SpO2 Accuracy of Noninvasive Pulse Oximeter Sensor

Study Overview
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Brief Summary
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The purpose of this clinical study is to validate the SpO2 accuracy of the Stryker Sustainability Solutions pulse oximetry sensors during non-motion conditions over the range of 70-100% SaO2 as compared to arterial blood samples assessed by CO-Oximetry. The end goal is to provide supporting documentation for the SpO2 accuracy validation of the reprocessed sensors.

Detailed Description
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In this study, the level of oxygen within the blood will be reduced in a controlled manner by reducing the concentration of oxygen the participant breathes. The accuracy of a noninvasive pulse oximeter sensor will be assessed by comparison to the oxygen saturation measurements from a laboratory blood gas analyzer. It is required that the Accuracy Root Mean Square (ARMS) performance of the Stryker pulse oximetry sensors will meet a specification of +/-3% or better in non-motion conditions for the range of 70 - 100% SaO2 (typically, saturation is determined once with air breathing and then at one of 6 levels, e.g. 94%, 90%, 85%, 80%, 75% and 70% saturation for about 30-60 seconds at each level), thereby demonstrating an acceptable SpO2 accuracy performance specification.

Official Title
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SpO2 Accuracy of Noninvasive Pulse Oximeter Sensor

Conditions
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Healthy, Hypoxia

Intervention / Treatment
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* Device: STRYKER SUSTAINABILITY SOLUTIONS PULSE OXIMETERS


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Good general health with no evidence of pre-existing medical problems Fluent in both written and spoken English Must be able to review informed consent and is willing to comply with study procedures Exclusion Criteria: Obesity (BMI >30) Known history of heart disease, lung disease, kidney or liver disease Prior diagnosis of asthma, sleep apnea, or use of CPAP Diabetes Clotting disorder Hemoglobinopathy or history of anemia that in the opinion of the investigators would make them unsuitable for study participation Any serious systemic illness Current smoker Any injury, deformity, or abnormality at the sensor sites that in the opinion of the investigator would interfere with the sensors working correctly History of fainting or vasovagal response History of sensitivity to local anesthesia Prior diagnosis of Raynaud's disease Unacceptable collateral circulation based on exam by investigators (Allen's test) Pregnant, lactating, or trying to get pregnant Unable or unwilling to provide informed consent, or unable or unwilling to comply with study procedures Any other condition which in the opinion of the investigators would make them unsuitable for the study

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 55 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Intervention Model: Single Group Assignment
Interventional Model Description: Participants will be in a reclined position for the study. Reference sensors will be placed on each participant to evaluate the SpO2 accuracy and performance. Sensors may be placed on non-adjacent fingers to prevent optical crosstalk. Simultaneous data collection will be set up for devices under test. The data from the test devices will be collected by the sponsor or trained UCSF staff. Data will be collected for 1-2 second intervals data analysis. The SpO2 accuracy of the test devices will be evaluated over the oxygen saturation range between 70-100%.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Healthy adult participants<br>All participants are enrolled in the test group and receive the noninvasive adhesive reprocessed pulse oximeter sensors | Device: STRYKER SUSTAINABILITY SOLUTIONS PULSE OXIMETERS<br>* Reprocessed noninvasive pulse oximeters 1859 & 2329 MAX-A & MAX-N<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Accuracy of Sensor by Arms Calculation | Percentage of SpO2 (oxygen saturation by pulse oximetry) measured by the Reprocessed Oximeter pulse oximetry sensors during non-motion conditions over the range of 70-100% SaO2 as compared to arterial blood samples assessed by CO-Oximetry. Accuracy root mean square (ARMS) between measured SpO2 and reference SaO2 (arterial oxygen saturation) must meet the 3% specification for each reprocessed pulse oximetry sensor style. Accuracy will be determined by comparing the noninvasive blood oxygen saturation measurement of the pulse oximeter to that obtained from a blood sample and calculating the arithmetic root mean square error (Arms) value. Standard deviation of the differences is computed as the precision. Square root of the sum of the squares of bias and precision is computed as the Arms Error value. | 1-2 hours |