Paige Prostate is an AI software device by Paige.AI designed to assist pathologists in detecting prostate cancer in digitized pathology slides from needle biopsies. It analyzes whole slide images scanned from H&E stained tissue samples and identifies areas most suspicious for cancer, helping pathologists to focus their review and improve diagnostic accuracy. It serves as an adjunct tool and supports clinicians in making more accurate prostate cancer diagnoses.
Intended Use
Software to assist pathologists in detecting foci suspicious for cancer in scanned whole slide images of prostate needle biopsies stained with hematoxylin and eosin
Technology
Deep learning based software analyzing digitized whole slide images from Philips Ultra Fast Scanner. Outputs binary classification and localizes a single coordinate with highest likelihood of cancer for pathologist review. Works as adjunct and integrates with Paige FullFocus viewing software.
Performance
Performance validated with large datasets (728 WSIs cancer and benign cases), showing sensitivity ~94.5% and specificity ~94.0%. Precision studies showed high reproducibility across scanners and operators. Clinical study with 16 pathologists showed improved sensitivity by 7.3% using the software assistance, with minimal specificity change. Risk mitigation includes careful labeling, software validation, and adjunct use only.
Device Timeline
- 1
Submission
12/31/2020
8 months - 2
FDA Approval
9/21/2021
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