Performance of Wearable Pulse Oximetry During Controlled Hypoxia Induction: Instrument Validation Study

Background Oxygen saturation is a crucial metric used for monitoring patients with lung disease or respiratory illness who are at risk of hypoxemia (low blood oxygen saturation). Early and accurate identification of abnormal oxygen saturation is important for these patients, who may develop significant desaturation and hypoxemia symptoms during their daily activities. Objective This study aimed to evaluate the accuracy of Apple Watch Series 7 and a clinical-grade pulse oximeter, Masimo MightySat Rx, under hypoxemia and to assess whether measurement error is influenced by the oxygen desaturation rate (ODR). Methods We calculated the ODR of each measurement and conducted a comparative analysis of the displayed oxygen saturation readings from both the Masimo MightySat Rx finger pulse oximeter and Apple Watch Series 7 with arterial blood oxygen saturation (SaO 2 ) readings obtained from a blood gas analyzer. Results Both the Masimo MightySat Rx pulse oximeter and the Apple Watch Series 7 tended to overestimate oxygen saturation. The pulse oximeter readings were more likely to fall within 2% of the acceptable (as specified by Masimo) peripheral oxygen saturation (SpO ₂ ) error range than the Apple Watch (49.03% vs 32.14%). Notably, both devices had limitations under low oxygen saturation levels (<88%), with an accuracy root mean square difference (A rms ) of 3.52% (95% CI 3.18%‐3.86%) and 5.82% (95% CI 5.32%‐6.31%) for the Masimo MightySat Rx and Apple Watch Series 7, respectively. Among the blood oxygen measurements taken during a high ODR (ie, ≥2% SpO 2 per minute), which is a rate clinically correlated with sleep apnea, the A rms increased slightly by 0.75% for the Masimo MightySat Rx and decreased by 0.28% for the Apple Watch Series 7. Conclusions Both devices consistently overestimated SpO 2 , with accuracy declining notably during hypoxemia. The Apple Watch Series 7 mean bias suggests a likelihood of missing instances of hypoxemia, particularly at arterial oxygen saturation values below but close to 88%. Both the Apple Watch Series 7 and Masimo MightySat Rx exhibited A rms values exceeding the US Food and Drug Administration threshold under conditions of hypoxemia. While past studies have implicated high ODRs in increasing measurement error, we found no statistically significant relationship between ODR and measurement error for either device. Overall, our findings of SpO 2 overestimation and high A rms values underscore the need for caution when interpreting oxygen saturation values from these devices. The small sample size and limited diversity in skin tone and age restrict the generalizability of our findings. Future studies should include larger and more diverse populations to evaluate the performance of wearable-based pulse oximetry.