{"id":"AIBD-0767","title":"FDA's De Novo review of Tyto Insights finds that it detected eardrum bulging in otoscope videos more accurately than three non-ENT clinicians","summary":"In the study that FDA reviewed, Tyto Insights detected eardrum bulging in 857 otoscope recordings with 0.9231 sensitivity, against 0.7242 for two pediatricians and a general practitioner.","date_observed":"2026-03-17","date_basis":"source publication","date_precision":"day","benefit_status":"intended","source_collection":null,"source_entry":null,"account":"Tyto Care of Netanya, Israel, makes Tyto Insights for Eardrum Bulging Detection, AI software that analyzes videos from its home otoscope. Its algorithms were trained on 3,102 recordings annotated by ear, nose and throat (ENT) specialists. For validation, the company used 857 recordings from real-world use, with ground truth set by a panel of ENT specialists. Three U.S.-licensed non-ENT clinicians, two pediatricians and a general practitioner, read the same recordings. FDA reviewers report that the device reached a sensitivity of 0.9231 and a specificity of 0.9463. The readers reached 0.7242 and 0.7325. The differences were statistically significant. They also favored the device in each subgroup evaluated, such as children aged 6 months to 2 years. FDA granted the De Novo request on 17 March 2026. The study was retrospective, so the output guided no care. FDA notes that the results are specific to this reader panel.","category":"aggregate result","unexpected":false,"purpose":"Tyto Care built Tyto Insights for Eardrum Bulging Detection to detect a bulging eardrum automatically in videos from its compatible otoscope.","system":"Tyto Insights for Eardrum Bulging Detection","model_version":null,"developer":"Tyto Care Ltd.","deployer":"Tyto Care (retrospective validation on 857 otoscope recordings from real-world use)","location":"Recording sites not stated in the decision summary","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":"The comparison used archived recordings, and no clinician acted on the device output."}],"ai_role":{"status":"assessed","statement":"The device and three non-ENT clinicians read the same recordings against the same ENT reference, so the gain is attributed to the software. Clinicians reading with and without the device were not compared."},"evidence":[{"kind":"regulatory document","citation":"U.S. Food and Drug Administration, Center for Devices and Radiological Health. De Novo classification request for Tyto Insights for Eardrum Bulging Detection (DEN250014): decision summary. Granted 2026-03-17.","title":"De Novo classification request for Tyto Insights for Eardrum Bulging Detection (DEN250014)","url":"https://www.accessdata.fda.gov/cdrh_docs/reviews/DEN250014.pdf","date":"2026-03-17","written_by":"independent","quote":"there is sufficient evidence to support concluding that the probable benefit of the Tyto Insights for Eardrum Bulging Detection exceeds the probable risks for its use to automatically detect the bulging of the eardrum in otoscopic video recordings."}],"replication":{"produced_by":["A quality filter excluded videos without a sufficiently visible eardrum before the bulging algorithm ran.","Recordings came from the compatible Tyto otoscope, used by lay people at home or by clinicians."],"must_hold":["Recordings must come from the compatible Tyto otoscope, used as its instructions direct.","A healthcare provider must interpret the result together with the recording and other patient data."],"echoes":[]},"paired_incident":null,"headline":"*Tyto Insights* spots bulging eardrums better than non-ENT doctors","metric":"a sensitivity of 0.9231","comparator":{"against":"Two pediatricians and one general practitioner reading the same recordings","before":"Sensitivity 0.7242, specificity 0.7325","after":"Sensitivity 0.9231, specificity 0.9463","basis":"measured","quote":"The study endpoints and hypothesis were met for the indicated patient population (difference in sensitivity of 0.1989 [0.1691 – 0.2315] and in specificity of 0.2087 [0.1756 – 0.2442], both in favor of the device).","url":"https://www.accessdata.fda.gov/cdrh_docs/reviews/DEN250014.pdf"},"later":null,"value":null,"developer_country":"Israel","deployer_country":"Israel","unrated_because":"The validation used recordings from past use and guided no care, so no realized outcome is reported for any group.","brief_notes":null,"brief":null,"revisions":[{"date":"2026-10-31","change":"Added the record from the finding of the U.S. Food and Drug Administration.","source":"https://www.accessdata.fda.gov/cdrh_docs/reviews/DEN250014.pdf","editor":"AIBD"}],"confidence":"found","shade":"high","claim_status":"Found by a regulator","claim_basis":"Sources: one independent regulatory document. The cited evidence includes no independent study or report.","case_jurisdictions":[],"profile":{"case_id":"AIBD-0767","catalog_version":"1.0.0","source_fingerprint":"7442233205b56a930236a9849bd9b5d83738a94d502e4fbc52cbdcd3e5a6ceb2","collection_refs":[{"collection_id":"aibd","version":"2026-10-31"},{"collection_id":"querist","version":"2026-10-25"}],"source_ids":["AIBD-0767-source-0001"],"families":{"strategic assessments":{"state":"unresolved","provenance":{"kind":"curatorial","basis":"Editorial assignment.","record_fields":[],"source_refs":[]},"reason":"Editorial assignment.","review_state":"not_assessed","coverage":"partial","record_ids":[]},"evaluations":{"state":"unresolved","provenance":{"kind":"curatorial","basis":"Editorial assignment.","record_fields":[],"source_refs":[]},"reason":"Editorial assignment.","review_state":"not_assessed","coverage":"partial","record_ids":[]},"monetary observations":{"state":"unresolved","provenance":{"kind":"curatorial","basis":"Editorial assignment.","record_fields":[],"source_refs":[]},"reason":"Editorial assignment.","review_state":"not_assessed","coverage":"partial","record_ids":[]},"institutional decisions":{"state":"unresolved","provenance":{"kind":"curatorial","basis":"Editorial assignment.","record_fields":[],"source_refs":[]},"reason":"Editorial assignment.","review_state":"not_assessed","coverage":"partial","record_ids":[]}},"fields":{"actors[]":{"state":"value_present","value":{"kind":"record_fields","fields":{"developer":"Tyto Care Ltd.","deployer":"Tyto Care (retrospective validation on 857 otoscope recordings from real-world use)"}},"provenance":{"kind":"legacy_record","basis":"Editorial assignment.","record_fields":["developer","deployer"],"source_refs":[]},"review_state":"record_mapped","coverage":"partial"},"actors[].ownership_control":{"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"},"ai_contribution":{"state":"value_present","value":{"kind":"record_fields","fields":{"ai_role":{"status":"assessed","statement":"The device and three non-ENT clinicians read the same recordings against the same ENT reference, so the gain is attributed to the software. Clinicians reading with and without the device were not compared."}}},"provenance":{"kind":"legacy_record","basis":"Editorial assignment.","record_fields":["ai_role"],"source_refs":[]},"review_state":"record_mapped","coverage":"partial"},"ai_relationship":{"state":"value_present","value":{"kind":"record_fields","fields":{"category":"aggregate result","ai_role":{"status":"assessed","statement":"The device and three non-ENT clinicians read the same recordings against the same ENT reference, so the gain is attributed to the software. Clinicians reading with and without the device were not compared."}}},"provenance":{"kind":"legacy_record","basis":"Editorial assignment.","record_fields":["ai_role","category"],"source_refs":[]},"review_state":"record_mapped","coverage":"partial"},"assessments[].alternatives":{"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"},"assessments[].assessor_date":{"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"},"assessments[].depth":{"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"},"assessments[].display_confidence":{"state":"value_present","value":{"kind":"structured","data":{"confidence":"high","evidence_word":"found","claim_status":"Found by a regulator","basis":"Sources: one independent regulatory document. The cited evidence includes no independent study or report.","interpretation":"Existing display rule preserved; the richer outcome-specific confidence question still needs review."}},"provenance":{"kind":"curatorial","basis":"Editorial assignment.","record_fields":[],"source_refs":[]},"review_state":"record_mapped","coverage":"partial"},"assessments[].rationale":{"state":"value_present","value":{"kind":"record_fields","fields":{"ratings":[{"group":"organizational","reason":"The comparison used archived recordings, and no clinician acted on the device output."}]}},"provenance":{"kind":"legacy_record","basis":"Editorial assignment.","record_fields":["ratings"],"source_refs":[]},"review_state":"record_mapped","coverage":"partial"},"assessments[].rubric_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"},"assessments[].status_basis":{"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"},"assessments[].target":{"state":"value_present","value":{"kind":"record_fields","fields":{"ratings":[{"group":"organizational","reason":"The comparison used archived recordings, and no clinician acted on the device output."}]}},"provenance":{"kind":"legacy_record","basis":"Editorial assignment.","record_fields":["ratings"],"source_refs":[]},"review_state":"record_mapped","coverage":"partial"},"availability":{"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"},"brief":{"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"},"case_kind":{"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"},"case_links[]":{"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"},"claims[].evidence_links":{"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"},"claims[].evidence_strength":{"state":"value_present","value":{"kind":"structured","data":{"answer":"Found by a regulator. Sources: one independent regulatory document. The cited evidence includes no independent study or report.","evidence_word":"found","claim_status":"Found by a regulator"}},"provenance":{"kind":"source_review","basis":"Editorial assignment.","record_fields":["evidence"],"source_refs":["AIBD-0767-source-0001"],"reviewed_on":"2026-10-29"},"review_state":"reviewed","coverage":"complete","display":{"answer":"Found by a regulator. Sources: one independent regulatory document. The cited evidence includes no independent study or report.","inferred":false}},"claims[].missingness":{"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"},"claims[].proposition":{"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"},"cross_border_flows[]":{"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"},"decisions[].action_outcome":{"state":"unresolved","review_state":"not_assessed","coverage":"partial","family":"institutional decisions"},"decisions[].grounds":{"state":"unresolved","review_state":"not_assessed","coverage":"partial","family":"institutional decisions"},"decisions[].institution_task":{"state":"unresolved","review_state":"not_assessed","coverage":"partial","family":"institutional decisions"},"decisions[].success_criterion":{"state":"unresolved","review_state":"not_assessed","coverage":"partial","family":"institutional decisions"},"deployment_stage":{"state":"value_present","value":{"kind":"structured","data":{"classification":"laboratory test","answer":"The system was tested in a laboratory. FDA reviewed a retrospective test on archived recordings in which the output guided no care.","scope":"The period and activity described in the case."}},"provenance":{"kind":"source_review","basis":"Editorial assignment.","record_fields":["account","evidence"],"source_refs":["AIBD-0767-source-0001"],"reviewed_on":"2026-10-29"},"review_state":"reviewed","coverage":"complete","display":{"answer":"The system was tested in a laboratory. FDA reviewed a retrospective test on archived recordings in which the output guided no care.","inferred":false}},"economics[].amount":{"state":"unresolved","review_state":"not_assessed","coverage":"partial","family":"monetary observations"},"economics[].costs[]":{"state":"unresolved","review_state":"not_assessed","coverage":"partial","family":"monetary observations"},"economics[].counterfactual":{"state":"unresolved","review_state":"not_assessed","coverage":"partial","family":"monetary observations"},"economics[].currency_price_basis":{"state":"unresolved","review_state":"not_assessed","coverage":"partial","family":"monetary observations"},"economics[].gross_net":{"state":"unresolved","review_state":"not_assessed","coverage":"partial","family":"monetary observations"},"economics[].measure_type":{"state":"unresolved","review_state":"not_assessed","coverage":"partial","family":"monetary observations"},"economics[].period_unit":{"state":"unresolved","review_state":"not_assessed","coverage":"partial","family":"monetary observations"},"economics[].realization":{"state":"unresolved","review_state":"not_assessed","coverage":"partial","family":"monetary observations"},"economics[].recipient_payer":{"state":"unresolved","review_state":"not_assessed","coverage":"partial","family":"monetary observations"},"economics[].return_payback":{"state":"unresolved","review_state":"not_assessed","coverage":"partial","family":"monetary observations"},"economics[].valuation_method":{"state":"unresolved","review_state":"not_assessed","coverage":"partial","family":"monetary observations"},"evaluations[].ai_uplift":{"state":"unresolved","review_state":"not_assessed","coverage":"partial","family":"evaluations"},"evaluations[].comparator":{"state":"unresolved","review_state":"not_assessed","coverage":"partial","family":"evaluations"},"evaluations[].design":{"state":"unresolved","review_state":"not_assessed","coverage":"partial","family":"evaluations"},"evaluations[].effect":{"state":"unresolved","review_state":"not_assessed","coverage":"partial","family":"evaluations"},"evaluations[].exposure":{"state":"unresolved","review_state":"not_assessed","coverage":"partial","family":"evaluations"},"evaluations[].id":{"state":"unresolved","review_state":"not_assessed","coverage":"partial","family":"evaluations"},"evaluations[].measurement_method":{"state":"unresolved","review_state":"not_assessed","coverage":"partial","family":"evaluations"},"evaluations[].metric":{"state":"unresolved","review_state":"not_assessed","coverage":"partial","family":"evaluations"},"evaluations[].reproduction_materials":{"state":"unresolved","review_state":"not_assessed","coverage":"partial","family":"evaluations"},"evaluations[].setting_sample":{"state":"unresolved","review_state":"not_assessed","coverage":"partial","family":"evaluations"},"evaluations[].uncertainty_limitations":{"state":"unresolved","review_state":"not_assessed","coverage":"partial","family":"evaluations"},"external_references[]":{"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"},"follow_up[]":{"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"},"human_oversight":{"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"},"id":{"state":"value_present","value":{"kind":"record_fields","fields":{"id":"AIBD-0767"}},"provenance":{"kind":"legacy_record","basis":"Editorial assignment.","record_fields":["id"],"source_refs":[]},"review_state":"record_mapped","coverage":"partial"},"infrastructure_dependencies[]":{"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"},"outcomes[].beneficiaries":{"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"},"outcomes[].beneficiary_count":{"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"},"outcomes[].benefit_type":{"state":"value_present","value":{"kind":"record_fields","fields":{"benefit_type":"Improved Task Accuracy"}},"provenance":{"kind":"legacy_record","basis":"Editorial assignment.","record_fields":["benefit_type"],"source_refs":[]},"review_state":"record_mapped","coverage":"partial"},"outcomes[].claim":{"state":"value_present","value":{"kind":"record_fields","fields":{"account":"Tyto Care of Netanya, Israel, makes Tyto Insights for Eardrum Bulging Detection, AI software that analyzes videos from its home otoscope. Its algorithms were trained on 3,102 recordings annotated by ear, nose and throat (ENT) specialists. For validation, the company used 857 recordings from real-world use, with ground truth set by a panel of ENT specialists. Three U.S.-licensed non-ENT clinicians, two pediatricians and a general practitioner, read the same recordings. FDA reviewers report that the device reached a sensitivity of 0.9231 and a specificity of 0.9463. The readers reached 0.7242 and 0.7325. The differences were statistically significant. They also favored the device in each subgroup evaluated, such as children aged 6 months to 2 years. FDA granted the De Novo request on 17 March 2026. The study was retrospective, so the output guided no care. FDA notes that the results are specific to this reader panel.","benefit_type":"Improved Task Accuracy"}},"provenance":{"kind":"legacy_record","basis":"Editorial assignment.","record_fields":["account","benefit_type"],"source_refs":[]},"review_state":"record_mapped","coverage":"partial"},"outcomes[].distribution":{"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"},"outcomes[].duration":{"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"},"outcomes[].id":{"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"},"outcomes[].stakeholder_group":{"state":"value_present","value":{"kind":"record_fields","fields":{"ratings":[{"group":"organizational","reason":"The comparison used archived recordings, and no clinician acted on the device output."}]}},"provenance":{"kind":"legacy_record","basis":"Editorial assignment.","record_fields":["ratings"],"source_refs":[]},"review_state":"record_mapped","coverage":"partial"},"outcomes[].status":{"state":"value_present","value":{"kind":"record_fields","fields":{"benefit_status":"intended"}},"provenance":{"kind":"legacy_record","basis":"Editorial assignment.","record_fields":["benefit_status"],"source_refs":[]},"review_state":"record_mapped","coverage":"partial"},"outcomes[].tradeoffs":{"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"},"outcomes[].unexpected":{"state":"value_present","value":{"kind":"record_fields","fields":{"unexpected":false,"purpose":"Tyto Care built Tyto Insights for Eardrum Bulging Detection to detect a bulging eardrum automatically in videos from its compatible otoscope."}},"provenance":{"kind":"legacy_record","basis":"Editorial assignment.","record_fields":["unexpected","purpose"],"source_refs":[]},"review_state":"record_mapped","coverage":"partial"},"places[]":{"state":"value_present","value":{"kind":"record_fields","fields":{"location":"Recording sites not stated in the decision summary","developer_country":"Israel","deployer_country":"Israel"}},"provenance":{"kind":"legacy_record","basis":"Editorial assignment.","record_fields":["location","developer_country","deployer_country"],"source_refs":[]},"review_state":"record_mapped","coverage":"partial"},"purpose":{"state":"value_present","value":{"kind":"record_fields","fields":{"purpose":"Tyto Care built Tyto Insights for Eardrum Bulging Detection to detect a bulging eardrum automatically in videos from its compatible otoscope."}},"provenance":{"kind":"legacy_record","basis":"Editorial assignment.","record_fields":["purpose"],"source_refs":[]},"review_state":"record_mapped","coverage":"partial"},"record_dates":{"state":"value_present","value":{"kind":"record_fields","fields":{"date_observed":"2026-03-17","date_basis":"source publication","date_precision":"day","revisions":[{"date":"2026-10-31","change":"Added the record from the finding of the U.S. Food and Drug Administration.","source":"https://www.accessdata.fda.gov/cdrh_docs/reviews/DEN250014.pdf","editor":"AIBD"}]}},"provenance":{"kind":"legacy_record","basis":"Editorial assignment.","record_fields":["date_observed","date_basis","date_precision","revisions"],"source_refs":[]},"review_state":"record_mapped","coverage":"partial"},"replication.attempts[]":{"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"},"replication.conditions":{"state":"value_present","value":{"kind":"record_fields","fields":{"replication":{"produced_by":["A quality filter excluded videos without a sufficiently visible eardrum before the bulging algorithm ran.","Recordings came from the compatible Tyto otoscope, used by lay people at home or by clinicians."],"must_hold":["Recordings must come from the compatible Tyto otoscope, used as its instructions direct.","A healthcare provider must interpret the result together with the recording and other patient data."],"echoes":[]}}},"provenance":{"kind":"legacy_record","basis":"Editorial assignment.","record_fields":["replication"],"source_refs":[]},"review_state":"record_mapped","coverage":"partial"},"revision_history[]":{"state":"value_present","value":{"kind":"record_fields","fields":{"revisions":[{"date":"2026-10-31","change":"Added the record from the finding of the U.S. Food and Drug Administration.","source":"https://www.accessdata.fda.gov/cdrh_docs/reviews/DEN250014.pdf","editor":"AIBD"}]}},"provenance":{"kind":"legacy_record","basis":"Editorial assignment.","record_fields":["revisions"],"source_refs":[]},"review_state":"record_mapped","coverage":"partial"},"sector":{"state":"value_present","value":{"kind":"record_fields","fields":{"domain":"Healthcare"}},"provenance":{"kind":"legacy_record","basis":"Editorial assignment.","record_fields":["domain"],"source_refs":[]},"review_state":"record_mapped","coverage":"partial"},"sources[].access_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"},"sources[].citation_locator":{"state":"value_present","value":{"kind":"record_fields","fields":{"evidence":[{"kind":"regulatory document","citation":"U.S. Food and Drug Administration, Center for Devices and Radiological Health. De Novo classification request for Tyto Insights for Eardrum Bulging Detection (DEN250014): decision summary. Granted 2026-03-17.","title":"De Novo classification request for Tyto Insights for Eardrum Bulging Detection (DEN250014)","url":"https://www.accessdata.fda.gov/cdrh_docs/reviews/DEN250014.pdf","date":"2026-03-17","written_by":"independent","quote":"there is sufficient evidence to support concluding that the probable benefit of the Tyto Insights for Eardrum Bulging Detection exceeds the probable risks for its use to automatically detect the bulging of the eardrum in otoscopic video recordings."}]}},"provenance":{"kind":"legacy_record","basis":"Editorial assignment.","record_fields":["evidence"],"source_refs":[]},"review_state":"record_mapped","coverage":"partial"},"sources[].id":{"state":"value_present","value":{"kind":"identifiers","identifiers":["AIBD-0767-source-0001"],"role":"Existing evidence items, in their original order"},"provenance":{"kind":"curatorial","basis":"Editorial assignment.","record_fields":[],"source_refs":[]},"review_state":"record_mapped","coverage":"complete"},"sources[].language":{"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"},"sources[].relationship":{"state":"value_present","value":{"kind":"record_fields","fields":{"evidence":[{"kind":"regulatory document","citation":"U.S. Food and Drug Administration, Center for Devices and Radiological Health. De Novo classification request for Tyto Insights for Eardrum Bulging Detection (DEN250014): decision summary. Granted 2026-03-17.","title":"De Novo classification request for Tyto Insights for Eardrum Bulging Detection (DEN250014)","url":"https://www.accessdata.fda.gov/cdrh_docs/reviews/DEN250014.pdf","date":"2026-03-17","written_by":"independent","quote":"there is sufficient evidence to support concluding that the probable benefit of the Tyto Insights for Eardrum Bulging Detection exceeds the probable risks for its use to automatically detect the bulging of the eardrum in otoscopic video recordings."}]}},"provenance":{"kind":"legacy_record","basis":"Editorial assignment.","record_fields":["evidence"],"source_refs":[]},"review_state":"record_mapped","coverage":"partial"},"sources[].upstream_sources":{"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"},"strategic_assessments[]":{"state":"unresolved","review_state":"not_assessed","coverage":"partial","family":"strategic assessments"},"summary":{"state":"value_present","value":{"kind":"record_fields","fields":{"summary":"In the study that FDA reviewed, Tyto Insights detected eardrum bulging in 857 otoscope recordings with 0.9231 sensitivity, against 0.7242 for two pediatricians and a general practitioner.","account":"Tyto Care of Netanya, Israel, makes Tyto Insights for Eardrum Bulging Detection, AI software that analyzes videos from its home otoscope. Its algorithms were trained on 3,102 recordings annotated by ear, nose and throat (ENT) specialists. For validation, the company used 857 recordings from real-world use, with ground truth set by a panel of ENT specialists. Three U.S.-licensed non-ENT clinicians, two pediatricians and a general practitioner, read the same recordings. FDA reviewers report that the device reached a sensitivity of 0.9231 and a specificity of 0.9463. The readers reached 0.7242 and 0.7325. The differences were statistically significant. They also favored the device in each subgroup evaluated, such as children aged 6 months to 2 years. FDA granted the De Novo request on 17 March 2026. The study was retrospective, so the output guided no care. FDA notes that the results are specific to this reader panel."}},"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":"Tyto Insights for Eardrum Bulging Detection"}},"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's De Novo review of Tyto Insights finds that it detected eardrum bulging in otoscope videos more accurately than three non-ENT clinicians","headline":"*Tyto Insights* spots bulging eardrums better than non-ENT doctors"}},"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":["6748f9ae53a869d2ba203f95affe63e8ef943d123430a80d8411024f6ff42d01"],"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":"Tyto Care of Netanya, Israel, makes Tyto Insights for Eardrum Bulging Detection, AI software that analyzes videos from its home otoscope. Its algorithms were trained on 3,102 recordings annotated by ear, nose and throat (ENT) specialists. For validation, the company used 857 recordings from real-world use, with ground truth set by a panel of ENT specialists. Three U.S.-licensed non-ENT clinicians, two pediatricians and a general practitioner, read the same recordings. FDA reviewers report that the device reached a sensitivity of 0.9231 and a specificity of 0.9463. The readers reached 0.7242 and 0.7325. The differences were statistically significant. They also favored the device in each subgroup evaluated, such as children aged 6 months to 2 years. FDA granted the De Novo request on 17 March 2026. The study was retrospective, so the output guided no care. FDA notes that the results are specific to this reader panel.","replication":{"produced_by":["A quality filter excluded videos without a sufficiently visible eardrum before the bulging algorithm ran.","Recordings came from the compatible Tyto otoscope, used by lay people at home or by clinicians."],"must_hold":["Recordings must come from the compatible Tyto otoscope, used as its instructions direct.","A healthcare provider must interpret the result together with the recording and other patient data."],"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":28,"reviewed":2,"reviewed_complete":2,"reviewed_partial":0,"record_mapped":26,"review_not_assessed":63,"not_assessed":0,"complete":false,"by_state":{"value_present":28,"not_reported":0,"unresolved":63,"not_assessed":0,"not_applicable":0,"withheld":0,"source_unavailable":0}}},"presentation_version":"5ddbee8ee5aed7c1c55e4aa58500e20f56ae662f9f3c034bd64ecae9b81dbf6d"}