{"id":"AIBD-0633","title":"FDA De Novo review of ArteraAI Prostate: AI risk categories from biopsy slides separate 10-year metastasis risk in 886 patients","summary":"In FDA's review of ArteraAI Prostate, among 886 patients, 10-year metastasis risk was 28.1% in its high risk category and 3.3% in its low category, against 8.1% overall.","date_observed":"2025-07-31","date_basis":"source publication","date_precision":"day","benefit_status":"intended","source_collection":null,"source_entry":null,"account":"Artera, Inc. of Los Altos, California, developed ArteraAI Prostate, deep learning software that reads digitized H&E slides from prostate needle biopsies and estimates the 10-year risk of distant metastasis and of death from prostate cancer. The model was trained on slides from randomized trials and other clinical studies with recorded outcomes. FDA reviewers describe a clinical validation in 886 patients at three US sites. The 10-year risk of distant metastasis was 28.1% for patients that the software placed in its high risk category and 3.3% for those in its low risk category, against 8.1% overall. FDA reviewers write that both differences are statistically and clinically significant. FDA granted the De Novo request on 31 July 2025 and found that the probable benefits outweigh the probable risks. The study measured how well the categories separate risk. It did not test whether treatment guided by the software changed outcomes, and only 72 patients were African American.","category":"general benefit","unexpected":false,"purpose":"ArteraAI Prostate was built to give physicians 10-year risk estimates of metastasis and prostate cancer death to support treatment decisions. The measured risk separation is that purpose.","system":"ArteraAI Prostate","model_version":null,"developer":"Artera, Inc.","deployer":"Artera (clinical validation at three US sites)","location":"Three sites, United States","domain":"Healthcare","segment":null,"benefit_type":"Improved Task Accuracy","taxonomy_note":null,"registry_ids":{},"ratings":[{"group":"organizational","depth":null,"reason":"The study tested how well the categories separate risk and did not test whether treatment guided by the software changed outcomes."}],"ai_role":{"status":"unassessed","statement":"The study measured how the software's categories track later metastasis. It did not compare decisions or outcomes with and without the software."},"evidence":[{"kind":"regulatory document","citation":"U.S. Food and Drug Administration, Center for Devices and Radiological Health. De Novo classification request for ArteraAI Prostate (DEN240068): decision summary. 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