{"architecture":{"family":"Not disclosed. Checked on 2026-09-06: paige.ai gives no network type, backbone, parameter count or training-data description. The public technical reference for this product is the FDA De Novo summary DEN200080, already linked on this card.","input":"Digitised H&E whole-slide images of prostate needle biopsies, on validated scanners.","output":"Flagging of areas suspicious for cancer for the reviewing pathologist; not a standalone diagnosis.","params":"not disclosed by the manufacturer"},"article":null,"cancer_slugs":["prostate"],"category":"pathology","confidence":"high","datasets":[],"developer":"Paige","evaluation":[{"benchmark":"AHRQ/NCBI evidence review of the Paige Prostate Suite (NBK608438) \u2014 pathologists reading prostate needle-biopsy whole-slide images without and then with the tool","external":true,"metric":"sensitivity and specificity of the pathologist, unassisted vs assisted","source":"https://www.ncbi.nlm.nih.gov/books/NBK608438/","value":"across the reviewed studies the reviewers report a sensitivity gain of 2.9% to 16% from unassisted to assisted reading, with assisted sensitivity between 90% and 96.9%; specificity stayed broadly unchanged \u2014 assisted specificity between 96.6% and 99.8%, the largest fall being 2.0% and one study reporting a rise of 0.7%. These are ranges across several studies, not the result of a single trial."}],"hf":null,"kind":"product","license":"proprietary","limitations":"- Cleared for prostate needle biopsies only, on validated scanners.\n- Closed weights; performance claims come from the regulatory submission.","links":{"demo":null,"docs":"https://www.accessdata.fda.gov/cdrh_docs/pdf20/DEN200080.pdf","doi":null,"github":null,"huggingface":null,"paper":null,"pmid":null},"modalities":["histopathology"],"name":"Paige Prostate Detect","notable_uses":"In published studies, pathologists working with the tool improved the sensitivity of cancer detection by roughly 3\u201316% depending on the study, with negative predictive values of about 96\u2013100%. Larger prospective trials are still needed to confirm performance in everyday practice.","openness":"closed","regulatory":{"details_en":"FDA De Novo DEN200080 (granted 2021-09-21) for Paige Prostate as software to assist pathologists in detecting areas suspicious for cancer on prostate needle biopsy slides.","details_pl":"FDA De Novo DEN200080 (udzielone 2021-09-21) dla Paige Prostate jako oprogramowania wspieraj\u0105cego patomorfolog\u00f3w w wykrywaniu obszar\u00f3w podejrzanych o raka na preparatach z biopsji ig\u0142owej prostaty.","intended_use_en":"Aid to pathologists reviewing digitised prostate needle-biopsy H&E slides; not for standalone diagnosis.","intended_use_pl":"Pomoc dla patomorfolog\u00f3w oceniaj\u0105cych zdigitalizowane preparaty H&E z biopsji ig\u0142owej prostaty; nie do samodzielnej diagnozy.","source_url":"https://www.accessdata.fda.gov/cdrh_docs/pdf20/DEN200080.pdf","status":"fda-de-novo"},"regulatory_status":"fda-de-novo","release_date":"2021-09-21","run_snippet":"","settings":["diagnosis"],"slug":"paige-prostate","sources":[{"label":"FDA De Novo decision summary DEN200080 (Paige Prostate)","url":"https://www.accessdata.fda.gov/cdrh_docs/pdf20/DEN200080.pdf"},{"label":"NCBI Bookshelf \u2014 evidence review of the Paige Prostate Suite (source of the sensitivity and specificity ranges quoted on this card)","url":"https://www.ncbi.nlm.nih.gov/books/NBK608438/"},{"label":"Pivotal validation study, cited after the review above: Raciti P, Sue J, Retamero JA et al. Clinical validation of artificial intelligence-augmented pathology diagnosis demonstrates significant gains in diagnostic accuracy in prostate cancer detection. Arch Pathol Lab Med 2023;147(10):1178-1185","url":"https://www.ncbi.nlm.nih.gov/books/NBK608438/"},{"label":"Independent (non-manufacturer) real-world validation, cited after the review above: da Silva LM et al. Independent real-world application of a clinical-grade automated prostate cancer detection system. J Pathol 2021;254(2):147-158","url":"https://www.ncbi.nlm.nih.gov/books/NBK608438/"}],"summary":"The first AI software for pathology authorised by the US FDA (De Novo, September 2021): flags prostate biopsy whole-slide images likely to contain cancer so the pathologist reviews the suspicious region.","tasks":["detection","classification"],"training":{"summary_en":"Not disclosed by the manufacturer. Checked on 2026-09-06: the Paige site (paige.ai) describes the Paige Prostate Suite functionally, as AI applications aiding detection and diagnosis of prostate cancer on H&E-stained whole-slide images of prostate needle biopsies, but names no training dataset, no number of whole-slide images or patients, no source institution and no architecture.","summary_pl":"Nieujawnione przez producenta. Sprawdzone 6.09.2026: strona Paige (paige.ai) opisuje Paige Prostate Suite funkcjonalnie, jako aplikacje AI wspierajace wykrywanie i rozpoznawanie raka gruczolu krokowego na skanach calych preparatow barwionych H&E z biopsji gruboiglowej, ale nie podaje zbioru treningowego, liczby skanow ani pacjentow, osrodka zrodlowego czy architektury."},"updated_at":"2026-09-07T07:06:50.538787","url":"/ai-oncology/models/paige-prostate","usage":{},"verified_at":"2026-09-07T07:06:50.537219","verified_by":"Occe3C","version":null,"what_it_does":"A second-read aid on digitised H&E prostate needle biopsies: outputs a slide-level suspicion flag and highlights the area of concern; the diagnosis remains the pathologist's."}