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About 69% of lesions without melanoma were classified positive."}},"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":"Nevisense (electrical impedance spectroscopy with a trained lesion classifier)"}},"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 Nevisense detected 95.9% of melanomas among lesions chosen for excision and raised dermatologists' sensitivity in a reader study","headline":"*Nevisense* caught nearly all melanomas at low specificity"}},"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":["9c820cfaf876cd3a9d93f4582e85d6f9260e8d71e56e261896193618e393a8fd"],"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":"SciBase of Stockholm, Sweden, makes Nevisense, a probe that measures the electrical impedance of a skin lesion. A classifier developed on data from nearly 2,000 patients turns the readings into a score and a positive or negative result. In the SIMPS study at 22 sites in Europe and the United States, 1,951 patients had 2,416 lesions that dermatologists had chosen to excise. The dermatologists did not see the device results. FDA reviewers report that the device detected 256 of 267 melanomas, a sensitivity of 95.9%, and that its specificity was 31.3%. In a reader study, 41 US dermatologists judged photographs of 141 lesions without and then with the device output. Their sensitivity for melanoma rose from 77.2% to 83.6%. Their specificity fell by 4% on average, a change that was not statistically significant. FDA approved Nevisense on 28 June 2017. About 69% of lesions without melanoma were classified positive.","replication":{"produced_by":["Clinicians measured lesions between 2 mm and 20 mm across that dermatologists had already chosen to excise.","Readers judged each lesion without the device score first and then with it."],"must_hold":["The lesion has clinical or historical signs of melanoma and is not clinically obvious melanoma.","The skin over the lesion is intact and outside hair-covered areas and special sites such as acral skin."],"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":29,"reviewed":2,"reviewed_complete":2,"reviewed_partial":0,"record_mapped":27,"review_not_assessed":62,"not_assessed":0,"complete":false,"by_state":{"value_present":29,"not_reported":0,"unresolved":62,"not_assessed":0,"not_applicable":0,"withheld":0,"source_unavailable":0}}},"presentation_version":"a636b7762ad012dac58dff085a805cf49800eed6a87aa6dcb812ada49c319778"}