Source record
Adjunct detection on prostate biopsy whole-slide images
이 언어의 본문은 아직 없어 영어로 보여 줍니다.
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
- 2021년 9월 21일 · 연도 2021
- Evidence label
- 규제
- Source type
- 뉴스
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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