Pulse Oximeter Validation Study for the Perin Health Patch

This study is designed to evaluate the oxygen saturation measurement performance of the Perin Health Patch, a chest-worn pulse oximeter, during controlled hypoxemia in healthy adult volunteers. The study is conducted using UCSF's standard protocol for pulse oximeter performance evaluation, which has historically informed FDA and ISO standards (including ISO 80601-2-61). The Perin Health Patch integrates photoplethysmography (PPG) and other sensing modalities into a wearable form factor intended for clinical and non-clinical monitoring settings. Participants will be enrolled to ensure demographic diversity, including representation across a wide spectrum of skin pigmentation, with a minimum of 15% of subjects having Fitzpatrick skin type V or VI. The study will control inspired gas concentrations to induce stable arterial oxygen saturation plateaus between 70% and 100%. These plateaus enable comparison of the device's displayed SpO₂ values to gold-standard SaO₂ values determined from arterial blood samples using co-oximetry. SpO₂ readings from the Perin Health Patch will be collected concurrently with FDA-cleared reference pulse oximeters placed on contralateral or adjacent fingers. Readings at each plateau will be compared to SaO₂ to assess device accuracy and bias across the range of hypoxemia. The study will follow ISO 80601-2-61 methodology, including at least 200 paired data points from a minimum of 10 subjects. Averaging times and perfusion indices will be documented for all devices. Data will be analyzed to determine root mean square error (Arms), bias, and standard deviation between device SpO₂ and co-oximeter SaO₂ readings. The results will be used to assess whether the Perin Health Patch meets regulatory performance requirements for oxygen saturation monitoring and to support future regulatory submissions. This study does not involve randomization to different treatments or control arms. All participants undergo the same measurement protocol. No investigational treatments are administered. Safety protocols, including continuous vital sign monitoring and immediate availability of emergency medical care, are employed throughout the study.