Code of Federal Regulations 
ECG 
Electrocardiography 
EMG 
Electromyography 
ES 
Enrolled Set 
FAS 
Full Analysis Set 
FDA 
Food and Drug Administration 
FPFV 
First Patient – First Visit 
GCP 
Good Clinical Practice 
HF/LF 
Ratio of power in the high-frequency and low-frequency 
HR 
Heart Rate 
HRV 
Heart Rate Variability 
ICH 
International Conference on Harmonization 
ICS 
Intercostal Space 
IFU 
Instructions for Use 
IRB 
Institutional Review Board 
ISO 
International Organization for Standardization 
MAE 
Mean Absolute Error 
MDDS 
Medical Device Data System 
NSR 
Non-Significant Risk 
RMSSD 
Root-Mean-Square Standard Deviation 
SADE 
Serious Adverse Device Effect 
SAE 
Serious Adverse Event 
SAP 
Statistical Analysis Plan 
SS 
Safety Set 
USADE 
Unanticipated Serious Adverse Device Effect 
WSP 
Wearable Sensor Patch 
 
 
 

 
 
 
 
 
 
 
 
 
Protocol: MC10-PTL-103, Revision 00 
 
13 
Confidential 
1.0 
BACKGROUND AND RATIONALE 
Objective and validated assessments of physiological metrics are critical for monitoring data and data 
trends, and as an aid to assessing disease progression and subsequent therapeutic intervention.  In 
current clinical practice and medical product development, patient historical data, patient-reported 
outcomes, and in-clinic assessments by physicians are used to evaluate biometrics, but these evaluations 
are time and context limited and present an incomplete picture of the subject as well as his/her current 
condition.  Some assessments are subjective, or rely on a patient’s memory and perception.  Other 
assessments are limited to a specific time interval in a particular environment, like a clinic, preventing 
accurate longitudinal assessment of fluctuations in physiological parameters.  This is particularly true of 
measurements taken by large stationary clinical instruments, which may limit not only the setting for the 
measurement but may also affect the subject and change the outcome of the measurement itself.  
Wearable sensors have the potential to enable longitudinal, objective monitoring of clinical signs  across 
patient populations, but conventional wearable devices are typically comprised of rigid, packaged 
electronics, which may compromise overall subject comfort, are often plainly visible when worn in public, 
and can interfere with activities of daily living and sleep.  Finally, emergence of smartphone and wrist-
based sensing has led to potential improvements in access and ease of use, but themselves carry 
limitations in night-time sensing or in creating lower-extremity insight.  Consequently, there is a need for 
assessment tools that are unobtrusive and provide clinical quality, medical grade continuous 
assessments from multiple body locations.   
Conformal, body-worn sensors may provide an easy-to-use and objective alternative.  Previously, studies 
have shown that wearable sensors can be used to provide greater insight into neurological (e.g. 
Parkinson’s disease1, Huntington’s disease2, multiple sclerosis3), sleep4 (e.g. periodic limb movements, 
respiration), cardiac monitoring5 and orthopedics (e.g. physical rehabilitation6) movement and biopotential 
measurements. These studies have demonstrated that data can be collected in an unobtrusive way in 
remote settings, supporting the possibility of providing more robust, data-based evidence to the clinician 
and thus to the patient.  
The BioStamp nPoint system combines a traditional, electronic platform for collecting Patient Reported 
Outcomes with multiple, location-agnostic sensors in an adhesive bandage-like form factor. These 
sensors are flexible enough to conform to the human body and eliminate the profound mismatch in 
physical properties at the interface between conventional wearable devices and the human body.  This 
new class of soft, conformal electronics and sensors interface better with the surface of the body to 
minimize discomfort and optimize skin coupling over prolonged use and multiple data-gathering locations. 
The potential for both in-clinic and remote, longitudinal, multi-sensor, multi-modal, passive and prescribed 
biometric data tracking is noteworthy.   
This first clinical evaluation aims to evaluate the accuracy, reliability, and ease of use of the BioStamp 
nPoint system as well as the safety, fidelity and tolerability of the BioStamp nPoint Sensors.  
2.0 
DEVICE DESCRIPTION 
The BioStamp nPoint system is a wireless remote monitoring platform intended for use by healthcare 
professionals and researchers for the continuous collection of physiological data in home and healthcare 
settings. The system is designed principally for data collection during research studies although may be 
used wherever and whenever collection of the relevant data is needed.  
 

 
 
 
 
 
Protocol: MC10-PTL-103, Revision 00 
 
14 
Confidential 
 
Figure 1: Illustration of BioStamp nPoint Sensor 
The BioStamp nPoint system centers on body-worn Wearable Sensor Patches (“Sensors”, “WSPs”) which 
can be worn in both in clinic (“supervised”) and remote (“unsupervised”) settings for up to 24 hours at a 
time, and can be worn repeatedly for multiple days. Study facilitators (either researchers or physicians) 
set up data collection studies using a web-based study configuration tool, called the Web Portal.  For in-
clinic uses, the BioStamp nPoint system includes an Investigator Tablet Application that study facilitators 
use to connect to and configure Sensors. When used at home, study subjects interact with the system 
through a Mobile Phone Application, the Link App.  The Link Hub is used to charge and synchronize data 
from the Sensors.  The BioStamp nPoint system includes an algorithm package that delivers processed 
metrics on general activity classification, heart rate, heart rate variability, posture, sleep, and respiration 
during sleep.  
2.1 
Principles of Operation 
When the facilitator configures the study design via the Web Portal, the study configuration is 
transferred to the Investigator Tablet App (and Link App for remote studies).  The Investigator Tablet 
App and Link App are automatically configured for the specific study design, and when connected to 
Sensors, configure them per the study design. When user entered data including activity annotations 
and survey answers are sent from the Investigator Tablet App or Link App, the data travel to an 
MDDS storage system and are then accessible to facilitators via the Web Portal, which pulls the data 
from the MDDS storage system.  Sensor data is transferred to the MDDS storage through the Link 
Hub and Link App. If the algorithm package was activated in the study, the algorithm module retrieves 
the data from the MDDS, processes the data and generates metrics that are returned to the MDDS 
system for storage. Study facilitators can access all study data (raw and processed) through the Web 
Portal.  
2.2 
Indications for Use 
The BioStamp nPoint system is a wireless remote monitoring system intended for use by researchers 
and healthcare professionals for continuous collection of physiological data in home and healthcare 
settings. These physiological data include heart rate, heart rate variability, respiration rate, activity 
(including step count and activity classification), and posture (body position relative to gravity). The 
system is also intended for measurement of surface electromyography and to monitor limb or body 
movements during daily living and sleep. Data is transmitted wirelessly from the Sensors for storage 
and analysis. 
 
The device is intended for use on general care patients who are 18 years of age or older as a general 
patient monitor to provide physiological information. The data from the BioStamp nPoint system are 
intended for use by researchers and healthcare professionals for research applications or, at the 
discretion of a qualified healthcare professional, as an aid to diagnosis and treatment. The device is 
not intended for use on critical care patients. 
 
 
 

 
 
 
 
 
Protocol: MC10-PTL-103, Revision 00 
 
15 
Confidential 
3.0 
STUDY PURPOSE AND OBJECTIVES 
The purpose of this pivotal study is to evaluate the performance, usability, and reliability of the BioStamp 
nPoint system for continuous collection of physiological data in remote (in-home) and healthcare (in-
clinic) settings. 
The primary objective of the clinical investigation is to evaluate the accuracy of the BioStamp nPoint 
system algorithm measurements and to evaluate the adhesion (reliability) of the Sensors. 
 
Safety and tolerability will be further assessed via a follow-up telephone call.   
4.0 
STUDY ENDPOINTS 
4.1 
Effectiveness Endpoints 
The effectiveness endpoints for this study are the various types of measurements made by the 
BioStamp nPoint system. All effectiveness endpoints to be statistically summarized will be collected 
using the BioStamp nPoint during in clinic supervised use.  The effectiveness endpoints are as 
follows: 
 
o 
Heart Rate (bpm) 
o 
Heart Rate Variability (RMSSD3 (msec) and LF/HF Ratio4) 
o 
Respiration (average respiration rate) 
o 
Activity Classification (activities – sleep, standing, sitting, lying, walking and other)  
o 
Activity Parameters - total step counts in a 6 minute walk test 
o 
Sleep (sleep onset time (hours, minutes, and seconds), sleep wake time (hours, minutes, 
and seconds)) 
o 
Posture Classification (sleep posture, stationary posture standing, stationary posture 
sitting) 
 
For each endpoint, the BioStamp nPoint measurements will be compared to a similar FDA-cleared 
measurement device, other measurement devices, or independent observer measurements.  The 
FDA-cleared measurement devices used as comparators for this study are the Actiheart heart rate 
reference device and the Capnostream portable respiratory monitor.  
 
Table 1 displays the comparator method for each endpoint category. 
 
Table 1: Endpoint Variable Group and Measurement Comparator 
Index Endpoint Variable Group 
Measurement Comparator 
1 
Heart Rate 
Actiheart Device 
2 
Heart Rate Variability 
Actiheart Device 
3 
Respiration 
Capnostream Device 
4 
Activity Classification 
Independent Observer 
5 
Activity Parameters 
Manual Step Counting Device 
6 
Sleep Parameters 
Independent Observer 
7 
Posture 
Independent Observer 
 
                                                 
 
3 RMSSD: root-mean-square of successive difference of the time intervals between successive heartbeats. 
4 LF/HF ratio: the ratio of power in the low-frequency (LF, 0.04-0.15 Hz) and high-frequency (HF, 0.15-0.4 Hz) bands of heart rate 
variability in the frequency domain. 

 
 
 
 
 
Protocol: MC10-PTL-103, Revision 00 
 
16 
Confidential 
Individual independent observers will receive training on the operation of all devices and 
execution of the study protocol before the enrollment of any subjects.   
 
For heart rate and heart rate variability, the values collected will be the one minute average heart 
rate, the one minute RMSSD and the five-minute LF/HF ratio from the BioStamp nPoint and the 
one minute average heart rate, RMSSD and five minute LF/HF ratio from the Actiheart device on 
each of six recording times for each subject.  Two readings will be taken while the subject is at 
rest, two while exercising and two while lying down. 
 
For respiration rate, the average sleep respiration rate values will be collected at one minute time 
intervals during two separate nights of sleep on each subject using both the BioStamp nPoint and 
the Capnostream while the subject is asleep.   
 
For the activity classification variable, each subject will be presented with five tasks (standing, 
sitting, lying, walking and stationary bike riding) in varied order and the activity classification will 
be recorded by the BioStamp nPoint and by the independent observer.  This procedure will be 
repeated five times for each subject.  
 
For the exercise parameter number of steps taken, the number of steps taken by the subject 
during a 6 minute walk test will be recorded using both the BioStamp nPoint and a simple step 
counting device. 
 
For the sleep parameters sleep onset time and wake time, the BioStamp nPoint values and 
independent observer values will be collected on each night at the study site.   
 
Posture classification variables will be analyzed separately for each type of posture activity (sleep 
positions, stationary posture standing and stationary posture sitting). For a given posture activity, 
the posture classification will be recorded by the BioStamp nPoint and the independent observer 
for two repeats each of each ground-truth posture for each subject.  Since sleep position and 
lying posture are identical, this variable will be assessed from awake subjects to ensure that all 
postures are represented. Each repeat will generate 5 independent observations of posture. The 
posture classifications for each posture classification variable are given in Table 2. 
Table 2: Posture Variable and Classification 
Index
Posture Variable 
Posture Classification 
1 
Sleep positions 
Supine, prone, left side and right side 
2 
Stationary Posture Standing 
Upright, lean left, lean right, lean back, lean forward 
3 
Stationary Posture Sitting 
Upright, lean left, lean right, lean back, lean forward 
 
In addition, sensor adhesion to the subject will be measured on a 4 point scale by the 
independent observer for each of four sensor patches on each subject following 24 hours of 
continuous wear.  The adhesion rating scale (Table 3) is as follows:  
 
Table 3: Sensor Adhesion Rating Scale 
Score 
Rating 
Description 
0 
= ≥90% adhered 
essentially no Sensor lift off the skin 
1 
= ≥75% to <90% adhered 
some edges only of the Sensor lifting off the 
skin 
2 
= ≥50% to <75% adhered 
less than half of the Sensor lifting off the skin 
3 
= >0% to <50% adhered but not 
detached 
more than half of the Sensor lifting off the skin 
without falling off 
4 
= 0% adhered – Sensor detached 
Sensor completely off the skin 

 
 
 
 
 
Protocol: MC10-PTL-103, Revision 00 
 
17 
Confidential 
 
Usability will also be assessed by the clinician observing the subject using the system and via a 
subject questionnaire. 
 
4.2 
Safety 
All adverse events (AEs) reported during the evaluation period will be collected and summarized.  
Serious AEs (SAEs) will be reported in accordance with US Code of Federal Regulation 
requirements. 
5.0 
STUDY DEVICES 
The materials presented in Table 4 are the devices required for the supervised and remote evaluation 
periods.  In addition to the investigational device, a Heart Rate Reference Device and a Respiration 
Reference Device will be used in this study, and will be applied to the subject as shown in Figure 2.  
Identification as well as traceability for each investigational and reference device at the study site will be 
maintained by serial number.  
 
The Actiheart (K052489, CamNtech Inc., Cambridge, UK), used here as the Heart Rate Reference 
device, is a commercially-available, FDA-cleared, chest-worn monitoring device that records heart rate, 
Inter-Beat-Interval (IBI), and physical activity.  It is designed for calculating and measuring heart rate and 
Energy Expenditure in free living.  The Actiheart has two clips which attach directly to standard ECG 
electrodes. Usually one electrode is adhered at V1 or V2 (4th intercostal) and the second electrode is 
placed approximately 10cm away on the left side at V4 or V5, although this placement can be adjusted to 
be more comfortable for the subject. The number of R-waves detected is recorded, and an internal 
accelerometer senses the frequency and intensity of the subject's torso movements. 
 
The Capnostream Portable Respiratory Monitor (K150272, Medtronic Inc., Dublin, IE) used here as the 
Respiration Reference device, is a commercially-available, FDA-approved, bedside, combined 
capnography/pulse oximetry monitor, capable of providing a complete picture of oxygenation and 
ventilation by monitoring a subject’s: 
 
• 
End tidal carbon dioxide (etCO2) - level of carbon dioxide in exhaled breath.  
• 
Respiratory rate (RR).  
• 
Fractional inspired carbon dioxide (FiCO2) - level of carbon dioxide present during inhalation. 
• 
Oxygen saturation (SpO2).  
• 
Pulse rate (PR). 
 
It is intended to provide professionally trained health care providers the continuous, non-invasive 
measurement and monitoring of carbon dioxide concentration of the expired and inspired breath and 
respiration rate, and for the continuous non-invasive monitoring of functional oxygen saturation of arterial 
hemoglobin (SpO2 and pulse rate).   
 
Additionally, a commercially-available manual “tally” counter will be used for counting steps.  
 

 
 
 
 
 
Protocol: MC10-PTL-103, Revision 00 
 
18 
Confidential 
Table 4: Devices for Study Activities 
Materials 
Purpose 
Supervised 
Remote 
MC10 BioStamp nPoint System 
 
 
 
Sensors 
Investigational device 
X 
X 
Link Hub 
Investigational device 
X 
X 
Adhesives 
Investigational device 
X 
X 
Adhesive Applicator 
Investigational device 
X 
X 
Mobile Phone with Link App 
Investigational device 
X 
X 
Actiheart (CamNtech Inc.) with electrodes 
Reference device: 
Heart Rate (HR),  
Heart Rate Variability (HRV) 
X 
X 
Capnostream 35 Portable Respiratory 
Monitor (Medtronic Inc.) with nasal cannula 
Reference device: 
Respiration Rate 
X 
- 
Manual step counter 
Reference device:  
Step Counting 
X 
- 
 
 
 
BioStamp nPoint Sensor 
 
Heart Rate Reference Device 
 
Respiration Reference Device 
Figure 2: Anatomical Locations for Investigational and Reference Devices  
 
 
 
 
 
 
 

 
 
 
 
 
Protocol: MC10-PTL-103, Revision 00 
 
19 
Confidential 
6.0 
STUDY DESIGN 
The study design is a non-significant risk, open-label, prospective non-randomized clinical investigation 
designed to validate the accuracy of the various physiological parameters that the MC10 Sensors acquire 
and the system processes, and to validate the performance of the Sensor skin adhesive. The study will 
be conducted at a single site in the United States.   
 
Figure 3: Study Design Flow Chart 
6.1 
Study Duration 
One supervised session of approximately four hours, with observation periods throughout and two 
night-time sleep periods; thus a total evaluation duration of approximately 48 hours.  
At least one safety and tolerability follow-up call will occur within three to five days post-sensor 
removal. 

 
 
 
 
 
Protocol: MC10-PTL-103, Revision 00 
 
20 
Confidential 
6.2 
Schedule of Events 
The evaluation period includes (refer to Section 4.1) clinician observed supervised testing. Subjects 
will wear a total of four BioStamp nPoint Sensors for this study; chest, thigh, shank, and forearm, and 
the BioStamp nPoint system will be configured, using only the chest and thigh Sensors, to measure 
and compute algorithm outputs. 
In addition to the algorithm determinate Sensor locations, the shank and forearm Sensors (no sensor 
data will be collected) will be utilized in combination with the chest and thigh locations to validate the 
Sensor adhesion performance.  The study is designed to capture supervised, observed 
measurements, as well as two nights of sleep in in clinic supervised setting.  
 
 
 

 
 
 
 
 
Protocol: MC10-PTL-103, Revision 00 
 
21 
Confidential 
 
Table 5: Schedule of Events 
 
Activities 
  
Screening 
Period 
Evaluation Period 
Safety  
Clinic 
Clinic 
Clinic 
Clinic 
Follow-Up 
Visit 
1 
1 or 2 
1 or 2 
2 or 3 
2 or 3 
Telephone 
Day 
-60 to 0 
0 
1 
1 
2 
3-5 
Screening & Enrollment Activities 
  
  
 
 
  
  
Informed Consent 
X 
 
 
Screening survey (demographics, medical 
history, etc.) 
X 
 
 
 
 
 
Baseline assessment (weight, Fitzpatrick, 
medical history, location irritation) 
X 
X 
 
 
 
 
Urine pregnancy and drug screen 
X 
X 
 
 
 
 
Sensor Application 
 
 
Application of Functional MC10 Sensors by 
Clinician 
 
X 
 
 
 
 
Application of Non-functional MC10 Sensors by 
Clinician 
 
X 
 
 
 
 
Adhesion application assessment 
 
X 
X 
 
 
 
Application of Functional MC10 Sensors by 
Subject 
 
 
X 
 
 
 
Application of Heart Rate Reference Device by 
clinician 
 
X 
 
 
 
 
Application of Respiration Reference Device for 
Sleep Respiration by clinician 
 
X 
 
X 
 
 
Prescribed Activities (Supervised) 
 
 
Activity Classification Activities 
X 
 
 
Heart Rate Activities 
 
X 
 
 
 
 
Subject training 
X 
 
Overnight sleep 
 
X 
 
X 
 
 
Prescribed Activities (Remote) 
 
 
X 
 
 
 
Time of Removal Assessments  
(MC10, Heart Rate Reference Device) 
 
 
 
 
 
 
Adhesion assessment 
 
X 
 
X 
Removal pain assessment 
 
X 
 
X 
Skin irritation assessment 
 
X 
 
X 
Sensor Removal 
 
 
Removal of Respiration Reference Device for 
Sleep Respiration by clinician 
 
 
X 
 
X 
 
Removal of MC10 Sensors by clinician 
X 
 
Clean MC10 Sensors by clinician 
 
 
X 
 
 
 
Removal of MC10 Sensors by Subject 
 
 
 
 
X 
 
Clean MC10 Sensors by Subject  
 
 
 
 
X 
 
Removal of Heart Rate Reference Device by 
clinician 
 
 
 
 
X 
 
Usability Survey 
X 
 
X 
Data Transfer 
 
 
MC10 Sensor data transfer 
 
X 
 
X 
Respiration Reference Device data transfer 
 
X 
 
X 
Heart Rate Reference Device data transfer 
 
 
X 
Return sensors to investigators 
 
 
X 
Safety follow-up call 
 
 
X 
Recording of adverse events 
X 
X 
X 
X 
X 
 
 
 

 
 
 
 
 
Protocol: MC10-PTL-103, Revision 00 
 
22 
Confidential 
7.0 
STUDY POPULATION 
Subjects must meet all inclusion criteria for enrollment in the clinical study and have no exclusion criteria.  
Reasons for screening failure(s) will be documented.    
7.1 
Number of Subjects 
Minimally, twenty-five (25) healthy subjects (defined as people who do not have the condition or 
related conditions or symptoms being studied to participate in that study; see also “Accepts Healthy 
Volunteers” on ClinicalTrials.gov) minimally will be enrolled in the study.  
7.1.1 
Inclusion Criteria  
Subjects must meet all of the following criteria to be eligible for participation in the study: 
1. Male or female volunteers, at least 18 years of age at the time of screening visit; 
2. Fluent in English; 
3. The subject is willing and physically able to comply with the protocol specified evaluations; 
4. Subject is willing and is cognitively able to sign informed consent 
7.1.2 
Exclusion Criteria 
Subjects must be excluded from participation in this study if any of the following criteria are met: 
1. Pregnancy; 
2. Positive urine drug screen 
3. History of active (clinically significant) skin disorders; 
4. History of allergic response to silicones or adhesives; 
5. Subjects with electronic implants of any kind (e.g. pacemaker) 
6. History of sleep disorders or self-reported insomnia or other sleep conditions; 
7. Broken, damaged or irritated skin or rashes near the sensor application sites; 
8. Subjects that are MC10 employees or shareholders, or a spouse or child of an MC10 
employee or shareholder; 
9. Subjects who are physically or cognitively unable to normally perform activities of daily living, 
assessed at the discretion of the investigator. 
8.0 
STUDY PROCEDURES & ASSESSMENTS 
The visit schedule, study procedures, and assessments are presented in the Study Design Flow Chart 
(Figure 3) and the Schedule of Events (Table 5).  Site personnel will be instructed via training conducted 
by MC10 of the investigational device and reference devices protocol specific operation and use and will 
be documented and approved by MC10 via a verification form. 
 
8.1 
Device and System Configuration 
Prior to first subject enrollment, for the investigational device, MC10 will design, via the Web Portal, 
the study activities associated with the BioStamp nPoint system, including appropriate annotation 
prompts required for execution.  
 
The reference devices and associated software will be configured as necessary to maintain subject 
traceability and facilitate subsequent data management and analysis. Study site staff will be trained 
on the proper configuration, application, and use of the reference devices that are presented in 
Section 5.0 per their associated Instructions for Use as they pertain to the metrics required to fulfil the 
study objectives. 

 
 
 
 
 
Protocol: MC10-PTL-103, Revision 00 
 
23 
Confidential 
8.2 
Subject Identification 
Each subject will be assigned a unique subject number.  Subject numbers will not be reassigned or 
reused for any reason.  Only their assigned subject number, initials, and date of birth should identify 
subjects to the Sponsor.  The investigator must maintain a list of potential subjects and enrolled 
subjects using the Subject Screening/Enrollment Log.  At a minimum, this log is faxed (or emailed) to 
the Sponsor each week.  Site will also maintain a Subject ID List in the PI’s records ensuring that 
subjects may be identified in case of product recalls or safety issues. 
 
Any potential subjects who are pre-screened can be added to the log by recording their screening 
number and initials only. Those who sign the ICF will be assigned a five-digit sequential number. The 
first two digits will represent the site number (i.e., 01) and the remaining three digits are a sequential 
patient number (i.e., 001, 002, 003, etc.). Therefore, the fourth subject screened at site number one 
will be Subject #01004.  
8.3 
Recruitment 
Participants will be recruited via an established database at the clinical site, use of IRB approved 
flyers and posting on the clinical site website.  The completely voluntary nature of participation will be 
underscored. 
8.4 
Subject Eligibility, Pre-Screening and Exclusions 
Subjects will be asked to participate in this study and will be screened for study eligibility.  Each 
subject will receive an anonymized subject identification number at time of screening that will serve 
as the subject’s identifier throughout the study.  A Screening/Enrollment Log will be maintained by the 
study site, in order to maintain a cumulative tracking of all screened subjects.  
8.5 
Written Informed Consent 
Subjects who pass initial pre-screening will be asked to sign the study-specific Informed Consent 
form before any study-specific tests or procedures are performed.  A member of the research team 
will inform the potential subject of the elements of the clinical study including, risks, potential benefits 
and required procedures prior to obtaining the potential subject’s informed consent.   
8.6 
Screening and Baseline (Day 0) Evaluation 
The following evaluations are required at the time of subject screening/baseline: 
1. Urine pregnancy test and drug screen; 
2. Medical History & Current Status – skin disorders; 
3. Medical History & Current Status – allergies; 
4. Medical History & Current Status – electronic implants; 
5. Medical History & Current Status – insomnia/sleep conditions; 
6. Evaluation of application sites for broken, damaged, or irritated skin or rashes; 
7. MC10 affiliation survey/question 
8. Demographics Information:  Age, Gender, Height, Weight, Fitzpatrick skin type. 
 
Source documents related to screening activities will be filled out for all screened subjects. 
8.7 
Subject Enrollment 
Subjects who meet all inclusion and none of the exclusion criteria will be considered eligible for 
enrollment.  Subjects will be considered enrolled at Visit 1 prior to application of study devices and 
measurement capability of the device on the subject has been verified.  If the subject does not meet 
the eligibility criteria at any time before enrollment then the subject will be considered a screen failure. 
Once enrolled, a subject may only exit the study as a withdrawal (not a screen failure).  The reason 

 
 
 
 
 
Protocol: MC10-PTL-103, Revision 00 
 
24 
Confidential 
for withdrawal will be documented by the investigator on the Study Termination CRF and early 
termination procedures will be completed for all withdrawn subjects.  All records of enrolled but 
withdrawn subjects will be retained as part of the study. 
 
8.8 
Study Assessments – In Clinic – Visit 1 (Supervised) 
During the supervised evaluation period, subjects will arrive at the study clinic on Day 0.  After 
admission to the clinic, but before the start of the evaluation period, a skin inspection of planned 
sensor application sites will be conducted.   
The clinical site staff will provision Sensors, a Link Hub, and a Link App phone to the subject using 
the Link App. They will then apply four Sensors and reference device sensors to the subject. Two of 
these Sensors will be applied following instructions on the Link App; the other two are for assessing 
adhesion only, and will be applied following written instructions.  
Site staff will then initiate and monitor the prescribed activities for the supervised portion of the study.  
The prescribed activities consist of general tasks: sitting, standing, lying down, leaning, walking, and 
biking.  The site staff will instruct the subject throughout the evaluation.  
For each of the prescribed activities, the site staff will start an annotation in the MC10 Link App to 
indicate that the subject is starting to perform an activity and will stop the annotation after a specific 
period of time when the subject has completed the activity.  Each annotation will be tagged with a 
letter and a number. The letter and number used for the annotation of each activity performed will be 
noted on the CRF. The following activities will be conducted as prescribed in sections 8.8.2 - 8.8.7. 
8.8.1 
Application of the Heart Rate Reference Device 
The Heart Rate Reference Device will be applied as described in Section 5.0, following the 
manufacturer’s IFU, 30 minutes prior to the start of study activities to allow for sensor to body 
continuity.  Heart rate will be monitored throughout the study including during the activities in 
Table 7 and Table 8.  
8.8.2 
BioStamp nPoint Sensor Application 
The clinician will apply sensors (turned off, no signal data) to the shank and forearm, and 
functional sensors to the chest, aligned to 60 degrees   from the transverse plane with the battery 
end pointed upwards (left nipple to right shoulder), and thigh, aligned vertically on the central 
thigh with the battery end pointed upwards, as prescribed by the BioStamp nPoint system IFU.  
MC10 Sensor adhesion will be assessed (refer to Table 3).  The activities in Table 6 will be 
conducted and annotated following the guided prompts provided by the Link App. 
 
Table 6: Application Activities 
Item 
Activity 
Description 
Time 
Repetitions 
1 
Posture Calibration  
Subject stands still in an upright vertical position  
10 s 
1 
 
8.8.3 
Activity Classification 
The activities in Table 7 will be conducted as prescribed, in a variable order, and will be 
annotated by the clinician marking the start and stop times for each activity using the Link App. 
The particular activity performed for a given annotation will be noted on the CRF. This set of 
activities will be performed 5 times in a random order each time, as listed in the Repetitions 
column of Table 7.  

 
 
 
 
 
Protocol: MC10-PTL-103, Revision 00 
 
25 
Confidential 
Table 7: Activity Classification Activities 
Item 
Activity 
Description 
Time 
Repetitions 
Metric 
1 
Standing 
Classification 
Instruct the subject to stand upright.  Once the 
subject is standing upright, start the activity. 
1 min 
5 
ADL Classifier – Standing 
HR/HRV – Resting 
2 
Sitting 
Classification 
Instruct the subject to sit in a chair.  Once the 
subject is sitting, start the activity. 
1 min 
5 
ADL Classifier – Sitting 
HR/HRV – Resting 
3 
Lying 
Classification 
Instruct the subject to lie supine.  Once the 
subject is lying in a supine position, start the 
activity. 
1 min 
5 
ADL Lying 
HR/HRV – Resting 
4 
Standing 
Upright 
Instruct the subject to stand against the 
marked wall, with their right side facing the 
wall.  Instruct the subject to stand 
upright.  Once the subject is in position, start 
the activity. 
1 min 
5 
Posture 
HR/HRV – Resting 
5 
Standing 
Leaning 
FRONT 
Instruct the subject to stand against the 
marked wall, with their right side facing the 
wall.  Instruct the subject to lean forward to the 
30-degree mark.  Once the subject is in 
position, start the activity. 
1 min 
5 
Posture 
HR/HRV – Resting 
6 
Standing 
Leaning BACK 
Instruct the subject to stand against the 
marked wall, with their right side facing the 
wall.  Instruct the subject to lean back to the 
30-degree mark.  Once the subject is in 
position, start the activity. 
1 min 
5 
Posture 
HR/HRV – Resting 
7 
Standing 
Leaning 
RIGHT 
Instruct the subject to stand facing the marked 
wall.  Instruct the subject to lean right to the 
30-degree mark.  Once the subject is in 
position, start the activity. 
1 min 
5 
Posture 
HR/HRV – Resting 
8 
Standing 
Leaning LEFT 
Instruct the subject to stand facing the marked 
wall.  Instruct the subject to lean left to the 30-
degree mark.  Once the subject is in position, 
start the activity. 
1 min 
5 
Posture 
HR/HRV – Resting 
9 
Sitting Upright 
Instruct the subject to sit in a straight-backed 
chair.  Instruct the subject to sit upright.  Once 
the subject is in position, start the activity. 
1 min 
5 
Posture 
HR/HRV – Resting 
10 
Sitting 
Leaning 
FRONT 
Instruct the subject to sit in a chair.  Instruct the 
subject to lean forward to the 30-degree 
mark.  Once the subject is in position, start the 
activity. 
1 min 
5 
Posture 
HR/HRV – Resting 
11 
Sitting 
Leaning BACK 
Instruct the subject to sit in a chair.  Instruct the 
subject to lean back to the 30-degree 
mark.  Once the subject is in position, start the 
activity. 
1 min 
5 
Posture 
HR/HRV – Resting 
12 
Sitting 
Leaning 
RIGHT 
Instruct the subject to sit in a chair.  Instruct the 
subject to lean right to the 30-degree 
mark.  Once the subject is in position, start the 
activity. 
1 min 
5 
Posture 
HR/HRV – Resting 
13 
Sitting 
Leaning LEFT 
Instruct the subject to sit in a chair.  Instruct the 
subject to lean left to the 30-degree 
mark.  Once the subject is in position, start the 
activity. 
1 min 
5 
Posture 
HR/HRV – Resting 
14 
Lying SUPINE 
Instruct the subject to lie on their back. Once 
the subject is in position, start the activity. 
1 min 
5 
Sleep posture 
HR/HRV – Resting 
15 
Lying PRONE 
Instruct the subject to lie flat on their stomach. 
Once the subject is in position, start the 
activity. 
1 min 
5 
Sleep posture 
HR/HRV – Resting 
16 
Lying RIGHT 
Instruct the subject to lie on their right side. 
Once the subject is in position, start the 
activity. 
1 min 
5 
Sleep posture 
HR/HRV – Resting 
17 
Lying LEFT 
Instruct the subject to lie on their left 
side.  Once the subject is in position, start the 
activity. 
1 min 
5 
Sleep posture 
HR/HRV – Resting 

 
 
 
 
 
Protocol: MC10-PTL-103, Revision 00 
 
26 
Confidential 
18 
Walking  
Instruct the subject to walk for 6 minutes.  
Once the subject starts walking, start the 
activity.  Count total steps taken by the subject, 
both legs.  
Post-activity assessment: How many total 
steps did the subject take during the walking 
activity? 
6 min 
5 
ADL Classifier – Walking 
Pedometer 
HR/HRV – Moving 
19 
Walking 
Classification 
Instruct the subject to walk on the treadmill at a 
constant, comfortable pace.  Once the subject 
starts walking, start the activity. 
1 min 
5 
ADL Classifier – Walking 
 
20 
Other 
Classification 
Instruct the subject to bike at a constant, 
comfortable, low-intensity pace.  Once the 
subject starts biking, start the activity. 
8 min 
5 
ADL Classifier – Other 
HR/HRV – Moving 
8.8.1 
Heart Rate Activities 
The activities in Table 8 will be conducted as prescribed and will be annotated by the subject 
marking the start and stop times for each activity using the Link App. The clinician will train the 
subject on Link App operation and monitor subject performance to ensure that the activities are 
properly annotated.   
Table 8: Heart Rate Activities 
Item 
Activity 
Description 
Time 
(minimum) 
Repetitions 
Metric 
1 
Sitting 
Sit comfortably in a chair  
22 min 
At least 2, 
up to 4 
HR/HRV – 
Resting 
2 
Walking 
Walk on a treadmill at a comfortable pace  
22 min 
At least 2, 
up to 4 
HR/HRV – 
Moving 
3 
Biking 
Bike on a recumbent bike at a comfortable pace 
22 min 
At least 2, 
up to 4 
HR/HRV – 
Moving 
 
8.8.2 
Application of the Respiration Reference Device 
The Respiration Reference Device will be applied as prescribed in Section 5.0, following the 
manufacturer’s IFU, prior to the subject going to bed.  
8.8.3 
Night-Time Sleep Duration 
When the subject goes to bed (lights out) and arises from bed (woken by site staff), the sleep 
onset time and wake time will be recorded by site staff on the CRF. Subjects will be observed 
throughout the night to annotate on the CRF any periods of wakefulness between these times.  
8.8.4 
Night-Time Sleep Respiration 
Respiration will be captured by the device for the duration of the subject’s night of sleep. 
8.8.5 
Removal of the Respiration Reference Device 
The Respiration Reference Device will be removed as prescribed in Section 5.0, following the 
manufacturer’s IFU after the subject arises from bed. 
 
8.8.6 
Sensor Adhesion Assessment 
On Day 1, prior to removal of the first set of sensors, and after 24 hours of sensor wear for the 
four body locations, clinical staff will rate the skin adhesion using a 5-point scale (0-4, refer to 
Table 3)7 .  
 
Adhesion will be scored by clinical staff based on visual observation and assessment of total 
unpeeled surface immediately prior to Sensor removal.  
 

 
 
 
 
 
Protocol: MC10-PTL-103, Revision 00 
 
27 
Confidential 
8.8.7 
Sensor Removal  
After at least 24 hours of wear, the clinician will remove Sensors from the chest, thigh, shank, and 
forearm as prescribed by the BioStamp nPoint system IFU.  
8.8.8 
Safety and Tolerability Assessment 
Safety and tolerability will be assessed immediately by the clinical staff after the Sensor’s removal 
based on qualitative (visual observations) assessments of skin redness.  
 
Skin irritation will be assessed on a 0 to 3 scale based on native assessments (visual 
observations) of skin irritation using the following scale8 (Table 9). 
 
 
Table 9: Irritation Rating Scale 
Score 
Rating 
Description 
0 
No reaction 
--- 
1 
Weakly positive reaction  
usually characterized by mild erythema and/or 
dryness across most of the treatment site 
2 
Moderately positive reaction  
usually distinct erythema or dryness, possibly 
spreading beyond the treatment site 
3 
Strongly positive reaction 
strong and often spreading erythema with 
edema and/or eschar formation 
 
8.8.9 
Data Download 
Site staff will download the data from and recharge the BioStamp nPoint chest and thigh sensors 
using the Link App.  The sensors will not be used again.  
 
Site staff will download the Heart Rate Reference Device data to a dedicated study computer at 
the end of the wear period using the manufacturer’s proprietary software per the instructions for 
use.  
 
Site staff will download the Respiratory Reference Device data after each night of sleep to a USB 
stick following the manufacturer’s instructions for use.  
 
8.8.10 Subject Training – Remote Kit 
The subject will be trained on the BioStamp nPoint system subject IFU and the Link App 
operations to be performed under observation, defined in Section 8.9. While observed by the 
clinician, the subject will then apply the sensors to the chest and thigh using the Link App, and will 
conduct and annotate the activities in Table 8 using the Link App prior to departure from the 
clinic.  The clinician will evaluate adhesion using the scale in Table 3 and observe the subject 
through re-applying any Sensors with a non-zero score for up to two applications.  If two non-zero 
scores are noted, the clinician should then apply the Sensor. 
8.9 
Study Assessments – Remote (Unobserved) 
After the completion of the supervised evaluation period, subject training, and replacement of 
BioStamp nPoint sensors on Day 1, the subject will remain in the clinic, where they will continue to 
wear the BioStamp nPoint system and the Heart Rate Reference Device and execute Table 8 
activities.  

 
 
 
 
 
Protocol: MC10-PTL-103, Revision 00 
 
28 
Confidential 
8.10 Study Assessments – In Clinic – Visit 2 (Supervised) 
On the same day (Day 1), the subject will go to bed.  Upon waking, clinical site staff will observe the 
subject removing, cleaning, synchronizing, and beginning to recharge the BioStamp nPoint sensors.  
Sensor safety and tolerability will then be assessed.   
8.10.1 Night-Time Sleep Duration 
When the subject goes to bed (lights out) and arises from bed (woken by site staff) the sleep 
onset time and wake time will be recorded by site staff on the CRF. Subjects will be observed 
throughout the night to annotate on the CRF any periods of wakefulness between these times 
8.10.2 Night-Time Sleep Respiration 
When the subject is ready to go to sleep, site staff will place the Respiration Reference Device on 
the subject as described in Section 5.0, following the manufacturer’s IFU.  Respiration will be 
captured by the device for the duration of the subject’s night of sleep.  After the subject wakes, 
the Respiration Reference Device will be removed as prescribed in Section 5.0, following the 
manufacturer’s IFU. 
8.10.3 Sensor Removal 
On the morning of Day 2, while observed by the site staff, the subject will remove sensors from 
the chest and thigh, and will clean them, synchronize the recorded data, and begin to recharge 
the sensors as prescribed by the BioStamp nPoint system IFU.  
8.10.4 Safety and Tolerability Assessment 
Safety and tolerability will be assessed immediately by the clinical staff after the Sensor’s removal 
based on qualitative (visual observations) assessments of skin redness level.  
 
Skin irritation will be assessed on a 0 to 3 scale based on native assessments (visual 
observations) of the skin sensor locations using the scale9 located in Table 9. 
 
8.10.5 Equipment Return 
The Heart Rate Reference Device will be removed. The subjects will return the provisioned 
equipment; equipment return will be documented on the Device Accountability Form.  
8.10.6 Usability Survey 
Subjects will complete a survey related to the intuitiveness and ease of use of the BioStamp 
nPoint system.   
8.11 Data Download 
The clinical staff will verify that the data from the BioStamp nPoint system has successfully been 
uploaded to the BioStamp nPoint cloud, and will download the data from the Heart Rate Reference 
Device and the Respiration Reference Device after the system is returned on Day 2.  Algorithm 
outputs will be derived from the Web Portal.  
8.12 Subject Follow-up 
A Safety follow-up telephone call will be made between Day 3 and Day 5 to assess for adverse 
events associated with study participation. 

 
 
 
 
 
Protocol: MC10-PTL-103, Revision 00 
 
29 
Confidential 
9.0 
Completion or Early Withdrawal of Subjects 
9.1 
Subject Completion 
Completion of the study is defined as: 
1. completing the supervised activities; 
2. wearing the sensors for two days; 
3. returning the sensors to the coordinators; 
4. completing the usability survey;  
5. completing the follow-up telephone call. 
9.2 
Subject Early Discontinuation / Withdrawal of Subjects 
Subjects are free to withdraw from the study at any time, without prejudice.  Subjects should be 
withdrawn from the study if any of the following events occur:   
1. Subject develops an illness or any other condition or event that would interfere with his/her 
continued participation;   
2. Subject is noncompliant with the study procedures, or unable to continue in the opinion of the 
Investigator;   
3. Subject withdraws his/her consent; 
4. The Sponsor or a regulatory agency requests withdrawal of the subject.   
Investigators should attempt to obtain information on subjects, in the case of withdrawal or 
discontinuation. For subjects considered as lost to follow-up, the Investigator should make an effort 
(at least 1 phone call to the subject on each of 2 separate days), and document his/her effort (date 
and summary of the phone call in the source documents) to complete the final evaluation. All results 
of these evaluations and observations, together with a narrative description of the reason(s) for 
discontinuing the subject, must be recorded in the source documents.  The Study Termination Case 
Report Form (CRF) must document the primary reason for withdrawal or discontinuation.   
10.0 
Risk / Benefit Analysis 
10.1 Benefits 
There are no direct benefits for the subjects participating in this study. However, the knowledge 
gained from this study may be important for improving short and long - term patient monitoring and 
providing subjective data, both in the clinic and remotely, for capturing physiological metrics that may 
aid researchers and healthcare professionals. 
10.2 Risks 
The risks of the investigational procedure to subjects are expected to be minimal under this protocol 
and are described in Section 14.5.  
The BioStamp nPoint system sensor includes a non-invasive biosensor that is attached to the surface 
of the skin using an adhesive sticker, and is designed to measure movement, heart rate, heart rate 
variability, and sleep metrics using embedded accelerometer, gyroscope, and electrodes.  The study 
is designed to assess the system’s ability to capture and analyze movement, heart rate, heart rate 
variability, and sleep.  
This is the first clinical trial for this device.  The study will enroll healthy subjects at one study site in 
the United States.   
The device will not be used in this study as an implant; it will not be used to support or sustain human 
life; it will not be of substantial importance in diagnosing, curing, mitigating, or treating disease, or 
otherwise preventing impairment of human health in this study; and the use in this study will not 
otherwise present a potential for serious risk to the health, safety, or welfare of a subject.  Harm 

 
 
 
 
 
Protocol: MC10-PTL-103, Revision 00 
 
30 
Confidential 
resulting from use of the device is not considered a serious risk.  In addition, no other study 
procedures will be performed that would place the subjects at significant risk.  As indicated in Section 
14.5, skin irritation is an anticipated risk.  
The BioStamp nPoint system is Non-Significant Risk under the proposed investigational study based 
on a comprehensive risk analysis per Investigational Device Exemptions, 21 C.F.R. § 812.3(m) 
(2016) and proposed use of the device10.  
10.3 Minimization of Risk and Monitoring Procedures 
MC10 has attempted to mitigate risks as much as possible through product design, testing, and 
through careful labeling and instructions for use. Risks will be further mitigated through selection of 
qualified physicians, appropriate training, and study monitoring ensured by the following: 
• 
Investigators who participate in the study will be experienced and skilled in collection of 
physiological data. Additionally, investigators, in conjunction with the investigational site, will 
have adequate resources for participation in a clinical study.    
• 
Each investigator will ensure oversight and approval of the study by an Institutional Review 
Board (IRB) prior to initiation of the clinical study at his/her investigational site.   
• 
The investigator and study personnel will be trained on the clinical protocol, investigational 
device and Instructions for Use.   
• 
Subjects will be carefully evaluated against the inclusion/exclusion criteria prior to entering 
the clinical study to ensure that their diagnosis and medical status are appropriate for 
participation in the clinical study.   
• 
Subjects will be monitored throughout the follow-up period as defined in the study protocol.   
• 
Any adverse events occurring during the time of the investigational procedure will be closely 
monitored and the subject shall be followed until resolution or is judged to be chronically 
stable, and any deleterious trends investigated as early as possible.   
11.0 
STATISTICAL METHODS 
11.1 Introduction 
The study is a non-significant risk, prospective, non-randomized study of the performance 
characteristics of the BioStamp nPoint device in healthy adult subjects.  Subjects will be enrolled in 
the trial for approximately 48 hours.  The primary objectives of the statistical analyses are to evaluate 
the agreement of the BioStamp nPoint measurements to commonly accepted measurement 
standards.   
A study center is defined as a hospital or medical office under the control and supervision of the 
Principal Investigator.   
11.2 Sample Size 
The sample size of n=25 subjects is sufficient to meet business needs of the Sponsor and is 
comparable to the size of studies with similar devices.  An additional 5 subjects may be enrolled to 
account for a 20% dropout rate.  
11.3 Effectiveness Variables 
The effectiveness endpoints for this study are the various types of measurements made by the 
BioStamp nPoint system. All effectiveness endpoints to be statistically summarized will be collected 
using the BioStamp nPoint during the supervised-use phase.  The effectiveness endpoints are as 
follows: 
 

 
 
 
 
 
Protocol: MC10-PTL-103, Revision 00 
 
31 
Confidential 
o 
Heart Rate (bpm) 
o 
Heart Rate Variability (RMSSD5 (msec) and LF/HF Ratio6) 
o 
Respiration (average respiration rate) 
o 
Activity Classification (activities – standing, sitting, lying, walking and other)  
o 
Activity Parameters - total step counts in a 6 minute walk test 
o 
Sleep (sleep onset time (hours, minutes, and seconds), sleep wake time (hours, minutes, 
and seconds)) 
o 
Posture Classification (sleep posture, stationary posture standing, stationary posture 
sitting) 
 
For each endpoint, the BioStamp nPoint measurements will be compared to a similar FDA 
approved measurement device, to other basic or manual measurement devices, or to 
independent observer measurements.  The FDA approved measurement devices for this study 
are the Actiheart heart rate reference device and the Capnostream portable respiratory monitor.  
Table 10 displays the comparator method for each endpoint category. 
Table 10: Endpoint Variable Group and Measurement Comparator 
Index Endpoint Variable Group 
Measurement Comparator 
1 
Heart Rate 
Actiheart Device 
2 
Heart Rate Variability 
Actiheart Device 
3 
Respiration 
Capnostream Device 
4 
Activity Classification 
Independent Observer 
5 
Activity Parameters 
Manual Step Counting Device 
6 
Sleep Parameters 
Independent Observer 
7 
Posture 
Independent Observer 
 
Individual independent observers will receive training on the operation of all devices and 
execution of the study protocol before the enrollment of any subjects.   
 
For heart rate and heart rate variability, the values collected will be the one minute average heart 
rate, the one minute RMSSD, and the five-minute LF/HF ratio from the BioStamp nPoint and the 
one minute average heart rate, the one minute RMSSD, and five minute LF/HF from the Actiheart 
device on each of six recording times for each subject.  Two readings will be taken while the 
subject is at rest, two while exercising and two while lying down. These readings will be collected 
during the activities listed in Table 7 and Table 8. 
 
For respiration rate, the average resting respiration rate values will be collected at one minute 
time intervals during sleep on each subject using both the BioStamp nPoint and the Respiration 
Reference Device.   
  
For the activity classification variable, each subject will be presented with five tasks (standing, 
sitting, lying, walking and stationary bike riding) in varied order and the activity classification will 
be recorded by the BioStamp nPoint and by the independent observer.  This procedure will be 
repeated five times for each subject.  
 
                                                 
 
5 RMSSD: root-mean-square of successive difference of the time intervals between successive heartbeats. 
6 LF/HF ratio: the ratio of power in the low-frequency (LF, 0.04-0.15 Hz) and high-frequency (HF, 0.15-0.4 Hz) bands of heart rate 
variability in the frequency domain. 

 
 
 
 
 
Protocol: MC10-PTL-103, Revision 00 
 
32 
Confidential 
For the exercise parameter “number of steps taken”, the number of steps taken by the subject 
during a 6 minute walk test will be recorded using both the BioStamp nPoint and a simple step 
counting device. This procedure will be repeated five times for each subject. 
 
For the sleep parameters sleep onset time and wake time, the BioStamp nPoint values and 
independent observer values will be collected on each night and morning at the study site.   
 
Posture classification variables will be analyzed separately for each type of posture activity (sleep 
positions, stationary posture standing and stationary posture sitting). For a given posture activity, 
the posture classification will be recorded by the BioStamp nPoint and the independent observer 
for two repeats each of each ground-truth posture for each subject. Each repeat will generate 5 
independent observations of posture. The posture classifications for each posture classification 
variable are given in Table 11. 
 
 
Table 11: Posture Variable vs Classification 
Index 
Posture Variable 
Posture Classification 
1 
Simulated sleep positions 
Supine, prone, left side and right side 
2 
Stationary Posture Standing 
Upright, lean left, lean right, lean back, lean forward 
3 
Stationary Posture Sitting 
Upright, lean left, lean right, lean back, lean forward 
 
Sensor adhesion to the subject will be measured on a 4 point scale by the independent observer 
for each of four sensor patches on each subject following 24 hours of continuous wear.  The 
adhesion rating scale is presented in Table 3.  
 
11.4 Analysis Populations 
The following analysis populations will be defined for the study: 
 
• 
Intent-to-Measure (ITM) Population – The ITM population will consist of all subjects who are 
enrolled in the study and for which the ability of each measurement device to measure the 
subject has been established. 
 
• 
Safety Population – The safety population will consist of all subjects who are enrolled in the 
study. 
 
The ITM population will be the primary analysis set for all effectiveness analyses.  The safety 
population will be used for the analysis of all safety variables and baseline characteristics. 
11.5 Analysis Subgroups 
There is no subgroup analysis planned for the study.  
11.6 Statistical and Analytical Plans 
11.6.1 Disposition and Demographics 
A table will be constructed with counts and percentages of the number of subjects who were 
screen failures, the number of subjects enrolled in the study, the number of subjects withdrawn 
from the study before study completion, and the number who completed the study.  For those 
subjects who withdrew before completion of the study, counts and percentages of the reasons for 
withdrawal will be tabulated.   
 

 
 
 
 
 
Protocol: MC10-PTL-103, Revision 00 
 
33 
Confidential 
The continuous demographic characteristics at screening will be summarized for all subjects in 
the safety population using descriptive statistics (mean, standard deviation, median, minimum, 
maximum, and number of non-missing observations).  The categorical baseline characteristics 
will be summarized for the safety population using frequency counts and percentages. 
11.6.2 Effectiveness Endpoint Analyses 
For pairs of measurements collected on the continuous scale (quantitative to quantitative 
comparisons), scatter plots with the 45 degree line of agreement superimposed will be 
constructed from paired observations from the two sources (BioStamp nPoint vs comparator)  
along with Bland-Altman plots of the data.  The mean absolute error (MAE) and the root-mean-
square error (RMSE) estimates of agreement will be calculated for each comparison.  The 
standard deviations of each of the agreement measures will also be computed.   
 
For pairs of measurements collected on a categorical scale (qualitative to qualitative 
comparisons), two-way tables of agreement will be constructed for each comparison.  The 
agreement percentage will be computed for each table. 
 
The number and percentage of sensor patches in each category of the adhesion scoring scale 
will be tabulated. 
 
The statistical analyses of the effectiveness data will also be described in the Statistical Analysis 
Plan (SAP) for the study.  The SAP will be written and finalized prior to database lock.    
 
11.6.3 Safety Analysis 
Prior to analysis, all AEs will be coded using the MedDRA coding dictionary. Based on these 
coded terms, TEAEs will be summarized using system organ class and preferred terms, as well 
as by relationship to the study devices. All AEs will be listed, regardless of whether or not they 
were study treatment related. 
11.7 Handling Missing Data 
In the statistical analysis of the primary effectiveness endpoints of the study, only the time points for 
each subject with evaluable endpoints for the both the BioStamp nPoint and the comparator method 
will be used in the statistical analysis, i.e., a complete case analysis.  The handling of missing values 
for all other study endpoints will be described in the SAP for the study. 
11.8 Interim Analysis 
There are no interim analyses planned for this study.   
 
12.0 
DATA MANAGEMENT 
12.1 Data Flow 
Data generated by the BioStamp nPoint system and the reference devices, as well as data annotated 
on the CRFs, will be extracted and time-aligned by MC10 for entry into the trial database.  During 
study execution, ground-truth data collected on CRFs and by reference devices will be stored at the 
study site.  Data collected using BioStamp nPoint will be transmitted to the MC10 Cloud for 
processing and generation of analytic outputs. The process described below allows verification that 
the extraction and time-alignment processes do not introduce changes in the underlying data. 
 
After the final subject has completed the study, the sum total of analytic outputs from the study will be 
exported from the MC10 Cloud and stored in a read-only archive. This archive will be entered into 

 
 
 
 
 
Protocol: MC10-PTL-103, Revision 00 
 
34 
Confidential 
MC10’s Quality system, and a checksum to uniquely represent this archive will be computed.  This 
checksum will be sent for entry into the trial database.  After the checksum has been entered, CTI will 
archive all ground-truth data in a read-only format and compute a checksum on the resulting archive.  
This checksum will also be entered into the trial database.  CTI will then send the ground-truth data 
archive to MC10 for data extraction and time-alignment.  MC10 will then send the relevant data for 
entry into the trial database and subsequent analysis.  All tools to be used in this process will be 
validated. 
12.2 Data Collection 
Data management will be performed by MC10 or their designee using a validated data system as 
specified in 21 CFR 11.  Subject data will be entered into CRFs and combined with data provided 
from other sources in a validated data system that will reside in the clinical data management 
database.   
Clinical data management will be performed in accordance with applicable MC10 or their designee’s 
SOPs; data cleaning procedures will be performed with the objective of ensuring all data fields are 
populated, and removing errors and inconsistencies in the data which would otherwise impact the 
analysis and reporting objectives, or the credibility of the final study report.   
The principal investigator is responsible for the accuracy and completeness of all study 
documentation. The clinical monitor will collect the originals and the investigational site shall retain 
the copies. 
12.3 Data Processing 
Visual and computer error checks will be carried out. The investigator will be queried on errors 
concerning completeness and consistency.  Audits may be performed for quality assurance of data 
handling. 
13.0 
MONITORING AND QUALITY CONTROL PROCEDURES 
13.1 Monitoring and Auditing 
Sponsor personnel or their designees will monitor the study and verify subject data and ensure 
compliance with Good Clinical Practice (GCP), clinical protocol and other study requirements. 
Monitoring visits to the clinical site(s) will be made periodically during the study, to ensure that all 
aspects of the current, approved protocol/amendment(s) are followed.  
Prior to the enrollment of any subject in this study, the Monitor and the Investigator will review the 
protocol, the procedure for obtaining informed consent and the procedure for reporting adverse 
events.  On-site and remote monitoring visits will be performed by the Monitor. Case report forms will 
be verified against source documentation and subject compliance will be monitored.  
The Monitor is responsible for ensuring, through personal contact with the Investigator and site 
personnel that the members of the clinical staff clearly understand and accept the obligations incurred 
in this investigation, and that these obligations are being fulfilled throughout the study.  Specifically, 
the Monitor will interact with the site via telephone contact and periodic on-site visits to ensure that:  
• 
Study facilities continue to be acceptable for the conduct of the study  
• 
Regulatory and study documents are complete and up-to-date  
• 
The protocol is appropriately followed  
• 
Protocol amendments have been approved by the IRB and the local regulatory authorities (as 
applicable), and the Sponsor has received the approval in writing   
• 
Qualified subjects are enrolled in a timely manner  
• 
Accurate, complete, and current records are maintained for all subjects  

 
 
 
 
 
Protocol: MC10-PTL-103, Revision 00 
 
35 
Confidential 
• 
The information recorded and submitted to the Sponsor is representative of the subject 
record and other supporting documentation  
• 
Problems with inconsistent and incomplete data are addressed  
• 
Accurate, complete, and timely adverse event reports are being made to the Sponsor  
• 
The Principal Investigator continues to assume primary responsibility for the study   
• 
Investigational devices are properly stored, dispensed, and accounted for  
13.2 Device Labeling 
Labeling for the investigational devices will be limited to product labels and the Instructions for Use 
(IFU) for the operation of the device.  The packaging of the BioStamp nPoint system will be labeled in 
compliance with 21 CFR Part 812.5.  Each device label will include the wording “Caution – 
Investigational Device. Limited to Investigational Use” or similar language. 
13.3 Device Accountability 
Access to investigational devices shall be controlled and used only in the clinical investigation and 
according to the Protocol.  
The Sponsor shall keep records to document the physical location of all investigational devices from 
shipment (or hand-carried) to the sites until return or disposal.  
The principal investigator or an authorized designee shall keep records documenting the receipt, use, 
return, and disposal of the investigational device, which shall include:  
• 
The date of receipt 
• 
Identification of each investigational device (serial and or lot number) 
• 
The date or dates of use 
• 
Subject identification 
• 
Date of return of unused, expired, or malfunctioning investigational device, if applicable 
The Investigator must explain in writing the reasons for any discrepancy noted in device 
accountability. 
14.0 
ADVERSE EVENTS 
14.1 Definitions 
Adverse events will be recorded and documented throughout the duration of the study.  In this study, 
adverse events will be defined and classified per ISO 14155:2011(E) Clinical Investigations of 
Medical Devices in Human Subjects - Good Clinical Practice and all applicable internal Sponsor 
procedures; see Table 12 for details.  Per ISO 14155:2011(F), “ADE” will include any AE related to 
the investigational device, as well as any AE related to study design.  
Table 12: Adverse Event Definitions 
Adverse Event 
Non-device related 
Device- or procedure-related 
Non-serious 
Adverse Event 
Adverse Device Effect (ADE) 
Serious 
Serious Adverse Event 
Serious Adverse Device Effect (SADE) 
Anticipated 
Unanticipated 
Anticipated Serious Adverse Device 
Effect 
Unanticipated Serious Adverse 
Device Effect 

 
 
 
 
 
Protocol: MC10-PTL-103, Revision 00 
 
36 
Confidential 
 
14.1.1 Adverse Events 
Adverse events (AE) are any untoward medical occurrence, unintended disease or injury, or 
untoward clinical signs (including abnormal laboratory findings) in which subjects, users or other 
persons, whether or not related to the investigational medical device. 
All adverse events, regardless of relationship to the device, must be recorded, as applicable, on 
the case report forms provided. Adverse events that occur during this study should be treated by 
established standards of care, which will protect the life and safety of the subjects. 
Adverse events shall be assessed and documented at the time of the procedure and at all study 
follow-up visits. Each investigator shall provide source documentation as requested by the 
Sponsor to facilitate reporting and adjudication of these events. 
14.1.2 Serious Adverse Events 
An adverse event is considered a Serious Adverse Event (SAE) that 
a. led to death 
b. led to a serious deterioration in the health of the subject, that either resulted in 
1) a life-threatening illness or injury, or  
2) a permanent impairment of a body structure or a body function, or  
3) in - patient hospitalization or prolongation of existing hospitalization, or  
4) a medical or surgical intervention to prevent permanent life-threatening illness or injury 
or permanent impairment to body structure or a body function.  
c. led to fetal distress, fetal death or a congenital abnormality 
14.1.3 Unanticipated Serious Adverse Device Effect 
An Unanticipated Serious Adverse Device Effect (USADE) is defined as any serious adverse 
effect on health or safety or any life-threatening problem or death caused by, or associated with, 
a device, if that effect, problem, or death were not previously identified in nature, severity, or 
degree of incidence in the investigational plan or labeling, or any other unanticipated serious 
problem associated with a device that relates to the rights, safety, or welfare of subjects.  
14.2 Adverse Event Reporting 
Any adverse event that occurs during the course of the study must be reported using the appropriate 
form in the CRFs and the Investigator must sign each report.  The Investigator must determine 
whether the adverse event is serious or unanticipated, its intensity, and the relationship of each 
adverse event to the investigational devices.  
All serious adverse events, including unanticipated serious adverse device effects, must be reported 
within 24 hours of the site first becoming aware of the event using the appropriate CRF. All other 
adverse events (i.e. other than serious adverse events or unanticipated adverse device effects) must 
be recorded on the appropriate CRFs. The Medical Monitor will contact the site for additional 
information, if required.  
For any adverse event that is ongoing at the time of the initial report, periodic follow-up information is 
required until the adverse event is resolved or is judged to be chronically stable.  The site should 
submit relevant follow-up information related to the adverse event as soon as it is available. 
Depending upon the nature and seriousness of the adverse event, the Medical Monitor may request 
the Investigator to provide copies of the subject’s medical records (such as the subject’s laboratory 
tests and hospital records, Investigator summaries, etc.) to document the adverse event.  The 
Medical Monitor is available to respond to any medical issues that arise during the conduct of this 

 
 
 
 
 
Protocol: MC10-PTL-103, Revision 00 
 
37 
Confidential 
study.  
The Investigator will report all serious adverse events, including unanticipated adverse device effects, 
to the IRB according to the IRB requirements.  A copy of this IRB communication should be sent to 
the Sponsor.  
Within 10 working days of notification, the Sponsor will report all unanticipated adverse device effects 
to the appropriate authority, all participating investigators, and all reviewing IRB.  The Sponsor will 
ensure that safety reporting for the study is conducted in compliance with all pertinent requirements 
and regulations. 
14.3 Adverse Event Reporting 
14.3.1 Initial Assessment 
The investigator must provide the following information:  
• 
Date of onset 
• 
Nature  
• 
Severity 
• 
Duration / date of resolution 
• 
Outcome 
• 
Relationship to investigational device 
• 
Other relevant information 
14.3.2 Assessment of Severity  
The Investigator must determine the severity of the adverse event according to the following 
definitions:  
• 
Mild - The adverse event is noticeable to the subject, but does not interfere with routine 
activity; the symptoms are easily tolerated and transient in nature.  
• 
Moderate – The adverse event interferes with routine activity but responds to 
symptomatic therapy or rest; the symptoms are poorly tolerated and sustained.  
• 
Severe – The adverse event significantly limits the subject’s ability to perform routine 
activities despite symptomatic therapy.  The adverse event requires medical or surgical 
treatment or results in hospitalization.  
• 
Life-Threatening – The subject is at immediate risk of death. 
14.3.3 Device Relatedness 
The Investigator must provide an assessment of the adverse event association of device 
relatedness according to the following definitions: 
• 
Definite – The adverse event is clearly related to the investigational device: the event 
has a temporal relationship to the investigational device, follows a known pattern of 
response, or is otherwise logically related to the investigational device, and no alternative 
cause is present. 
• 
Probable (Likely) – The adverse event is likely related to the investigational device: the 
event has a temporal relationship to the investigational device, follows a known or 
suspected pattern of response, or is otherwise logically related to the investigational 
device, but an alternative cause may be present. 
• 
Possible (Unlikely) – The adverse event is unlikely related to the investigational device: 
the event does not follow a clear temporal relationship to the investigational device or 

 
 
 
 
 
Protocol: MC10-PTL-103, Revision 00 
 
38 
Confidential 
does not follow a known pattern of response, or is otherwise likely to be due to the 
subject’s clinical state or other modes of therapy. 
• 
Not Related – The adverse event is clearly not related to the investigational device: the 
event has no temporal or other relationship to the administration of the investigational 
device follows no known or suspected pattern of response, and an alternative cause is 
present. 
• 
Unknown – Unable to determine the relationship based on all available information. 
14.4 Device Deficiency 
A Device Deficiency is an inadequacy of a medical device with respect to its identity, quality, 
durability, reliability, safety or performance (includes malfunctions, use errors, and inadequate 
labeling).  Sponsor will assess all device deficiencies that could have led to a serious adverse device 
effect for potential regulatory reporting requirements.   
In the event of a suspected malfunction or device deficiency, the investigational device shall be 
returned to the Sponsor for analysis. Instructions for returning the investigational device will be 
provided by the sponsor. 
14.5 Anticipated Device Related Effects 
As a dermal application, the BioStamp nPoint sensors may cause mild skin irritation/reactions; 
however, these reactions can be moderate to severe. These skin reactions (such as macular 
erythema, allergic reactions, inflammation, pain, skin irritation/damage) are expected to be minor 
because the patient contact material of the BioStamp nPoint was specifically selected based on its 
biocompatibility. However, these skin reactions may manifest to a more severe form (such as burning, 
blistering, and intense redness). If an anticipated device related effect manifests in an 
uncharacteristic or unusual manner (e.g., an effect occurs with greater severity or specificity from that 
mentioned above), the effect should no longer be considered anticipated. 
 
Any anticipated device effect that results in a SAE or SADE must be reported to MC10 in accordance 
with the procedures outlined in Section 14.3. 
15.0 
MEDICAL MONITORING  
The principal investigator will review adverse event reports as they arise and be responsible for 
determining whether to alter or stop a subject’s participation.  Subjects are instructed to report any 
adverse effects or concerns immediately; in addition, we will directly inquire as to adverse events at the 
exit interview.  Subjects are free to terminate participation in the study at any time.  No formal Data Safety 
Monitoring Board is planned. 
  
Adverse events and unanticipated problems involving risks to subjects or others will be reviewed by the 
principal investigator, who will judge whether event(s) were expected or not, or related or not to the study.  
In addition, the investigator will also determine the best course of action to ensure subject safety. 
 
MC10 will be responsible for receiving SAE reports from the study site, gathering information from the 
study site concerning these Serious Adverse Events, reporting these SAEs to FDA on the proper forms 
within the time constraints specified in the CFR, and following up with the study site until the SAE 
resolves.   
16.0 STUDY ADMINISTRATION  
16.1 Statement of Compliance 
The clinical investigations will be in accordance with the ethical principles of the Declaration of 
Helsinki (64th WMA General Assembly, Fortaleza, Brazil October 2013), ISO 14155:2011 and ICH-
GCP Guidelines. 

 
 
 
 
 
Protocol: MC10-PTL-103, Revision 00 
 
39 
Confidential 
• 
The clinical investigation shall not commence until approval by the IRB.   
• 
Any additional requirements imposed by the IRB or regulatory authority shall be followed. 
• 
The Sponsor shall maintain a Clinical Trial Liability Policy with an insurance company. 
16.2 IRB Approval 
The study protocol shall be reviewed and approved by the investigator’s IRB or a contract IRB if the 
participating institution allows, prior to subject enrollment.  The Sponsor must review any proposed 
changes to the investigational plan prior to implementation.  The Sponsor and the IRB must approve 
significant changes to the investigational plan in writing by prior to implementation.  A significant 
change is one which may increase the risk or present a new risk to a subject, or which may adversely 
affect the scientific validity of the study. 
Prior to shipment of investigational devices, a signed copy of the IRB approval letter identifying the 
clinical study and investigational site is required to be submitted to the Sponsor.  Investigators are 
responsible for obtaining and maintaining annual renewal of the study by their IRB (or according to 
renewal schedule imposed by the IRB).  Evidence of renewal and continued IRB approval must be 
provided to the Sponsor accordingly. 
16.3 Informed Consent 
Informed consent is mandatory and must be obtained from all subjects as per local regulations, prior 
to their participation in the study.  
It is the responsibility of the Investigator to ensure that written informed consent from each subject, or 
the legally authorized representative of the subject, is obtained prior to the initiation of any study-
related procedures.   
Subjects who agree to participate in this study will do so voluntarily.  They will be treated on an equal 
basis with all other subjects.  
Study personnel fully knowledgeable in the purposes and procedures of the study will approach all 
prospective study participants. The facilities and settings in which prospective participants will be 
presented with the opportunity to learn about and consent to participation in the study will provide 
them sufficient quiet and unhurried time to be informed of the study, to ask questions, and between 
consent being given and the initiation of study procedures. Study personnel will, after presenting the 
study to prospective participants, assess the subject’s understanding and autonomy by asking the 
subject to explain the study in his/her own words.  
Once that step is completed, consent will be able to be given by the subject’s signing the consent 
form. A copy of the consent form will be given to all consented participants.   
Signed subject consent forms must be retained in the study files by the Investigator, and available for 
review by the Sponsor and/or regulatory agencies, as applicable.  
The informed consent form and any other written information provided to subjects will be revised 
whenever important new information becomes available, or if there is an amendment to the protocol 
which necessitates a change to the content of subject information and/or to the consent form.  The 
Investigator will inform the subject of changes in a timely manner, and will ask the subject to confirm 
his/her continuation in the study by signing a revised consent form.   
Any revised informed consent form and other written information provided to subjects must receive 
IRB, Sponsor, and regulatory agency approval, as applicable. 
16.4 Amending the Protocol 
This protocol is to be followed exactly, and will only be altered by written amendments. Amendments 
must be approved by all parties responsible for approving the Protocol including the IRB prior to 
implementation. However, in situations where the amendment is regarding safety issues and there is 

 
 
 
 
 
Protocol: MC10-PTL-103, Revision 00 
 
40 
Confidential 
an immediate hazard to subjects, the amendment will be submitted as an urgent amendment and can 
be implemented in the study prior to approval.  The Informed Consent and CRFs will be reviewed to 
ensure these are amended if necessary.  
Administrative changes that do not affect the subject benefit/risk ratio (e.g., editorial changes for 
clarity) may be made without any further approvals.  
16.5 Protocol Deviations/Violations and Medical Emergencies 
A protocol deviation or violation is a failure to comply with the requirements of the clinical study as 
specified in the protocol.  Examples of protocol deviations include late visits, missed visits, required 
follow-up testing not completed.  An example of a protocol violation includes enrollment of a study 
subject who fails to meet inclusion/exclusion criteria as specified in the protocol.  Each investigator 
shall conduct this clinical study in accordance with the study protocol and any conditions required by 
the reviewing IRB. 
Deviations/violations from clinical protocol requirements will be reviewed and evaluated on an 
ongoing basis and, as necessary, appropriate corrective actions put into place.  The Sponsor accepts 
the right of the Investigator to deviate from the protocol in an emergency when necessary to 
safeguard the life or the physical well-being of a study subject. Such deviations must be reported 
within 5 working days of implementation to the IRB and Sponsor. The Investigator must give notice of 
any emergency deviations and justification for the deviation to MC10, Inc. and the IRB as quickly as 
possible after the episode, in any event no later than 24 hours after the emergency.  
Each study site should maintain a list of protocol deviations that can be reviewed by the Sponsor.  
Subject numbers should be indicated for each protocol deviation on the lists.  
16.6 Pre-Study Documentation Requirements 
Prior to shipment or receipt of investigational product, the following documents must be provided to 
the Sponsor: 
• 
Signed protocol/protocol amendments 
• 
Signed and dated Investigator Agreement(s) 
• 
A copy of the written IRB approval of the protocol  
• 
A copy of the written IRB approval of the Informed Consent Form  
• 
Signed and dated Curriculum Vitae of the Investigator(s) 
• 
Copy of the Investigator(s)’ current medical license(s), or equivalent 
• 
Signed and dated Non-Disclosure Agreement(s), if required 
• 
Signed and dated Certification/Financial Disclosure Form(s) 
16.7 Record Retention 
The Investigator will maintain all essential trial documents and source documentation that support the 
data collected on the study subjects in compliance with FDA and ICH/GCP guidelines. Documents 
must be retained until at least 2 years have elapsed since the date the investigation is completed or 
terminated or the records are no longer required to support a regulatory submission, whichever date 
is later. These documents will be retained for a longer period of time by agreement with the Sponsor 
or in compliance with other regulatory requirements. The investigator will take measures to ensure 
that these essential documents are not accidentally damaged or destroyed. If for any reason the 
investigator withdraws responsibility for maintaining these essential documents, custody must be 
transferred to an individual who will assume responsibility. The Sponsor must receive written 
notification of this custodial change.  

 
 
 
 
 
Protocol: MC10-PTL-103, Revision 00 
 
41 
Confidential 
16.8 Criteria for Terminating Study 
The Sponsor reserves the right to terminate the study but intends only to exercise this right for valid 
scientific or administrative reasons and reasons related to protection of subjects. Investigators and 
associated IRB will be notified in writing in the event of termination.  
Possible reasons for study termination include: 
• 
The discovery of an unexpected, significant, or unacceptable risk to the subjects enrolled in 
the study. 
• 
A decision on the part of the Sponsor to suspend or discontinue development of the device. 
16.9 Criteria for Suspending/Terminating an Investigational Site  
The Sponsor reserves the right to stop the enrollment of subjects at an investigational site at any time 
after the study initiation visit if no subjects have been enrolled or if the center has multiple or severe 
protocol violations without justification or fails to follow remedial actions. 
Possible reasons for suspending/terminating a study center include: 
• 
Failure to obtain written Informed Consent. 
• 
Failure to report SAE or UADE to the Sponsor within 24 hours of knowledge. 
• 
Failure to complete data forms prior to the scheduled monitoring visits. 
• 
Loss of (or unaccounted for) investigational product inventory. 
16.10 
Sponsor Responsibilities 
The Sponsor, MC10, Inc., is responsible for selecting qualified investigators and providing them with 
the information and materials necessary to conduct this trial appropriately, ensuring proper monitoring 
of the investigation, and that IRB review and approval are obtained, and ensuring that the 
Investigators and the reviewing IRB are promptly notified of significant new information about this 
investigation. 
Specifically, the Sponsor will be responsible for: 
• 
Securing compliance with the clinical protocol, Investigator Agreement, and federal, state and 
local regulations; 
• 
Conducting evaluations of all adverse events; 
• 
Controlling the distribution of the device(s) under investigation; 
• 
Maintaining records and reports; 
• 
Analyzing and reporting data; 
• 
Designating appropriately qualified medical personnel to be available to advise on study-
related medical questions or problems 
• 
Addressing any device-related inquiries outside the expertise of the site staff. 
16.11 
Investigator Responsibilities 
• 
Agree to sign and adhere to the Investigator Agreement. 
• 
Obtain approval from the IRB including subsequent protocol amendments and changes to the 
Informed Consent form and obtaining annual IRB approval and renewal throughout the 
duration of the study. 

 
 
 
 
 
Protocol: MC10-PTL-103, Revision 00 
 
42 
Confidential 
• 
Await IRB approval, as well as, any additional hospital or facility requirements prior to 
requesting written informed consent from any potential study subject or prior to allowing any 
subject to participate in the study. 
• 
Complete and provide signed copies of all required investigator documentation such as an 
Investigator Agreement or Disclosure of Financial Interest. 
• 
Be willing to perform and be capable of performing study procedures as outlined in this 
protocol. 
• 
Comply with all required elements of this protocol (e.g., perform testing and follow-up as 
specified, especially during personnel transitions). 
• 
Agree to obtain written Informed Consent before any study specific procedures are performed 
in accordance with GCP. 
• 
Control Secure storage area for any investigational device(s) stored at their site. 
• 
Be aware of, and comply with, GCP and applicable regulatory requirements. 
• 
Permit monitoring and auditing by the Sponsor, and inspection by the appropriate regulatory 
authorities. 
• 
Have available an adequate number of qualified staff and adequate facilities to properly 
conduct the study. 
• 
Ensure that study personnel are adequately informed about the protocol, the investigational 
device and study-related duties and functions. 
• 
Provide subject support for device-related questions and subsequently contact the sponsor 
for any inquiries outside their expertise. 
 
 
 
 

 
 
 
 
 
Protocol: MC10-PTL-103, Revision 00 
 
43 
Confidential 
 
 
17.0 
REVISION HISTORY 
 
Date 
Description 
 
Version 00.  Initial Release. 
 

 
 
 
 
 
Protocol: MC10-PTL-103, Revision 00 
 
44 
Confidential 
18.0 
BIBLIOGRAPHY 
                                                 
 
1 S. Patel, et al., “Monitoring Motor Fluctuations in Patients with Parkinson’s Disease Using Wearable 
Sensors”, IEEE Trans. Info. Tech in Biomed., vol. 13, no. 6, Nov 2009.  
2 Jamie Adams, MD et al., “Wearable Sensors for the Objective Measurement of Motor Features of 
Huntington Disease – a Pilot Study”, Huntington Study Group, Nashville, TN, Nov 2016. 
3 Moon, Y. et al. “Monitoring of gait in Multiple Sclerosis with novel wearable motion sensors”, PLOS 
ONE, 2017. 
4 Kelly, J.M., Strecker, R.E., Bianchi, M.T., “Recent Developments in Home Sleep-Monitoring Devices”, 
ISRN Neurology, vol. 2012, art. 768794, 2012.  
5 Schultz, K. et al. “The Days of the Holter Monitor Are Numbered: Extended Continuous Rhythm 
Monitoring Detects More Clinically Significant Arrhythmias in Adults with Congenital Heart Disease”, 
American Heart Association Scientific Sessions, vol. 134, Nov 2016.  
6 McGinnis, R.S. et al. “Skin Mounted Accelerometer System for Measuring Knee ROM”, 8th Annual 
International Conference of the IEEE Engineering in Medicine and Biology Society (EMBC), 2016. 
7U.S. FDA Guidance for Industry: Assessing Adhesion with Transdermal Delivery Systems and Topical 
Patches for ANDAs (June, 2016). 
8ISO 10993-10:2010 “Biological evaluation of medical devices Part 10: Tests for irritation and skin 
sensitization”, Annex C, Page 45, 2010. 
9ISO 10993-10:2010 “Biological evaluation of medical devices Part 10: Tests for irritation and skin 
sensitization”, Annex C, Page 45, 2010. 
10Investigational Device Exemptions, 21 C.F.R. § 812.3(m), 2016.