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For those children it had a positive predictive value of 81%, a negative predictive value of 98%, a sensitivity of 98% and a specificity of 79%. The device gave no result for 68% of children. FDA granted the De Novo request on 2 June 2021. The reviewers note that the average age at diagnosis was 2.8 years in the trial, against 4.3 years nationally. Clinicians in the study were blinded to the device output, so it did not change care.","category":"general benefit","unexpected":false,"purpose":"The Cognoa ASD Diagnosis Aid was built to help healthcare providers diagnose autism spectrum disorder in young children. The measured accuracy is that purpose.","system":"Cognoa ASD Diagnosis Aid","model_version":null,"developer":"Cognoa, Inc.","deployer":"Fourteen US sites in the Cognoa ASD Diagnosis Aid validation study","location":"Fourteen sites, United States","domain":"Healthcare","segment":null,"benefit_type":"Improved Task Accuracy","taxonomy_note":null,"registry_ids":{},"ratings":[{"group":"organizational","depth":null,"reason":"The device output was hidden from the clinicians, so no site gained a diagnosis that it would otherwise have missed or delayed."}],"ai_role":{"status":"unassessed","statement":"The study compared the device output with a specialist reference diagnosis. It did not compare diagnosis with and without the device."},"evidence":[{"kind":"regulatory document","citation":"U.S. Food and Drug Administration, Center for Devices and Radiological Health. De Novo classification request for Cognoa ASD Diagnosis Aid (DEN200069): decision summary. Granted 2021-06-02.","title":"De Novo classification request for Cognoa ASD Diagnosis Aid (DEN200069)","url":"https://www.accessdata.fda.gov/cdrh_docs/reviews/DEN200069.pdf","date":"2021-06-02","written_by":"independent","quote":"Currently, the average age of diagnosis for ASD in the United States is 4.3 years, as compared to 2.8 years observed in the pivotal trial of the Cognoa ASD Diagnosis Aid."},{"kind":"peer-reviewed study","citation":"Megerian JT, Dey S, Melmed RD, et al. Evaluation of an artificial intelligence-based medical device for diagnosis of autism spectrum disorder. npj Digital Medicine 2022;5:57.","title":"Evaluation of an artificial intelligence-based medical device for diagnosis of autism spectrum disorder","url":"https://pmc.ncbi.nlm.nih.gov/articles/PMC9072329","date":"2022-05-05","written_by":"makers","quote":"The Device yielded these ASD positive or negative results with a PPV of 80.8% (95% CI, 70.3%-88.8%), NPV of 98.3% (95% CI, 90.6%-100%), sensitivity of 98.4% (95% CI, 91.6%-100%), and specificity of 78.9% (95% CI, 67.6%-87.7%)."}],"replication":{"produced_by":["Caregivers answered a questionnaire and recorded home videos through a smartphone app.","Trained analysts rated the videos and a clinician completed a questionnaire."],"must_hold":["The child is 18 to 72 months old with a developmental concern.","The clinician uses the result with other clinical evidence."],"echoes":[]},"paired_incident":null,"headline":"*Cognoa ASD Diagnosis Aid* matched specialists when it gave a result","metric":"a positive predictive value of 81%","comparator":{"against":"Specialist diagnosis validated by blinded central reviewers","before":"Reference diagnosis","after":"PPV 81%, NPV 98%, sensitivity 98%, specificity 79% among determinate outputs","basis":"measured","quote":"The number of patients in the study who received a false negative device output was low (n=1).","url":"https://www.accessdata.fda.gov/cdrh_docs/reviews/DEN200069.pdf"},"later":null,"value":null,"developer_country":"United States","deployer_country":"United States","unrated_because":"The device output was blinded from clinicians and changed no care, so no realized outcome is reported for any group.","brief_notes":null,"brief":null,"revisions":[{"date":"2026-10-29","change":"Added the case.","source":"https://www.accessdata.fda.gov/cdrh_docs/reviews/DEN200069.pdf","editor":"AIBD"},{"date":"2026-10-29","change":"Corrected the benefit status; revised the depth ratings.","source":null,"editor":"AIBD"}],"confidence":"found","shade":"high","claim_status":"Found by a regulator","claim_basis":"Sources: one independent regulatory document and the makers' peer-reviewed study. 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