Vital USA SpO2 Accuracy Comparison to Arterial Blood CO-Oximetry

Clinical Investigation Plan: Vital USA SpO2 Accuracy Comparison to Arterial Blood CO-Oximetry Study ID# PR 2019-353, Version: Rev 1, Date: 15 Oct 2019 Study Dates: November 4-5, 2019

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 International Standards Organization (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).

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.

Eligibility Criteria:
Inclusion Criteria

1. 10-15 Adults with a minimum of 3 males and a minimum of 3 females, with the balance made up of either
2. Subject must have the ability to understand and provide written informed consent
3. Subject is 18 to 50 years of age
4. Subject must be willing and able to comply with study procedures and duration
5. Subject is a non-smoker or who has not smoked within 2 days prior to the study

Exclusion Criteria

1. Subject is considered as being morbidly obese (defined as BMI \>39.5).
2. 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.)
3. 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).
4. Smoker Subjects who have refrained will be screened for COPD levels \>3% as assessed with a Radical 7 (Rainbow)
5. Subjects with known respiratory conditions such as: (self-reported):

   1. uncontrolled / severe asthma,
   2. flu,
   3. pneumonia / bronchitis,
   4. shortness of breath / respiratory distress,
   5. unresolved respiratory or lung surgery with continued indications of health issues,
   6. emphysema, COPD, lung disease.
6. Subjects with known heart or cardiovascular conditions such as: (self-reported, except for blood pressure and ECG review)

   1. hypertension: systolic \>140mmHg, Diastolic \>90mmHg on 3 consecutive readings (reviewed during health screen).
   2. have had cardiovascular surgery
   3. Chest pain (angina)
   4. heart rhythms other than a normal sinus rhythm or with respiratory sinus arrhythmia (reviewed during health screen)
   5. previous heart attack
   6. blocked artery
   7. unexplained shortness of breath
   8. congestive heart failure (CHF)
   9. history of stroke
   10. transient ischemic attack
   11. carotid artery disease
   12. myocardial ischemia
   13. myocardial infarction
   14. cardiomyopathy
7. Self-reported health conditions as identified in the Health Assessment Form (self-reported)

   1. diabetes,
   2. uncontrolled thyroid disease,
   3. kidney disease / chronic renal impairment,
   4. history of seizures (except childhood febrile seizures),
   5. epilepsy,
   6. history of unexplained syncope,
   7. recent history of frequent migraine headaches,
   8. recent symptomatic head injury (within the last 2 months)
   9. cancer / chemotherapy
8. Subjects with known clotting disorders (self-reported)