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No patient outcome was measured."}},"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":"Caption Interpretation Automated Ejection Fraction Software (AutoEF)"}},"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 Caption Health's AutoEF came within its error goal for ejection fraction on echocardiograms from 186 patients","headline":"*AutoEF* estimated how well the heart pumps within its error goal"}},"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":["bf1c2d307b517f8aae442c3ca06ef2065f34007706ce17b87702d8f6b7f014fa"],"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":"Caption Health of Brisbane, California, makes Caption Interpretation Automated Ejection Fraction Software, known as AutoEF. It applies machine learning to ultrasound clips of the heart to estimate left ventricular ejection fraction, a measure of how well the heart pumps. A convolutional neural network picks the best views, and a deep learning model, locked before validation, makes the estimate. The clinician can edit the result and must accept or reject it. A retrospective study used 186 patient studies from Minneapolis Heart Institute, Duke University and Northwestern University. Expert cardiologists' biplane measurements served as the reference. FDA reviewers report that the root mean square deviation was 7.21 for the best available view, within the acceptance criterion of 9.2%. Every combination of views and each single view also met its goal. FDA granted the De Novo request on 24 February 2023, together with a plan that sets how Caption Health may retrain and update the model. The study used stored images, so the estimates guided no care. No patient outcome was measured.","replication":{"produced_by":["A convolutional neural network classified the clips and selected the best available views.","The model that estimates ejection fraction was trained on apical and parasternal long-axis views and locked before validation.","Expert cardiologists measured the reference values with the biplane Modified Simpson's method."],"must_hold":["The patient is an adult with a transthoracic echocardiogram.","A qualified professional checks that the images are adequate for the measurement.","The clinician reviews the estimate and accepts, edits or rejects it."],"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":"4f36ffc87885555ef56a2666fe25e667ac204f00a216f7ef6c6566dfaa71992f"}