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It rechecks prostate biopsy slides that a pathologist has called benign and flags slides likely to hold cancer. In the AIDER-2 study at three sites, two of them in the United States, it analyzed 347 retrospectively collected cases first diagnosed as benign. It flagged 202 cases, and expert pathologists confirmed cancer or atypical small acinar proliferation in 46 of them. In the AIDER-1 reader study, 12 pathologists at four sites read 772 cases with and without the software, two weeks apart. FDA reviewers report that sensitivity rose from 90.5% to 93.9% and specificity fell from 91.1% to 87.9%. FDA cleared the software on 24 January 2025. Both studies used archived slides. The reviewers write that the drop in specificity can be managed with additional stains to confirm positive calls.","replication":{"produced_by":["Slides were scanned on a Philips Ultra Fast Scanner at 40x magnification.","The software analyzed only cases that a pathologist had already diagnosed as benign."],"must_hold":["A pathologist makes the final diagnosis after reviewing the flagged slides.","The slides are H&E-stained prostate core needle biopsies."],"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":30,"reviewed":2,"reviewed_complete":2,"reviewed_partial":0,"record_mapped":28,"review_not_assessed":61,"not_assessed":0,"complete":false,"by_state":{"value_present":30,"not_reported":0,"unresolved":61,"not_assessed":0,"not_applicable":0,"withheld":0,"source_unavailable":0}}},"presentation_version":"d117a006164a45a10dc4165385bc7a848922b2b191275044b517fff4113480b2"}