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Its specificity was 10.6%, against 5.5% for the study dermatologists. In a web-based reader study, MelaFind's sensitivity was 97%, while dermatologists who reviewed the images missed 28% of melanomas. Their specificity was 51%, against 9% for MelaFind. An advisory panel split 8 to 7 on whether benefits outweigh risks. FDA approved MelaFind on 1 November 2011 for trained dermatologists and required a post-approval study. About 9% of lesions could not be evaluated, and 18.7% of those were melanomas or high-grade lesions.","category":"aggregate result","unexpected":false,"purpose":"MELA Sciences built MelaFind to give dermatologists more information about atypical pigmented lesions when they decide whether to biopsy to rule out melanoma.","system":"MelaFind","model_version":null,"developer":"MELA Sciences, Inc.","deployer":"Seven dermatology sites in the blinded study (Protocol 20061) and physicians in a web-based reader study (Protocol 20063)","location":"Seven dermatology sites, United States","domain":"Healthcare","segment":null,"benefit_type":"Improved Task Accuracy","work_activities":["4.A.1.b.1"],"taxonomy_note":null,"registry_ids":{},"ratings":[{"group":"organizational","depth":null,"reason":"Dermatologists did not see the device results in the blinded study, so no biopsy decision changed because of it."}],"ai_role":{"status":"unassessed","statement":"FDA reviewers compared the device's output with dermatologists' biopsy decisions on the same lesions. 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A classifier algorithm, developed and tested on 9439 images of 9078 lesions, labels the lesion positive or negative. In a blinded study at seven sites in 2007 and 2008, dermatologists did not see results for lesions that they had chosen to biopsy. FDA reviewers report that MelaFind detected 112 of 114 melanomas, a sensitivity of 98.3%. Its specificity was 10.6%, against 5.5% for the study dermatologists. In a web-based reader study, MelaFind's sensitivity was 97%, while dermatologists who reviewed the images missed 28% of melanomas. Their specificity was 51%, against 9% for MelaFind. An advisory panel split 8 to 7 on whether benefits outweigh risks. FDA approved MelaFind on 1 November 2011 for trained dermatologists and required a post-approval study. About 9% of lesions could not be evaluated, and 18.7% of those were melanomas or high-grade lesions."}},"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":"MelaFind"}},"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 MelaFind detected 98.3% of melanomas among lesions chosen for biopsy, at a low specificity that still beat dermatologists'","headline":"*MelaFind* caught nearly all melanomas at very 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":["95071152676f18a3bd5154db1b97f720b2a6b9fb5effeeddeaef71baca4ad625"],"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":"MELA Sciences of Irvington, New York, makes MelaFind, a handheld imager that takes a ten-band image of a pigmented skin lesion. A classifier algorithm, developed and tested on 9439 images of 9078 lesions, labels the lesion positive or negative. In a blinded study at seven sites in 2007 and 2008, dermatologists did not see results for lesions that they had chosen to biopsy. FDA reviewers report that MelaFind detected 112 of 114 melanomas, a sensitivity of 98.3%. Its specificity was 10.6%, against 5.5% for the study dermatologists. In a web-based reader study, MelaFind's sensitivity was 97%, while dermatologists who reviewed the images missed 28% of melanomas. Their specificity was 51%, against 9% for MelaFind. An advisory panel split 8 to 7 on whether benefits outweigh risks. FDA approved MelaFind on 1 November 2011 for trained dermatologists and required a post-approval study. About 9% of lesions could not be evaluated, and 18.7% of those were melanomas or high-grade lesions.","replication":{"produced_by":["Operators cleaned the lesion with alcohol and held the imager steady for 2-3 seconds.","Five earlier clinical studies developed the classifier before the blinded study tested it."],"must_hold":["The lesion is clinically atypical and has no clinical diagnosis of melanoma.","The user is a dermatologist who has completed training in the device.","Lesions that the device cannot evaluate are considered for biopsy."],"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":"14543817521d241a53f44cccc7a9556b1bdabd03c05ad2b1c4b41d533ecd3e67"}