{"id":"AIBD-0788","title":"FDA finds that the Claire OCT System's AI helped surgeons clear residual breast cancer at lumpectomy margins in 7 of 35 patients","summary":"In a trial that FDA reviewed, surgeons using the Claire OCT System after standard care cleared residual cancer in 7 of 35 patients, a 20.0% relative reduction.","date_observed":"2026-03-03","date_basis":"source publication","date_precision":"day","benefit_status":"reported","source_collection":null,"source_entry":null,"account":"Perimeter Medical Imaging AI of Toronto, Canada, makes the Claire OCT System. It takes images up to 2 mm below the surface of tissue removed in breast-conserving surgery, and a deep learning algorithm, ImgAssist, marks areas suspicious for cancer. In a randomized trial at US sites, surgeons first completed standard margin assessment. Patients in the device arm then had their specimens imaged, with optional extra shaves. Of 206 patients in the device arm, 35 still had a positive margin after standard care. FDA reviewers report that the device helped remove all residual disease in seven of them, an absolute reduction of 3.4% and a relative reduction of 20.0%. Surgeons' margin sensitivity rose from 48.7% to 61.5%, and their specificity fell from 72.1% to 65.8%. No device-related adverse events occurred. FDA approved the system on 3 March 2026. The reviewers note that real-world use may differ and that pathology samples only part of each margin.","category":"aggregate result","unexpected":false,"purpose":"Perimeter Medical Imaging AI built the Claire OCT System to help surgeons evaluate the margins of tissue removed during lumpectomy for breast cancer.","system":"Claire OCT System with the ImgAssist AI detection algorithm","model_version":"ImgAssist 2.0","developer":"Perimeter Medical Imaging AI, Inc.","deployer":"Breast surgeons at the investigational sites of the randomized trial (NCT05113927)","location":"Investigational sites, United States","domain":"Healthcare","segment":null,"benefit_type":"Improved Task Accuracy","work_activities":["4.A.1.b.1"],"taxonomy_note":null,"registry_ids":{"clinicaltrials_gov":"NCT05113927"},"ratings":[{"group":"personal","depth":3,"reason":"Seven of 35 patients with a positive margin after standard care had all residual disease removed in the first operation."},{"group":"organizational","depth":2,"reason":"Surgeons' sensitivity for diseased margins rose from 48.7% to 61.5% with the device, while their specificity fell."}],"ai_role":{"status":"assessed","statement":"Each patient in the device arm was assessed first with standard care alone and then with the device, so the seven conversions are attributed to decisions aided by the device."},"evidence":[{"kind":"regulatory document","citation":"U.S. Food and Drug Administration, Center for Devices and Radiological Health. Summary of Safety and Effectiveness Data (SSED), P250008: Claire OCT System. Approved 2026-03-03.","title":"Summary of Safety and Effectiveness Data (SSED), P250008: Claire OCT System","url":"https://www.accessdata.fda.gov/cdrh_docs/pdf25/P250008B.pdf","date":"2026-03-03","written_by":"independent","quote":"Seven (7) out of 35 patients in the study with one or more positive margin after a SOC lumpectomy procedure were converted to fully negative margins after device-aided adjunctive decisions."}],"replication":{"produced_by":["Surgeons trained to read OCT images completed a supervised roll-in phase before the randomized phase.","The device was used after standard intraoperative margin assessment was complete.","The algorithm was locked before the final part of the trial."],"must_hold":["The patient has biopsy-confirmed breast cancer and undergoes lumpectomy.","Surgeons use the images alongside standard methods and keep post-operative pathology."],"echoes":[]},"paired_incident":null,"headline":"*Claire OCT System* helped surgeons remove cancer left at the margins","metric":"a 20.0% relative reduction","comparator":{"against":"The same patients' margins after standard care alone","before":"17.0% with at least one unaddressed positive margin","after":"13.6% after use of the device","basis":"measured","quote":"Specifically, the positive margin rate in the study was 17.0% after SOC procedures and 13.6% after adjunctive used of the device.","url":"https://www.accessdata.fda.gov/cdrh_docs/pdf25/P250008B.pdf"},"later":null,"value":null,"developer_country":"Canada","deployer_country":"United States","unrated_because":null,"brief_notes":null,"brief":null,"revisions":[{"date":"2026-10-31","change":"Added the record from the finding of the FDA Center for Devices and Radiological Health.","source":"https://www.accessdata.fda.gov/cdrh_docs/pdf25/P250008B.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":["United States"],"profile":{"case_id":"AIBD-0788","catalog_version":"1.0.0","source_fingerprint":"b11e2b0dbde1377a8110eca768805c3d3a347e9c3ce9d876db9306ed83854a94","collection_refs":[{"collection_id":"aibd","version":"2026-10-31"},{"collection_id":"querist","version":"2026-10-25"},{"collection_id":"viator","version":"2026-10-25"}],"source_ids":["AIBD-0788-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":"Perimeter Medical Imaging AI, Inc.","deployer":"Breast surgeons at the investigational sites of the randomized trial (NCT05113927)"}},"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":"Each patient in the device arm was assessed first with standard care alone and then with the device, so the seven conversions are attributed to decisions aided by the device."}}},"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":"Each patient in the device arm was assessed first with standard care alone and then with the device, so the seven conversions are attributed to decisions aided by the device."}}},"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":"value_present","value":{"kind":"record_fields","fields":{"ratings":[{"group":"personal","depth":3,"reason":"Seven of 35 patients with a positive margin after standard care had all residual disease removed in the first operation."},{"group":"organizational","depth":2,"reason":"Surgeons' sensitivity for diseased margins rose from 48.7% to 61.5% with the device, while their specificity fell."}]}},"provenance":{"kind":"legacy_record","basis":"Editorial assignment.","record_fields":["ratings"],"source_refs":[]},"review_state":"record_mapped","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":"personal","depth":3,"reason":"Seven of 35 patients with a positive margin after standard care had all residual disease removed in the first operation."},{"group":"organizational","depth":2,"reason":"Surgeons' sensitivity for diseased margins rose from 48.7% to 61.5% with the device, while their specificity fell."}]}},"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":"personal","depth":3,"reason":"Seven of 35 patients with a positive margin after standard care had all residual disease removed in the first operation."},{"group":"organizational","depth":2,"reason":"Surgeons' sensitivity for diseased margins rose from 48.7% to 61.5% with the device, while their specificity fell."}]}},"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-0788-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":"pilot","answer":"The system was used in a pilot. A randomized trial at US hospitals before approval.","scope":"The period and activity described in the case."}},"provenance":{"kind":"source_review","basis":"Editorial assignment.","record_fields":["account","evidence"],"source_refs":["AIBD-0788-source-0001"],"reviewed_on":"2026-10-29"},"review_state":"reviewed","coverage":"complete","display":{"answer":"The system was used in a pilot. A randomized trial at US hospitals before approval.","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":"value_present","value":{"kind":"record_fields","fields":{"registry_ids":{"clinicaltrials_gov":"NCT05113927"}}},"provenance":{"kind":"legacy_record","basis":"Editorial assignment.","record_fields":["registry_ids"],"source_refs":[]},"review_state":"record_mapped","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-0788"}},"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":"Perimeter Medical Imaging AI of Toronto, Canada, makes the Claire OCT System. It takes images up to 2 mm below the surface of tissue removed in breast-conserving surgery, and a deep learning algorithm, ImgAssist, marks areas suspicious for cancer. In a randomized trial at US sites, surgeons first completed standard margin assessment. Patients in the device arm then had their specimens imaged, with optional extra shaves. Of 206 patients in the device arm, 35 still had a positive margin after standard care. FDA reviewers report that the device helped remove all residual disease in seven of them, an absolute reduction of 3.4% and a relative reduction of 20.0%. Surgeons' margin sensitivity rose from 48.7% to 61.5%, and their specificity fell from 72.1% to 65.8%. No device-related adverse events occurred. FDA approved the system on 3 March 2026. The reviewers note that real-world use may differ and that pathology samples only part of each margin.","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":"personal","depth":3,"reason":"Seven of 35 patients with a positive margin after standard care had all residual disease removed in the first operation."},{"group":"organizational","depth":2,"reason":"Surgeons' sensitivity for diseased margins rose from 48.7% to 61.5% with the device, while their specificity fell."}]}},"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":"reported"}},"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":"Perimeter Medical Imaging AI built the Claire OCT System to help surgeons evaluate the margins of tissue removed during lumpectomy for breast cancer."}},"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":"Investigational sites, United States","developer_country":"Canada","deployer_country":"United States"}},"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":"Perimeter Medical Imaging AI built the Claire OCT System to help surgeons evaluate the margins of tissue removed during lumpectomy for breast cancer."}},"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":"2026-03-03","date_basis":"source publication","date_precision":"day","revisions":[{"date":"2026-10-31","change":"Added the record from the finding of the FDA Center for Devices and Radiological Health.","source":"https://www.accessdata.fda.gov/cdrh_docs/pdf25/P250008B.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":["Surgeons trained to read OCT images completed a supervised roll-in phase before the randomized phase.","The device was used after standard intraoperative margin assessment was complete.","The algorithm was locked before the final part of the trial."],"must_hold":["The patient has biopsy-confirmed breast cancer and undergoes lumpectomy.","Surgeons use the images alongside standard methods and keep post-operative pathology."],"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 FDA Center for Devices and Radiological Health.","source":"https://www.accessdata.fda.gov/cdrh_docs/pdf25/P250008B.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. Summary of Safety and Effectiveness Data (SSED), P250008: Claire OCT System. Approved 2026-03-03.","title":"Summary of Safety and Effectiveness Data (SSED), P250008: Claire OCT System","url":"https://www.accessdata.fda.gov/cdrh_docs/pdf25/P250008B.pdf","date":"2026-03-03","written_by":"independent","quote":"Seven (7) out of 35 patients in the study with one or more positive margin after a SOC lumpectomy procedure were converted to fully negative margins after device-aided adjunctive decisions."}]}},"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-0788-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. Summary of Safety and Effectiveness Data (SSED), P250008: Claire OCT System. Approved 2026-03-03.","title":"Summary of Safety and Effectiveness Data (SSED), P250008: Claire OCT System","url":"https://www.accessdata.fda.gov/cdrh_docs/pdf25/P250008B.pdf","date":"2026-03-03","written_by":"independent","quote":"Seven (7) out of 35 patients in the study with one or more positive margin after a SOC lumpectomy procedure were converted to fully negative margins after device-aided adjunctive decisions."}]}},"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 a trial that FDA reviewed, surgeons using the Claire OCT System after standard care cleared residual cancer in 7 of 35 patients, a 20.0% relative reduction.","account":"Perimeter Medical Imaging AI of Toronto, Canada, makes the Claire OCT System. It takes images up to 2 mm below the surface of tissue removed in breast-conserving surgery, and a deep learning algorithm, ImgAssist, marks areas suspicious for cancer. In a randomized trial at US sites, surgeons first completed standard margin assessment. Patients in the device arm then had their specimens imaged, with optional extra shaves. Of 206 patients in the device arm, 35 still had a positive margin after standard care. FDA reviewers report that the device helped remove all residual disease in seven of them, an absolute reduction of 3.4% and a relative reduction of 20.0%. Surgeons' margin sensitivity rose from 48.7% to 61.5%, and their specificity fell from 72.1% to 65.8%. No device-related adverse events occurred. FDA approved the system on 3 March 2026. The reviewers note that real-world use may differ and that pathology samples only part of each margin."}},"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":"value_present","value":{"kind":"record_fields","fields":{"model_version":"ImgAssist 2.0"}},"provenance":{"kind":"legacy_record","basis":"Editorial assignment.","record_fields":["model_version"],"source_refs":[]},"review_state":"record_mapped","coverage":"partial"},"systems[].product_name":{"state":"value_present","value":{"kind":"record_fields","fields":{"system":"Claire OCT System with the ImgAssist AI detection algorithm"}},"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 finds that the Claire OCT System's AI helped surgeons clear residual breast cancer at lumpectomy margins in 7 of 35 patients","headline":"*Claire OCT System* helped surgeons remove cancer left at the margins"}},"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":["792cf151316aa192dc647249b79d35fe09dbddeac3dfa610f28c5fc21ff7f078"],"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":"Perimeter Medical Imaging AI of Toronto, Canada, makes the Claire OCT System. It takes images up to 2 mm below the surface of tissue removed in breast-conserving surgery, and a deep learning algorithm, ImgAssist, marks areas suspicious for cancer. In a randomized trial at US sites, surgeons first completed standard margin assessment. Patients in the device arm then had their specimens imaged, with optional extra shaves. Of 206 patients in the device arm, 35 still had a positive margin after standard care. FDA reviewers report that the device helped remove all residual disease in seven of them, an absolute reduction of 3.4% and a relative reduction of 20.0%. Surgeons' margin sensitivity rose from 48.7% to 61.5%, and their specificity fell from 72.1% to 65.8%. No device-related adverse events occurred. FDA approved the system on 3 March 2026. The reviewers note that real-world use may differ and that pathology samples only part of each margin.","replication":{"produced_by":["Surgeons trained to read OCT images completed a supervised roll-in phase before the randomized phase.","The device was used after standard intraoperative margin assessment was complete.","The algorithm was locked before the final part of the trial."],"must_hold":["The patient has biopsy-confirmed breast cancer and undergoes lumpectomy.","Surgeons use the images alongside standard methods and keep post-operative pathology."],"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":31,"reviewed":2,"reviewed_complete":2,"reviewed_partial":0,"record_mapped":29,"review_not_assessed":60,"not_assessed":0,"complete":false,"by_state":{"value_present":31,"not_reported":0,"unresolved":60,"not_assessed":0,"not_applicable":0,"withheld":0,"source_unavailable":0}}},"presentation_version":"df0082af26e13a0e272c272488b954c56aa5504d0120f9ee3687b333bfcf93f5"}