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In 280 subjects, its weekly AFib burden differed from an ECG patch by 0.67% on average.","account":"Apple's AFib History Feature analyzes pulse data from the Apple Watch optical sensor. It estimates the share of time that a user with atrial fibrillation spent in AFib over the past week. FDA qualified it as a medical device development tool, so makers of cardiac ablation devices can use its weekly estimates as a secondary endpoint in trials. The evidence came from Apple's prospective clinical study of 280 subjects with an ECG patch as the reference. The average difference in weekly burden was 0.67%, and 92.9% of subjects were within ±5%. FDA wrote that developers will be able to capture this information more easily and consistently in their studies. FDA issued its qualification summary in May 2024. In 36 subjects with a prior ablation, the upper limit of agreement exceeded the 15% criterion. The feature does not identify atrial flutter and works only while the watch is worn."}},"provenance":{"kind":"legacy_record","basis":"Editorial assignment.","record_fields":["summary","account"],"source_refs":[]},"review_state":"record_mapped","coverage":"partial"},"systems[].autonomy_permissions":{"state":"unresolved","provenance":{"kind":"curatorial","basis":"Editorial assignment.","record_fields":[],"source_refs":[]},"reason":"This is an explicit unresolved assignment: the sources on record do not settle this question.","review_state":"not_assessed","coverage":"partial"},"systems[].component_role":{"state":"unresolved","provenance":{"kind":"curatorial","basis":"Editorial assignment.","record_fields":[],"source_refs":[]},"reason":"This is an explicit unresolved assignment: the sources on record do not settle this question.","review_state":"not_assessed","coverage":"partial"},"systems[].deployment_configuration":{"state":"unresolved","provenance":{"kind":"curatorial","basis":"Editorial assignment.","record_fields":[],"source_refs":[]},"reason":"This is an explicit unresolved assignment: the sources on record do not settle this question.","review_state":"not_assessed","coverage":"partial"},"systems[].inputs_outputs":{"state":"unresolved","provenance":{"kind":"curatorial","basis":"Editorial assignment.","record_fields":[],"source_refs":[]},"reason":"This is an explicit unresolved assignment: the sources on record do not settle this question.","review_state":"not_assessed","coverage":"partial"},"systems[].model_name":{"state":"unresolved","provenance":{"kind":"curatorial","basis":"Editorial assignment.","record_fields":[],"source_refs":[]},"reason":"This is an explicit unresolved assignment: the sources on record do not settle this question.","review_state":"not_assessed","coverage":"partial"},"systems[].model_version":{"state":"unresolved","provenance":{"kind":"curatorial","basis":"Editorial assignment.","record_fields":[],"source_refs":[]},"reason":"This is an explicit unresolved assignment: the sources on record do not settle this question.","review_state":"not_assessed","coverage":"partial"},"systems[].product_name":{"state":"value_present","value":{"kind":"record_fields","fields":{"system":"Apple Atrial Fibrillation History Feature"}},"provenance":{"kind":"legacy_record","basis":"Editorial assignment.","record_fields":["system"],"source_refs":[]},"review_state":"record_mapped","coverage":"partial"},"systems[].provider":{"state":"unresolved","provenance":{"kind":"curatorial","basis":"Editorial assignment.","record_fields":[],"source_refs":[]},"reason":"This is an explicit unresolved assignment: the sources on record do not settle this question.","review_state":"not_assessed","coverage":"partial"},"taxonomy_crosswalks[]":{"state":"unresolved","provenance":{"kind":"curatorial","basis":"Editorial assignment.","record_fields":[],"source_refs":[]},"reason":"This is an explicit unresolved assignment: the sources on record do not settle this question.","review_state":"not_assessed","coverage":"partial"},"title":{"state":"value_present","value":{"kind":"record_fields","fields":{"title":"FDA qualified Apple's AFib History Feature for ablation device trials after finding that its weekly AFib burden estimates were clinically acceptable","headline":"FDA qualified the *AFib History Feature* for ablation device trials"}},"provenance":{"kind":"legacy_record","basis":"Editorial assignment.","record_fields":["title","headline"],"source_refs":[]},"review_state":"record_mapped","coverage":"partial"},"version":{"state":"value_present","value":{"kind":"identifiers","identifiers":["21d359d007667778906ef8da2eede5e9048ac5e5efc4fc1234ab111d78405bf5"],"role":"SHA-256 of the complete public record and its assessments"},"provenance":{"kind":"curatorial","basis":"SHA-256 of the public record, its assessments, and its displayed answers and notes, excluding its own identifier and the derived coverage summary.","record_fields":[],"source_refs":[]},"review_state":"record_mapped","coverage":"complete"},"workflow":{"state":"value_present","value":{"kind":"record_fields","fields":{"account":"Apple's AFib History Feature analyzes pulse data from the Apple Watch optical sensor. It estimates the share of time that a user with atrial fibrillation spent in AFib over the past week. FDA qualified it as a medical device development tool, so makers of cardiac ablation devices can use its weekly estimates as a secondary endpoint in trials. The evidence came from Apple's prospective clinical study of 280 subjects with an ECG patch as the reference. The average difference in weekly burden was 0.67%, and 92.9% of subjects were within ±5%. FDA wrote that developers will be able to capture this information more easily and consistently in their studies. FDA issued its qualification summary in May 2024. In 36 subjects with a prior ablation, the upper limit of agreement exceeded the 15% criterion. The feature does not identify atrial flutter and works only while the watch is worn.","replication":{"produced_by":["The feature analyzed beat-to-beat intervals from the Apple Watch photoplethysmography sensor over seven days of wear.","A Cardea SOLO wireless ECG patch gave the reference AFib burden."],"must_hold":["The tool serves only as a secondary endpoint in studies of cardiac ablation devices.","The participant wears the watch for at least seven days before an estimate is given."],"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":"554b66eff6a9127d7cb21be4a62a5ebc611b509794ed376549e814a393bf09e0"}