Comparison of Non-invasive Respiratory Monitoring System (RMS) to Capnography for Respiratory Rate (RR)
Phase: NA
Conditions: Respiratory Monitoring
Sponsor: Makani Science

CP-0004, Rev A
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Makani Science Respiration Monitoring System
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THIS DOCUMENT CONTAINS CONFIDENTIAL AND PROPRIETARY INFORMATION OF MAKANI SCIENCE, INC. 
 
 
 
 
CLINICAL STUDY PROTOCOL FOR THE  
MAKANI SCIENCE RESPIRATION MONITORING SYSTEM  
 
Title:  
Comparison of Non-Invasive Respiratory Monitoring System (RMS) to 
Capnography for Respiratory Rate (RR) 
 
 
 
 
 
Protocol CP-0004 
 
 
May 08, 2024 
 
 
Makani Science, Inc. 
5270 California Ave, Ste 300 
Irvine, CA 92617 
U.S.A. 

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Contents 
Investigator Approval .................................................................................................................................... 4 
Version History .............................................................................................................................................. 4 
Study Summary ............................................................................................................................................. 5 
Abbreviations ................................................................................................................................................ 6 
Makani Science Pivotal Clinical Study Protocol ............................................................................................ 7 
1 
Introduction .......................................................................................................................................... 7 
1.1 
Clinical Background ....................................................................................................................... 7 
1.2 
Study Rationale ............................................................................................................................. 9 
2 
Study Device .......................................................................................................................................... 9 
2.1 
Device Description ........................................................................................................................ 9 
2.2 
Indications for Use ...................................................................................................................... 10 
3 
Study Overview ................................................................................................................................... 11 
3.1 
Study Objectives ......................................................................................................................... 11 
3.1.1 Primary Objective .................................................................................................................... 11 
3.1.2 Additional Objectives .............................................................................................................. 11 
3.2 
Study Population ......................................................................................................................... 11 
3.2.1 Inclusion Criteria ..................................................................................................................... 11 
3.2.2 Exclusion Criteria ..................................................................................................................... 11 
3.2.3 Subject Enrollment Plan .......................................................................................................... 12 
3.3 
Study Data to be Recorded ......................................................................................................... 12 
3.3.1 Subject Baseline Data .............................................................................................................. 12 
3.3.2 Relevant Medical History and Medications ............................................................................ 12 
3.3.3 Data for Primary and Secondary Objectives ........................................................................... 12 
3.3.4 Safety Analysis and Adverse Event Recording ........................................................................ 13 
3.3.5 Protocol Deviations ................................................................................................................. 13 
3.4 
Risk Analysis ................................................................................................................................ 14 
3.4.1 Risks......................................................................................................................................... 14 
3.4.2 Minimization of Risks .............................................................................................................. 14 
4 
Study Design........................................................................................................................................ 14 
4.1 
Performance Goal ....................................................................................................................... 15 

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4.2 
Study Procedure .......................................................................................................................... 15 
4.3 
System Verification and Calibration ............................................................................................ 15 
4.3.1 Subject Device ......................................................................................................................... 15 
4.3.2 Reference Device .................................................................................................................... 15 
4.4 
Data Acquisition .......................................................................................................................... 15 
4.4.1 Clinician Scored Capnograph Results (Reference) .................................................................. 16 
4.5 
Data Handling .............................................................................................................................. 16 
4.5.1 Data Storage ............................................................................................................................ 16 
4.5.2 Data Processing and Quality Control ...................................................................................... 16 
4.5.3 Identifying and Handling Respiratory Deviations during Primary Objective .......................... 17 
4.6 
Statistical Endpoints and Analyses .............................................................................................. 17 
4.6.1 Study Endpoints ...................................................................................................................... 17 
4.6.2 Primary Analysis ...................................................................................................................... 17 
4.6.3 Additional Analyses ................................................................................................................. 17 
4.6.4 Subgroup Analyses .................................................................................................................. 17 
4.6.5 Demographic and Baseline Characteristics ............................................................................. 18 
4.6.6 Sample Size Estimation ........................................................................................................... 18 
4.7 
Ethical and Regulatory Considerations  ...................................................................................... 18 
4.7.1 Role of Makani Science as Study Sponsor ............................................................................... 18 
4.7.2 IRB Approval ............................................................................................................................ 18 
4.7.3 Informed Consent ................................................................................................................... 18 
4.7.4 Subject Confidentiality ............................................................................................................ 18 
5 
Appendices .......................................................................................................................................... 19 
5.1 
Appendix 1 – Study Procedure .................................................................................................... 19 
5.1.1 Study Material ......................................................................................................................... 19 
5.1.2 Study Procedure ...................................................................................................................... 19 
5.1.3 Follow up Assessment ............................................................................................................. 20 
5.2 
Appendix 2 – Adverse Events Definitions ................................................................................... 20 
6 
References .......................................................................................................................................... 21 
 
 
 

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Investigator Approval  
Approval will be given electronically via Makani Science’s electronic quality management system.  
Version History 
Version
Date
Author
Description of Change
Justification
A 
27-Feb-2024 
Michael Chu 
Initial Version  
New revision based on CP-0001 that 
addresses feedback from FDA 
A 
08-May-2024 
Michael Chu 
Protocol changes 
Changed based on feedback from 
the FDA.  
 
 

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Study Summary 
Study Title  
Comparison of Non-Invasive Respiratory Monitoring System (RMS) to 
Capnography for Respiratory Rate (RR)  
Study Device 
Makani Science Respiration Monitoring System 
Study Objective 
The study objective is to compare the accuracy of the Makani Science 
Respiration Monitoring System (RMS) to capnography measurements 
manually scored by a healthcare professional (reference) for measuring 
respiratory rate in adult subjects, supporting its indications for use as a 
non-invasive system intended to monitor a patient’s breathing using two 
Makani Science sensors.  
Indications for Use 
The Makani Science Respiration Monitoring System (RMS) is a non-
invasive system intended to monitor a patient’s breathing. It graphically 
displays respiration versus time and reports an approximate value of 
respiratory rate. Its measurements are used as an adjunct to other clinical 
information sources.  
The Makani Science RMS is intended to be used by healthcare 
professionals in healthcare facilities and dental offices on adult patients. 
Study Design 
Prospective, open-label, non-significant risk, single-arm study 
Primary Objective 
Demonstrate respiratory rate (RR) accuracy of the Makani Science RMS 
compared to manually scored etCO2 recordings from an FDA cleared 
capnography device within 3 bpm. 
Additional Objectives 
 
Demonstrate system’s ability to recover after motion artifacts.  
 
Demonstrate system’s ability to perform while subject is lying on side 
and in reclined position.  
 
Demonstrate system performance for BMI and biological sex 
subgroups. 
Statistical Endpoints 
The primary endpoint is RR accuracy of the Makani Science RMS as 
compared to manual, clinician-scored etCO2 waveform (capnography), 
which will be estimated using mean absolute error (MAE). Additionally, 
bias will be summarized as the actual difference between Makani Science 
RMS and capnography (Makani Science RMS – capnography). 
Primary Analysis 
For the primary analysis, accuracy and the associated 95% confidence 
interval will be calculated. The lower confidence limit will be compared to 
the performance goal of 3 bpm. 
Additional Analyses 
 
Bias and the associated 95% confidence interval will be calculated. 
 
A Bland-Altman analysis will be performed for the difference in RR 
between Makani Science RMS and capnography. 
 
Accuracy and bias will be summarized descriptively after artifacts and 
in different body positions. 
Subgroup Analyses 
Accuracy and bias will be summarized descriptively by: 
 
Subject BMI (normal: BMI < 25 and overweight: BMI ≥ 25) 
 
Biological sex. 

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Safety Analysis 
Any and all adverse events will be recorded for the duration of the study 
period. The severity of all adverse events will be assessed based on risk 
management procedures and will be recorded. Serious adverse events 
will be recorded. 
Inclusion Criteria 
 
Adult subjects between ages of 22 and 99 years old. 
 
Body mass index between 15 and 40 kg/m2. 
Exclusion Criteria 
 
Currently has serious symptomatic, cardiac, or pulmonary disease. 
 
History of serious skin irritation (severe rash or blisters) caused by 
medical adhesives (tape). 
 
Subject cannot lie still on their back for one (1) or more hours. 
 
Subject is unable to give written, informed consent. 
 
Subject is unable to follow instructions.  
Principal Investigator 
Michael Chu, Ph.D. 
Biostatistician  
Willes Consulting Group, Inc. 
Study Sponsor 
Makani Science, Inc.  
5270 California Ave, Ste 300 
Irvine, CA 92617 
U.S.A. 
Study Management 
Contact 
Michael Chu, Ph.D. 
michael@makaniscience.com 
 
 
Abbreviations 
Abbreviation
Term
BMI
Body Mass Index
etCO2
End-Tidal Carbon Dioxide
HCP
Healthcare Professional 
MAE
Mean Absolute Error
MKS
Makani Science
RMS
Respiratory Monitoring System
RR
Respiratory Rate
 
 

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Makani Science Pivotal Clinical Study Protocol  
1 Introduction 
1.1 Clinical Background 
Continuous respiratory monitoring is critical for situations where the patient’s breathing is at risk [2, 3, 
4]. For example, high risk sedated patients undergoing, or recovering from, medical procedures are at a 
higher risk of developing respiratory failure and require continuous monitoring [5, 6]. Failure to detect 
such events in a timely manner can lead to preventable complications and even death, commonly 
described as “found dead in bed” [7]. Respiratory failure events that occur after medical procedures 
involving sedatives or opioids are significant contributors to complications, death, and prolonged 
hospital length of stay [8, 9]. 
Respiratory rate can be measured by a trained individual counting the number of breaths a patient 
breathes per minute. This is the standard practice for measuring rate during patient spot checks, but it is 
has neglected by health care professionals for several different reasons [10]. Breathing can also be 
measured continuously using certain monitoring systems. However, the current standard of care 
monitors for respiration, pulse oximetry and capnography, are ill-suited for detecting incipient 
respiratory failure. A recent study across 16 sites in 1,335 patients receiving parenteral opioid showed 
that capnography and pulse oximeters were least accurate measure for respiratory depression in these 
patients [11]. Additionally, both systems have known shortcomings described below.  
Pulse oximetry is a measure of a patient’s blood oxygenation through an optical sensor. While this type 
of monitor is ubiquitous and low cost, it is known to be a late indicator of respiratory depression. The 
Joint Commission Sentinel Event Alert, Issue #49 (now updated to the R3 Report on Pain Assessment 
and Management Standards), on the Safe Use of Opioids in Hospitals recommends that health care 
workers should be educated not to rely on pulse oximetry alone because it can indicate adequate 
oxygen saturation even in patients who are actively experiencing respiratory depression, especially 
when they are receiving supplemental oxygen [12]. Other important limitations of pulse oximetry 
include: (1) frequent false alarms; (2) its susceptibility to motion artifact; (3) its poor ability to predict 
respiratory decline; and (4) insensitivity to early signs of hypoventilation. Moreover, on February 19th, 
2021, the US Food & Drug Administration issued a Safety Communication stating that pulse oximetry 
frequently gives inaccurate readings based on patient’s skin color, skin thickness, and temperature [13].  
Capnography measures the partial pressure of exhaled carbon dioxide (etCO2) and is widely used for 
patients under general anesthesia [14]. While this is the standard for monitoring ventilation, use of the 
system outside the operating room is inconsistent and facilities have been slow to adopt this technology 
[15, 16]. Additionally, capnography also has limitations, including: (1) delayed response time; (2) 
frequent false alarms; (3) readings that often are inaccurate and unclear; (4) complicated to use and 
interpret; (5) accuracy highly dependent on sensor position, which often can be dislodged from the 
patient’s nose; and (6) uncomfortable to wear over time. 

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While pulse oximetry and capnography can monitor patient respiration continuously, respiratory 
depression and failure can be best detected by measuring the patient’s ventilation (breathing rate and 
depth) [16]. This is currently done via spot checks by a trained individual in hospital settings [10]. 
Changes in ventilation can indicate respiratory failure much earlier than the current standard of care  [3, 
17]. Respiratory rate in particular, is an underutilized ventilatory parameter that can be important in 
assessing a patient’s health [18, 10]. Additionally, a patient’s respiration is a dynamic process that 
changes over time [3, 19]. The ability to monitor changes in breathing patterns can provide better 
information about the patient and may even permit inference about future adverse respiratory events. 
Therefore, a need exists for an accurate monitor to provide continuous information on the patient’s 
ventilatory status.  
Patient ventilation can be continuously monitored through different methods including direct 
measurement of flow in line with the airway, through bioimpedance measurements of the chest wall, 
acoustically through the airways, or by measuring torso movements.   
Direct Airway Measurement 
The current gold standard for continuous ventilatory monitoring is through capnography measuring 
respiratory rate using a mask or nasal cannula. Use of capnography is included in many standards and is 
well accepted by the field. Direct measurement of ventilation from the airway can also be made through 
other flow-meter type devices, such as the Linshom monitor [20], which hooks onto a capnography 
mask. Apart from the general problems associated with capnography, direct measurement of ventilation 
in line with the airway requires access to the patient’s mouth or airway, which is not always possible.  
Bioimpedance Measurement 
The flow of air into and out of the lungs will change the overall impedance of the chest cavity. The 
change in impedance can be measured by injecting an electrical signal into the body and measuring it’s 
change with breathing. This data can then be used to calculate respiratory rate and volume. Systems like 
Respiratory Motion’s ExSpiron 1Xi monitor uses this method to great effect [21]. However, while this 
method can provide both respiratory rate and volume, it adds another wire, which tethers the patient to 
a large, bulky monitor.  
Acoustic Measurement 
Breathing will generate turbulence in the airway, which can be measured acoustically [22]. Monitoring 
for breathing sound not only provides respiratory rate information, but can also indicate other patient 
states, such as wheezing, etc. Equipment like a precordial stethoscope makes it possible to listen to the 
patient’s respiration; however, acoustic systems are very susceptible to motion artifacts and noise, 
limiting its use to certain environments.  
Chest Wall Movement 
Patient chest wall and abdomen will naturally move from breathing. Medical professionals are trained to 
look at the chest wall movement to assess the patient’s respiratory status. Quantitatively measuring the 
chest wall movement can also provide ventilatory information; for example, respiratory inductive 

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plethysmography (RIP) uses two large bands placed around the patient’s torso to measure the change in 
circumference. A similar technology is PMD Solution’s RespiraSense, which uses a piezoelectric sensor to 
monitor for chest wall movements [23, 1]. While simple to use, these types of systems are prone to 
motion artifacts. Chest rise and fall can also be monitored using a contactless method via radar (Circadia 
Health) [24]. This method requires direct line of site to the patient’s chest wall and offers the advantage 
of not adding an additional wire to the patient. However, direct line of sight limits the use case of such a 
system to environment where the patient’s chest is exposed.  
While all the methods described above monitor ventilation continuously, they are either cumbersome to 
use or are subject to certain common environmental factors. The Makani Science Respiration 
Monitoring System provides a ventilatory monitoring solution that removes the cumbersomeness of 
wires and a bulky monitor while providing a simple way to monitor respiration that medical 
professionals are already familiar with (chest wall movement).  
1.2 Study Rationale  
The purpose of this study is to demonstrate that the Makani Science Respiration Monitoring System 
(RMS) can accurately measure respiratory rate, compared to manually scored etCO2 recordings from an 
FDA cleared capnography device.  
2 Study Device  
2.1 Device Description  
The Makani Science RMS (subject device) uses a wireless, wearable sensor that can measure respiratory 
rate based on the expansion and contraction of the patient’s chest (Figure 2-1a). The device uses highly 
stretchable soft strain sensors to measure torso expansion and contraction from respiration. The change 
in sensor length is then used to calculate respiratory rate.  
The concept of using thoracic deflection to calculate the breathing rate is well documented and has 
been applied with respiratory inductive plethysmography (RIP), commonly used in sleep labs. RIP 
 
Figure 2-1. Representative diagram of the Makani Science RM starting from the sensor placed on the torso (left), Bluetooth 
communication to the iPad (middle) and image of the Makani Science app displaying the chest wall waveform and 
respiratory rate.  

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measures the change in transverse circumference of the chest using large bands; the changes in chest 
wall circumference has been shown to have a linear correlation with tidal volume waveform [25]. In a 
previous publication, it was demonstrated that the concept behind RIP can be preserved even when the 
measurement length of the chest wall is reduced to a 1 cm length of skin on the torso by using a highly 
sensitive strain sensor (Figure 2-1b). [26] This significantly reduces the footprint needed for the 
measurement, making a wearable system more practical.  
The Makani Science RMS consists of two disposable “Band-Aid®” size sensors and an iPad, which serves 
as the monitor. The sensors consist of a Bluetooth-enabled circuit connected to the soft strain sensor; 
the iPad has a custom app that connects with each sensor via Bluetooth and displays the respiratory 
rate and waveform. The sensors are attached to the skin with medical grade adhesives, to measure the 
torso expansion and contraction. A single sensor can be used to capture movement from the abdomen; 
two sensors can be combined to capture the movement of both the chest wall and abdomen. As the app 
receives the raw waveforms from the sensors, it will calculate the respiratory rate and display a filtered 
waveform representing the chest wall rising and falling (Figure 2-2).   
The Makani Science RMS is an adjunct device that is to be used simultaneously with another standard 
respiratory monitoring device (e.g., capnography). The Makani Science RMS will be an FDA Class II 
device. 
2.2 Indications for Use  
The Makani Science RMS is a non-invasive system intended to monitor a patient’s breathing. It 
graphically displays respiration versus time and reports an approximate value of respiratory rate. Its 
measurement is used as an adjunct to other clinical information sources.  
The Makani Science RMS is intended to be used on adults by professionals in healthcare facilities and 
dental offices. 
 
Figure 2-2 (a) Image of the Makani Science RMS sensor (prototype). The Bluetooth circuit and the stretchable strain sensors 
are labeled within the image. (b) Waveforms showing the ribcage and abdomen rise and fall compared against the tidal 
volume waveform from a flow meter. [26] 

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3 Study Overview  
The study objective is to compare the accuracy of the Makani Science Respiration Monitoring System 
(RMS) to manually scored etCO2 recordings from an FDA cleared capnography device, supporting its 
indications for use as a non-invasive system intended to monitor a patient’s respiration. This will be a 
prospective, open-label, non-significant risk, single-arm study. This study will use the same type of 
reference device as Makani Science’s predicate device (PMD Solution’s RespiraSense) [23, 1]. 
Participants will follow the protocol-specified breathing procedures and respiratory data will be 
simultaneously recorded for each participant using: (1) the Makani Science RMS and (2) manually scored 
etCO2 recordings from an FDA cleared capnography device. Enrollment will be targeted to balance 
normal (BMI < 25) and overweight (BMI ≥ 25) subjects, biological sex (male and female), and provide a 
representative range of age.  
There will be two investigators present during the study. The first investigator will be a healthcare 
professional (HCP investigator) responsible for recording the RR from the reference device. This 
investigator will be blinded to the data from the Makani Science RMS. The second investigator (MKS 
investigator) will be responsible for recording data from the Makani Science RMS.  
3.1 Study Objectives 
3.1.1 Primary Objective 
 
The primary study objective is to demonstrate RR accuracy of the Makani Science RMS as compared 
to manual, clinician-scored etCO2 waveform (capnography) within 3 bpm. 
3.1.2 Additional Objectives  
 
Demonstrate system’s ability to recover after motion artifacts.  
 
Demonstrate system’s ability to perform while subject is lying on side and in reclined position.  
 
Demonstrate system performance for BMI and biological sex subgroups. 
3.2 Study Population  
3.2.1 Inclusion Criteria  
Subjects must meet the following inclusion criteria to participate in the study: 
 
Adult subjects between ages of 22 and 99 years old.  
 
Body mass index (BMI) between 15 and 40 kg/m2. 
3.2.2 Exclusion Criteria  
Subjects who meet any of the following exclusion criteria will not be eligible to participate in the study: 
 
Currently has serious symptomatic, cardiac, or pulmonary, disease. 
 
History of serious skin irritation (severe rash or blisters) caused by medical adhesives (tape). 
 
Subject cannot lie still on their back for one (1) or more hour. 
 
Subject is unable to give written, informed consent. 
 
Subject is unable to follow instructions. 

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3.2.3 Subject Enrollment Plan  
A representative sample of the target patient population will be enrolled for this study. The intended 
use population will be adult individuals in ambulatory settings (such as dental office sedation procedures 
and clinics) outside of the hospital. Thus, the recruitment for this study will target patients from a 
recuperative care medical clinic where patient conditions should be representative of the population 
outside of a hospital; additionally, adults outside of the clinic can enroll in the study as well. 
Enrollment will be targeted to balance normal (BMI < 25) and overweight (BMI ≥ 25) subjects, biological 
sex (male and female), and provide a representative range of age.  
3.3 Study Data to be Recorded  
3.3.1 Subject Baseline Data 
The following baseline data will be recorded for each participant.  
 
Age  
 
Biological sex 
 
Weight 
 
Height 
 
Abdomen circumference  
 
Chest wall circumference  
 
Relevant medical history and medications (See section 3.3.2) 
3.3.2 Relevant Medical History and Medications  
Relevant medical history and medications will either be collected from the subject’s medical files from 
the clinic or from the subject themselves.  
Conditions such as cardiorespiratory conditions, neurological conditions, diabetes, obesity, 
hypertension, chronic obstructive pulmonary disease, asthma, congestive heart failure, and other 
relevant conditions will be documented. The following information will be collected:  
 
Relevant applicable condition and status (active, remission, cured) for each subject.  
 
If the subject is currently symptomatic. If they are, the symptoms will be documented.  
 
If the subject is currently on medication. If they are, the specific medication, dosage, and 
frequency will be documented.  
3.3.3 Data for Primary and Secondary Objectives 
The following data will be collected for primary and additional endpoint analyses. The data will be 
recorded manually by the investigators as well as continuously captured via video recording of the 
monitor’s screen and subject torso.  
 
Manually scored subject respiratory rate from the capnography monitor.  
 
Concurrent respiratory rate from the Makani Science RMS. 
Respiratory rate within a reasonable range for an adult (12 to 20 BPM) is expected to be measured. All 
respiratory rates will also be verified through benchtop testing. Additionally, RR will also be measured 

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with the subject in different positions and performing different respiratory maneuvers (coughing and 
shallow breathing). Additional information on specific positions and maneuvers are listed in Appendix 1 
– Study Procedure. 
3.3.4 Safety Analysis and Adverse Event Recording 
The safety analysis shall be performed by recording adverse events (AE) for the study period. The study 
period is defined as the period from the start of any study procedures to the end of the study follow-up. 
For this study, the subject’s study period is defined as the start of placing the non-invasive Makani 
Science device on the subject until removal of the device, which defines the subject’s study exit.  
Information on all adverse events shall be recorded immediately in the source document and in the 
appropriate adverse event module of the Case Report Form (CRF). All clearly related signs, symptoms, 
and abnormal diagnostic procedure results will be recorded in the source documentation.  
All adverse events occurring during the study period will be recorded and reported in the associated 
Clinical Study Report. The clinical course of each event will be followed until resolution, stabilization, or 
until it has been determined that the study participation or device is not the cause. The severity of all 
adverse events will also be assessed based on current risk management procedures and will also be 
reported in the Clinical Study Report.  
Serious adverse events (SAE) that are still ongoing at the end of the study period must be followed-up to 
determine the outcome. Any serious adverse event that occurs after the study period and is possibly 
related to study participation will be recorded and reported immediately to Makani Science. Adverse 
events definitions are detailed in Appendix 2 – Adverse Events Definition.  
3.3.5 Protocol Deviations  
Any deviations from this protocol will be recorded in the associated Clinical Study Report. Potential 
major deviations will be reported using the following categories: 
 
Makani Science RMS failure  
If the Makani Science RMS fails to operate at any point of the study (e.g., the subject device fails 
to turn on, turns off, disconnects, shows non-continuous waveforms, or any other unforeseen 
condition), the troubleshooting protocol in the instruction for use will be followed. If it is 
determined that the device is no longer operational or the study cannot be continued, the study 
will be stopped. The investigator will determine whether a new sensor should be applied to 
complete the study, time permitting. Any data collected prior to the termination of the study, 
and at the HCP investigator’s discretion, can still be used in the primary endpoint of the study.   
 
Deviation from normal breathing  
If the subject’s breathing becomes noticeably abnormal (e.g., erratic, coughing, etc.), it will be 
the HCP investigator’s discretion to determine whether that abnormal breathing has affected 
the reference monitors and whether the data from the abnormal period should be discarded. 
Additional detail can be found in section 4.5.3.  
 
Subject is unable to follow instructions 

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If the investigator determines that the subject is unable to follow instructions, the study will be 
terminated. Any data collected prior to the termination of the study, and at the HCP 
investigator’s discretion, can still be used in study analyses.  
 
Study time limit reached 
If the study time limit is reached, and the protocol could not be completed for the study. The 
data collected will be used for analysis. Any required data not recorded will be marked as 
missing and an explanation will be provided.  
 
Failure to record baseline information  
If the investigator fails to record the subject baseline information or has reason to believe the 
subject baseline information is not accurate, the investigator will follow up with the subject or 
clinic via phone to obtain the information. The deviation will be recorded. 
3.4 Risk Analysis 
3.4.1 Risks 
The subject device does not have known direct major risks to the health and safety of the subject. There 
is no SAE anticipated for this study.  
Anticipated minor risks include:  
 
Minor skin irritation in certain participants from the adhesive used in the Makani Science RMS 
sensor.  
3.4.2 Minimization of Risks  
Precautions that will be taken to avoid risks related to the study include: 
 
Well-defined clinical study protocol, including specific inclusion and exclusion criteria to enroll 
appropriate subjects in the trial. 
o Subjects with significant and extreme skin reaction to adhesives will be excluded from 
the study.  
 
Use of approved medical grade materials and adhesives designed and tested to current FDA 
consensus biocompatibility standards. 
 
Explanation of potential study risks and adverse events to each subject, and 
 
Ensuring that each subject fully understands the Informed Consent process and has provided 
their written consent prior to proceeding with any study procedures. 
4 Study Design 
This is a prospective, open-label, non-significant risk, single-arm study. Participants will follow the 
protocol-specified breathing procedures and respiratory data will be simultaneously recorded for each 
participant using (1) the Makani Science RMS and (2) manually scored etCO2 recordings from an FDA 
cleared capnography while the subject breaths normally. Enrollment will be targeted to balance normal 
(BMI < 25) and overweight (BMI ≥ 25) subjects, biological sex, and provide a representative range of age. 
All testing with the Makani Science RMS will be performed according to the final draft of the Makani 
Science RMS instruction for use with the final design and app.   

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4.1 Performance Goal 
The primary study objective is to demonstrate that the performance of the Makani Science RMS is 
equivalent to the reference (capnography) within 3 bpm. Additionally, this study will use the same type 
of reference device (Capnography monitor) as our predicate device.  
4.2 Study Procedure 
The final Makani Science device, algorithm, and instructions for placing the sensor will be followed for 
this procedure. Additionally, the subject will also be monitored by a multi vital sign monitor (Philips 
IntelliVue MP50). This represents the same environment the patient will be in for most outpatient 
procedures (i.e., lying in the supine position with multi-vital monitor attached). Thus, this protocol 
captures a realistic use case of the Makani Science RMS.  
The subject’s respiration will be monitored simultaneously by the Makani Science RMS and the 
reference device. Respiratory rate will be recorded for each subject as they breathe normally (free 
spontaneous breathing) in the supine position. Additionally, respiratory rate will also be recorded with 
the subject in different position and performing different respiratory maneuvers to simulate artifacts. 
Details for the steps of the study procedure are provided in Appendix 1 – Study Procedure.  
4.3 System Verification and Calibration 
4.3.1 Subject Device 
This study will use the final design (sensors, software, and algorithm) of the Makani Science RMS. 
Sensors may be reused during this study. Any Makani Science sensors that have been used will be 
reprocessed and undergo the same inspection and testing done during factory assembly to ensure that 
the performance is equivalent. The sensors will be documented and tracked through the clinical study.  
4.3.2 Reference Device 
The reference device used for this study will be a Philips InvelliVue MP50 multi-vital monitor with the 
capnography module. This is an FDA cleared monitor and will be calibrated for all vital signs prior to use.  
4.4 Data Acquisition  
Respiratory data will be simultaneously recorded for each participant from: (1) the Makani Science RMS 
and (2) a capnography device. A video camera will also be continuously recording the values from the 
monitors present as well as the movement of the subject’s chest. All subject baseline data will be 
recorded prior to the start of the study by the investigators. 
The HCP investigator will be recording the respiratory rate in 60 second intervals from the Philips 
IntelliVue MP50 monitor and will be blinded to respiratory rate information from the Makani Science 
RMS. The MKS investigator will be recording respiratory rate during the same 60 second intervals from 
the Makani Science RMS.  
Data from both the Makani Science system and the Philips IntelliVue MP50 vital monitor will be 
recorded electronically as applicable. Data from the Philips IntelliVue MP50 vital monitor may be 
recorded continuously over time via an ethernet cable to an open-source software (VitalSignsCapture by 
Xeonfusion) as a comma separated value format [27]. Data from the Makani Science RMS monitor will 

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be downloaded as a CSV file. The electronically recorded data will not be used in the final primary 
endpoint analysis of this clinical study but will as used for future studies.   
4.4.1 Clinician Scored Capnograph Recording (Reference)  
Data from the Philips InvelliVue MP50 monitor will be assessed and recorded by the HCP investigator. 
The investigator will be counting each waveform from the etCO2 for a duration of 60 seconds; they will 
be blinded to any respiratory rate values reported on the monitor. The accuracy of the data will be 
determined by the HCP investigator. Basic guidelines for handling artifacts are listed in section 4.5.3. If 
the investigator has reason to believe that the capnograph was not functioning properly, the data from 
that 60 second period will be discarded. The HCP investigator will not be required to interpret the actual 
etCO2 values.  
4.5 Data Handling 
4.5.1 Data Storage 
All data recorded by the investigators will be assigned a de-identified file name and input digitally as an 
excel file format. Notes taken during the study, including subject baseline information and any 
deviations from the protocol, will be scanned, and assigned a de-identified file name. Video recording of 
the monitor screen will also be assigned a de-identified file name. All the files will then be uploaded 
onto an external memory drive and kept in a secure, locked, location.  
4.5.2 Data Processing and Quality Control  
The HCP investigator will be a qualified healthcare professional who can manually count the etCO2 
waveform from the capnograph for respiration rate. During the study, they will be asked to assess for 
and record any abnormal breathing events, which will be reported [28, 24]. The HCP investigator will be 
blinded to all Makani Science RMS information so that they remain unbiased while making the 
measurement and decision on artifacts.  
The respiratory rate data will be inputted electronically as an excel file with the columns as time, 
manually counted respiratory rate, and respiratory rate from the Makani Science RMS. The processed 
data will be provided for statistical analyses. Table 1 shows an example of the data format.  
Table 1. Example of the table provided for final analysis 
Time
(HH:MM:SS) 
Manually Counted
Capnography RR 
(BPM) 
Makani Science RR
(BPM) 
3:01:51
5
4
3:02:56
5
5
3:03:55
6
5
3:04:58
6
6
If there is reason to believe that an error has occurred, the video recording of the session will be 
reviewed and new values for respiratory rate will be recorded and verified.  

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4.5.3 Identifying and Handling Respiratory Deviations during Primary Objective 
Capnographs are prone to artifacts from the environment (i.e., motion, etc.). Thus, it is pertinent to 
define a set of criteria for identifying any artifacts in the reference data. This process will heavily rely on 
the experience and discretion of the HCP investigator present recording the capnography waveform 
from the subjects. Criteria for identifying artifacts are as follows:  
 
End-Tidal CO2 Waveform  
The waveform should show clean repeated patterns for the duration of the monitoring segment 
(60 seconds). Appearance of incomplete or multiple waveforms should be identified as artifacts.  
 
General subject condition 
Visual assessment of the subject’s visual breathing pattern should be periodically made. This will 
help confirm that the subject is comfortable and breathing normally. If there are any indication 
that the subject is breathing outside of their normal state during the study (i.e. coughing, apnea, 
etc.), the healthcare professional should note the artifact during the study.   
Determination of artifacts during the study will be at the sole discretion of the HCP investigator, who will 
be blinded to the Makani Science RMS data. If they have reason to believe that the data from the 
reference device has been affected by the artifact (i.e. subject coughing or system malfunction), then 
any data recorded will be discarded.  
4.6 Statistical Endpoints and Analyses 
Full statistical analysis details and statistical considerations will be provided in the Statistical Analysis 
Plan (SAP) for this pivotal study.  
4.6.1 Study Endpoints 
The primary endpoint is RR accuracy of the Makani Science RMS as compared to manual, clinician-
scored etCO2 waveform (capnography). Accuracy will be estimated using mean absolute error (MAE).  
An additional endpoint, bias, will be summarized as the actual difference between Makani Science RMS 
and capnography (Makani Science RMS – capnography). 
4.6.2 Primary Analysis 
For the primary analysis, accuracy and the associated 95% confidence interval will be calculated. The 
lower confidence limit will be compared to the performance goal of 3 bpm.  
4.6.3 Additional Analyses 
 
Bias and the associated 95% confidence interval will be calculated. 
 
A Bland-Altman analysis will be performed for the difference in RR between Makani Science RMS 
and capnography. 
 
Accuracy and bias will be summarized descriptively after artifacts and in different body positions. 
4.6.4 Subgroup Analyses  
Accuracy and bias will be summarized descriptively by subject BMI (normal: BMI < 25 and overweight: 
BMI ≥ 25) and biological sex. 

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4.6.5 Demographic and Baseline Characteristics 
Demographic and baseline characteristics will be summarized descriptively.  This information includes:  
 
Age 
 
Biological sex 
 
Weight 
 
Height 
 
BMI 
 
Abdomen circumference 
 
Chest wall circumference 
 
Relevant medical information (i.e., relevant disease, active symptoms, and current medication) 
4.6.6 Sample Size Estimation 
The study will target a total of 30 subjects with a maximum enrollment of 40 subjects. This will ensure 
adequate data for the primary and subgroup analysis.    
4.7 Ethical and Regulatory Considerations  
4.7.1 Role of Makani Science as Study Sponsor  
As the study sponsor, Makani Science, Inc. has the overall responsibility for conducting the study, 
including any applicable national requirements. In this study, Makani Science will have certain direct 
responsibilities and may delegate others to qualified consultants. This protocol and any amendments 
will be documented and maintained at Makani Science. 
4.7.2 IRB Approval  
Prior to conduction of this study, investigator review board (IRB) approval will be received by Advarra.  
4.7.3 Informed Consent  
Informed consent forms will be obtained from all participants of the study prior to start of study 
conduction.  
4.7.4 Subject Confidentiality  
Subject confidentiality will be maintained throughout the clinical study. A unique subject de-
identification code will be assigned and used to allow identification of all data reported for each subject. 
Any video recorded will not include any identifiable material (i.e., subject face or any tattoos).  
Study data may be made available to third parties, e.g., in the case of an audit, provided the data is 
treated confidentially and that the subject’s privacy is guaranteed. The identity of a subject will never be 
disclosed in the event that the study data is published.  
 
 

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5 Appendices   
5.1 Appendix 1 – Study Procedure  
Respiration rate will be measured concurrently using capnography and the Makani Science RMS.  
5.1.1 Study Material  
 
Makani Science RMS  
 
Philips IntelliVue MP50 Vital Monitor + Sensors  
 
Computer with VitalSignsCaptureMP Software available (Optional) 
 
Ethernet Crossover Cable (Optional) 
 
Scale  
 
Tape measure  
 
Camera (3x) 
 
USB drive and USB to iPad adapter 
 
Resting/massage tables or bed 
5.1.2 Study Procedure 
1. The procedure will be explained to the subject and consent will be acquired.  
2. The subject baseline information will be collected.  
3. The subject will be asked to lay in the supine position.  
4. The subject’s skin will be cleaned with alcohol wipes.  
5. The Philips IntelliVue MP50 vital monitoring sensors will be placed on the subject. This includes:  
5.1. ECG 
5.2. Capnography 
5.3. Pulse oximeter  
6. The Makani Science sensor will be applied onto the subject.  
7. The subject will be asked to breathe quietly for approximately 1 hour.  
8. Respiratory rate will be recorded simultaneously from the Makani Science RMS and the 
capnograph monitor approximately every 2 minutes.  
8.1. The HCP investigator will count the number of etCO2 waveforms on the capnograph 
monitor for a 60 second duration.   
8.2. The MKS investigator will record the respiratory rate reported by the Makani Science RMS 
for the same duration.    
9. The subject will be asked to perform common breathing artifacts (coughing and shallow 
breathing). The subject Respiratory rate recorded after each artifact has been performed.  
9.1. The Subject will be asked to cough. 30 seconds after the cough, the respiratory rate will be 
recorded for a 60 second duration. This will be repeated three times.    
9.2. The subject will be asked to perform shallow breathing for 30 seconds. 30 seconds after the 
shallow breathing, the respiratory rate will be recorded for a 60 second duration. This will 
be repeated three times.   
10. The subject will be asked to change position and breath for an additional 5 minutes for 
additional body positions. Respiratory rates will be collected during this entire duration.  

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 
The subject will be roll onto their right side and breath for 5 minutes. 
 
The subject will be asked to roll onto their left side and breath for 5 minutes.  
 
The subject will be reclined slightly and breath for 5 minutes.  
11. All sensors will be removed and the subject will be presented with their compensation. 
5.1.3 Follow up Assessment 
 
No follow up assessment is required. 
5.2 Appendix 2 – Adverse Events Definitions  
Adverse Event (AE):  
Any unintended medical occurrence, unintended disease or injury, or untoward clinical signs (including 
abnormal laboratory findings) in subjects, users, or other persons, whether related to the study medical 
device. 
Serious Adverse Event (SAE):  
An adverse event when the subject outcome is: 
a. Death 
b. Life-threatening  
c. Hospitalization (initial or prolonged); including emergency room visits that do not result in 
admission to the hospital but were evaluated for one of these other serious outcomes 
d. Disability or permanent damage  
e. Required intervention to prevent permanent impairment or damage 
f. 
Other serious important medical events (if serious event does not fit the other outcomes, but 
event may jeopardize the subject and may require medical or surgical intervention (treatment) 
to prevent one of the other outcomes (i.e., seizures/convulsions that do not result in 
hospitalization) 
Note that planned hospitalization for a pre-existing condition, or a procedure required by the study 
protocol without serious deterioration in health, is not considered a serious adverse event. 
Device-Related Adverse Event (DRAE):  
An adverse event or effect related to the use of the investigational or study medical device.

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