Evaluation of Pulse Oximetry Accuracy in a Commercial Smartphone and Smartwatch Device During Human Hypoxia Laboratory Testing.

ABSTRACT: Background: The US Food and Drug Administration (FDA) and International Organization for Standardization (ISO) clearance standards for the clinical use of smart device pulse oximetry require in-laboratory human hypoxemia testing in healthy human individuals using arterial blood gas analysis. Methods: We evaluated the SpO₂ measurements of the Samsung smartphone (Galaxy S9/10) and smartwatch (Galaxy 4) at stable arterial oxygen saturations (SaO₂) between 70 and 100% in 24 healthy participants. Testing followed FDA/ISO-stipulated procedures for pulse oximetry performance validation, which include questionnaire estimation of skin tone based on Fitzpatrick estimation of skin types I-VI. During testing, inspired oxygen, nitrogen, and carbon dioxide partial pre

SUBMITTER: Browne SH 

PROVIDER: S-EPMC11902706 | biostudies-literature | 2025 Feb

REPOSITORIES: biostudies-literature