Pivot Breath Sensor Performance Study
Phase: NA
Conditions: Smoking Cessation, Smoking, Tobacco
Sponsor: Jennifer Marler, MD



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Synopsis 
Device Names 
1) 
Pivot Breath Sensor  
2) 
Micro+™ Smokerlyzer® 
Protocol Title 
Pivot Breath Sensor Performance Study 
 
Principal Investigators 
  
Co-Investigators 
 
Protocol Number 
 
Protocol Version 
 
Sponsor 
Carrot Inc., 
 
Study Design 
Prospective, observational open label, single center study enrolling 70 subjects 
to evaluate performance of the Pivot Breath Sensor. No medical decisions will 
be made related to test results. 
Primary Objective 
Performance:  
• Non-invasively measure carbon monoxide (CO) levels in the exhaled 
breath of study subjects using two different types of measurement 
devices.   
• We will assess the correlation between the measured CO levels (in 
parts per million, or ppm) of the study CO breath sensor (Carrot Inc.) 
and the predicate CO breath sensor (Bedfont). 
Potential Subjects 
70 subjects who self-report smoking 2 or more cigarettes each day. 
Inclusion Criteria 
• 18-80 years of age 
• Owns and uses a smartphone 
• Willing to sign the Informed Consent Form 
• Resident of the United States 
• Able to read and comprehend English 
Exclusion Criteria 
• Prior experience with a study sponsored by Carrot Inc. 
• Pregnancy 
Recruitment 
Eligible subjects will be identified via a clinical research recruiter and/or 
advertisement at outdoor locations (i.e. flea markets, outside of movie theaters, 
shopping malls, train stations, stores that sell cigarettes), print media (i.e., local 
newspapers, billboards), and web media (i.e., Craigslist, Facebook).   
Study Session 
Single day study collecting 1 paired breath sample from each subject using two 
non-invasive breath sampling devices (Pivot Breath Sensor and Smokerlyzer), 
as well as collecting participant response to rating scales. 
Performance Variable 
CO concentrations in parts per million (ppm) in exhaled breath from subjects. 
Performance Endpoint 
and Analysis 
CO concentrations from each sensor type will be plotted for comparison.  
 
 

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Contents 
 
List of Abbreviations ........................................................................................................... 4 
 
Introduction .......................................................................................................................... 5 
2.1 
Background ....................................................................................................................... 5 
2.2 
Study Rationale ................................................................................................................. 6 
2.3 
Potential Risks and Benefits .............................................................................................. 6 
 
Objectives ............................................................................................................................ 7 
 
References ............................................................................................................................ 7 
 
Definitions............................................................................................................................ 7 
 
Device Description............................................................................................................... 8 
6.1 
Pivot Breath Sensor, Study Device ................................................................................... 8 
6.2 
Labeling and Packaging .................................................................................................... 8 
6.3 
MICRO+™ SMOKERLYZER®, comparator device ...................................................... 8 
6.4 
GASTROLYZER®, hydrogen measuring device® .......................................................... 9 
6.5 
Pivot Breath Sensor Submitting a Breath Sample (Specific Steps) .................................. 9 
6.6 
CO Log ............................................................................................................................ 10 
 
Study Design and Overview .............................................................................................. 11 
7.1 
Study Design ................................................................................................................... 11 
7.2 
Study Endpoints .............................................................................................................. 11 
7.3 
Eligibility Criteria ............................................................................................................ 11 
7.4 
Subject Recruitment ........................................................................................................ 12 
7.5 
Subject Stipend ................................................................................................................ 12 
7.6 
Sample Size and justification .......................................................................................... 12 
7.7 
Study articles ................................................................................................................... 15 
7.8 
Equipment and Materials ................................................................................................. 15 
7.9 
User Manual and Training ............................................................................................... 15 
7.10 Test Environment ............................................................................................................ 15 
7.11 Study Personnel ............................................................................................................... 16 
7.12 IRB Oversight .................................................................................................................. 16 
 
Study Procedure ................................................................................................................. 16 
 
Data Collection .................................................................................................................. 17 
 
Technical Approach and Study Design.............................................................................. 18 
10.1 Acceptance Criteria ......................................................................................................... 18 
 
Study Results ..................................................................................................................... 18 
11.1 Data Collection and Confidentiality ................................................................................ 18 
11.2 Analysis ........................................................................................................................... 18 
11.3 Report .............................................................................................................................. 19 
11.4 Deviations From Protocol ............................................................................................... 19 
11.5 Record Retention ............................................................................................................. 19 
 
Conflicts of Interest............................................................................................................ 19 
 
  ........................................................................................................... 20 
 
Literature References ......................................................................................................... 20 
 
Document Revision History:.............................................................................................. 20 
 
 
 

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 LIST OF ABBREVIATIONS 
CO 
Carbon Monoxide 
CRF 
Case Report Form 
USB 
Universal Serial Bus 
IRB 
Institutional Review Board 
ICF 
Informed Consent Form 
HCP 
Health Care Provider 
ppm 
parts per million 
 
 
 

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 INTRODUCTION 
2.1 
BACKGROUND 
The smoking of tobacco products is a leading cause of preventable morbidity and 
mortality, excess health care expenditure, and lost work productivity.  
 
 
 
   
 
 
 
 
 
 
 
 
   
 
 
 
 
  
 
 
 
   
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
  
 
 
 
 

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Since our 2018 study, Carrot Inc. (Redwood City, CA, USA) has made improvements to 
the CO breath sensor (the Pivot Breath Sensor). The Pivot Breath Sensor consists of a 
stand-alone handheld breath sensor to measure CO in exhaled breath with a display screen 
to show results. This breath sensor can optionally be used with a smartphone app (Pivot 
Application). The Pivot Breath Sensor is intended to be used as a personal and mobile 
product and to be available ‘over the counter’.  
This study will assess the performance of the Pivot Breath Sensor relative to the Micro+™ 
Smokerlyzer®. 
2.2 
STUDY RATIONALE 
Performance: We aim to non-invasively measure carbon monoxide (CO) levels in the 
exhaled breath of study subjects using two different types of measurement devices.  We 
will assess the correlation between the measured CO levels (in ppm) of the study CO 
breath sensor (Pivot Breath Sensor; Carrot Inc.; Redwood City, CA, USA) completed by a 
lay user with no personal instruction (using labeling only) and the predicate CO breath 
sensor (Micro+™ Smokerlyzer®; Bedfont Scientific Ltd; Harrietsham, UK) administered 
by a person trained to instruct users on submitting a sample with the device. 
2.3 
POTENTIAL RISKS AND BENEFITS 
 Known Potential Risks 
There are no anticipated risks or harms to the subject.  No medical decisions are made 

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based on study data. 
 Known Potential Benefits 
While we do not anticipate that subjects will receive any benefit from their 
participation in this study, it is possible that some subjects may experience an 
increased awareness of their smoking behavior. 
 Risk Benefit Assessment 
Given the non-invasive nature of the breath sampling and the data collection, there are 
no anticipated risks to subject safety.  Study staff will be with subjects and monitoring 
their use of the study devices for the duration of the study. Subjects are not asked to 
change their smoking behavior.  No medical decisions are made based on study data. 
 OBJECTIVES 
We aim to non-invasively measure carbon monoxide (CO) levels in the exhaled breath of 
study subjects using two different types of measurement devices.  We will assess the 
correlation between the measured CO levels (in ppm) of the study CO breath sensor (Pivot 
Breath Sensor, Carrot Inc.; Redwood City, CA, USA) and the predicate CO breath sensor 
(Micro+™ Smokerlyzer®, ,Bedfont Scientific Ltd; Harrietsham, UK; 510K number: 
K082315). 
 REFERENCES 
• FDA Guidance Document Entitled, “Guidance for Industry and Food and Drug 
Administration Staff: Applying Human Factors and Usability Engineering to Medical 
Devices,” issued on February 3, 2016 
• FDA Guidance Document Entitled, “Design Considerations for Devices Intended for 
Home Use, Guidance for Industry and Food and Drug Administration Staff” issued on 
November 24, 2014 
• ISO/IEC 62366-1:2015, Medical devices – Application of usability engineering to 
medical devices. Geneva, International Electro technical Commission. 
• AAMI/ANSI HE75:2009, Human Factors Engineering – Design of Medical Devices. 
• https://www.bluetooth.com/what-is-bluetooth-technology/bluetooth-technology-basics 
 DEFINITIONS 
Bluetooth Low Energy (BLE): a global wireless communication standard that connects 
devices together over a certain distance.  
Objective Data: Data collected through direct observation. 
Pivot Breath Sensor:  The study device.  It is a personal mobile breath sensor that is capable 
of measuring the level of carbon monoxide (CO) in exhaled breath.  It is portable, battery-
powered, and small enough to be carried by the user throughout the day (pocket, purse, 
backpack).  The sensor is intended for single-user use by cigarette smokers to inform the user 
about how breath carbon monoxide levels are affected by smoking behavior.  The user 
submits a breath sample by exhaling (blowing) directly into the mouthpiece connected to the 
sensor with breath sample results displayed on a screen on the sensor.   
Subjective Data: Data collected through user feedback via responses to rating scales provided 

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by participants. 
User: Person who interacts with (i.e., operates or handles) the Pivot Breath Sensor. 
 DEVICE DESCRIPTION 
6.1 
PIVOT BREATH SENSOR, STUDY DEVICE 
The Pivot Breath Sensor comprises a personal mobile breath sensor that measures the level of 
CO in exhaled breath and displays the exhaled breath CO value to the user directly on the 
device. The range of CO measurement is 0-100 ppm.  
The Pivot Breath Sensor (Figure 1) is portable, battery-powered, and small enough to be 
conveniently carried by the user throughout the day (pocket, purse, backpack).  The Pivot 
Breath Sensor is rechargeable using a micro-USB cable.  The user submits a breath sample 
by exhaling (blowing) into the mouthpiece of the Pivot Breath Sensor.  
 Indications for Use 
The Pivot Breath Sensor is a breath carbon monoxide monitor intended for single-user use 
by cigarette smokers to inform the user about how breath carbon monoxide levels are 
affected by smoking behavior.  The device is not intended to be used with other inhaled 
products. 
Figure 1. Pivot Breath Sensor 
 
6.2 
LABELING AND PACKAGING 
The Pivot Breath Sensor package includes: 
• 1 Pivot Breath Sensor 
• 1 USB charging cable 
• 1 Replaceable Mouthpiece 
• 1 Quick Start Guide 
 
The Pivot Breath Sensor packaging is shown in 
.  
6.3 
MICRO+™ SMOKERLYZER®, COMPARATOR DEVICE 
The Micro+™ Smokerlyzer® (Bedfont Scientific Ltd; Harrietsham, UK; 510K number: 
K082315) is an FDA-cleared hand-held, battery powered instrument which uses 

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electrochemical technology to sample the gas and a microprocessor to convert the output 
from the sensor to a carbon monoxide (CO) concentration. The result and menus are 
displayed on a color LCD and an accompanying buzzer sounds in response to the CO 
level. The instrument is controlled using a touch screen operation. The range of CO 
measurement is 0-500 ppm.  
Figure 2. Micro+™ Smokerlyzer® CO Breath Sensor 
 
 Indications for Use 
The Micro+™ Smokerlyzer® is a Breath Carbon Monoxide Monitor intended for 
multi-patient use by healthcare professionals in smoking cessation programs and as an 
indicator of Carbon Monoxide poisoning in healthcare environments. 
6.4 
GASTROLYZER®, HYDROGEN MEASURING DEVICE® 
Gastrolyzer® is a breath hydrogen monitor intended for multi-patient use by healthcare 
professionals in as an indicator of hydrogen produced gastrointestinal microbe based on 
diet of person and can indicate disorders such as lactose intolerance and carbohydrate 
breakdown deficiency. While the Gastrolyzer is not a comparator device, hydrogen may 
confound CO readings from CO breath sensors, so a measurement during the study is 
desired.  
6.5 
PIVOT BREATH SENSOR SUBMITTING A BREATH SAMPLE (SPECIFIC STEPS) 
Submitting a breath sample involves the following steps. Instructions can be accessed in 
multiple locations including the Pivot Sensor’s display screen, in the User Manual, Quick 
Start Guide, and on the packaging.  
1. User presses any button to turn on the Pivot Breath Sensor. 
2. User presses and holds the center button on the Pivot Breath Sensor until the sensor 
beeps once. 
3. User takes a deep breath in and holds their breath for 10 seconds. 
4. After about 10 seconds, the device beeps 3 times, and the user then will exhale slowly 
until the sensor vibrates at 12 seconds. 
5. The user’s CO level will display on the sensor’s screen. 
A properly submitted breath sample is defined as one that initiates after the third beep 
prompt and is of at least 6 seconds duration.  Breath sensor hardware and firmware is 
capable of detecting when a breath sample submission starts and stops. 
The CO Log screen in the Pivot Breath Sensor provides the CO (ppm) value for properly 
submitted breath samples, and provides a descriptive error message for improperly 
submitted breath samples (i.e. “Error: breath sample too late”).  

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The computation of concentration of CO (ppm) is performed within the Pivot Breath 
Sensor firmware and the data (CO ppm concentration, time and date) are stored in the 
Pivot Breath Sensor memory.   
6.6 
CO LOG 
The CO Log can be accessed from the Pivot Breath Sensor’s display screen and shows the 
most recent exhaled breath CO value in ppm at the top of the screen.  The user can view 
previous values by scrolling within the log (Figure 3).   
Values are color coded and can be interpreted by the user with help from the labeling 
(Figure 4).  
 
Figure 3. CO log on Pivot Breath Sensor  
 

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Figure 4. Package labeling to interpret results  
 STUDY DESIGN AND OVERVIEW 
7.1 
STUDY DESIGN 
This is a prospective open-label performance study conducted with IRB approval enrolling 
70 subjects who report daily smoking at our research center 
 or an 
equivalent location. Subjects will be asked to set up the Pivot Breath Sensor and provide a 
breath sample using the device during a 60-minute session. No follow-up visit is required. 
7.2 
STUDY ENDPOINTS 
Comparison of paired breath sample values from the study and predicate devices. 
7.3 
ELIGIBILITY CRITERIA 
The intended user population for the Pivot Breath Sensor System are lay users who are 
smokers, ages 18-80, capable of using a smartphone to track/monitor health-related data. 
The intended users range in age, degree of smoking, mental and physical capabilities, 
health literacy, experience using other CO analyzers or home use medical devices, and 
experience using smartphones.  
Study participants will consist of individuals who represent the intended user profile, 
current smokers. Participant criteria include all of the following: 
Inclusion Criteria 
• 18-80 years of age 
• Current daily cigarette smokers (at least 2 cigarettes per day with target 
distribution of individuals who smoke: 2-5 cigarettes per day, 6-10 cigarettes per 
day, 11-15 cigarettes per day and 16+ cigarettes per day)  
• Resident of the United States 
• Able to read and comprehend English 

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• Currently own and use an Apple, Inc. iPhone iOS smartphone or an Android 
smartphone for at least one month (such that they are familiar with basic 
operations of the mobile platform) 
• Willing to sign the Informed Consent Form 
Exclusion Criteria 
• Prior experience with a study sponsored by Carrot Inc. 
• Pregnancy  
7.4 
SUBJECT RECRUITMENT 
Subjects will be recruited in the United State by a clinical research recruiter and/or 
through advertisement at outdoor locations (i.e. flea markets, outside of movie theaters, 
shopping malls, train stations, stores that sell cigarettes), print media (i.e., local 
newspapers, billboards), and web media (e.g. Craigslist, Facebook, Task Rabbit, Google 
Ads) 
. Respondents will be asked to provide contact information (phone 
number, email address), and answer questions on demographics (gender, age), smartphone 
ownership and smoking behavior using the Online Screening Form 
 or 
through the clinical research recruiter, if applicable. Study staff will review each potential 
participant’s responses to the eligibility questions.  
Potential subjects may also convey their interest in participating in the study by calling or 
emailing study personnel using the contact information provided in the recruitment 
materials, or responding to outreach from the clinical recruiter. 
All study participants will undergo a screening call where they will be asked questions to 
confirm study eligibility. During this call, study personnel will inform the potential subject 
of the study details and will answer any questions. Eligible participants who meet the 
inclusion/exclusion criteria will be offered the opportunity to participate in the study. 
Potential subjects will then determine if they would like to proceed with scheduling, and if 
so, study personnel will schedule the subject for a test session.  At the test session, an 
Informed Consent Form 
 will be signed prior to participation. 
7.5 
SUBJECT STIPEND 
Participants will be compensated $100 in the form of a Visa Gift card for the test session 
lasting approximately 60 minutes. Participants will be compensated at the end of their 
study session. 
7.6 
SAMPLE SIZE AND JUSTIFICATION 
This study will include 70 subjects. This sample size is expected to provide adequate data to 
compare CO measurements between the devices. Sample size needed was determined as 
described below. 
Data from formative studies was used to develop the statistical methodology for the present 
study.  We conducted formative studies titled 
, with approval by the 
Institutional Review Board.  The studies were conducted with signed informed consent.  
 
 
 
 
 

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Figure 5a. Study 
 Correlation of Pivot Breath Sensor and Smokerlyzer CO (ppm) breath sample 
measurements, three paired samples per participant. 
 
Figure 5b. Study 
 Correlation of Pivot Breath Sensor and Smokerlyzer CO (ppm) breath sample 
measurements, one paired sample per participant 
 
 
 

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7.7 
STUDY ARTICLES 
Pivot Breath Sensor in representative packaging 
 that includes: 
• Pivot Breath Sensor  
• USB charging Cable 
• Replaceable Mouthpiece  
• Quick Start Guide 
 
In addition, the testing room will be equipped with electrical outlets and a charging cube.  
7.8 
EQUIPMENT AND MATERIALS 
• A pre-set Pivot Breath Sensor with example CO breath samples, or a CO Log 
Print Out 
• Printed prompt cards for the participant to reference  
• Timer or clock 
• Video recording equipment 
• Camera 
• Post-it notes 
• Quick Start Guide for study staff 
• User Manual for study staff 
• Electronic Surveys 
• Case Report Forms 
A full list of equipment and materials used during the study will be recorded in the report. 
7.9 
USER MANUAL AND TRAINING 
The Pivot Breath Sensor was designed to be as intuitive as possible, such that users are 
able to understand how to use the product on their own. No in-person training is formally 
offered to Pivot Breath Sensor users. A Quick Start Guide and package labeling is 
included with the device to aid the user and an online User Manual 
 is also 
available. All of these items will be accessible to the study participant plus a phone and a 
phone number within the labeling material to contact technical support. Since in-person 
training will not be formally offered to all users who purchase the Pivot Breath Sensor, in-
person training will not be included in this study. Study participants will have access to 
the aforementioned materials.   
While participants will have the User Manual, Quick Start Guide and packaging available 
to them at any point during the study, they will not be asked to read instructions or use any 
of the forms of training available.  
7.10 TEST ENVIRONMENT 
The study will be performed in an office building conference room or office. 
 Location testing will be performed:  
The location of testing will 
 
 For example, office space may be rented 
to be nearer to test subjects.  

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7.11 STUDY PERSONNEL 
The study team members will be trained by reading the study protocol and reviewing the 
case report forms. The study team members will have full training on the operation of the 
study devices. 
7.12 IRB OVERSIGHT 
This study will be conducted under IRB oversight.  
 STUDY PROCEDURE 
Each study session will have the following format: 
1. Introduction and informed consent  
2. Device Setup 
3. Breath Sampling and Interpretation  
4. Rating Scales  
At the beginning of the 60-minute test session, subjects will have ample time to read the 
Informed Consent Form (ICF) and the opportunity to ask questions. The subject will sign the 
ICF before participating in this study. Once signing the ICF, the subject will be given a 
unique identifier to protect subject privacy. Subjects may choose to exit the study at any 
time.  They are not required to complete the study if they choose to stop. 
Study participants will self-train on how to use the study device using only the available 
study Pivot Breath Sensor device labeling, including product packaging, Quick Start Guide, a 
technical support line (phone number provided in packaging/Quick Start Guide), and User 
Manual.  These labeling materials will be available to study participants at any point during 
the study. Study participants will not be asked to read instructions or use any of the forms of 
training available. Study personnel will refrain from answering questions on how to use the 
study device during the study.  
After completing baseline questions (age, gender, ethnicity, pregnancy status, smoking 
history and behavior, use of smoking cessation medications, issues with vision/hearing, 
smartphone type, attitudes towards smoking, past use of carbon monoxide breath sensors) 
participants will be provided the Pivot Breath Sensor package. They will be instructed to start 
using the product. Upon initiating use of the product, participants are automatically taken 
through a self-training that is delivered through the labeling and device. Study staff will 
observe but not deliver any components of this training. Completing self-training includes 
the successful completion of at least one breath sample. Participants will be asked how that 
went for them, and allowed to repeat a breath sample until they indicate they are satisfied 
with their breath sample Once the study participant has completed the self-training on the 
Pivot Breath Sensor, they will be asked to interpret their own breath sample results as well as 
hypothetical breath sample results. They will be asked if they feel ready to proceed with 
submitting a breath sample.  If a participant indicates they do not feel ready, they will be 
asked to do what they would normally do at home to prepare to use the product and to let the 
test administrator know when they are ready to submit a breath sample. 
When the participant indicates readiness to provide a breath sample, he/she will be instructed 
to proceed to provide one breath sample using the study device. This is the performance 
breath sample. Participants will be asked how that went for them, and allowed to repeat a 

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breath sample until they indicate they are satisfied with their breath sample. After providing 
this breath sample, the subject will be asked to interpret his/her breath sample result. This 
will be followed by a breath sample using the predicate device. A test administrator will 
instruct the participant how to give this breath sample before proceeding, and will direct the 
participant through the breath sample in real-time. This will be followed by a breath sample 
using a breath sensor that measures hydrogen in exhaled breath (Gastrolyzer®, Bedfont 
Scientific Ltd; Harrietsham, UK). This measurement is obtained because hydrogen levels can 
impact carbon monoxide readings on the Micro+™ Smokerlyzer® device. A test 
administrator will instruct the participant how to give this breath sample before proceeding, 
and will direct the participant through the breath sample in real-time.  
Next, participants may be asked to refer to the Pivot Breath Sensor labeling to answer 
questions regarding interpretation of other possible breath sample results (optional). This is 
followed by obtaining participant input using rating scales. 
As needed, photo and video recordings may be implemented during the study to facilitate 
post-study analysis. 
 
 DATA COLLECTION 
Study personnel will collect information about the participant including 
• Age 
• Gender  
• Pregnant? 
• Race/ethnicity  
• Vision 
o Wear glasses? 
o Color blind? 
• Hearing 
o Hearing issues? 
o Use a hearing aid? 
• Type of smartphone participant uses (iPhone or Android) 
• Number of years smoking  
• Number of quit attempts over the past 12 months 
• Number of cigarettes currently smoked per day 
• Smoking history in the past 24 hours  
o Number of cigarettes smoked 
o Time of last cigarette 
o Use of any combustible, inhaled tobacco product other than cigarettes (pipes, 
cigars, cigarillos, etc.), any electronic cigarette product (e-cigs, vape, vapor), and 
any other inhaled combustible material 
• Attitudes towards smoking 
o Desire to quit 
o Readiness to quit 

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o Confidence to quit 
o Perceived difficulty of staying quit 
• Current smoking cessation medications 
• Participation in a smoking cessation program 
o Past 
o Present 
• Breath sensor use (past) 
o Use of CO breath sensors in the past 
• Breath sensor use during the study session 
o Model#/Serial# of breath sensor 
o CO measurements 
 TECHNICAL APPROACH AND STUDY DESIGN 
10.1 ACCEPTANCE CRITERIA 
Data will be accepted if the participant meets eligibility criteria and completes breath 
sampling, including providing a sample from the predicate device, as instructed. 
 STUDY RESULTS 
11.1 DATA COLLECTION AND CONFIDENTIALITY 
Subjects will be assigned a unique subject ID which will be used for data collection. Data 
collection will take place on paper or electronic case report forms (CRFs) completed by 
the study team and study subjects. CRFs will be reviewed by the study team prior to the 
end of the study session to ensure completeness and then stored in a secure filing cabinet 
at the end of the day with access limited to necessary study personnel. Study data will be 
kept in a secure database by the investigator. This database will be accessible only by 
necessary study personnel. The database will not contain personal identifying information; 
all subject data in the database will be associated with study identification numbers. The 
data will be kept for a minimum of 5 years. 
11.2 ANALYSIS 
 
 Performance  
A paired breath sample is defined as subject submitting a breath sample unassisted 
using the study device, and submitting a breath sample assisted by a health care 
professional (or test administrator) using the predicate device.  
• Participant breath sample CO measurement done with the study device compared 
to the CO measurement of the participant’s breath sample done with the 
predicate device. 
• Participant’s interpretation of results will be tallied for correct interpretation 
 Subjective data  

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Subjective data will include: 
• Participant ratings which will be summarized. 
11.3 REPORT 
A final report will be issued upon completion of testing, allowable in PowerPoint format, 
and will include the following: 
• Report must include testing details such as description of products tested and 
identification numbers. 
• Report must identify staff members who tested and evaluated/inspected samples. Test 
date(s) must be identified. 
• Report must identify any deviation from the protocol, and any anomalies in sample 
testing. Justification and approval of deviation must be documented. 
• Report must include test results section and must identify any changes to the testing 
samples. 
• Report must include summary of rating scales data 
• Report must be signed by the primary investigator or study team designee. It must also be 
reviewed and approved by the study team.  
11.4 DEVIATIONS FROM PROTOCOL 
To be determined by the study team during performance study. Deviations will be 
assessed through a consensus review of the study team. All deviations will be identified, 
recorded and analyzed in the final report.  
11.5 RECORD RETENTION 
Record keeping is performed in accordance with the SOP Control of Quality Records, 
 
 CONFLICTS OF INTEREST 
The following conflicts of interest are noted: 
• The study sponsor is Carrot Inc., 
 
• The principal investigator and co-investigators own equity in Carrot Inc., which is the 
company that invented and owns the Pivot Breath Sensor, which is being evaluated in 
this study.   
• The company (Carrot Inc.) holds patent rights to one of the devices being evaluated in 
the study (the Pivot Breath Sensor). 
The investigator (Jennifer Marler, MD) holds a position of senior management officer, as Sr. 
Director of Clinical and Medical Affairs. The Co-Investigator (Craig Fujii, BS), holds a 
position of Director of Clinical Affairs. The Co-Investigator (Kristine Wong, BS), holds a 
position of Senior Clinical Research Associate. These conflicts of interest are mitigated by 
the following: 
• The risk profile of the study, specifically, that there are no anticipated risks or harms to 
the subject.  No medical decisions are made based on study data. The process of 
setting up the Pivot Breath Sensor and providing breath samples is non-invasive, and 

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Rev.  B     Updated and provided more explicit detail for study session flow in Section 8: baseline 
questions-self-training-subjective input-interpret results-performance breath sample-subjective 
input-predicate breath sample-hydrogen breath sensor breath sample-interpret results using 
labeling materials-rating scales.