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The films came from male heavy smokers aged 45 or older, and the system placed 5.3 false positive marks per image."}},"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":"RapidScreen RS-2000"}},"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 found that radiologists reading chest X-rays with the RapidScreen RS-2000 detected lung cancers of 9.5-27.5 mm better than without it","headline":"*RapidScreen RS-2000* helped radiologists spot small lung cancers"}},"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":["a28f43296d6c471bfd0d33a74d7b25d991161a0b731e7b46e2836b58d7cc3aad"],"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":"Deus Technologies of Rockville, Maryland, built the RapidScreen RS-2000, which marks possible lung nodules on digitized chest radiographs. Its classifier combines heuristic rules, an artificial neural network and fuzzy logic. It was developed on more than 1,000 radiographs with early lung cancer and more than 10,000 cancer-free images. In a reader study at Georgetown University Medical Center, 15 community radiologists read 240 archived films, 80 of them with cancer. They first read every film without the system. At least a month later, they read each film again, first alone and then with the marks. FDA reviewers report that the area under the ROC curve rose from 0.8288 to 0.8654. Sensitivity rose from 71% to 78%, and the false positive fraction rose from 21% to 22%. FDA approved the device on 12 July 2001. The films came from male heavy smokers aged 45 or older, and the system placed 5.3 false positive marks per image.","replication":{"produced_by":["Each chest radiograph was digitized, and the system marked suspected nodules above a fixed likelihood threshold.","Radiologists read each film without the system before they reviewed the marked image."],"must_hold":["The physician completes an initial interpretation before consulting the marks.","The patient belongs to the group in which the device was validated, adult male smokers aged 45 or older at high risk for cancer."],"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":"be7412ad518423c34ed03852f4b84ffa876af31fdc0e0a4eda3fd08f2936c63a"}