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It looks for repeated drops in oxygen over two nights and includes machine-learned algorithms. An accredited sleep lab ran a multi-center study in an enriched adult population, with polysomnography as the reference. FDA reviewers report that sensitivity was 82.7%, or 167 of 202 people with moderate to severe obstructive sleep apnea. Specificity was 87.7%, or 235 of 268, which missed the acceptance criterion. After review of the false positives, FDA accepted a modified specificity of 91.1%. Of 33 false positives, 10 previously undiagnosed people had mild apnea, and FDA wrote that the result benefited them. FDA granted the De Novo request on 6 February 2024. The feature assesses risk and makes no diagnosis. FDA reports no follow-up of whether participants sought care.","replication":{"produced_by":["The watch derived blood oxygen from its PPG sensors and scored each of two nights within 10 days.","Nights with under three hours of sleep, or with oxygen readings for under 70% of the time, gave an insufficient-data notice."],"must_hold":["The user is 22 or older and has no diagnosis of sleep apnea.","Users with symptoms see a clinician whatever the result."],"echoes":[]}}},"provenance":{"kind":"legacy_record","basis":"Editorial assignment.","record_fields":["account","replication"],"source_refs":[]},"review_state":"record_mapped","coverage":"partial"}},"summary":{"total":91,"addressed":91,"known":27,"reviewed":2,"reviewed_complete":2,"reviewed_partial":0,"record_mapped":25,"review_not_assessed":64,"not_assessed":0,"complete":false,"by_state":{"value_present":27,"not_reported":0,"unresolved":64,"not_assessed":0,"not_applicable":0,"withheld":0,"source_unavailable":0}}},"presentation_version":"aa2653bddcb5100e8fb2f72663a149327208680be2413e105c36b56274fbba2c"}