Makani Science Respiration Monitoring System Pivotal Clinical Study Protocol
Conditions: Respiratory Monitoring
Sponsor: Michael Chu

CP-0001, Rev B
Clinical Study Protocol
Makani Science Respiration Monitoring System
07/29/2022
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CLINICAL STUDY PROTOCOL 
FOR THE 
MAKANI SCIENCE RESPIRATION MONITORING SYSTEM 
Pivotal Clinical Study Protocol
Protocol CP-0001
07/29/2022
Makani Science, Inc.
5270 California Ave, Ste 300
Irvine, CA 92617
U.S.A.

CP-0001, Rev B
Clinical Study Protocol
Makani Science Respiration Monitoring System
07/29/2022
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Contents
Contents........................................................................................................................................................2
Investigator Approval....................................................................................................................................4
Version History..............................................................................................................................................5
Study Summary.............................................................................................................................................6
Makani Science Pivotal Clinical Study Protocol ............................................................................................8
1
Introduction ..........................................................................................................................................8
1.1
Clinical Background.......................................................................................................................8
1.2
Study Rationale...........................................................................................................................10
2
Study Device........................................................................................................................................11
2.1
Device Description ......................................................................................................................11
2.2
Indications for Use ......................................................................................................................12
3
Study Overview...................................................................................................................................12
3.1
Study Objective...........................................................................................................................12
3.2
Study Endpoints ..........................................................................................................................13
3.2.1
Primary Endpoint ....................................................................................................................13
3.2.2
Secondary Endpoints ..............................................................................................................13
3.2.3
Subgroup Analysis...................................................................................................................13
3.3
Study Population.........................................................................................................................13
3.3.1
Inclusion Criteria .....................................................................................................................13
3.3.2
Exclusion Criteria.....................................................................................................................13
3.3.3
Patient Enrollment Plan..........................................................................................................13
3.4
Study Data to be Recorded.........................................................................................................14
3.4.1
Patient Baseline Data..............................................................................................................14
3.4.2
Data for Primary and Secondary Endpoints............................................................................14
3.4.3
Data for Subgroup Analysis.....................................................................................................14
3.4.4
Safety Analysis and Adverse Event Recording ........................................................................14
3.4.5
Protocol Deviations.................................................................................................................15
3.5
Risk Analysis................................................................................................................................15
3.5.1
Risks.........................................................................................................................................15
3.5.2
Minimization of Risks..............................................................................................................16

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4
Study Design........................................................................................................................................16
4.1
Performance Goal.......................................................................................................................16
4.2
Study Procedure..........................................................................................................................16
4.3
System Verification and Calibration............................................................................................17
4.4
Data Acquisition..........................................................................................................................17
4.5
Data Handling..............................................................................................................................17
4.5.1
Initial Data Storage..................................................................................................................17
4.5.2
Data Processing and Quality Control ......................................................................................17
4.6
Data Analysis and Statistical Considerations ..............................................................................18
4.6.1
Primary Study Hypothesis and Analysis..................................................................................18
4.6.2
Secondary Study Endpoint Analyses.......................................................................................19
4.6.3
Demographic and Baseline Characteristics.............................................................................19
4.6.4
Subgroup Analysis...................................................................................................................19
4.6.5
Sample Size Estimation ...........................................................................................................19
4.6.6
Interim Analysis.......................................................................................................................19
4.7
Ethical and Regulatory Considerations.......................................................................................20
4.7.1
Role of Makani Science as Study Sponsor...............................................................................20
4.7.2
IRB Approval............................................................................................................................20
4.7.3
Informed Consent ...................................................................................................................20
4.7.4
Subject Confidentiality............................................................................................................20
5
Appendices..........................................................................................................................................21
5.1
Appendix 1. Study Procedure .....................................................................................................21
5.1.1
Study Material.........................................................................................................................21
5.1.2
Primary and Secondary Endpoint Study Procedure................................................................21
5.1.3
Follow up Assessment.............................................................................................................22
5.2
Appendix 2. Adverse Events Definitions.....................................................................................22
6
References ..........................................................................................................................................23

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Investigator Approval
Study Title: 
Pivotal Clinical Study for the Makani Science Respiration Monitoring System
Study Device: 
Makani Science Respiration Monitoring System (RMS)
Study Sponsor: 
Makani Science, Inc.
5270 California Ave, Ste 300
Irvine, CA 92617
U.S.A.
Principal Investigator Acknowledgement Signature:
I have received and reviewed this version of the above noted study protocol and will conduct the study 
in accordance with the outlined protocol requirements, all attachments, and applicable local and Food 
and Drug Administration (FDA) regulations. 
______________________________________
______________________________________ ______________________
Date

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Makani Science Respiration Monitoring System
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Version History
Version
Date
Author
Description of Change
Justification
A
22-Apr-2022
Michael Chu
Initial Version 
B
07/29/2022
Michael Chu
Changed protocol and 
reference measurement. 
Based on feedback on data 
from first study. 

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Study Summary
Study Title 
Pivotal Clinical Study for the Makani Science Respiration Monitoring System
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 manual respiration rate counting by 
a trained individual (reference) for measuring respiratory rate in adult 
subjects, supporting its indications for use as a non-invasive system intended 
in both supine and reclined positions using 
two Makani Science sensors. It graphically displays respiration versus time 
and reports an approximate respiratory rate value. Its measurements are 
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.
Indications for Use
The Makani Science Respiration Monitoring System (RMS) is a non-invasive 
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, non-blinded, open-label, single-arm study
Enrollment/Number 
of Sites
Single-center/two sites
Subject Population
30 healthy adult subjects: 15 subjects with normal BMI; 15 subjects with 
overweight BMI
Primary Endpoint
To evaluate the respiratory rate (RR) accuracy of the Makani Science RMS 
compared to manual respiratory rate counting by a trained individual in with 
subject in a supine and reclined positions.
Secondary Endpoints
1.
RR bias of the Makani Science RMS compared to manual respiratory rate 
counting by a trained individual.  
2.
RR precision of the Makani Science RMS compared to manual respiratory 
rate counting by a trained individual.  
Subgroup Analysis
Subgroup analyses of primary and secondary endpoints will be presented by 
subject BMI (normal: BMI < 25 and overweight: BMI 25).
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.
Statistical 
Considerations
The null and alternative hypotheses for the primary endpoints are as follows:
,

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where 
is the RR accuracy represented by the root-mean-squared-
percentage-error (RMSPE) for data collected in the supine position, 
is the 
RMSPE for data collected in the reclined position, and PG is the performance 
goal. The PG for the primary endpoint is set at 20% defined based as in 
Atkinson et al. using the ExSpiron respiratory volume monitor by Respiratory 
Motion Incorporated.  The primary hypotheses will be sequentially tested 
using a gate-keeping approach, each with a one-sided significance level of 
0.025.  If 
is rejected, 
may be tested.  If 
is not rejected, 
will not 
be tested.
Once 50% of the planned subjects have completed the study, an interim 
analysis of RR accuracy will be performed and sample size re-estimated. The 
new sample size will be calculated as the sample size necessary to yield an 
80% conditional probability of trial success (i.e., meeting both primary 
endpoints), given the interim results. If the conditional probability of 
demonstrating accuracy in the supine position is less than 50%, the study will 
be stopped for reassessment of the protocol. If the conditional probability is 
greater than or equal to 50%, the study will proceed to completion with the 
new sample size, capped at a maximum of 50 participants.  If the study 
continues following the interim analysis, the sponsor will remain blinded to 
the primary endpoint results and thus, no overall alpha adjustment is 
required.
Inclusion Criteria
Healthy adult subjects between ages of 22 and 99 years old.
Body mass index between 15 and 35 kg/m2.
Exclusion Criteria
Medical history of serious cardiac (e.g., heart failure, coronary artery
disease) or pulmonary diseases/conditions (e.g., poorly controlled
asthma, chronic obstructive pulmonary disease, chronic cough).
History of serious skin irritation (severe rash or blisters) caused by
medical adhesives (tape).
Subject cannot lie still on their back for one (1) hour.
Subject is pregnant.
Subject is unable to give written, informed consent.
Principal 
Investigator
Dr. Vinit Joshi
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

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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 
[1, 2, 
3]. For example, sedated patients undergoing, or recovering from, medical procedures are at a higher 
risk of developing respiratory failure and require continuous monitoring [4, 5]. Failure to detect such 
events in a timely manner can lead to preventable complications and even death, commonly described 
[6] Respiratory failure events that occur after medical procedures involving 
sedatives or opioids are significant contributors to complications, death, and prolonged hospital length 
of stay [7, 8].
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 a number of different reasons [9]. 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 [10]. Additionally, both systems have known shortcomings described below. 
Pulse oximetry 
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, 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 [11]. 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 
temperature [12].
Capnography measures the partial pressure of exhaled carbon dioxide (EtCO2) and is widely used for 
patients under general anesthesia [13]. However, use of the system outside the operating room is
inconsistent and facilities have been slow to adopt this technology [14, 15]. While capnography better 
detects respiratory failure than pulse oximetry, it 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 

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While pulse oximetry and capnography can monitor patient respiration continuously, respiratory 
depression and failure can be best detected by measuring
ventilation (breathing rate and 
depth) [15]. This is currently done via spot checks by a trained individual in hospital settings [9]. Changes 
in ventilation can indicate respiratory failure much earlier than the current standard of care [2, 16].
Respiratory rate in particular, is an underutilized ventilatory parameter that can be important in 
assessing
[17, 18].
changes over time [2, 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 continu
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 re
Bioimpedance Measurement
The flow of air into and out of the lungs will change the overall impedance of the chest cavity. The 
change with breathing. This data can then be used to calculate respiratory rate and volume. Systems like 
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 
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
Quantitatively measuring the 

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chest wall movement can also provide ventilatory information; for example, respiratory inductive 
plethysmography (RIP)
n 
circumference. While simple to use, this type of system is prone to motion artifacts and the bands 
slipping away from their required placement locations. Chest rise and fall can also be monitored using a 
contactless method via radar (Circadia Health) [23]. This method requires direct line of site to the 
direct line of sight limits the use case of such a system to environmen
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 ventilation 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 a trained individual manually counting 
breathing for subjects in both supine and reclined positions.
The Makani Science RMS is a non-
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 on adult patients by trained professionals in healthcare facilities, and dental offices.

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2
Study Device
2.1 Device Description
The Makani Science RMS (subject device) uses a wireless, wearable sensor that can measure respiratory
rate
(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 
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 [24]. 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). [25] This significantly reduces the footprint needed for the 
measurement, making a wearable system more practical. 
The Makani Science RMS consists of two disposable 
nd-Aid®
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). 
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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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 int
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 RVM is intended to be used on adults by professionals in healthcare facilities and 
dental offices.
3
Study Overview
This is a prospective, non-blinded, open-label, 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) manual respiratory rate counting by a trained individual. This 
study uses the same reference for measuring respiratory rate as Respiratory Motion for their ExSpiron 
device [26].  Enrollment will be targeted to balance normal (BMI < 25) and overweight (BMI 25) 
subjects.
3.1 Study Objective
The study objective is to compare the accuracy of the Makani Science Respiration Monitoring System
(RMS) to manual counting by a trained individual for measuring respiratory rate in adult subjects,
supporting its indications for use as a non-invasive system 
in 
the supine and reclined positions using two Makani Science sensors. It graphically displays respiration 
versus time and reports an approximate respiratory rate value. Its measurements are used as an adjunct 
to other clinical information sources.
Figure 2-2 (a) Image of the Makani Science RM sensor. 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. [25]

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The Makani Science RMS is intended to be used on adults by professionals in healthcare facilities and 
dental offices.
3.2 Study Endpoints
3.2.1
Primary Endpoint
Respiratory rate (RR) accuracy of the Makani Science RMS compared to manual counting by a 
trained individual for both supine and reclined positions. Accuracy is estimated using the root-
mean-squared-percentage-error (RMSPE) comparing the Makani Science RMS and the reference 
device.
3.2.2
Secondary Endpoints
RR bias of the Makani Science RMS compared to manual counting by a trained individual for 
both supine and reclined positions.  Bias is estimated using the mean paired difference 
comparing the Makani Science RMS and the reference.
RR precision of the Makani Science RMS compared to manual counting by a trained individual
for both supine and reclined positions.  Precision is estimated using the standard deviation of 
the paired differences of the Makani Science and the reference.
3.2.3
Subgroup Analysis
Subgroup analyses of primary and secondary endpoints will be presented by subject BMI (normal: BMI < 
25 and overweight: BMI 25).
3.3 Study Population
3.3.1
Inclusion Criteria
Subjects must meet the following inclusion criteria to participate in the study:
Healthy adult subjects between ages of 22 and 99 years old. 
Body mass index (BMI) between 15 and 35 kg/m2.
3.3.2
Exclusion Criteria
Subjects who meet any of the following exclusion criteria will not be eligible to participate in the study:
Medical history of serious cardiac (e.g., heart failure, coronary artery disease) or pulmonary 
diseases/conditions (e.g., poorly controlled asthma, chronic obstructive pulmonary disease, 
chronic cough).
History of serious skin irritation (severe rash or blisters) caused by medical adhesives (tape).
Subject cannot lay still on their back for one (1) hour.
Subject is pregnant.
Subject is unable to give written, informed consent.
3.3.3
Patient Enrollment Plan
A representative sample of the target patient population will be enrolled for this study. 

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Specific enrollment numbers will be targeted for participants with normal and overweight BMI 
(15 normal subjects, defined as BMI between 15 and 25, and 15 overweight subjects, defined as 
BMI between 25 and 35). 
3.4 Study Data to be Recorded
3.4.1
Patient Baseline Data
The following baseline data will be recorded for each participant. 
Birthdate (age) 
Sex
Weight
Height
Abdomen circumference 
Torso circumference 
3.4.2
Data for Primary and Secondary Endpoints
The following data will be collected and analyzed specifically for the primary and secondary endpoints. 
The data will be recorded by the investigator as well as captured via video recording of the screen. 
Subject respiratory rate via manual counting by a trained individual for both supine and reclined 
positions. 
Concurrent respiratory rate over time from the Makani Science RMS system for both supine and 
reclined positions.
Baseline patient information recorded by the clinical researcher 
3.4.3
Data for Subgroup Analysis
The following data will be collected for the subgroup analyses of the primary and secondary endpoints 
presenting the data by subject BMI: 
Normal BMI <25 
Overweight BMI 25
3.4.4
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 any and 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. 
Any and 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, 

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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. 
3.4.5
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 that causes the investigator to pause the study for a prolonged period of time), all 
study results will be discarded, a new Makani Science RMS sensor will be applied to the subject, 
and the study will be restarted. This will be considered a device failure, and not a failure of the 
study. The Makani Science RMS failure will be recorded and a root cause analysis for the failure 
will be performed. 
Deviation from Guided Breathing 
If the subject noticeably deviates from the guided breathing protocol (e.g., falls asleep or is 
showing difficulty following the guided breathing), the study results from that specific segment 
will be discarded, and the subject will be asked to repeat the breathing protocol for that 
segment. If the subject deviates excessively from the protocol (i.e., over twice per respiratory 
maneuver), their data will be removed from the overall analysis. All cases described here will be 
Failure to record baseline information 
If the investigator fails to record the subject baseline information or has reason to believe the 
patient baseline information is not accurate, the investigator will follow up with the subject via 
phone. The deviation will be recorded.
3.5 Risk Analysis
3.5.1
Risks
The subject device does not have known direct major risks to the health and safety of the patient. There 
is no SAE anticipated for this study. 
Anticipated minor risks includes: 
Minor skin irritation in certain participants from the adhesive used in the Makani Science RMS
sensor. 

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3.5.2
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
Patients with significant and extreme skin reaction to adhesives will be excluded from 
the study. 
Use of approved medical grade adhesives.
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, non-blinded, open-label, 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) a trained individual manually counting respiration for two 
positions (supine and reclined).  Enrollment will be targeted to balance normal (BMI < 25) and 
overweight (BMI 25) subjects. To satisfy select design requirements (detailed in section 4.8), all testing 
will include an operational and active multi-vital monitor (Phillips MP50), be done with the Makani 
Science RMS sensors pre-stretched, and be done with the application site of the Makani RMS sensors 
cleaned with alcohol wipes. 
4.1 Performance Goal
The study objective is to compare the accuracy of the Makani Science RMS to manual respiratory rate 
counting by a trained individual (reference) for measuring respiratory rate in adult subjects to support 
its indications for use as a non-
in the supine 
and reclined positions. The Makani Science RMS 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 on adult patients by professionals 
in healthcare facilities and dental offices.
The primary study objective is to demonstrate that the RR accuracy of the Makani Science RMS
compared to manual counting by a trained professional is within a performance goal (PG) of 20%.  The 
PG for the Makani Science RMS was determined to be 20% based on the PG used by Respiratory Motion 
ExSpiron; this study also uses the same reference as the Respiratory Motion ExSpiron device.
4.2 Study Procedure
monitored simultaneously by the Makani Science RMS and a trained individual. Each subject will be 
asked to breath according to a number of pre-defined maneuvers. The order of the pre-defined 
breathing maneuvers and the position of the subjects will be randomized [27]. 

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Details for the steps of the study procedure are provided in the Appendix 1
Study Procedure. 
4.3 System Verification and Calibration
The algorithm used by the Makani Science RMS will be the final version to be implemented in the 
Makani Science RMS product. Any Makani Science sensors that has been used and reprocessed for the 
clinical study will undergo the same inspection and testing done during factory assembly to ensure that 
the performance will be equivalent. The sensors will also be documented and tracked through the 
clinical study. 
The Phillips MP50 vital monitor will be calibrated for all vital signs. 
4.4 Data Acquisition
Respiratory data will be simultaneously recorded for each participant from: (1) the Makani Science RMS
and (2) by a trained individual counting respiration manually (reference). The clinical investigator will be 
recording the respiratory rate every 60 seconds, and will be blinded from any respiratory rate 
information from the monitor and guided breathing. A video camera will also be recording the values 
  
Data from both the Makani Science system and the Phillips MP50 vital monitor will also be recorded 
electronically. Data from the Phillips MP50 vital monitor will be recorded continuously over time via an 
ethernet cable to an open-source software (VitalSignsCapture by Xeonfusion) as a comma separated 
value format [28]. Data from the Makani Science RMS will be downloaded afterwards. The electronically 
recorded data will not be used in the analysis of this clinical study, but will as exploratory for future 
studies. 
All subject baseline data will be recorded prior to the start of the study by the investigator.
4.5 Data Handling
4.5.1
Initial Data Storage
All data recorded by the clinical investigator will be assigned a de-identified file name and inputted 
digitally as an excel file format. Notes taken during the study, including patient baseline information and 
deviation 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 location. 
4.5.2
Data Processing and Quality Control
The clinical investigator will be a qualified individual who can manually count the patient respiration 
rate. During the study, they will be asked to assess for and record any abnormal breathing events, which 
will be reported [29, 30]. The trained individual manually counting respiratory rate will be blinded to all 
monitor information as well as any guided breathing rates so that they remain unbiased while making 
the measurement. 
The respiratory rate data will be saved 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 

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for the statistical analysis. Data from the supine and reclined position will be stored as separate tabs.
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 RR
(BPM)
Makani Science RR
(BPM)
4:01:51
5
4
4:02:56
5
5
4:03:55
6
5
4:04:58
6
6
4:05:50
6
6
4.6 Data Analysis and Statistical Considerations
Detailed statistical analysis and considerations are provided in the Statistical Analysis Plan (SAP) for this 
pivotal study. The primary analysis will be conducted twice.  An interim analysis will be generated as 
described in Section 4.6.6, once 50% of subjects have been enrolled.  The final analysis will take place 
once all subjects have completed the study and all data have been downloaded, monitored and 
processed.  All analyses will be performed using all subjects who meet the inclusion and exclusion 
criteria and have simultaneous monitoring using the two study devices for any amount of time.
4.6.1
Primary Study Hypothesis and Analysis
The null and alternative hypotheses for the primary endpoint are as follows:
,
where 
is the accuracy represented by the RMSPE for data collected in the supine position, 
is the 
RMSPE for data collected in the reclined position, and PG is the performance goal.  The PG for the 
primary endpoint is set at 20% defined based as in Atkinson et al. [31] using the ExSpiron respiratory 
volume monitor by Respiratory Motion Incorporated.  The primary hypotheses will be sequentially 
tested using a gate-keeping approach, each with a one-sided significance level of 0.025.  If 
is 
rejected, 
may be tested.  If 
is not rejected, 
will not be tested.
For each primary hypothesis, the percentage RMSPE for RR will be calculated using the paired difference 
between log-transformed Makani Science and reference RR measurements analyzed in a mixed-effects 
linear model with random subject effects to account for repeated measurements. The RMSPE will be 
estimated as the sum of the squared bias, the within-subjects variance and the between-subjects 
variance, back-transformed with the usual equation for coefficients of variation: 
and 
expressed as a percentage. Bootstrapped confidence intervals for RMPSE will be calculated by randomly 
Following the sequential gate-keeping approach, if the upper one-sided 97.5% confidence interval for 
the RMSPE is less than the corresponding performance goal, then accuracy can be claimed.

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4.6.2
Secondary Study Endpoint Analyses
The RR percentage bias and precision for both supine and reclined positions will be calculated using a 
similar mixed-effects linear model as described for the primary endpoint analysis.  The bias is the 
estimated geometric mean paired difference from the model, back-transformed and expressed as a 
percentage.  The precision is the standard deviation of the square root of the sum of the within-subjects 
variance and the between-subjects variance, back-transformed and expressed as a percentage. 
Bootstrapped 95% confidence intervals will be generated for percentage bias and precision.   
4.6.3
Demographic and Baseline Characteristics
Demographic and baseline characteristics will be summarized descriptively.  Demographic 
characteristics include age, sex, weight, height, BMI, abdomen circumference, and torso circumference.
4.6.4
Subgroup Analysis
For each monitoring position (supine and reclined), a subgroup analysis for the primary endpoint will be 
generated for BMI comparing subjects in the Normal (BMI<25) and Overweight (BMI 25) categories.  
The RMSPE will be estimated for each BMI category using the same methods as described in Section 
4.6.1 and will be compared using a randomization test.  Secondary endpoints will also be summarized 
for each monitoring position by BMI category with no formal statistical comparisons.
4.6.5
Sample Size Estimation
The sample size to achieve an 80% probability of rejecting the null hypothesis at a significance level of 
0.
assuming the standard deviation of the RMSPE is 4.51% as observed in a pilot study for data 
collected in supine position and the observed RMSPE in the Pivotal study is 17.5%, is 28 subjects.  This 
was calculated using the One Sample T-tests Procedure of NCSS Power Analysis Statistical Software, 
Version 20 (PASS 20, [32]). Assuming a potential 5% dropout rate, 30 subjects (28/0.95) will be enrolled.   
An interim analysis is planned once 50% of the subjects have completed the study to verify these 
assumptions and re-estimate the sample size if needed.
4.6.6
Interim Analysis
Once 50% of the planned subjects have completed the study, an interim analysis of RR accuracy will be 
performed and sample size re-estimated. The conditional probability of demonstrating accuracy in the 
supine position at the end of the trial, given the interim results, will be calculated. If this conditional 
probability is less than 50%, the study will be stopped for reassessment of the protocol; if the 
conditional probability is greater than or equal to 50%, the study will proceed to completion with the 
new sample size, capped at a maximum of 50 participants.  The new sample size will be calculated as the 
sample size necessary to yield an 80% conditional probability of trial success (i.e., meeting both primary 
endpoints), given the interim results.   If the study continues following the interim analysis, the sponsor 
will remain blinded to the primary endpoint results and no overall alpha adjustment is required.  This 
procedure has been shown by Gao et al. [33] to control the overall significance level at 5%.

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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. 
Study data may be made available to third parties, e.g., in the case of an audit, provided the data is
ty 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 on healthy adult participants using capnography and the 
Makani Science RMSS. 15 patients will initially be enrolled for the study. 
5.1.1
Study Material
Makani Science RMS
Phillips MP40 Vital Monitor + Sensors 
Computer with VitalSignsCaptureMP Software available
NIST calibrated stop watch or timer
Ethernet Crossover Cable
Scale 
Tape measure 
iPad with paced breathing video
Camera
USB drive and USB to iPad adapter
Chairs
Resting/massage tables or bed
5.1.2
Primary and Secondary Endpoint 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 or recline position (order will be randomized per 
subject). 
4.
The subject
n will be cleaned with alcohol wipes. 
5.
The Phillips MP50 vital monitoring sensors will be placed on the subject. This includes: 
5.1. ECG
5.2. Capnography
5.3. Pulse oximeter 
5.4. Blood pressure cuff 
6.
The subject will be asked to perform the following breathing exercises in a random order [29]
[30]. They will be given a break between each exercise or as needed. 
6.1. The subject will be asked to breath quietly for 90 seconds. 
6.2. The subject will be asked to breath at a slow, but consistent rate for 90 seconds. 
6.3. The subject will be asked to breath at a medium, but consistent rate for 90 seconds. 
6.4. The subject will be asked to breath at a fast, but consistent rate for 90 seconds. 
6.5. 15 breaths-min-1for 90 seconds.
6.6. 12 breaths-min-1 for 90 seconds. 
6.7. 9 breaths-min-1 for 90 seconds. 
6.8. 6 breaths-min-1 for 90 seconds. 

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6.9. 18 breaths-min-1 for 90 seconds.  
6.10.
21 breaths-min-1for 90 seconds 
6.11.
24 breaths-min-1 for 90 seconds.  
7.
The subject will be moved into the supine or recline position (whatever position they did not lay 
in step 3). 
8.
A new set of Makani Science sensors will be placed on the subject. 
9.
The subject will repeat the breathing exercises in step 6. 
5.1.3
Follow up Assessment
No follow up assessment is required.
5.2 Appendix 2. Adverse Events Definitions
Adverse Event (AE): 
Any untoward 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 patient 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 patient 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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6
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