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No clinical study of the device in cardiac arrest is reported, and demographic information on the recordings is limited."}},"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":"Avive AED System rhythm recognition detector"}},"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 finds that the neural network that reads heart rhythms in the Avive AED exceeded American Heart Association goals in bench tests on ECG recordings","headline":"*Avive AED* exceeded AHA goals for spotting shockable rhythms"}},"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":["7eb0967530fc61800c36a561f4be7f7e5549bc5e2749cb5605368d421af10bea"],"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":"Avive Solutions of San Francisco makes the Avive AED, a portable automated external defibrillator that guides rescuers by voice. Its rhythm detector is a neural network that decides whether a heart rhythm should be shocked. Avive developed it on separate training, validation and test sets drawn from more than 23,000 ECG recordings. FDA reviewers report results on the test set, one record per person, against goals from the American Heart Association. Sensitivity was 98.9% for coarse ventricular fibrillation against a goal above 90%. For rapid ventricular tachycardia it was 99.0% against a goal above 75%. Specificity was 100% for normal sinus rhythm and 99.3% for other rhythms that should not be shocked. FDA approved the AED on 31 October 2022. The evidence for rhythm detection comes from bench tests on recordings. No clinical study of the device in cardiac arrest is reported, and demographic information on the recordings is limited.","replication":{"produced_by":["The network was developed on non-overlapping training, validation and test sets from more than 23,000 recordings.","Test recordings came from defibrillators with multifunction electrodes, one record per person."],"must_hold":["The patient is unresponsive and not breathing normally.","Rescuers use Child Mode for children under 8 years old or under 55 pounds."],"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":"aff44d4ee85dafbc6d3825926149a330597b9b28fc13953b00c3fece0632034b"}