Source record
Adjunct detection on prostate biopsy whole-slide images
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The source is the U.S. FDA De Novo decision DEN200080 for Paige Prostate, dated 21 September 2021. It authorizes the software as an adjunct that marks a location on a digitized prostate biopsy after the pathologist’s own first look. 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 benign slides. The study did not measure the effect on the final patient diagnosis.
- Source date
- 21. Sept. 2021 · Jahr 2021
- Evidence label
- Regulatorisch
- Source type
- Nachricht
Citation
U.S. FDA De Novo DEN200080
U.S. Food and Drug Administration. De Novo classification request DEN200080, Paige Prostate. Decision date 21 September 2021. https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/denovo.cfm?id=DEN200080
Key public facts
- FDA authorized Paige Prostate on 21 September 2021 as an adjunct, not as the diagnosis.
- The mark is placed on a hematoxylin-and-eosin prostate needle biopsy scanned on a supported whole-slide scanner, after the pathologist’s first look.
- Across 16 pathologists and 527 slide images, cancer detection on individual slides improved by 7.3% on average versus unassisted reads.
- The read of benign slides was reported as unaffected.
- The study did not measure the effect on the final patient diagnosis, which usually rests on more than one core.
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