Results of the SpO2 and Pulse Rate Accuracy Comparison of VitalDetect™ to Arterial Blood CO-Oximetry and Reference ECG
Phase: NA
Conditions: Arterial Disease
Sponsor: Vital USA, Inc.

CLINIMARK, LLC 
 
 
 
 
 
 
(303) 717-4820 
 
80 Health Park Drive Suite 20, Louisville, Colorado, 80027     USA 
www.clinimark.com 
 
 
 
Clinimark, LLC 
80 Health Park Drive, Suite 20 
Louisville, Colorado 80027, 
USA 
TITLE: Final Test Report For Vital USA 
Results of the SpO2 and Pulse Rate Accuracy Comparison of 
VitalDetect™ to Arterial Blood CO-Oximetry and Reference ECG 
Clinimark Study ID# PR 2019-353 
Principal Investigator: Arthur Ruiz Cabrera, MD     Site ID # 001 
DOCUMENT NUMBER 
TR# 2019-353 
Page   1   of   39 
REV 
1 
 
 
Final Test Report For Vital USA 
Results of the SpO2 and Pulse Rate Accuracy Comparison of VitalDetect™ to Arterial Blood 
CO-Oximetry and Reference ECG 
Study ID# PR 2019-353 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Protocol Title:  
 
“Vital USA SpO2 Accuracy Comparison to Arterial Blood CO-Oximetry“ 
 
Protocol No.:  
PR 2019-353 
 
Investigational Device:  
VitalDetect™ pulse oximetry system 
 
Commercial Sponsor:  
 
Vital USA  525 S Flagler Dr. Suite 301, West Palm Beach, FL 33402  
 
Document 
Ownership: 
 
Function, Title 
Name 
Signature 
Date 
Clinimark Sub-Investigator, 
Chief Technical Officer 
Dena Raley 
 
05 Dec 2019 
Document  
Approver: 
 
Function, Title 
Name 
Signature 
Date 
Clinimark Sub-Investigator 
Chief Clinical Officer 
Paul Batchelder 
 
05 Dec 2019 
Principal Investigator 
Arthur Cabrera, 
MD 
05 Dec 2019 
This study was conducted in accordance to CFR for Non-Significant Risk Medical Device Study, following ISO 
14155:2011 as appropriate. 
 
Origination Date:     03 Dec 2019 
 
Revised Date: 03 Dec 2019 
 
 

CLINIMARK, LLC 
 
 
 
 
 
 
(303) 717-4820 
 
80 Health Park Drive Suite 20, Louisville, Colorado, 80027     USA 
www.clinimark.com 
 
 
 
Clinimark, LLC 
80 Health Park Drive, Suite 20 
Louisville, Colorado 80027, 
USA 
TITLE: Final Test Report For Vital USA 
Results of the SpO2 and Pulse Rate Accuracy Comparison of 
VitalDetect™ to Arterial Blood CO-Oximetry and Reference ECG 
Clinimark Study ID# PR 2019-353 
Principal Investigator: Arthur Ruiz Cabrera, MD     Site ID # 001 
DOCUMENT NUMBER 
TR# 2019-353 
Page   2   of   39 
REV 
1 
 
Final Test Report For Vital USA 
Results of the SpO2 and Pulse Rate Accuracy Comparison of VitalDetect™ to Arterial Blood 
CO-Oximetry and Reference ECG 
Study ID# PR 2019-353 
 
Table of Contents 
Table of Contents ............................................................................................................................ 2 
Summary ......................................................................................................................................... 4 
Introduction: ................................................................................................................................ 4 
Purpose:....................................................................................................................................... 4 
Subjects: ...................................................................................................................................... 4 
Methods: ..................................................................................................................................... 4 
Results: ........................................................................................................................................ 5 
Table 1: Summary of SpO2 Accuracy Results ........................................................................ 5 
Table 2: Summary of Pulse Rate Accuracy Results ............................................................... 5 
Conclusions: ................................................................................................................................ 5 
1. Introduction ................................................................................................................................. 6 
2. Investigational Device and Methods ........................................................................................... 6 
2.1 Device Description: .............................................................................................................. 6 
2.2 Gas Delivery & Monitoring System with data collection ..................................................... 8 
Desaturation Study Gas Delivery System ............................................................................... 8 
Control Oximetry System ....................................................................................................... 8 
Safety Equipment .................................................................................................................... 8 
2.3 Reference Equipment ............................................................................................................ 8 
Reference CO-Oximeters ........................................................................................................ 8 
2.4 Study Procedure / Clinical Investigative Plan (CIP) Summary: ........................................... 8 
Inclusion Criteria .................................................................................................................... 8 
Exclusion Criteria ................................................................................................................... 9 
3. Results ....................................................................................................................................... 11 
3.1 Subject Demographics ........................................................................................................ 11 
Table 3: Summary of Subject Demographics Record ........................................................... 11 
3.2 Equipment Record: ............................................................................................................. 12 
Table 4: Equipment Record .................................................................................................. 12 
4. Data Analysis ............................................................................................................................ 12 
4.1 Control Oximeter Stability handling:.................................................................................. 13 

CLINIMARK, LLC 
 
 
 
 
 
 
(303) 717-4820 
 
80 Health Park Drive Suite 20, Louisville, Colorado, 80027     USA 
www.clinimark.com 
 
 
 
Clinimark, LLC 
80 Health Park Drive, Suite 20 
Louisville, Colorado 80027, 
USA 
TITLE: Final Test Report For Vital USA 
Results of the SpO2 and Pulse Rate Accuracy Comparison of 
VitalDetect™ to Arterial Blood CO-Oximetry and Reference ECG 
Clinimark Study ID# PR 2019-353 
Principal Investigator: Arthur Ruiz Cabrera, MD     Site ID # 001 
DOCUMENT NUMBER 
TR# 2019-353 
Page   3   of   39 
REV 
1 
 
4.2 Test SpO2 Data handling: ................................................................................................... 13 
4.3 CO-Oximeter Data handling: .............................................................................................. 13 
4.4 Description of Statistics ...................................................................................................... 13 
4.5 SpO2 Accuracy Results: ..................................................................................................... 14 
Table 5: Comparison to Reference CO-Oximetry ................................................................ 14 
Table 6: Comparison to Reference ECG Heart Rate ............................................................ 15 
5.1 VitalDetectTM pulse oximetry vs Reference CO-Oximetry ................................................. 16 
5.2 Bland-Altman Plot: VitalDetectTM pulse oximetry ............................................................. 17 
5.3 Error Plot: VitalDetectTM pulse oximetry ............................................................................ 18 
5.4 Individual Subject 1 Error Plots .......................................................................................... 19 
5.5 Individual Subject 2 Error Plots .......................................................................................... 20 
5.6 Individual Subject 4 Error Plots .......................................................................................... 21 
5.7 Individual Subject 5 Error Plots .......................................................................................... 22 
5.8 Individual Subject 6 Error Plots .......................................................................................... 23 
5.9 Individual Subject 7 Error Plots .......................................................................................... 24 
5.10 Individual Subject 8 Error Plots ........................................................................................ 25 
5.11 Individual Subject 9 Error Plots ........................................................................................ 26 
5.12 Individual Subject 10 Error Plots ...................................................................................... 27 
5.13 Individual Subject 11 Error Plots ...................................................................................... 28 
6. Conclusions ............................................................................................................................... 30 
Table 7: Summary of SpO2 Accuracy Results ...................................................................... 30 
Table 8: Summary of Pulse Rate Accuracy Results ............................................................. 30 
7. Abbreviated Terms And Definitions ......................................................................................... 30 
8. Ethics......................................................................................................................................... 32 
9. Investigators and Administrative Structure of Investigation .................................................... 32 
10. Revision History ..................................................................................................................... 32 
11. Annexes to the Report ............................................................................................................. 32 
11.1 Line Listing / Data Removal Record ................................................................................ 33 
11.2  Clinical Investigation Plan  - (Separate Attachment) ...................................................... 39 
 
 
 
 
 
 

CLINIMARK, LLC 
 
 
 
 
 
 
(303) 717-4820 
 
80 Health Park Drive Suite 20, Louisville, Colorado, 80027     USA 
www.clinimark.com 
 
 
 
Clinimark, LLC 
80 Health Park Drive, Suite 20 
Louisville, Colorado 80027, 
USA 
TITLE: Final Test Report For Vital USA 
Results of the SpO2 and Pulse Rate Accuracy Comparison of 
VitalDetect™ to Arterial Blood CO-Oximetry and Reference ECG 
Clinimark Study ID# PR 2019-353 
Principal Investigator: Arthur Ruiz Cabrera, MD     Site ID # 001 
DOCUMENT NUMBER 
TR# 2019-353 
Page   4   of   39 
REV 
1 
 
Final Test Report For Vital USA 
Results of the SpO2 and Pulse Rate Accuracy Comparison of VitalDetect™ to Arterial Blood CO-
Oximetry and Reference ECG 
Study ID# PR 2019-353 
 
 
Summary 
Clinical Investigation Plan: “Vital USA SpO2 Accuracy Comparison to Arterial Blood CO-Oximetry“  
Clinimark Study ID# PR 2019-353, Version: Rev 1, Date: 15 Oct 2019 
Study Dates: November 4-5, 2019 
 
Introduction: 
An SpO2 accuracy comparison was conducted as part of the final validation of the VitalDetect™ pulse oximetry 
system. The study was conducted in accordance to Code of Federal Regulations (CFR) for Non-Significant Risk (NSR) 
investigational studies, following ISO 14155:2011 as appropriate and the pulse oximetry guidelines of ISO 80601-2-
61:2017 applicable sections, and Pulse Oximeters – Premarket Notifications Submissions [510(k)s] Guidance For 
Industry and Food and Drug Administration Staff (issued: March 4, 2013). 
 
Purpose: 
The purpose of this study was to validate the SpO2 accuracy of the VitalDetect™ pulse oximetry system during non-
motion conditions over the range of 70-100% SaO2 as compared to arterial blood samples assessed by CO-
Oximetry.  It was expected that the Accuracy Root Mean Square (ARMS) performance of the oximetry system would 
meet the required specification of ARMS of 3.0% or less.  
 
A secondary goal was to evaluate the pulse rate performance simultaneously collected over the SpO2 range 
covered. The Pulse Rate Accuracy Root Mean Square (Arms) performance of the VitalDetect™ pulse oximetry 
system, were expected to meet a specification of 3 bpm. 
 
Subjects: 
Following Institutional Review Board (IRB) approval Title: “Vital USA SpO2 Accuracy Comparison to Arterial Blood 
CO-Oximetry”, Clinimark Study ID# PR 2019-353, eleven healthy adult volunteer subjects were screened and 
enrolled into the study. One subject was withdrawn from the study due to poor device placement and time sync 
with the control oximeter. The demographics of subjects included were five males and five females (age: 19-38yrs, 
weight: 105-228 lbs, height: 63-75”, BMI: 18.0-34.7). For race and ethnicity, the subject pool included two Black / 
African-Americans, one Asian, and seven White. Nine subjects were of Non-Hispanic / Non-Latino and one of 
Hispanic /Latino ethnicity. The skin pigmentation / tones ranged from light to dark meeting the requirement of at 
least 2 darkly pigmented or 15 % of the subject pool whichever is larger. All subjects completed the study without 
incidence. There were no significant adverse events, device effects or other, observed during the study.  
 
Methods: 
Testing was conducted under normal office environment conditions. The VitalDetect™ pulse oximetry was placed 
on the right index finger of all subjects to evaluate the SpO2 and pulse rate accuracy performance during steady 
state non-motion conditions.  A Clinimark Control Pulse Oximetry system was also placed on the subject to 
evaluate the stability of the draws and the real time oxygen saturation status. The subject was in a reclined 
position and connected to a breathing circuit, for administering medical grade oxygen and nitrogen. The gas flow 
delivery was adjusted for subject comfort. The gas mixture was controlled to various levels of induced hypoxia 
resulting in stable oxygen saturation plateaus between 100% and 67% SaO2. Arterial blood samples were drawn 
during simultaneous data collection from the control pulse oximeter and the test oximeters. The blood was 
immediately analyzed by Reference CO-Oximetry providing functional SaO2 for the basis of the SpO2 accuracy 

CLINIMARK, LLC 
 
 
 
 
 
 
(303) 717-4820 
 
80 Health Park Drive Suite 20, Louisville, Colorado, 80027     USA 
www.clinimark.com 
 
 
 
Clinimark, LLC 
80 Health Park Drive, Suite 20 
Louisville, Colorado 80027, 
USA 
TITLE: Final Test Report For Vital USA 
Results of the SpO2 and Pulse Rate Accuracy Comparison of 
VitalDetect™ to Arterial Blood CO-Oximetry and Reference ECG 
Clinimark Study ID# PR 2019-353 
Principal Investigator: Arthur Ruiz Cabrera, MD     Site ID # 001 
DOCUMENT NUMBER 
TR# 2019-353 
Page   5   of   39 
REV 
1 
 
comparison. The pulse rate for the VitalDetect™ was compared to Reference ECG Heart Rate collected during the 
study. 
 
 
Results: 
The SpO2 accuracy performance results showed the following ARMS values for a range of 70-100%.  
 
 
Table 1: Summary of SpO2 Accuracy Results 
Comparison to Reference CO-Oximetry 
 (functional SaO2) 
ARMS SpO2 70-100% 
ARMS Spec 3.0% for a 
range of 70-100% 
VitalDetect™ pulse oximetry 
3.06 (239 pts) 
Fails to meet 
 
Note: The range of 70% to 100% includes reference data down to 67%. 
 
 
Table 2: Summary of Pulse Rate Accuracy Results 
Comparison to Reference ECG Heart Rate 
Pulse Rate ARMS  
For Heart Rate  
range 50-118 bpm 
ARMS Spec 3 bpm for 
the range collected 
during SpO2 of 70-
100% 
VitalDetect™ pulse oximetry 
2.7 (239 pts) 
pass 
 
 
 
Conclusions: 
The results of the study show that the VitalDetect™ pulse oximetry fails to meet an ARMS specification of 3.0% 
under steady state / non-motion conditions for the range 70-100%. The graphical data shows the VitalDetectTM to 
in general, under estimate the SaO2 readings below 80% with increased scatter. 
 
Reviewing the pulse rate accuracy, the VitalDetectTM pulse oximetry provides accurate pulse rate values for the 
range of 50-118 bpm, observed over the oxygen saturation levels between 70-100% meeting a specification of 3 
beats per minute.  

CLINIMARK, LLC 
 
 
 
 
 
 
(303) 717-4820 
 
80 Health Park Drive Suite 20, Louisville, Colorado, 80027     USA 
www.clinimark.com 
 
 
 
Clinimark, LLC 
80 Health Park Drive, Suite 20 
Louisville, Colorado 80027, 
USA 
TITLE: Final Test Report For Vital USA 
Results of the SpO2 and Pulse Rate Accuracy Comparison of 
VitalDetect™ to Arterial Blood CO-Oximetry and Reference ECG 
Clinimark Study ID# PR 2019-353 
Principal Investigator: Arthur Ruiz Cabrera, MD     Site ID # 001 
DOCUMENT NUMBER 
TR# 2019-353 
Page   6   of   39 
REV 
1 
 
Final Test Report For Vital USA 
Results of the SpO2 and Pulse Rate Accuracy Comparison of VitalDetect™ to Arterial Blood 
CO-Oximetry and Reference ECG 
Study ID# PR 2019-353 
 
1. Introduction 
Pulse oximetry monitoring is considered a standard physiological measurement and is used by clinicians in 
everyday situations to estimate arterial oxygen saturation. A pulse oximeter is a device that measures the oxygen 
saturation of arterial blood non-invasively. In general, pulse oximeters use two wavelength absorption 
spectrophotometry to measure oxygen saturation based on the amount of reflected or scattered radiation. The 
wavelengths are selected to provide the best separation of absorbencies of oxy-hemoglobin (O2Hb) and deoxy-
hemoglobin (HHb) states. The ratio of the two absorbencies is used to calculate the oxygen saturation (SpO2) 
value. Because an arterial sample of blood is not required to make the measurement, the pulse oximeter can 
provide non-invasive real time information. The clinical use of pulse oximeters has reduced the frequency and 
necessity of invasive arterial blood sampling and has helped to improve patient safety by providing information to 
clinicians about patients’ oxygenation status. 
 
The purpose of this study was to validate the SpO2 and pulse rate accuracy of the VitalDetect™ pulse oximetry 
during non-motion conditions over the range of 70-100% SaO2 as compared to arterial blood samples assessed by 
CO-Oximetry and Reference ECG respectively.  
 
The goal, was to provide supporting documentation for the SpO2 accuracy validation and performance for the 
VitalDetect™ pulse oximetry.  It was expected that the Accuracy Root Mean Square (ARMS) performance would 
meet the required specification of ARMS 3.0% or lower in non-motion conditions for the range of 70 – 100% SaO2 
thereby demonstrating an acceptable SpO2 accuracy performance specification. As a secondary goal, the pulse rate 
accuracy performance was reviewed for the range observed during the non-motion hypoxia study. The pulse rate 
accuracy was expected to meet an ARMS of 3 bpm as compared to Reference ECG Heart Rate. 
 
No risks or adverse device effects were expected. There were no contraindications for use in the study / study 
population. 
 
The study was conducted in accordance to the code of federal regulations for non-significant risk medical device 
studies and applicable ISO 14155 (2nd edition 2011-02-01), applicable sections of ISO 80601-2-61:2017, and Pulse 
Oximeters – Premarket Notifications Submissions [510(k)s] Guidance For Industry and Food and Drug 
Administration Staff (issued: March 4, 2013).  
 
2. Investigational Device and Methods 
2.1 Device Description:   
The VitalDetect™ is a non-invasive device designed for spot-checking physiological parameters, such as Non- 
Invasive Blood Pressure (NIBP), Oxygen Saturation (SpO2), Pulse Rate (PR), Body Temperature (TEMP) and 
Respiratory Rate (RR). This device is a finger-cuff technology which is applicable for use at-home use or in 
healthcare facilities in/on individuals 18 years of age and older. It may be used by the individual themselves, or an 
operator. The VitalDetect™ is not intended for continuous monitoring, or for use with high frequency surgical 
equipment. It is non transit-operable. 
 
This study focused on the pulse oximetry, SpO2 parameter. The Vital USA Vital Detect is composed of a sensor head 
mounted on a base connected to a phone or computer via VitalDetect™ App which is free to download. The pulse 
oximeter being used in this study collects data from the finger by transmittance of radiation at known 
wavelength(s) through tissue to measure blood oxygen saturation.    

CLINIMARK, LLC 
 
 
 
 
 
 
(303) 717-4820 
 
80 Health Park Drive Suite 20, Louisville, Colorado, 80027     USA 
www.clinimark.com 
 
 
 
Clinimark, LLC 
80 Health Park Drive, Suite 20 
Louisville, Colorado 80027, 
USA 
TITLE: Final Test Report For Vital USA 
Results of the SpO2 and Pulse Rate Accuracy Comparison of 
VitalDetect™ to Arterial Blood CO-Oximetry and Reference ECG 
Clinimark Study ID# PR 2019-353 
Principal Investigator: Arthur Ruiz Cabrera, MD     Site ID # 001 
DOCUMENT NUMBER 
TR# 2019-353 
Page   7   of   39 
REV 
1 
 
      
 
 
The device under test was connected to a mobile and/or PC application that collected data continuously during the 
hypoxia protocol. Collected data included: 
 
Measured Heart Rate 
 
Measured Ratio of Ratios and/or SpO2 value 
 
Raw data coming from the sensor including PPG signal stored for offline process 
The accompanying acquisition software was provided by Vital USA.  
 
Intended Use: 
The Vital Detect Pulse Oximeter is indicated for the noninvasive spot checking of: 
 
Blood Oxygen Saturation, Functional (%SpO2), 
 
Pulse Rate (PR), 
 
Respiratory rate (RR), 
 
Body temperature (TEMP) 
 
Pulse Rate or Heart rate (PR or HR) 
 
Non-Invasive Blood Pressure (NIBP) 
The VitalDetect™ pulse oximetry is the system that was studied in this investigation. 
 
 
 

CLINIMARK, LLC 
 
 
 
 
 
 
(303) 717-4820 
 
80 Health Park Drive Suite 20, Louisville, Colorado, 80027     USA 
www.clinimark.com 
 
 
 
Clinimark, LLC 
80 Health Park Drive, Suite 20 
Louisville, Colorado 80027, 
USA 
TITLE: Final Test Report For Vital USA 
Results of the SpO2 and Pulse Rate Accuracy Comparison of 
VitalDetect™ to Arterial Blood CO-Oximetry and Reference ECG 
Clinimark Study ID# PR 2019-353 
Principal Investigator: Arthur Ruiz Cabrera, MD     Site ID # 001 
DOCUMENT NUMBER 
TR# 2019-353 
Page   8   of   39 
REV 
1 
 
2.2 Gas Delivery & Monitoring System with data collection 
Desaturation Study Gas Delivery System 
The Clinimark proprietary Desaturation Fixture with Automated Data Collection is a single limb blow by system 
used to deliver medical grade oxygen and nitrogen gas mixtures to induce various hypoxic levels in subjects at 
a slow steady rate allowing an automatic marking and collection of the Control or secondary Transfer 
Reference Pulse Oximeter pulse oximetry system at 1 second intervals.  Description of Clinimark Desaturation 
Fixture with Automated Data Collection: 
 
Computer with desaturation gas control software and automated data collection system 
 
Sealink Mux box – 8 channel, communication cables 
 
Gas control fixture  
 
Medical grade oxygen and nitrogen cylinders  
 
 
Control Oximetry System 
The Control Pulse Oximeter, an FDA cleared device, is used to monitor the oxygen saturation levels real time 
throughout the study for subject safety and to target stable plateaus. This device is used to assess the stability 
of the data.  
 
GE Healthcare (Datex-Ohmeda) 3900 TruTrak+ / OxyTip+ Oxy-F-UN Sensor and Oxy-OL3 cable 
 
Covidien Nellcor N-600x with MaxFast Forehead sensor and DOC-10 cable, for additional stability monitor.  
 
Safety Equipment 
Multi-parameter monitor used during the study to observe a subject’s vital signs including ECG tracing, heart 
rate, respiratory rate, end-tidal CO2 with capnograph, secondary monitor for the oxygen concentration being 
delivered to the subject.  
 
GE Healthcare S5 Compact Monitor, M-NESTPR module with ECG 
 
Portable oxygen tank, mask and ambu bag 
 
Blood pressure cuff and stethoscope 
 
2.3 Reference Equipment 
Reference CO-Oximeters 
A whole blood analyzer (CO-Oximeter) is used as the reference standard device for obtaining the functional 
SaO2 value from arterial blood samples obtained during the study. 
 
Radiometer ABL 80 Flex OSM (ABL cal) and associated supplies ID#:313093, 317104 
 
2.4 Study Procedure / Clinical Investigative Plan (CIP) Summary: 
This study was a comparative, single-center, non-randomized study conducted to evaluate the SpO2 accuracy per 
standards and guidelines identified above for SpO2 accuracy for pulse oximetry equipment over the range of 70-
100% SaO2 under non-motion conditions. Arterial blood sampling measured by functional SaO2 CO-Oximetry, was 
used as the basis for comparison. As a secondary goal, the pulse rate accuracy was compared to ECG Heart Rate 
realized over the range throughout the hypoxia procedure. Testing was conducted under normal office 
environment conditions. 
 
Subjects were provided with an IRB approved Informed Consent form. For subject enrollment, the subject needed 
to understand the study, provide consent to participate by signing the Informed Consent Form and satisfactorily 
completing a health assessment form, meet the inclusion criteria and none of the exclusion criteria prior to 
starting the test.  
 
Inclusion Criteria 
 
10-15 Adults with a minimum of 3 males and a minimum of 3 females, with the balance made up of 
either 
 
Subject must have the ability to understand and provide written informed consent 

CLINIMARK, LLC 
 
 
 
 
 
 
(303) 717-4820 
 
80 Health Park Drive Suite 20, Louisville, Colorado, 80027     USA 
www.clinimark.com 
 
 
 
Clinimark, LLC 
80 Health Park Drive, Suite 20 
Louisville, Colorado 80027, 
USA 
TITLE: Final Test Report For Vital USA 
Results of the SpO2 and Pulse Rate Accuracy Comparison of 
VitalDetect™ to Arterial Blood CO-Oximetry and Reference ECG 
Clinimark Study ID# PR 2019-353 
Principal Investigator: Arthur Ruiz Cabrera, MD     Site ID # 001 
DOCUMENT NUMBER 
TR# 2019-353 
Page   9   of   39 
REV 
1 
 
 
Subject is 18 to 50 years of age 
 
Subject must be willing and able to comply with study procedures and duration 
 
Subject is a non-smoker or who has not smoked within 2 days prior to the study 
 
Exclusion Criteria 
 
Subject is considered as being morbidly obese (defined as BMI >39.5) 
 
Compromised circulation, injury, or physical malformation of fingers, wrist, hands, ears or 
forehead/skull or other sensor sites which would limit the ability to test sites needed for the study.  
(Note: Certain malformations may still allow subjects to participate if the condition is noted and 
would not affect the particular sites utilized.)  
 
Female subjects that are actively trying to get pregnant or are pregnant (confirmed by positive urine 
pregnancy test unless the subject is known to be not of child-bearing potential). 
 
Smoker Subjects who have refrained will be screened for COHb levels >3% as assessed with a Masimo 
Radical 7 (Rainbow)  
 
Subjects with known respiratory conditions such as: (self-reported) 
o 
uncontrolled / severe asthma,  
o 
flu,  
o 
pneumonia / bronchitis,  
o 
shortness of breath / respiratory distress,  
o 
unresolved respiratory or lung surgery with continued indications of health issues,  
o 
emphysema, COPD, lung disease 
 
Subjects with known heart or cardiovascular conditions such as: (self-reported, except for blood 
pressure and ECG review) 
o 
hypertension: systolic >140mmHg, Diastolic >90mmHg on 3 consecutive readings (reviewed 
during health screen). 
o 
have had cardiovascular surgery 
o 
Chest pain (angina) 
o 
heart rhythms other than a normal sinus rhythm or with respiratory sinus arrhythmia 
(reviewed during health screen)  
o 
previous heart attack 
o 
blocked artery 
o 
unexplained shortness of breath 
o 
congestive heart failure (CHF) 
o 
history of stroke 
o 
transient ischemic attack 
o 
carotid artery disease 
o 
myocardial ischemia 
o 
myocardial infarction 
o 
cardiomyopathy 
 
Self-reported health conditions as identified in the Health Assessment Form (self-reported) 
o 
diabetes,  
o 
uncontrolled thyroid disease,  
o 
kidney disease / chronic renal impairment,  
o 
history of seizures (except childhood febrile seizures),  
o 
epilepsy,  
o 
history of unexplained syncope,  
o 
recent history of frequent migraine headaches,  
o 
recent symptomatic head injury (within the last 2 months)   
o 
cancer / chemotherapy 
 
 Subjects with known clotting disorders (self-reported) 

CLINIMARK, LLC 
 
 
 
 
 
 
(303) 717-4820 
 
80 Health Park Drive Suite 20, Louisville, Colorado, 80027     USA 
www.clinimark.com 
 
 
 
Clinimark, LLC 
80 Health Park Drive, Suite 20 
Louisville, Colorado 80027, 
USA 
TITLE: Final Test Report For Vital USA 
Results of the SpO2 and Pulse Rate Accuracy Comparison of 
VitalDetect™ to Arterial Blood CO-Oximetry and Reference ECG 
Clinimark Study ID# PR 2019-353 
Principal Investigator: Arthur Ruiz Cabrera, MD     Site ID # 001 
DOCUMENT NUMBER 
TR# 2019-353 
Page   10   of   39 
REV 
1 
 
o 
history of bleeding disorders or personal history of prolonged bleeding from injury 
o 
history of blood clots 
o 
hemophilia 
o 
current use of blood thinner: prescription or daily use of aspirin 
 
Subjects with severe contact allergies to standard adhesives, latex or other materials found in pulse 
oximetry sensors, ECG electrodes, respiration monitor electrodes or other medical sensors (self-
reported) 
 
Subjects with severe allergies to iodine (only applicable if iodine is used)  
 
Subjects with severe allergies to lidocaine (or similar pharmacological agents, e.g. Novocain)  
 
Failure of the Perfusion Index Ulnar/Ulnar+Radial Ratio test (Ratio < 0.4)  
 
Unwillingness or inability to remove colored nail polish from test digits. 
 
Other known health condition, should be considered upon disclosure in health assessment form 
 
Subjects were instructed that they could terminate the test at any time. The principal investigator, clinician or gas 
controller could terminate the test based on such request or judgment of the well-being of the subject. 
 
Following completion of the initial screening, a vascular assessment was conducted prior to cannulation of the 
artery to verify the presence of adequate collateral blood flow to the hand. Precautions to minimize discomfort 
were taken by including a small injection of Lidocaine (a numbing medicine) under the skin at the insertion site. A 
radial arterial line was then placed. Radial arterial line placement involves introduction of a standard arterial 
catheter or angiocath into the radial artery.  Since the arterial catheter is placed into the artery using a needle, 
mild to moderate discomfort was expected.  Blood samples were drawn to a 3cc arterial blood sample syringe with 
dry lithium heparin. The total amount of blood drawn during the procedure was less than 150cc. 
 
Subjects were reclined for the study. The sensors were placed on the right wrist of each subject to evaluate the 
SpO2 accuracy performance. As a secondary goal, the Pulse Rate accuracy was evaluated over the range of oxygen 
saturation levels elicited during the study.  
 
Subjects were given medical grade mixtures of oxygen and nitrogen to induce stable plateaus across the range of 
100% to 70%. The goal was to have an equal distribution of data by decade. The stable plateaus allowed data 
collection in the following SaO2 ranges 95-100, 90-95, 85-90, 80-85, 75-80, 67-75. In general, 4 to 8 discrete points 
were collected at each of the levels such that the overall data of the population was evenly distributed by decade 
and the minimum number of points was met for the data analysis. Fewer data points were expected in subjects 
that were unable to tolerate the duration of the lower hypoxic levels. Data was collected under non-motion 
conditions. Arterial blood samples were drawn simultaneously to SpO2 data collection and measured immediately 
on the gold standard Reference CO-Oximeters. 
 
After the test, the clinician reviewed any final questions raised by the subject and the subject was released. Follow 
up was made to subjects post study for any questions regarding the study and status of the site where the arterial 
line was placed. There were no significant adverse events reported. 
 
The endpoint comparator for data collection was a minimum of 200 points evenly distributed across the full range 
of 70-100% SaO2 on at least ten subjects as well as to document the accuracy for the specified range of 70-100%. 
The Accuracy Root Mean Square (ARMS) calculation was used for statistical analysis comparison for the test device 
vs Reference CO-Oximetry, functional SaO2. The pulse rate accuracy was also documented over the range realized 
from the hypoxia changes across the range of 70-100% SaO2. 
 
Data analysis results provide documentation showing SpO2 and Pulse Rate accuracy performance of the 
VitalDetect™ pulse oximetry as compared to arterial blood samples measured by Reference CO-Oximetry and ECG 
heart rate respectively. 
 

CLINIMARK, LLC 
 
 
 
 
 
 
(303) 717-4820 
 
80 Health Park Drive Suite 20, Louisville, Colorado, 80027     USA 
www.clinimark.com 
 
 
 
Clinimark, LLC 
80 Health Park Drive, Suite 20 
Louisville, Colorado 80027, 
USA 
TITLE: Final Test Report For Vital USA 
Results of the SpO2 and Pulse Rate Accuracy Comparison of 
VitalDetect™ to Arterial Blood CO-Oximetry and Reference ECG 
Clinimark Study ID# PR 2019-353 
Principal Investigator: Arthur Ruiz Cabrera, MD     Site ID # 001 
DOCUMENT NUMBER 
TR# 2019-353 
Page   11   of   39 
REV 
1 
 
The passing criteria identified in the clinical investigation plan for oxygen saturation was an ARMS specification of 
3.0% or less under steady state / non-motion conditions for the range 70-100%. Data analysis results provide 
documentation showing SpO2 accuracy performance of the VitalDetect™ pulse oximetry as compared to arterial 
blood samples measured by Reference CO-Oximetry. 
 
The pulse rate accuracy was compared to ECG Heart Rate as recorded by the S5 Multi-parameter monitor. Passing 
criteria was an ARMS of 3 bpm or better based measurements observed during the pulse oximetry evaluation. 
 
3. Results 
Institutional Review Board (IRB) approval1 was obtained for validation testing. The study was conducted November 
4-5, 2019, in the Clinimark Laboratories located in Avista Adventist Hospital Plaza in Louisville, CO in accordance 
with the study procedure2. There were no deviations to the study procedure. Eleven subjects were screen with all 
being enrolled into the study. Following the study, one subject was identified as having poor sensor placement and 
as well as an incorrect time sync with the control oximeter. This subject was not included in the data analysis. Each 
subject was cannulated with an indwelling catheter in the left radial artery. The control oximeter3 was attached to 
the hand on the cannulated side to evaluate the stability of the SpO2 level during the data collection process. 
Testing was conducted under non-motion conditions. The device under test was VitalDetect™ pulse oximetry. 
 
Each subject was presented with various levels of induced hypoxia resulting in stable oxygen saturation levels 
between 100% and 70% SaO2. Arterial blood draws were collected under non-motion conditions. SpO2 and Pulse 
Rate values from the pulse oximeters as well as the Reference ECG Heart Rate values were collected electronically 
at one second intervals simultaneously to blood drawn from the indwelling catheter. Four to eight arterial blood 
samples were collected, approximately 20-40 seconds apart for each stable level. The blood was immediately 
analyzed by the Reference CO-Oximeter4 to measure the arterial oxygen saturation (Functional SaO2).  
 
All subjects completed the study without incidence. The stable data from each system for ten subjects was 
included for analysis. There were no serious adverse events or adverse device effects during the study. 
 
 
3.1 Subject Demographics 
 
Table 3: Summary of Subject Demographics Record 
 
Sex 
Male 
50% 
(5/10) 
Female 
50% 
(5/10) 
 
Race 
Black / African-American 
20% 
(2/10) 
Asian 
10% 
(1/10) 
White 
70% 
(7/10) 
 
Ethnicity 
Hispanic or Latino 
10% 
(1/10) 
Not Hispanic or Latino 
90% 
(9/10) 
                                                          
 
1 IRB approval: Salus Independent Review Board, Board 3 #IRB00009473, Approval 25 Oct 2019 
2 Clinical Investigation Test Plan for: “Vital USA SpO2 Accuracy Comparison to Arterial Blood CO-Oximetry“  
Clinimark Study ID# PR 2019-353, Version: Rev 1, Date: 15 Oct 2019 
3 Control Oximeter: Datex-Ohmeda 3900 TruTrak®+ Pulse Oximeter. TruTrak+ is a registered trademark of Datex-Ohmeda Inc., 
now GE Healthcare.  
4 Reference CO-Oximeter: ABL80 Flex OSM, Radiometer   

CLINIMARK, LLC 
 
 
 
 
 
 
(303) 717-4820 
 
80 Health Park Drive Suite 20, Louisville, Colorado, 80027     USA 
www.clinimark.com 
 
 
 
Clinimark, LLC 
80 Health Park Drive, Suite 20 
Louisville, Colorado 80027, 
USA 
TITLE: Final Test Report For Vital USA 
Results of the SpO2 and Pulse Rate Accuracy Comparison of 
VitalDetect™ to Arterial Blood CO-Oximetry and Reference ECG 
Clinimark Study ID# PR 2019-353 
Principal Investigator: Arthur Ruiz Cabrera, MD     Site ID # 001 
DOCUMENT NUMBER 
TR# 2019-353 
Page   12   of   39 
REV 
1 
 
 
Skin Tone 
Light 
40% 
(4/10) 
Medium Light 
20% 
(2/10) 
Medium 
10% 
(1/10) 
Dark 
30% 
(3/10) 
 
Age 
Mean +/-SD (N) 
25.9 +/- 5.8 
10 
Median 
26 
Range (min, max) 
(19, 38) 
  
 
Weight 
Mean +/-SD (N) 
161.0 +/- 41.4 
10 
Median 
155 
Range (min, max) 
(105, 228) 
  
 
 
 
 
Height 
Mean +/-SD (N) 
68.4 +/- 4.2 
10 
Median 
68.5 
Range (min, max) 
(63, 75) 
  
 
BMI 
Mean +/-SD (N) 
24.0 +/- 5.1 
10 
Median 
22.3 
Range (min, max) 
(18.0, 34.7) 
  
 
 
3.2 Equipment Record: 
 
Table 4: Equipment Record 
 
 
Comm. 
Unit/Rev. 
Unit S/N      
Sensor 
Sensor S/N 
Site 
Oxim 1 
Desat 
3900P TT+      
9.000/11.000 
FBZ200195 
Oxy-FUN 
Oxy-OL3 Cable 
31601 
ABS010804-18 
Lot #  36303 
 
Finger  
Oxim 2 
N395 
Nellcor N-600X          
V 1.6.0.0 
G08817962 
Nellcor MAX-Fast 
DOC-10 Cable 
ID #      Prod                   
Lot # 170410208H 
Forehead 
Oxim 3 
Safety 
Datex-Ohmeda S5 
Monitor 5014850   MNESTPR 
3645308  
M-CAiO 3611324 
3 lead ECG 
ECG 891402-1.0 
1997-01-09 
Chest 
Sponsor 
VitalDetectTM 
App: v1.0.14-34 
Main: V10.7.32-48 
Tablet: Digiland 
E010000012 
Built: 2018-12-19 
 
Tablet: 181020101900816 
NA 
Index 
Finger 
 
 
4. Data Analysis 
Excel was used as the data analysis tool. Data analysis follows ISO80601-2-61:2017, Annex EE and Pulse Oximeters 
– Premarket Notifications Submissions [510(k)s] Guidance For Industry and Food and Drug Administration Staff 
(issued: March 4, 2013). The reference guidance documents clearly define the study, number of subjects, data 

CLINIMARK, LLC 
 
 
 
 
 
 
(303) 717-4820 
 
80 Health Park Drive Suite 20, Louisville, Colorado, 80027     USA 
www.clinimark.com 
 
 
 
Clinimark, LLC 
80 Health Park Drive, Suite 20 
Louisville, Colorado 80027, 
USA 
TITLE: Final Test Report For Vital USA 
Results of the SpO2 and Pulse Rate Accuracy Comparison of 
VitalDetect™ to Arterial Blood CO-Oximetry and Reference ECG 
Clinimark Study ID# PR 2019-353 
Principal Investigator: Arthur Ruiz Cabrera, MD     Site ID # 001 
DOCUMENT NUMBER 
TR# 2019-353 
Page   13   of   39 
REV 
1 
 
points needed for the analysis and handling of missing data or data that is removed from the analysis. Complying 
with the standards was achieved through more than 200 paired observations of Test and Reference values equally 
distributed over the specified SpO2 accuracy range (70-100%) of the device under test. The data was collected on 
healthy adult volunteer subjects who range in age, gender and skin tone with at least two subjects having deep 
skin pigmentation tones. Controls for the study were maintained by using a control oximeter to assess the stability 
of the plateaus for data collection and a Reference Standard Pulse Oximetry value for oxygen saturation level of 
the subject during the study. An Accuracy Root Mean Square (ARMS) calculation was used to determine SpO2 
Accuracy as compared to “gold standard” measurements of blood SaO2 by Reference CO-Oximetry. Simultaneous 
to oxygen saturation measurements, pulse rate from the test device and the Reference ECG monitor were 
collected for comparison. 
 
4.1 Control Oximeter Stability handling: 
The data was analyzed in the following manner. The Control Oximeter SpO2 data was reviewed for Stability. The 
data points are considered unstable and removed prior to the analysis: 
- 
if the Control Oximeter SpO2 value varies by >2% during the draw 
- 
if the combined minimum and maximum deviations of the Control Oximeter SpO2 value are > 3%  during the 
review period of 20-30 sec prior to draw period through the draw as defined by ISO 80601-2-61:2017. 
 
4.2 Test SpO2 Data handling: 
Data recorded as 100% or higher was removed prior to the analysis. Data collected under poor perfusion 
conditions or invalid / zero readings were also removed prior to the analysis.  
 
4.3 CO-Oximeter Data handling: 
The third step in the process was to review the CO-Oximetry data for outliers or anomalous readings prior to 
pairing of the CO-Oximeter value with the test device SpO2 value. 
 
The CO-Oximeter data was reviewed for outliers or anomalous readings from which these plateaus were subject to 
removal. The functional oxygen saturation value was used for the basis of comparison to SpO2 value collected from 
the pulse oximeter. Subjects with elevated COHB (>3%), MetHb (>2%) and/or tHb (<10g/dl) levels were excluded 
from the data collection. The tHb, COHb, MetHb values were reviewed for consistency to the other draws for each 
subject. If those values were found to not be similar in readings for a given subject, then it is determined that the 
reference value was unstable and the point was to be removed from the analysis.  
 
Draws with CO-Oximeter data that were <67% were excluded from the analysis for the evaluation of the accuracy 
specification claim. Overall stable data 70-100% SaO2 is presented in the statistics for each graph. Summary 
statistics includes data for claims only.  
 
A rationale was provided for data that was excluded from the data analysis due to the Control Oximeter Stability, 
the Test Device and the Reference CO-Oximetry values. Please refer to the Line Listing below for the rational of 
excluded data. 
 
4.4 Description of Statistics 
The final step was to pair the remaining CO-Oximeter functional SO2 value with the Test device SpO2. 
Ref = Reference CO-Oximetry SO2 
DUT = Device Under test SpO2, pulse oximetry system. 
 
For Pulse Rate: 
Ref = Reference ECG Heart Rate 
DUT = Device Under test Pulse Rate, pulse oximetry system. 
 

CLINIMARK, LLC 
 
 
 
 
 
 
(303) 717-4820 
 
80 Health Park Drive Suite 20, Louisville, Colorado, 80027     USA 
www.clinimark.com 
 
 
 
Clinimark, LLC 
80 Health Park Drive, Suite 20 
Louisville, Colorado 80027, 
USA 
TITLE: Final Test Report For Vital USA 
Results of the SpO2 and Pulse Rate Accuracy Comparison of 
VitalDetect™ to Arterial Blood CO-Oximetry and Reference ECG 
Clinimark Study ID# PR 2019-353 
Principal Investigator: Arthur Ruiz Cabrera, MD     Site ID # 001 
DOCUMENT NUMBER 
TR# 2019-353 
Page   14   of   39 
REV 
1 
 
The data was plotted and analyzed through the following statistics, using the Reference CO-Oximetry SO2 or ECG 
Heart Rate value for the x value and the Device Under Test SpO2 or Pulse Rate value for the y value. 
 
The accuracy was evaluated for root-mean-square (rms) difference between the DUT and the reference for the 
overall range and by decade. 
 
n
i
i
Arms
n
i
f
DUT




1
2)
Re
(
 
 
The average difference was calculated to show the bias of the device under test as compared to the reference. The 
bias is calculated for the overall range and by decade. 
 
n
Bias
n
i
i
i
f
DUT
)
(
1
Re




 
 
A least squares line was generated for the overall range. 
The minimum and maximum deviations of the test device were calculated from the reference. 
 
Bland-Altman graphical plots, error (SpO2 – SaO2) versus average SaO2 +SpO2 were generated with linear regression 
fit, mean, and upper 95% and lower 95% limits of agreement according to Section 3 of “Agreement Between 
Methods Of Measurement With Multiple Observations Per Individual” by Bland and Altman in 2007 Journal of 
Biopharmaceutical Statistics. Individual test subjects were color coded in the Bland-Altman graphical plot. 
 
Error plots were generated showing the difference of SpO2 – SaO2 versus the Reference SaO2. 
 
Pass / Fail Criteria: 
The statistical results of the data were reviewed for the following pass/fail criteria. 
 
Over the clinical evaluation range 70 – 100% SaO2 
 
SpO2 ARMS ≤ 3.0% in non-motion conditions – Pass result 
Pulse Rate ARMS ≤ 3bpm in non-motion conditions – Pass result 
 
4.5 SpO2 Accuracy Results: 
 
Table 5: Comparison to Reference CO-Oximetry 
 
Comparison to Reference CO-Oximetry 
 
VitalDetectTM pulse oximetry 
*70—100 
90--100 
80--<90 
67--<80 
ARMS Spec 3.0% for range of 
70-100% 
# pts 
239 
75 
82 
82 
Fails to meet 
Bias 
-0.6 
-0.4 
0.7 
-2.0 
ARMS 
3.1 
1.5 
2.1 
4.6 
 
 
     
 * Note: The range of 70% to 100% includes reference data down to 67%  

CLINIMARK, LLC 
 
 
 
 
 
 
(303) 717-4820 
 
80 Health Park Drive Suite 20, Louisville, Colorado, 80027     USA 
www.clinimark.com 
 
 
 
Clinimark, LLC 
80 Health Park Drive, Suite 20 
Louisville, Colorado 80027, 
USA 
TITLE: Final Test Report For Vital USA 
Results of the SpO2 and Pulse Rate Accuracy Comparison of 
VitalDetect™ to Arterial Blood CO-Oximetry and Reference ECG 
Clinimark Study ID# PR 2019-353 
Principal Investigator: Arthur Ruiz Cabrera, MD     Site ID # 001 
DOCUMENT NUMBER 
TR# 2019-353 
Page   15   of   39 
REV 
1 
 
 
Table 6: Comparison to Reference ECG Heart Rate 
 
Comparison to Reference ECG Heart Rate 
 
VitalDetectTM pulse oximetry 
50-119 
bpm 
ARMS Spec 3 bpm for range of 
70-100% SaO2 
# pts 
239 
Pass 
Bias 
0.6 
ARMS 
2.7 
 
 
 
5. Graphs – List of Graphs 
 
5.1 VitalDetectTM pulse oximetry vs Reference CO-Oximetry 
 
5.2 Bland-Altman Plot: VitalDetectTM  pulse oximetry 
 
5.3 Error Plot: VitalDetectTM  pulse oximetry 
 
5.4 Individual Subject 1 Error Plots 
 
5.5 Individual Subject 2 Error Plots 
 
5.6 Individual Subject 4 Error Plots 
 
5.7 Individual Subject 5 Error Plots 
 
5.8 Individual Subject 6 Error Plots 
 
5.9 Individual Subject 7 Error Plots 
 
5.10 Individual Subject 8 Error Plots 
 
5.11 Individual Subject 9 Error Plots 
 
5.12 Individual Subject 10 Error Plots 
 
5.13 Individual Subject 11 Error Plots 
 
5.14 VitalDetectTM Pulse Rate vs Reference ECG Heart Rate 
 
 
 

CLINIMARK, LLC 
 
 
 
 
 
 
(303) 717-4820 
 
80 Health Park Drive Suite 20, Louisville, Colorado, 80027     USA 
www.clinimark.com 
 
 
 
Clinimark, LLC 
80 Health Park Drive, Suite 20 
Louisville, Colorado 80027, 
USA 
TITLE: Final Test Report For Vital USA 
Results of the SpO2 and Pulse Rate Accuracy Comparison of 
VitalDetect™ to Arterial Blood CO-Oximetry and Reference ECG 
Clinimark Study ID# PR 2019-353 
Principal Investigator: Arthur Ruiz Cabrera, MD     Site ID # 001 
DOCUMENT NUMBER 
TR# 2019-353 
Page   16   of   39 
REV 
1 
 
5.1 VitalDetectTM pulse oximetry vs Reference CO-Oximetry 
 
 
 
 
Vital SpO2 vs. CO-Ox ABL  
69--100 
70--100 
90--100 
80--<90 
70--<80 
60--<70 
# pts 
239 
233 
75 
82 
79 
3 
Bias 
-0.6 
-0.5 
-0.4 
0.7 
-1.9 
-3.3 
ARMS 
3.1 
3.1 
1.5 
2.1 
4.6 
3.5 
SDadc 
3.0 
Min diff 
-11.7 
Max diff 
9.0 
LR Slope 
Y = 1.066 X – 6.130 
SEE 
3.0 
 
 
 
 
CC 
0.95 
Upper 95% 
0.9 
Lower 95% 
-0.2 
 
Discussion by subject for noticeable outliers with offsets >5%: 
There were twenty-eight points or 12% of the data, that were considered as outliers, reading >5% from the 
Reference CO-Oximeter reading. Subject #1 (9 pts), Subject #2 (2 pts), Subject #4 (1 pt), Subject #8 (8 pts), Subject 
#10 (8 pts). All points with a reading >5% from the Reference occurred below 80%. Of the outlying points, only 
errors for Subject #10 were in the positive direction. Additionally, the data appeared to have a hard lower limit of 
65% in the readings. It is expected that greater scatter will occur in the lower oxygen saturation range. The amount 
of errors observed resulted in a poorer ARMS performance.  
60
65
70
75
80
85
90
95
100
60
65
70
75
80
85
90
95
100
Vital SpO2 (SpO2) 
Average Reference CO-Oximeter (Functional SaO2) 
Vital Detect SpO2 vs Reference CO-Oximetry 
Non-motion, 10 Subjects, November 4-5, 2019 

CLINIMARK, LLC 
 
 
 
 
 
 
(303) 717-4820 
 
80 Health Park Drive Suite 20, Louisville, Colorado, 80027     USA 
www.clinimark.com 
 
 
 
Clinimark, LLC 
80 Health Park Drive, Suite 20 
Louisville, Colorado 80027, 
USA 
TITLE: Final Test Report For Vital USA 
Results of the SpO2 and Pulse Rate Accuracy Comparison of 
VitalDetect™ to Arterial Blood CO-Oximetry and Reference ECG 
Clinimark Study ID# PR 2019-353 
Principal Investigator: Arthur Ruiz Cabrera, MD     Site ID # 001 
DOCUMENT NUMBER 
TR# 2019-353 
Page   17   of   39 
REV 
1 
 
5.2 Bland-Altman Plot: VitalDetectTM pulse oximetry 
 
 
 
 
 
Reference: Bland-Altman Range 
70-100% 
Linear Regression (Bland Altman) 
y = -10.1356 + 0.11400 x 
Mean Bias 
-0.56 
# pts 
239 
Bland-Altman Results for Multiple Observations Per Individual 
Between-Subject Variance (σµ
2) 
4.64 
Within-Subject Variance (σ2) 
4.90 
Upper 95% Limits of Agreement 
5.50 
Lower 95% Limits of Agreement 
-6.61 
 
 
 
-10
-8
-6
-4
-2
0
2
4
6
8
10
65
70
75
80
85
90
95
100
Vital SpO2 - Ref CO-Oximeter  
(SpO2 - SaO2) 
Reference CO-Oximeter & Vital SpO2 (SaO2+ SpO2 )/2 
Bland-Altman Plot: Vital SpO2 vs Ref CO-Ox ABL 
Non-motion, 10 Subjects, November 4-5, 2019 
1
2
4
5
6
7
8
9
10
11
Upper LOA
Lower LOA
Mean
Regression Line

CLINIMARK, LLC 
 
 
 
 
 
 
(303) 717-4820 
 
80 Health Park Drive Suite 20, Louisville, Colorado, 80027     USA 
www.clinimark.com 
 
 
 
Clinimark, LLC 
80 Health Park Drive, Suite 20 
Louisville, Colorado 80027, 
USA 
TITLE: Final Test Report For Vital USA 
Results of the SpO2 and Pulse Rate Accuracy Comparison of 
VitalDetect™ to Arterial Blood CO-Oximetry and Reference ECG 
Clinimark Study ID# PR 2019-353 
Principal Investigator: Arthur Ruiz Cabrera, MD     Site ID # 001 
DOCUMENT NUMBER 
TR# 2019-353 
Page   18   of   39 
REV 
1 
 
 
5.3 Error Plot: VitalDetectTM pulse oximetry  
 
 
 
 
 
Reference: Reference CO-Oximetry 
70-100% 
Linear Regression (Error Plot) 
y = -6.1295 + 0.06611 x 
Mean Bias (o) 
-0.56 
# pts 
239 
 
 
 
 
-10
-8
-6
-4
-2
0
2
4
6
8
10
65
70
75
80
85
90
95
100
Vital SpO2 - Ref CO-Oximeter  
(SpO2 - SaO2) 
Reference CO-Oximeter (SaO2) 
Error Plot: Vital SpO2 vs Ref CO-Ox ABL 
Non-motion, 10 Subjects, November 4-5, 2019 
1
2
4
5
6
7
8
9
10
11
Mean
Regression Line

CLINIMARK, LLC 
 
 
 
 
 
 
(303) 717-4820 
 
80 Health Park Drive Suite 20, Louisville, Colorado, 80027     USA 
www.clinimark.com 
 
 
 
Clinimark, LLC 
80 Health Park Drive, Suite 20 
Louisville, Colorado 80027, 
USA 
TITLE: Final Test Report For Vital USA 
Results of the SpO2 and Pulse Rate Accuracy Comparison of 
VitalDetect™ to Arterial Blood CO-Oximetry and Reference ECG 
Clinimark Study ID# PR 2019-353 
Principal Investigator: Arthur Ruiz Cabrera, MD     Site ID # 001 
DOCUMENT NUMBER 
TR# 2019-353 
Page   19   of   39 
REV 
1 
 
 
5.4 Individual Subject 1 Error Plots 
 
Subject 
ID# 
Gender 
Age 
(yrs) 
Weight 
(lbs) 
Height 
(in) 
BMI 
Skin Tone 
Race 
Ethnicity 
1 
F 
20 
125 
66 
20.2 
Med Light 
White 
Non-Hispanic 
 
   
   
Mean Bias 
-4.5 
# pts 
23 
Linear Regression 
y = -25.2186 + 0.24046 x 
Data points with abs(error) > 3 
11 
82.1 
-3.8 
82.9 
-4.2 
81.9 
-4.6 
79.8 
-5.6 
77.3 
-5.9 
78.1 
-7.0 
78.9 
-7.9 
77.0 
-6.5 
76.6 
-9.0 
77.0 
-11.7 
75.6 
-6.6 
 
 
 
-12
-8
-4
0
4
8
12
65
70
75
80
85
90
95 100
Vital SpO2 - Ref CO-Oximeter  
(SpO2 - SaO2) 
Reference CO-Oximeter (SaO2) 
Error Plot: Vital SpO2 vs Ref CO-Ox ABL 
Subject 1 
1
Upper LOA
Lower LOA
Regression
Line

CLINIMARK, LLC 
 
 
 
 
 
 
(303) 717-4820 
 
80 Health Park Drive Suite 20, Louisville, Colorado, 80027     USA 
www.clinimark.com 
 
 
 
Clinimark, LLC 
80 Health Park Drive, Suite 20 
Louisville, Colorado 80027, 
USA 
TITLE: Final Test Report For Vital USA 
Results of the SpO2 and Pulse Rate Accuracy Comparison of 
VitalDetect™ to Arterial Blood CO-Oximetry and Reference ECG 
Clinimark Study ID# PR 2019-353 
Principal Investigator: Arthur Ruiz Cabrera, MD     Site ID # 001 
DOCUMENT NUMBER 
TR# 2019-353 
Page   20   of   39 
REV 
1 
 
 
5.5 Individual Subject 2 Error Plots 
 
Subject 
ID# 
Gender 
Age 
(yrs) 
Weight 
(lbs) 
Height 
(in) 
BMI 
Skin Tone 
Race 
Ethnicity 
2 
M 
27 
207 
70 
29.7 
Dark 
Asian 
Non-Hispanic 
 
    
 
Mean Bias 
-1.3 
# pts 
24 
Linear Regression 
y = -13.7607 + 0.15060 x 
Data points with abs(error) > 3 
6 
74.2 
-4.0 
74.4 
-4.2 
73.5 
-3.2 
71.9 
-3.2 
70.7 
-5.6 
70.9 
-5.9 
 
 
 
  
 
 
-10
-8
-6
-4
-2
0
2
4
6
8
10
65
70
75
80
85
90
95 100
Vital SpO2 - Ref CO-Oximeter  
(SpO2 - SaO2) 
Reference CO-Oximeter (SaO2) 
Error Plot: Vital SpO2 vs Ref CO-Ox ABL 
Subject 2 
2
Upper LOA
Lower LOA
Regression Line

CLINIMARK, LLC 
 
 
 
 
 
 
(303) 717-4820 
 
80 Health Park Drive Suite 20, Louisville, Colorado, 80027     USA 
www.clinimark.com 
 
 
 
Clinimark, LLC 
80 Health Park Drive, Suite 20 
Louisville, Colorado 80027, 
USA 
TITLE: Final Test Report For Vital USA 
Results of the SpO2 and Pulse Rate Accuracy Comparison of 
VitalDetect™ to Arterial Blood CO-Oximetry and Reference ECG 
Clinimark Study ID# PR 2019-353 
Principal Investigator: Arthur Ruiz Cabrera, MD     Site ID # 001 
DOCUMENT NUMBER 
TR# 2019-353 
Page   21   of   39 
REV 
1 
 
5.6 Individual Subject 4 Error Plots 
 
Subject 
ID# 
Gender 
Age 
(yrs) 
Weight 
(lbs) 
Height 
(in) 
BMI 
Skin Tone 
Race 
Ethnicity 
4 
F 
25 
105 
64 
18.0 
Light 
White 
Non-Hispanic 
 
    
 
Mean Bias 
0.19 
# pts 
24 
Linear Regression 
y = -11.4844 + 0.13933 x 
Data points with abs(error) > 3 
6 
85.5 
3.2 
80.1 
4.2 
73.5 
-3.7 
72.8 
-3.5 
74.9 
-5.2 
76.7 
-4.1 
         
 
 
 
 
-10
-8
-6
-4
-2
0
2
4
6
8
10
65 70 75 80 85 90 95 100
Vital SpO2 - Ref CO-Oximeter  
(SpO2 - SaO2) 
Reference CO-Oximeter (SaO2) 
Error Plot: Vital SpO2 vs Ref CO-Ox ABL 
Subject 4 
4
Upper LOA
Lower LOA
Regression
Line

CLINIMARK, LLC 
 
 
 
 
 
 
(303) 717-4820 
 
80 Health Park Drive Suite 20, Louisville, Colorado, 80027     USA 
www.clinimark.com 
 
 
 
Clinimark, LLC 
80 Health Park Drive, Suite 20 
Louisville, Colorado 80027, 
USA 
TITLE: Final Test Report For Vital USA 
Results of the SpO2 and Pulse Rate Accuracy Comparison of 
VitalDetect™ to Arterial Blood CO-Oximetry and Reference ECG 
Clinimark Study ID# PR 2019-353 
Principal Investigator: Arthur Ruiz Cabrera, MD     Site ID # 001 
DOCUMENT NUMBER 
TR# 2019-353 
Page   22   of   39 
REV 
1 
 
5.7 Individual Subject 5 Error Plots 
 
Subject 
ID# 
Gender 
Age 
(yrs) 
Weight 
(lbs) 
Height 
(in) 
BMI 
Skin Tone 
Race 
Ethnicity 
5 
M 
32 
150 
69 
22.1 
Light 
White 
Non-Hispanic 
 
 
     
 
Mean Bias 
-1.76 
# pts 
24 
Linear Regression 
y = -3.7164 + 0.02334 x 
Data points with abs(error) > 3 
2 
74.1 
-4.5 
72.1 
-3.1 
 
 
 
-10
-8
-6
-4
-2
0
2
4
6
8
10
65 70 75 80 85 90 95 100
Vital SpO2 - Ref CO-Oximeter  
(SpO2 - SaO2) 
Reference CO-Oximeter (SaO2) 
Error Plot: Vital SpO2 vs Ref CO-Ox ABL 
Subject 5 
5
Upper LOA
Lower LOA
Regression
Line

CLINIMARK, LLC 
 
 
 
 
 
 
(303) 717-4820 
 
80 Health Park Drive Suite 20, Louisville, Colorado, 80027     USA 
www.clinimark.com 
 
 
 
Clinimark, LLC 
80 Health Park Drive, Suite 20 
Louisville, Colorado 80027, 
USA 
TITLE: Final Test Report For Vital USA 
Results of the SpO2 and Pulse Rate Accuracy Comparison of 
VitalDetect™ to Arterial Blood CO-Oximetry and Reference ECG 
Clinimark Study ID# PR 2019-353 
Principal Investigator: Arthur Ruiz Cabrera, MD     Site ID # 001 
DOCUMENT NUMBER 
TR# 2019-353 
Page   23   of   39 
REV 
1 
 
5.8 Individual Subject 6 Error Plots 
 
Subject 
ID# 
Gender 
Age 
(yrs) 
Weight 
(lbs) 
Height 
(in) 
BMI 
Skin Tone 
Race 
Ethnicity 
6 
F 
27 
228 
68 
34.7 
Dark 
Black / African-
American 
Non-Hispanic 
 
 
   
 
 
Mean Bias 
1.24 
# pts 
24 
Linear Regression 
y = 7.0782 + -0.06914 x 
Data points with abs(error) > 3 
1 
80.9 
3.2 
 
 
 
 
 
-10
-8
-6
-4
-2
0
2
4
6
8
10
65 70 75 80 85 90 95100
Vital SpO2 - Ref CO-Oximeter  
(SpO2 - SaO2) 
Reference CO-Oximeter (SaO2) 
Error Plot: Vital SpO2 vs Ref CO-Ox ABL 
Subject 6 
6
Upper LOA
Lower LOA
Regression
Line

CLINIMARK, LLC 
 
 
 
 
 
 
(303) 717-4820 
 
80 Health Park Drive Suite 20, Louisville, Colorado, 80027     USA 
www.clinimark.com 
 
 
 
Clinimark, LLC 
80 Health Park Drive, Suite 20 
Louisville, Colorado 80027, 
USA 
TITLE: Final Test Report For Vital USA 
Results of the SpO2 and Pulse Rate Accuracy Comparison of 
VitalDetect™ to Arterial Blood CO-Oximetry and Reference ECG 
Clinimark Study ID# PR 2019-353 
Principal Investigator: Arthur Ruiz Cabrera, MD     Site ID # 001 
DOCUMENT NUMBER 
TR# 2019-353 
Page   24   of   39 
REV 
1 
 
5.9 Individual Subject 7 Error Plots 
 
Subject 
ID# 
Gender 
Age 
(yrs) 
Weight 
(lbs) 
Height 
(in) 
BMI 
Skin Tone 
Race 
Ethnicity 
7 
M 
27 
200 
75 
25.0 
Light 
White 
Non-Hispanic 
 
 
 
   
 
 
Mean Bias 
-1.03 
# pts 
24 
Linear Regression 
y = -3.3709 + 0.02789 x 
Data points with abs(error) > 3 
2 
69.2 
-4.2 
68.9 
-3.9 
 
 
 
 
 
-10
-8
-6
-4
-2
0
2
4
6
8
10
65 70 75 80 85 90 95 100
Vital SpO2 - Ref CO-Oximeter  
(SpO2 - SaO2) 
Reference CO-Oximeter (SaO2) 
Error Plot: Vital SpO2 vs Ref CO-Ox ABL 
Subject 7 
7
Upper LOA
Lower LOA
Regression
Line

CLINIMARK, LLC 
 
 
 
 
 
 
(303) 717-4820 
 
80 Health Park Drive Suite 20, Louisville, Colorado, 80027     USA 
www.clinimark.com 
 
 
 
Clinimark, LLC 
80 Health Park Drive, Suite 20 
Louisville, Colorado 80027, 
USA 
TITLE: Final Test Report For Vital USA 
Results of the SpO2 and Pulse Rate Accuracy Comparison of 
VitalDetect™ to Arterial Blood CO-Oximetry and Reference ECG 
Clinimark Study ID# PR 2019-353 
Principal Investigator: Arthur Ruiz Cabrera, MD     Site ID # 001 
DOCUMENT NUMBER 
TR# 2019-353 
Page   25   of   39 
REV 
1 
 
5.10 Individual Subject 8 Error Plots 
 
Subject 
ID# 
Gender 
Age 
(yrs) 
Weight 
(lbs) 
Height 
(in) 
BMI 
Skin Tone 
Race 
Ethnicity 
8 
F 
38 
120 
63 
21.3 
Medium 
White 
Hispanic 
 
    
 
Mean Bias 
-1.55 
# pts 
24 
Linear Regression 
y = -30.1614 + 0.34422 x 
Data points with abs(error) > 3 
9 
82.8 
3.3 
72.7 
-7.7 
71.4 
-6.3 
72.1 
-7.1 
70.4 
-5.4 
71.4 
-6.3 
71.4 
-6.3 
74.6 
-9.6 
73.3 
-8.2 
 
 
 
 
 
-10
-8
-6
-4
-2
0
2
4
6
8
10
65
70
75
80
85
90
95 100
Vital SpO2 - Ref CO-Oximeter  
(SpO2 - SaO2) 
Reference CO-Oximeter (SaO2) 
Error Plot: Vital SpO2 vs Ref CO-Ox ABL 
Subject 8 
8
Upper LOA
Lower LOA
Regression
Line

CLINIMARK, LLC 
 
 
 
 
 
 
(303) 717-4820 
 
80 Health Park Drive Suite 20, Louisville, Colorado, 80027     USA 
www.clinimark.com 
 
 
 
Clinimark, LLC 
80 Health Park Drive, Suite 20 
Louisville, Colorado 80027, 
USA 
TITLE: Final Test Report For Vital USA 
Results of the SpO2 and Pulse Rate Accuracy Comparison of 
VitalDetect™ to Arterial Blood CO-Oximetry and Reference ECG 
Clinimark Study ID# PR 2019-353 
Principal Investigator: Arthur Ruiz Cabrera, MD     Site ID # 001 
DOCUMENT NUMBER 
TR# 2019-353 
Page   26   of   39 
REV 
1 
 
5.11 Individual Subject 9 Error Plots 
 
Subject 
ID# 
Gender 
Age 
(yrs) 
Weight 
(lbs) 
Height 
(in) 
BMI 
Skin Tone 
Race 
Ethnicity 
9 
F 
21 
135 
65 
22.5 
Med Light 
White 
Non-Hispanic 
 
   
 
Mean Bias 
-0.40 
# pts 
24 
Linear Regression 
y = -8.4837 + 0.09565 x 
Data points with abs(error) > 3 
1 
76.4 
-3.1 
 
 
 
-10
-8
-6
-4
-2
0
2
4
6
8
10
65
70
75
80
85
90
95 100
Vital SpO2 - Ref CO-Oximeter  
(SpO2 - SaO2) 
Reference CO-Oximeter (SaO2) 
Error Plot: Vital SpO2 vs Ref CO-Ox ABL 
Subject 9 
9
Upper LOA
Lower LOA
Regression
Line

CLINIMARK, LLC 
 
 
 
 
 
 
(303) 717-4820 
 
80 Health Park Drive Suite 20, Louisville, Colorado, 80027     USA 
www.clinimark.com 
 
 
 
Clinimark, LLC 
80 Health Park Drive, Suite 20 
Louisville, Colorado 80027, 
USA 
TITLE: Final Test Report For Vital USA 
Results of the SpO2 and Pulse Rate Accuracy Comparison of 
VitalDetect™ to Arterial Blood CO-Oximetry and Reference ECG 
Clinimark Study ID# PR 2019-353 
Principal Investigator: Arthur Ruiz Cabrera, MD     Site ID # 001 
DOCUMENT NUMBER 
TR# 2019-353 
Page   27   of   39 
REV 
1 
 
5.12 Individual Subject 10 Error Plots 
 
Subject 
ID# 
Gender 
Age 
(yrs) 
Weight 
(lbs) 
Height 
(in) 
BMI 
Skin Tone 
Race 
Ethnicity 
10 
M 
19 
160 
75 
20.0 
Dark 
Black / African-
American 
Non-Hispanic 
 
   
 
Mean Bias 
4.076466 
# pts 
24 
Linear Regression 
y = 30.8014 + -0.31596 x 
Data points with abs(error) > 3 
15 
86.7 
4.4 
87.0 
3.1 
86.4 
4.2 
81.5 
4.6 
81.4 
4.8 
82.4 
5.0 
82.2 
4.0 
76.4 
6.7 
76.9 
6.8 
75.9 
5.8 
75.8 
7.5 
74.8 
7.8 
73.7 
7.3 
73.4 
6.3 
72.6 
9.0 
-10
-8
-6
-4
-2
0
2
4
6
8
10
65
70
75
80
85
90
95
100
Vital SpO2 - Ref CO-Oximeter  
(SpO2 - SaO2) 
Reference CO-Oximeter (SaO2) 
Error Plot: Vital SpO2 vs Ref CO-Ox ABL 
Subject 10 
10
Upper LOA
Lower LOA
Regression
Line

CLINIMARK, LLC 
 
 
 
 
 
 
(303) 717-4820 
 
80 Health Park Drive Suite 20, Louisville, Colorado, 80027     USA 
www.clinimark.com 
 
 
 
Clinimark, LLC 
80 Health Park Drive, Suite 20 
Louisville, Colorado 80027, 
USA 
TITLE: Final Test Report For Vital USA 
Results of the SpO2 and Pulse Rate Accuracy Comparison of 
VitalDetect™ to Arterial Blood CO-Oximetry and Reference ECG 
Clinimark Study ID# PR 2019-353 
Principal Investigator: Arthur Ruiz Cabrera, MD     Site ID # 001 
DOCUMENT NUMBER 
TR# 2019-353 
Page   28   of   39 
REV 
1 
 
 
5.13 Individual Subject 11 Error Plots 
 
Subject 
ID# 
Gender 
Age 
(yrs) 
Weight 
(lbs) 
Height 
(in) 
BMI 
Skin Tone 
Race 
Ethnicity 
11 
M 
23 
180 
69 
26.6 
Light 
White 
Non-Hispanic 
 
    
 
 
Mean Bias 
-0.71 
# pts 
24 
Linear Regression 
y = -4.8837 + 0.04856 x 
Data points with abs(error) > 3 
2 
75.1 
-4.4 
75.2 
-3.1 
 
 
 
 
-10
-8
-6
-4
-2
0
2
4
6
8
10
65
70
75
80
85
90
95 100
Vital SpO2 - Ref CO-Oximeter  
(SpO2 - SaO2) 
Reference CO-Oximeter (SaO2) 
Error Plot: Vital SpO2 vs Ref CO-Ox ABL 
Subject 11 
11
Upper LOA
Lower LOA
Regression
Line

CLINIMARK, LLC 
 
 
 
 
 
 
(303) 717-4820 
 
80 Health Park Drive Suite 20, Louisville, Colorado, 80027     USA 
www.clinimark.com 
 
 
 
Clinimark, LLC 
80 Health Park Drive, Suite 20 
Louisville, Colorado 80027, 
USA 
TITLE: Final Test Report For Vital USA 
Results of the SpO2 and Pulse Rate Accuracy Comparison of 
VitalDetect™ to Arterial Blood CO-Oximetry and Reference ECG 
Clinimark Study ID# PR 2019-353 
Principal Investigator: Arthur Ruiz Cabrera, MD     Site ID # 001 
DOCUMENT NUMBER 
TR# 2019-353 
Page   29   of   39 
REV 
1 
 
5.14 VitalDetectTM Pulse Rate vs Reference ECG Heart Rate 
 
 
 
Vital PR vs. ECG 
50-119 
# pts 
239 
Bias 
0.6 
ARMS 
2.7 
SDadc 
2.6 
Range of diff 
-13.2  to 11.9 
LR Slope 
Y = 1.006x + 0.165 
SEE 
2.7 
CC 
0.98 
Upper 95% 
0.98 
Lower 95% 
-0.3 
 
 
40
50
60
70
80
90
100
110
120
130
40
50
60
70
80
90
100
110
120
130
Vital PR (bpm) 
Average Reference ECG Heart Rate (bpm) 
Vital Detect Pulse Rate vs Reference ECG  
Non-motion, 10 Subjects, November 4-5, 2019 

CLINIMARK, LLC 
 
 
 
 
 
 
(303) 717-4820 
 
80 Health Park Drive Suite 20, Louisville, Colorado, 80027     USA 
www.clinimark.com 
 
 
 
Clinimark, LLC 
80 Health Park Drive, Suite 20 
Louisville, Colorado 80027, 
USA 
TITLE: Final Test Report For Vital USA 
Results of the SpO2 and Pulse Rate Accuracy Comparison of 
VitalDetect™ to Arterial Blood CO-Oximetry and Reference ECG 
Clinimark Study ID# PR 2019-353 
Principal Investigator: Arthur Ruiz Cabrera, MD     Site ID # 001 
DOCUMENT NUMBER 
TR# 2019-353 
Page   30   of   39 
REV 
1 
 
6. Conclusions 
The Accuracy root mean square (ARMS) between measured SpO2 and reference SaO2 did not meet a 3.0% 
specification for the VitalDetect pulse oximetry.  The results for SpO2 accuracy as indicated below is an ARMS of 3.1. 
ARMS is based on statistically distributed measurements, therefore, a sensor/oximeter with an ARMS specification of 
3, is expected to have approximately 68% of the data points fall within that range. This in turn means that 
approximately one-third of the measurements fall outside the range of ± 3 of the reference SaO2.   
 
The SpO2 and Pulse Rate accuracy performance results showed the following ARMS values for the SaO2 range of 70-
100%.  
 
Table 7: Summary of SpO2 Accuracy Results 
Comparison to Reference CO-Oximetry 
 (functional SaO2) 
ARMS SpO2 70-100% 
ARMS Spec 3.0% for a 
range of 70-100% 
VitalDetectTM  pulse oximetry 
3.1 (239 pts) 
Fails to meet 
 
Table 8: Summary of Pulse Rate Accuracy Results 
Comparison to Reference ECG Heart Rate 
  
Pulse Rate ARMS  
For Heart Rate  
range 50-118 bpm 
ARMS Spec 3 bpm for 
the range collected 
during SpO2 of 70-
100% 
VitalDetectTM  Pulse Rate 
2.7 (239 pts) 
Pass 
 
 
Note: The range of 70% to 100% includes reference data down to 67%. 
 
The results of the study provide evidence that the VitalDetectTM pulse oximetry fails to meet an ARMS specification 
of 3.0% under steady state / non-motion conditions for the range 70-100%. It is recommended that the sponsor 
review and determine a means to improve accuracy performance especially for SpO2 levels <80%. 
 
Reviewing the pulse rate accuracy, VitalDetectTM pulse oximetry provides accurate pulse rate values for the range 
of 50-119 bpm, observed during simultaneous data collection of oxygen saturation levels between 70-100%.  
 
7. Abbreviated Terms And Definitions 
 
ARMS - Accuracy Root Mean Square 
 
n
i
i
Arms
n
i
f
DUT




1
2)
Re
(
 
 
 
Where: 
ARMS is the accuracy root mean square. 
DUT is the test pulse oximetry readings during sample i. 
Ref is the Reference CO-Oximetry functional oxygen saturation SO2 reading during sample i. 
n is the number of points. 
 
Bias – The mean difference between the Device Under Test and the Reference CO-Oximetry oxygen saturation 
readings. 

CLINIMARK, LLC 
 
 
 
 
 
 
(303) 717-4820 
 
80 Health Park Drive Suite 20, Louisville, Colorado, 80027     USA 
www.clinimark.com 
 
 
 
Clinimark, LLC 
80 Health Park Drive, Suite 20 
Louisville, Colorado 80027, 
USA 
TITLE: Final Test Report For Vital USA 
Results of the SpO2 and Pulse Rate Accuracy Comparison of 
VitalDetect™ to Arterial Blood CO-Oximetry and Reference ECG 
Clinimark Study ID# PR 2019-353 
Principal Investigator: Arthur Ruiz Cabrera, MD     Site ID # 001 
DOCUMENT NUMBER 
TR# 2019-353 
Page   31   of   39 
REV 
1 
 
 
n
Bias
n
i
i
i
f
DUT
)
(
1
Re




 
BMI – Body Mass Index 
 
COHb – Carboxyhemoglobin 
 
CIP - Clinical Investigative Plan 
 
ECG – Electrocardiogram. Electrical rhythm of the heart 
 
EtCO2 – End tidal CO2 – as measured by respiration on exhalation 
 
FDA – Food and Drug Administration 
 
HHb – reduced hemoglobin or deoxyhemoglobin 
 
HR – Heart Rate as measured by electrical activity from and electrocardiogram. 
 
IRB - Institutional Review Board 
 
ISO – the International Organization for Standardization 
 
MetHb – Methhemoglobin 
 
NSR – Non-Significant Risk 
 
OEM – Original Equipment Manufacturer 
 
O2Hb – oxygenated hemoglobin 
 
PI – Perfusion Index – strength of signal 
 
PR – Pulse Rate as measured by photoplethysmography from a pulse oximeter 
 
SaO2 – arterial oxygen saturation  
 
SO2 – arterial oxygen function saturation as measured by a CO-Oximeter 
 
SpO2 – oxygen saturation as measured by a pulse oximeter 
 
 
 

CLINIMARK, LLC 
 
 
 
 
 
 
(303) 717-4820 
 
80 Health Park Drive Suite 20, Louisville, Colorado, 80027     USA 
www.clinimark.com 
 
 
 
Clinimark, LLC 
80 Health Park Drive, Suite 20 
Louisville, Colorado 80027, 
USA 
TITLE: Final Test Report For Vital USA 
Results of the SpO2 and Pulse Rate Accuracy Comparison of 
VitalDetect™ to Arterial Blood CO-Oximetry and Reference ECG 
Clinimark Study ID# PR 2019-353 
Principal Investigator: Arthur Ruiz Cabrera, MD     Site ID # 001 
DOCUMENT NUMBER 
TR# 2019-353 
Page   32   of   39 
REV 
1 
 
8. Ethics 
Ethics committee review of the Protocol / Clinical Investigation Plan was provided: 
 
ETHICS COMMITTEE REVIEW: 
Salus Independent Review Board 
2111 West Braker Lane, Suite 100 Austin, TX 78758 
Alexander Kenaston, RN, MS, PhD, CIP : Chairman Board 3 
 
IRB approval: Salus Independent Review Board, Approval 25 October 2019, 
 
IRB Protocol Title:  
 
“Vital USA SpO2 Accuracy Comparison to Arterial Blood CO-Oximetry“  
 
IRB Protocol #: PR 2019-353, Version: Rev 1, Date: 15 Oct 2019 
 
9. Investigators and Administrative Structure of Investigation 
Clinimark was retained by Vital USA to conduct an impartial SpO2 accuracy investigation of the VitalDetectTM 
pulse oximetry, during stationary (non-motion) conditions over the range of 70-100% SpO2 compared to a 
Reference CO-Oximetry and pulse rate to Reference ECG heart rate. Financial support to the study was 
provided by Vital USA. 
 
Commercial Sponsor:  
 
Vital USA,  525 S Flagler Dr. Suite 301, West Palm Beach, FL 33402  
 
Principal Investigator:  
 
Arthur Ruiz Cabrera, MD.,  
Avista Adventist Hospital, Staff Anesthesiologist 
100 Health Park Drive, Louisville, CO  
 
Sub-Investigators:  
Paul Batchelder, LRCP, RRT 
 
 
Dena Raley, BS Bio-Engineer 
Clinimark, Chief Clinical Officer  
 
Clinimark, Chief Technical Officer 
Clinimark, LLC, 1923 Pinal Road, Golden, CO  
 
Study Site: 
Clinimark Desaturation Laboratory, 
303 717-4820 
80 Health Park Drive Suite 20 Louisville, CO  
 
Site #001 
 
10. Revision History 
 
Revision 
Date 
Description 
1  
03 Dec 2019 
Initial Release  
 
 
 
 
11. Annexes to the Report 
 
11.1 Line Listing / Data Removal Record 
 
11.2 Clinical Investigation Plan – (Separate Attachment) 

CLINIMARK, LLC 
 
 
 
 
 
 
(303) 717-4820 
 
80 Health Park Drive Suite 20, Louisville, Colorado, 80027     USA 
www.clinimark.com 
 
 
 
Clinimark, LLC 
80 Health Park Drive, Suite 20 
Louisville, Colorado 80027, 
USA 
TITLE: Final Test Report For Vital USA 
Results of the SpO2 and Pulse Rate Accuracy Comparison of 
VitalDetect™ to Arterial Blood CO-Oximetry and Reference ECG 
Clinimark Study ID# PR 2019-353 
Principal Investigator: Arthur Ruiz Cabrera, MD     Site ID # 001 
DOCUMENT NUMBER 
TR# 2019-353 
Page   33   of   39 
REV 
1 
 
 
11.1 Line Listing / Data Removal Record 
 
 
Pink highlighted cells indicate data that has been removed. See column “Reason for Removal” 
 
Column “>3” indicates stability of the Control Oximeter. Pink highlighted is unstable / removed. 
 
Removal of Test SpO2 data highlighted in pink. See column “Reason for Removal” 
 
Test values >3% from the Ref CO-Ox are highlighted in yellow. 
 
Test values >5% form the Ref CO-Ox are highlighted in orange. 
 
 
Subject 
ID# 
CO-Ox 
ABL  
ECG 
Syringe 
# 
Control 
3900 
Vital 
SpO2 
Vital PR 
Score 
>= 3 
Reason for 
Removal 
1 
98.05 
83.25 
1 
97.43 
95.85 
86.80 
1 
0.5 
1 
98.25 
89.00 
2 
97.60 
95.69 
89.50 
1 
0.2 
1 
98.55 
88.40 
3 
97.76 
95.90 
84.27 
1 
0.4 
1 
98.4 
98.91 
4 
97.46 
95.67 
93.71 
1 
0.4 
1 
94.9 
89.40 
5 
93.57 
91.91 
83.51 
1 
1.1 
1 
94.45 
86.20 
6 
93.61 
92.06 
99.45 
1 
1 
1 
93.5 
97.82 
7 
92.97 
90.76 
100.77 
1 
0.6 
1 
93.4 
97.80 
8 
92.11 
90.44 
91.76 
1 
0.6 
1 
87.65 
101.20 
9 
87.51 
85.65 
103.55 
1 
1.4 
1 
88.05 
94.80 
10 
87.55 
85.21 
90.82 
1 
1 
1 
88.3 
93.00 
11 
88.93 
86.53 
103.73 
1 
1.7 
1 
89.6 
110.50 
12 
88.30 
86.86 
102.39 
1 
3.1 
 Control Unstable 
1 
82.1 
108.90 
13 
82.97 
79.60 
114.89 
1 
2.5 
1 
82.1 
110.56 
14 
82.76 
78.27 
109.68 
1 
1.1 
1 
82.85 
105.42 
15 
82.26 
78.68 
106.16 
1 
1.7 
1 
81.9 
105.00 
16 
83.12 
77.26 
116.38 
1 
1.5 
1 
79.8 
110.80 
17 
79.83 
74.19 
114.62 
1 
0.4 
1 
77.3 
113.20 
18 
78.09 
71.36 
114.40 
1 
2 
1 
78.05 
111.60 
19 
78.14 
71.01 
112.24 
1 
1.1 
1 
78.85 
107.25 
20 
77.68 
70.91 
104.07 
1 
1 
1 
77 
114.40 
21 
77.45 
70.55 
117.85 
1 
2.2 
1 
76.6 
118.25 
22 
76.33 
67.60 
121.06 
1 
1.3 
1 
77 
113.25 
23 
75.12 
65.29 
111.45 
2 
2.1 
1 
75.6 
113.00 
24 
76.50 
68.99 
120.29 
1 
1.8 
  
  
  
  
  
  
  
  
  
  
2 
96.6 
71.50 
1 
95.93 
96.26 
71.74 
1 
0.8 
2 
96.9 
68.00 
2 
96.32 
96.14 
69.38 
1 
0.6 
2 
97 
73.33 
3 
96.29 
96.35 
74.08 
1 
0.3 
2 
96.75 
78.67 
4 
96.10 
96.23 
76.91 
1 
0.4 
2 
90.2 
83.00 
5 
89.94 
90.12 
79.26 
1 
0.5 
2 
89.35 
84.40 
6 
89.80 
90.08 
86.26 
1 
0.8 
2 
89.25 
80.00 
7 
88.86 
89.47 
78.26 
1 
1.2 
2 
88.55 
80.50 
8 
89.11 
88.61 
82.08 
1 
0.6 
2 
86.25 
87.25 
9 
87.13 
86.24 
86.91 
1 
0.8 

CLINIMARK, LLC 
 
 
 
 
 
 
(303) 717-4820 
 
80 Health Park Drive Suite 20, Louisville, Colorado, 80027     USA 
www.clinimark.com 
 
 
 
Clinimark, LLC 
80 Health Park Drive, Suite 20 
Louisville, Colorado 80027, 
USA 
TITLE: Final Test Report For Vital USA 
Results of the SpO2 and Pulse Rate Accuracy Comparison of 
VitalDetect™ to Arterial Blood CO-Oximetry and Reference ECG 
Clinimark Study ID# PR 2019-353 
Principal Investigator: Arthur Ruiz Cabrera, MD     Site ID # 001 
DOCUMENT NUMBER 
TR# 2019-353 
Page   34   of   39 
REV 
1 
 
2 
86.25 
85.67 
10 
86.43 
86.19 
86.02 
1 
0.7 
2 
85.8 
86.00 
11 
86.60 
85.72 
84.75 
1 
0.3 
2 
85.35 
84.00 
12 
87.05 
86.04 
87.21 
1 
0.8 
2 
80.5 
88.60 
13 
83.21 
80.89 
92.12 
1 
0.8 
2 
81 
91.00 
14 
81.78 
80.12 
93.39 
1 
1.2 
2 
79.3 
90.00 
15 
82.10 
79.65 
91.72 
1 
1 
2 
80.1 
90.00 
16 
81.32 
79.09 
90.82 
1 
1 
2 
73.6 
89.80 
17 
78.09 
73.86 
94.81 
2 
2.9 
2 
74.15 
94.60 
18 
75.66 
70.19 
93.56 
1 
2.5 
2 
74.35 
97.80 
19 
76.26 
70.18 
94.25 
1 
1.6 
2 
73.5 
96.20 
20 
76.52 
70.27 
98.63 
1 
1.1 
2 
71.9 
97.18 
21 
75.26 
68.70 
100.51 
1 
0.9 
2 
70.3 
98.18 
22 
74.12 
67.31 
96.10 
1 
1.7 
2 
70.65 
99.00 
23 
73.18 
65.01 
96.22 
1 
0.5 
2 
70.9 
96.67 
24 
73.07 
65.00 
96.72 
1 
0.6 
  
  
  
  
  
  
  
  
  
  
4 
95.7 
79.00 
1 
95.29 
96.61 
79.98 
1 
1.3 
4 
95.65 
82.80 
2 
94.81 
96.26 
82.93 
1 
1 
4 
96.05 
83.00 
3 
94.64 
95.88 
85.35 
1 
0.5 
4 
95.95 
83.00 
4 
95.45 
96.17 
83.86 
1 
0.6 
4 
90.45 
87.00 
5 
90.57 
92.21 
86.08 
1 
2 
4 
90.55 
88.80 
6 
90.06 
91.26 
91.06 
1 
0.6 
4 
90.35 
94.00 
7 
89.88 
90.87 
91.63 
1 
0.9 
4 
89.25 
92.50 
8 
90.15 
91.28 
94.97 
1 
0.6 
4 
85.5 
93.00 
9 
87.97 
88.68 
94.20 
1 
0.6 
4 
86.55 
90.17 
10 
86.91 
86.73 
90.72 
1 
0.9 
4 
85.5 
88.45 
11 
86.67 
87.19 
87.71 
1 
1.1 
4 
84.8 
90.80 
12 
85.87 
86.14 
91.71 
1 
0.6 
4 
82.35 
90.60 
13 
84.79 
85.23 
93.14 
1 
2 
4 
83.55 
91.20 
14 
85.13 
84.95 
91.28 
1 
1.5 
4 
80.05 
88.73 
15 
83.57 
84.21 
91.29 
1 
3 
4 
79.85 
93.45 
16 
82.44 
81.07 
95.87 
1 
1.2 
4 
76.55 
94.82 
17 
78.80 
75.97 
99.29 
1 
2 
4 
75.7 
93.60 
18 
78.39 
75.53 
95.74 
1 
1.1 
4 
73.3 
94.27 
19 
76.04 
72.56 
96.02 
1 
2.1 
4 
73.45 
97.00 
20 
75.11 
69.73 
96.86 
1 
0.7 
4 
72.8 
99.73 
21 
75.45 
69.28 
99.31 
1 
0.9 
4 
74.85 
94.40 
22 
75.21 
69.66 
98.34 
1 
2 
4 
76.7 
95.40 
23 
77.34 
72.58 
97.04 
1 
1.2 
4 
75.3 
97.20 
24 
78.22 
75.24 
97.02 
1 
1.2 
  
  
  
  
  
  
  
  
  
  
5 
96.7 
66.57 
1 
94.91 
94.36 
66.03 
1 
0.5 
5 
96.75 
62.82 
2 
95.36 
94.95 
64.65 
1 
0.5 

CLINIMARK, LLC 
 
 
 
 
 
 
(303) 717-4820 
 
80 Health Park Drive Suite 20, Louisville, Colorado, 80027     USA 
www.clinimark.com 
 
 
 
Clinimark, LLC 
80 Health Park Drive, Suite 20 
Louisville, Colorado 80027, 
USA 
TITLE: Final Test Report For Vital USA 
Results of the SpO2 and Pulse Rate Accuracy Comparison of 
VitalDetect™ to Arterial Blood CO-Oximetry and Reference ECG 
Clinimark Study ID# PR 2019-353 
Principal Investigator: Arthur Ruiz Cabrera, MD     Site ID # 001 
DOCUMENT NUMBER 
TR# 2019-353 
Page   35   of   39 
REV 
1 
 
5 
97 
65.83 
3 
95.33 
94.86 
66.14 
1 
0.3 
5 
97.1 
63.38 
4 
95.52 
94.90 
64.01 
1 
0.3 
5 
91.35 
72.17 
5 
90.32 
89.48 
69.91 
1 
1 
5 
91.05 
67.50 
6 
89.87 
89.57 
69.29 
1 
0.4 
5 
90.05 
70.69 
7 
89.39 
88.86 
71.02 
1 
1 
5 
89.8 
72.08 
8 
88.60 
88.38 
71.45 
1 
0.4 
5 
87 
72.00 
9 
86.31 
85.99 
72.27 
1 
1 
5 
86.35 
72.67 
10 
85.54 
84.80 
74.79 
1 
0.9 
5 
85.5 
75.50 
11 
85.12 
84.51 
73.71 
1 
1 
5 
85.35 
74.25 
12 
84.87 
84.27 
73.33 
1 
0.3 
5 
81.95 
76.67 
13 
81.63 
80.44 
78.39 
1 
1.7 
5 
81.6 
74.67 
14 
81.08 
80.70 
75.65 
1 
0.5 
5 
80.85 
79.85 
15 
80.37 
79.93 
80.76 
1 
0.8 
5 
81 
76.50 
16 
80.41 
80.14 
78.14 
1 
0.2 
5 
77.25 
78.67 
17 
76.99 
75.66 
78.61 
1 
0.9 
5 
75.3 
78.57 
18 
76.21 
73.64 
76.14 
2 
1.8 
5 
74.8 
77.67 
19 
75.18 
73.49 
76.72 
1 
0.4 
5 
74.45 
79.00 
20 
74.56 
72.33 
80.03 
1 
0.7 
5 
74.05 
94.00 
21 
73.05 
69.58 
82.07 
1 
1.7 
5 
72.8 
76.93 
22 
72.64 
70.48 
78.49 
1 
0.4 
5 
72.1 
78.42 
23 
72.44 
69.00 
80.03 
1 
1.4 
5 
71 
80.85 
24 
71.62 
68.57 
78.72 
1 
0.4 
  
  
  
  
  
  
  
  
  
  
6 
96.45 
90.50 
1 
96.06 
96.16 
90.63 
1 
0.8 
6 
96.7 
89.80 
2 
95.90 
96.19 
89.15 
1 
0.6 
6 
97 
90.00 
3 
96.39 
96.29 
90.51 
1 
0.5 
6 
96.75 
90.00 
4 
96.35 
96.29 
91.42 
1 
0.5 
6 
91.8 
94.45 
5 
91.40 
92.60 
93.37 
1 
1.7 
6 
90.8 
90.09 
6 
91.54 
92.00 
91.19 
1 
1.2 
6 
90.7 
89.90 
7 
91.06 
91.37 
92.37 
1 
0.7 
6 
90.4 
94.20 
8 
90.34 
91.96 
94.04 
1 
0.5 
6 
86.15 
93.73 
9 
86.82 
88.08 
95.88 
1 
2.1 
6 
85.85 
98.33 
10 
86.03 
87.90 
100.32 
1 
0.5 
6 
85.35 
93.82 
11 
85.76 
87.64 
98.65 
1 
0.5 
6 
85.65 
99.00 
12 
85.53 
87.28 
96.59 
1 
0.7 
6 
82.15 
98.91 
13 
82.49 
84.42 
100.44 
1 
0.7 
6 
80.9 
97.20 
14 
82.23 
84.06 
96.72 
1 
0.7 
6 
81.15 
98.20 
15 
80.66 
83.25 
100.74 
1 
1.3 
6 
81.15 
101.20 
16 
81.56 
83.56 
97.87 
1 
1 
6 
77.4 
98.64 
17 
77.95 
79.71 
100.94 
1 
1.7 
6 
77.15 
97.10 
18 
76.96 
78.19 
99.80 
1 
1 
6 
76.55 
99.78 
19 
76.52 
78.11 
98.67 
1 
1 
6 
75.95 
100.00 
20 
76.25 
77.01 
98.35 
1 
0.6 

CLINIMARK, LLC 
 
 
 
 
 
 
(303) 717-4820 
 
80 Health Park Drive Suite 20, Louisville, Colorado, 80027     USA 
www.clinimark.com 
 
 
 
Clinimark, LLC 
80 Health Park Drive, Suite 20 
Louisville, Colorado 80027, 
USA 
TITLE: Final Test Report For Vital USA 
Results of the SpO2 and Pulse Rate Accuracy Comparison of 
VitalDetect™ to Arterial Blood CO-Oximetry and Reference ECG 
Clinimark Study ID# PR 2019-353 
Principal Investigator: Arthur Ruiz Cabrera, MD     Site ID # 001 
DOCUMENT NUMBER 
TR# 2019-353 
Page   36   of   39 
REV 
1 
 
6 
75.65 
100.00 
21 
75.47 
76.61 
101.18 
1 
1 
6 
75.25 
100.44 
22 
75.03 
76.31 
100.63 
1 
0.5 
6 
74.75 
100.30 
23 
74.70 
75.54 
100.66 
1 
1.1 
6 
74.2 
100.00 
24 
74.08 
75.14 
101.51 
1 
1.2 
  
  
  
  
  
  
  
  
  
  
7 
99.05 
51.57 
1 
97.30 
96.96 
52.11 
1 
0.2 
7 
98.85 
51.54 
2 
97.02 
96.57 
53.05 
1 
0.4 
7 
99.05 
50.67 
3 
96.83 
96.66 
51.60 
1 
0.1 
7 
98.9 
51.00 
4 
96.92 
96.53 
52.19 
1 
0.5 
7 
93.25 
50.77 
5 
92.20 
92.27 
53.18 
1 
1.1 
7 
92.8 
54.50 
6 
91.88 
91.99 
54.00 
1 
0.9 
7 
92.15 
53.18 
7 
90.76 
91.43 
53.81 
1 
1 
7 
92.05 
51.73 
8 
90.91 
91.43 
53.01 
1 
0.4 
7 
88.1 
55.36 
9 
88.32 
88.87 
54.94 
1 
1.1 
7 
88.35 
54.36 
10 
88.08 
88.54 
54.91 
1 
0.8 
7 
87.65 
52.18 
11 
87.47 
87.69 
59.69 
1 
1.6 
7 
88.75 
53.69 
12 
88.01 
88.20 
53.50 
1 
2.2 
7 
83.95 
55.73 
13 
84.49 
84.37 
57.49 
1 
2.2 
7 
83.9 
56.69 
14 
84.68 
84.95 
55.36 
1 
0.8 
7 
81.75 
55.67 
15 
83.42 
83.34 
57.60 
1 
2.4 
7 
80.65 
54.92 
16 
81.95 
82.28 
55.88 
1 
0.6 
7 
73.55 
62.42 
17 
76.66 
72.81 
63.53 
1 
1.4 
7 
73.15 
59.67 
18 
76.49 
74.09 
61.18 
2 
3 
7 
71 
61.85 
19 
72.75 
68.28 
62.20 
2 
3 
7 
71.8 
63.33 
20 
73.97 
69.28 
66.77 
1 
1.7 
7 
71.3 
62.46 
21 
72.95 
68.86 
62.81 
1 
1.1 
7 
69.15 
63.00 
22 
72.65 
65.00 
61.26 
1 
1.4 
7 
69.9 
61.20 
23 
71.72 
67.94 
62.46 
1 
1.3 
7 
68.9 
69.36 
24 
71.11 
65.00 
61.64 
1 
2.7 
  
  
  
  
  
  
  
  
  
  
8 
97.25 
66.00 
1 
98.27 
98.11 
65.24 
1 
0.5 
8 
96.85 
66.57 
2 
98.13 
98.20 
67.62 
1 
0.6 
8 
97.35 
66.00 
3 
97.42 
97.81 
68.02 
1 
0.3 
8 
97.45 
68.92 
4 
97.70 
98.12 
67.13 
1 
0.5 
8 
90.75 
70.09 
5 
90.75 
91.99 
71.56 
1 
1.5 
8 
90.35 
72.79 
6 
90.99 
91.76 
73.34 
1 
0.9 
8 
90.4 
70.55 
7 
92.12 
92.75 
69.53 
1 
1.7 
8 
90.85 
72.00 
8 
90.20 
91.20 
70.25 
1 
1.4 
8 
82.8 
75.46 
9 
85.92 
86.10 
78.76 
1 
2.5 
8 
84.95 
75.33 
10 
85.86 
84.56 
75.68 
1 
2.5 
8 
86.3 
74.36 
11 
87.72 
86.96 
71.59 
1 
2 
8 
85.65 
77.67 
12 
87.55 
87.56 
76.08 
1 
1.1 
8 
82.15 
71.40 
13 
84.67 
84.32 
74.75 
1 
1.5 

CLINIMARK, LLC 
 
 
 
 
 
 
(303) 717-4820 
 
80 Health Park Drive Suite 20, Louisville, Colorado, 80027     USA 
www.clinimark.com 
 
 
 
Clinimark, LLC 
80 Health Park Drive, Suite 20 
Louisville, Colorado 80027, 
USA 
TITLE: Final Test Report For Vital USA 
Results of the SpO2 and Pulse Rate Accuracy Comparison of 
VitalDetect™ to Arterial Blood CO-Oximetry and Reference ECG 
Clinimark Study ID# PR 2019-353 
Principal Investigator: Arthur Ruiz Cabrera, MD     Site ID # 001 
DOCUMENT NUMBER 
TR# 2019-353 
Page   37   of   39 
REV 
1 
 
8 
82.65 
70.78 
14 
84.04 
83.62 
73.50 
1 
1 
8 
81.5 
72.40 
15 
83.47 
83.34 
74.26 
1 
0.9 
8 
80.7 
71.33 
16 
81.78 
81.25 
74.89 
2 
2.6 
8 
72.65 
76.00 
17 
71.63 
65.00 
80.17 
1 
1.7 
8 
71.35 
80.58 
18 
71.13 
65.00 
82.97 
2 
2.7 
8 
72.05 
83.50 
19 
69.12 
65.00 
82.18 
1 
1.8 
8 
70.4 
84.91 
20 
69.57 
65.00 
84.71 
1 
2.1 
8 
71.35 
83.93 
21 
69.46 
65.00 
82.75 
1 
0.7 
8 
71.35 
83.40 
22 
70.24 
65.00 
82.83 
1 
1.1 
8 
74.55 
78.86 
23 
69.91 
65.00 
77.05 
1 
1 
8 
73.25 
79.86 
24 
72.02 
65.05 
82.89 
1 
1 
  
  
  
  
  
  
  
  
  
  
9 
96.7 
65.85 
1 
95.62 
96.58 
66.86 
1 
0.6 
9 
97.1 
63.77 
2 
95.88 
96.88 
65.21 
1 
0.4 
9 
97 
65.62 
3 
96.03 
96.73 
65.62 
1 
0.4 
9 
97.15 
66.08 
4 
95.90 
96.95 
66.12 
1 
0.3 
9 
91.75 
71.00 
5 
90.43 
91.79 
70.02 
1 
0.8 
9 
91.4 
72.33 
6 
89.58 
91.63 
74.08 
1 
1.1 
9 
90.75 
72.00 
7 
89.80 
91.06 
73.49 
1 
0.9 
9 
90.2 
71.00 
8 
89.38 
91.12 
73.72 
1 
0.6 
9 
86.55 
80.00 
9 
86.13 
87.97 
80.69 
1 
1.4 
9 
86.6 
77.92 
10 
85.63 
87.62 
80.31 
1 
0.8 
9 
85.8 
87.00 
11 
85.23 
86.83 
85.22 
1 
1.4 
9 
85.95 
79.82 
12 
84.69 
86.88 
79.50 
1 
0.5 
9 
82.1 
87.31 
13 
80.44 
81.99 
86.46 
1 
2.2 
9 
82.65 
83.00 
14 
81.23 
82.58 
82.90 
1 
0.9 
9 
82.6 
84.00 
15 
81.62 
82.97 
86.75 
1 
1 
9 
81.9 
88.00 
16 
80.91 
82.00 
83.93 
1 
0.8 
9 
76.35 
91.00 
17 
74.01 
73.20 
90.10 
2 
3 
9 
76.4 
93.00 
18 
74.39 
75.02 
91.93 
1 
1.2 
9 
76.45 
87.29 
19 
74.26 
75.08 
89.03 
1 
0.8 
9 
75.7 
92.00 
20 
73.78 
74.65 
90.72 
1 
1.3 
9 
74.65 
93.73 
21 
72.72 
72.96 
92.55 
1 
1.2 
9 
74.8 
92.08 
22 
73.24 
72.61 
91.84 
1 
1.4 
9 
74.15 
93.92 
23 
71.60 
72.15 
95.24 
1 
1 
9 
73.75 
92.00 
24 
71.48 
71.62 
94.79 
1 
0.8 
  
  
  
  
  
  
  
  
  
  
10 
97.05 
85.93 
1 
96.43 
96.87 
87.01 
1 
0.6 
10 
97.4 
88.62 
2 
96.83 
97.07 
87.34 
1 
0.8 
10 
97.75 
88.08 
3 
97.33 
97.04 
87.31 
1 
0.4 
10 
97.4 
88.50 
4 
97.60 
97.38 
88.35 
1 
0.4 
10 
91.9 
85.57 
5 
92.56 
94.25 
91.05 
1 
1.1 
10 
91.8 
92.33 
6 
92.40 
94.41 
89.30 
1 
0.4 

CLINIMARK, LLC 
 
 
 
 
 
 
(303) 717-4820 
 
80 Health Park Drive Suite 20, Louisville, Colorado, 80027     USA 
www.clinimark.com 
 
 
 
Clinimark, LLC 
80 Health Park Drive, Suite 20 
Louisville, Colorado 80027, 
USA 
TITLE: Final Test Report For Vital USA 
Results of the SpO2 and Pulse Rate Accuracy Comparison of 
VitalDetect™ to Arterial Blood CO-Oximetry and Reference ECG 
Clinimark Study ID# PR 2019-353 
Principal Investigator: Arthur Ruiz Cabrera, MD     Site ID # 001 
DOCUMENT NUMBER 
TR# 2019-353 
Page   38   of   39 
REV 
1 
 
10 
91.75 
92.38 
7 
92.41 
93.89 
92.49 
1 
0.4 
10 
91.4 
89.85 
8 
91.98 
93.71 
89.50 
1 
1 
10 
86.7 
90.42 
9 
88.75 
91.09 
92.88 
1 
0.8 
10 
86.8 
92.50 
10 
87.90 
89.21 
94.98 
1 
0.7 
10 
86.95 
91.69 
11 
88.38 
90.01 
94.44 
1 
0.4 
10 
86.4 
88.85 
12 
88.47 
90.57 
90.13 
1 
0.5 
10 
81.45 
93.36 
13 
83.79 
86.08 
95.27 
1 
0.8 
10 
81.4 
92.77 
14 
83.54 
86.22 
94.57 
1 
1.1 
10 
82.4 
98.15 
15 
83.42 
87.40 
96.58 
1 
0.8 
10 
82.15 
99.09 
16 
84.26 
86.11 
97.36 
1 
0.6 
10 
76.4 
97.00 
17 
79.48 
83.09 
100.33 
1 
0.9 
10 
76.9 
95.46 
18 
79.21 
83.70 
97.22 
1 
1 
10 
75.85 
96.55 
19 
79.39 
81.68 
95.62 
1 
0.8 
10 
75.75 
99.25 
20 
79.22 
83.21 
102.52 
1 
0.7 
10 
74.75 
98.50 
21 
79.05 
82.58 
96.81 
1 
1.1 
10 
73.65 
99.27 
22 
78.18 
80.95 
101.06 
1 
0.8 
10 
73.4 
99.62 
23 
77.45 
79.68 
98.18 
1 
1.4 
10 
72.6 
101.83 
24 
76.48 
81.64 
105.16 
1 
0.8 
  
  
  
  
  
  
  
  
  
  
11 
96.1 
66.00 
1 
95.76 
96.07 
62.30 
1 
0.3 
11 
96.05 
59.83 
2 
95.67 
95.69 
57.96 
1 
0.4 
11 
96.2 
63.50 
3 
96.08 
96.32 
61.26 
1 
0.3 
11 
96.45 
65.55 
4 
95.90 
96.05 
63.89 
1 
0.5 
11 
87.85 
74.36 
5 
88.63 
89.28 
73.61 
1 
1.4 
11 
87.4 
70.50 
6 
87.74 
88.33 
75.70 
1 
1.1 
11 
86.75 
69.64 
7 
86.72 
87.72 
71.01 
1 
0.6 
11 
85.85 
72.25 
8 
85.55 
86.55 
72.51 
1 
1.1 
11 
83.8 
78.55 
9 
81.91 
82.49 
77.06 
1 
2 
11 
82.8 
75.55 
10 
82.67 
82.87 
77.32 
1 
1.6 
11 
82.3 
78.73 
11 
81.58 
82.38 
78.84 
1 
1 
11 
80.9 
80.31 
12 
81.31 
81.67 
78.94 
1 
0.9 
11 
75.7 
87.70 
13 
75.75 
75.84 
87.69 
1 
0.9 
11 
76.4 
82.91 
14 
74.88 
74.43 
84.40 
1 
1.3 
11 
74.6 
86.00 
15 
74.04 
73.71 
87.48 
1 
0.3 
11 
74.7 
88.18 
16 
73.08 
73.11 
87.09 
1 
1.6 
11 
74.65 
86.00 
17 
71.67 
72.00 
88.24 
1 
1.3 
11 
75.1 
89.60 
18 
71.50 
70.71 
89.50 
1 
0.9 
11 
75.2 
83.55 
19 
72.99 
72.15 
86.26 
1 
1.6 
11 
72.1 
83.00 
20 
71.80 
70.66 
84.95 
1 
1.3 
11 
100.2 
60.00 
21 
99.18 
99.06 
63.45 
1 
0.5 
11 
100.1 
61.60 
22 
99.06 
99.00 
60.28 
1 
0.3 
11 
100.15 
60.54 
23 
99.15 
98.96 
61.12 
1 
0.3 
11 
99.9 
60.67 
24 
99.40 
99.11 
60.67 
1 
0.5 

CLINIMARK, LLC 
 
 
 
 
 
 
(303) 717-4820 
 
80 Health Park Drive Suite 20, Louisville, Colorado, 80027     USA 
www.clinimark.com 
 
 
 
Clinimark, LLC 
80 Health Park Drive, Suite 20 
Louisville, Colorado 80027, 
USA 
TITLE: Final Test Report For Vital USA 
Results of the SpO2 and Pulse Rate Accuracy Comparison of 
VitalDetect™ to Arterial Blood CO-Oximetry and Reference ECG 
Clinimark Study ID# PR 2019-353 
Principal Investigator: Arthur Ruiz Cabrera, MD     Site ID # 001 
DOCUMENT NUMBER 
TR# 2019-353 
Page   39   of   39 
REV 
1 
 
   
 
11.2  Clinical Investigation Plan  - (Separate Attachment) 
 
IRB Protocol Title:  
 
“Vital USA SpO2 Accuracy Comparison to Arterial Blood CO-Oximetry“  
 
IRB Protocol #: PR 2019-353, Version: Rev 1, Date: 15 Oct 2019 
 
Salus Independent Review Board 
2111 West Braker Lane, Suite 100 Austin, TX 78758 
IRB Approved Study: Salus Independent Review Board, Board 3 Review & Approval    25 Oct 2019