Pulse Oximeter Validation Study for the Perin Health Patch

Study Summary

The goal of this clinical trial is to evaluate the accuracy of the Perin Health Patch, a chest-worn pulse oximeter, in healthy adult volunteers by comparing its measurements to arterial blood gas analysis during controlled hypoxemia. This study will help determine whether the device meets the performance requirements of ISO 80601-2-61 and FDA 510(k) for SpO₂ measurement accuracy. The main questions it aims to answer is whether the Perin Health Patch meet the required accuracy performance (Arms ≤ 3.5%) across the full range of 70-100% SaO₂ as defined by ISO 80601-2-61. Participants will be healthy adults aged 18 to 50 years old, representing a diverse range of skin tones (including ≥15% with Fitzpatrick V or VI). Inclusion criteria require general good health and no chronic medical conditions. Exclusion criteria include obesity, cardiopulmonary conditions, hemoglobinopathies, pregnancy, and other safety considerations. Participants will: * Undergo screening and informed consent, including skin tone assessment using colorimetry and spectrophotometry. * Be instrumented with the Perin Health Patch and reference pulse oximeters on randomized fingers. * Undergo placement of an arterial catheter by a trained physician. * Be asked to breathe through a mouthpiece while inspired oxygen concentration is gradually reduced under physician control to generate multiple plateaus of hypoxemia (70-100% SaO₂). * Provide up to 30 arterial blood samples at steady-state hypoxemia levels to determine functional SaO₂ via co-oximetry. * Be continuously monitored for SpO₂, heart rate, ECG, respiratory rate, and blood pressure during the study. * Return to normoxia, and have the arterial line removed with hemostasis confirmed before discharge. This protocol, based on UCSF's standard hypoxia lab procedures, has been used in over 3000 subjects and is designed to meet or exceed requirements of ISO 80601-2-61, ISO 14155, and FDA 510(k) standards.

Primary Outcome

The primary outcome is the accuracy of the oxygen saturation (SpO₂) values reported by the Perin Health Patch compared to functional arterial oxygen saturation (SaO₂) measured by co-oximetry from arterial blood samples. Accuracy will be assessed according to ISO 80601-2-61 standards using root-mean-square error (Arms), bias (mean difference), and standard deviation. Measurements will be collected at multiple stable plateaus of oxygen saturation induced by adjusting inspired gas concentrations in

Interventions

• DEVICE Chest Worn Pulse Oximeter