Adjunct detection on prostate biopsy whole-slide images
O texto aparece em inglês até haver tradução.
Paige Prostate marks a location on a digitized prostate biopsy slide that the model ranks as the most suspicious for cancer, after the pathologist’s own first look. FDA authorized it in 2021 as an adjunct. The output is not the diagnosis. The pathologist still signs out, using the full clinical context and any extra stains they choose to order.
Cenário clínico
Surgical pathology laboratories reading hematoxylin-and-eosin prostate needle biopsies that have been scanned on a supported whole-slide scanner.
Ferramentas e fornecedores
Paige Prostate
Paige FullFocus
O que a fonte relatou
FDA reported that, across 16 pathologists and 527 slide images, cancer detection on individual slides improved by 7.3% on average versus unassisted reads, with no effect on the read of benign slides. The study did not measure the effect on the final patient diagnosis, which usually rests on more than one core.
Fonte
U.S. FDA De Novo DEN200080 · 21 de set. de 2021 · Ano 2021
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