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Device specificity was 20.7%, against 54.2% for the physicians. In a companion reader study, 108 primary care physicians reviewed 50 lesion images with and without the device output. Their sensitivity rose from 82.0% to 91.4%, and their specificity fell from 44.2% to 32.4%. FDA granted the De Novo request on 12 January 2024. The reviewers note that the device will raise referrals of benign lesions and that patients with darker skin had limited representation.","category":"general benefit","unexpected":false,"purpose":"DermaSensor was built to help physicians who are not dermatologists decide whether to refer a suspicious skin lesion. Better referral sensitivity is that purpose.","system":"DermaSensor","model_version":null,"developer":"DermaSensor, Inc.","deployer":"Primary care sites in the DERM-SUCCESS study","location":"Twenty-two sites in the United States and Australia","domain":"Healthcare","segment":null,"benefit_type":"Improved Task Accuracy","taxonomy_note":null,"registry_ids":{},"ratings":[{"group":"organizational","depth":2,"reason":"Primary care physicians aided by the device reached 91.4% sensitivity for skin cancer referral against 82.0% unaided."}],"ai_role":{"status":"assessed","statement":"In the reader study each physician judged every lesion with and without the device output, so the change in sensitivity is attributed to the device."},"evidence":[{"kind":"regulatory document","citation":"U.S. Food and Drug Administration, Center for Devices and Radiological Health. De Novo classification request for DermaSensor (DEN230008): decision summary. Granted 2024-01-12.","title":"De Novo classification request for DermaSensor (DEN230008)","url":"https://www.accessdata.fda.gov/cdrh_docs/reviews/DEN230008.pdf","date":"2024-01-12","written_by":"independent","quote":"The main benefit of the DermaSensor device is the demonstrated ability to improve the management decision of PCPs in the intended use population."}],"replication":{"produced_by":["Physicians applied the device to lesions they already found suspicious.","Physicians used the output as a second read after their own assessment."],"must_hold":["The patient is aged 40 or older.","A dermatologist makes the final management decision after referral."],"echoes":[]},"paired_incident":null,"headline":"*DermaSensor* raised primary care sensitivity for skin cancer","metric":"Their sensitivity rose from 82.0% to 91.4%","comparator":{"against":"The same primary care physicians judging the same lesion images without the device output","before":"Sensitivity 82.0%, specificity 44.2%","after":"Sensitivity 91.4%, specificity 32.4%","basis":"measured","quote":"device-aided PCPs had a higher sensitivity of 91.4% (95% CI: 85.7-97.1%) compared with unaided PCP sensitivity 82.0% (95% CI: 76.4-87.6%; p=0.0027)","url":"https://www.accessdata.fda.gov/cdrh_docs/reviews/DEN230008.pdf"},"later":null,"value":null,"developer_country":"United States","deployer_country":"United States; Australia","unrated_because":null,"brief_notes":null,"brief":null,"revisions":[{"date":"2026-10-29","change":"Added the case.","source":"https://www.accessdata.fda.gov/cdrh_docs/reviews/DEN230008.pdf","editor":"AIBD"}],"confidence":"found","shade":"high","claim_status":"Found by a regulator","claim_basis":"Sources: one independent regulatory document. 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