In Vivo Pulse Oximeter Validation Study

In Vivo Testing for SpO2 Accuracy on Healthy Adults Under Laboratory Conditions

The goal of this clinical trial is to compare values of SpO2 provided by the DUT and the SaO2 used as a reference in healthy adults. The main question it aims to answer is: what is the accuracy of the subject device compared to the 510(k)-cleared reference device

A radial arterial cannula was placed in the wrist of each subject for arterial blood sampling and a subject device was placed on each arm of the patients. Then, hypoxia was induced to different stable levels of oxyhemoglobin saturation between 70-100% by having subjects breathe mixtures of nitrogen, air, and carbon dioxide controlled by the study physician. Values of SpO2 and SaO2 were then compared to provide a root mean square error and conclude on the subject device accuracy.

Inclusion Criteria:

• Healthy adult
• Normal hemoglobin levels (Hemoglobin > 10 g/dL)

Exclusion Criteria:

• Systemic illness
• Obesity