Description of use

Paige Prostate Grade & Quantify is offered and sold as part of the Paige Prostate Suite.

Intended Use: For use with digitized H&E stained prostate needle biopsy images. A qualified pathologist should employ appropriate procedures to ensure the quality of the images and use manual visualization and re-evaluate the product’s result before incorporation into the final diagnosis. The results shall only be considered after a pathologist’s initial review of the entire WSI.

Performance: Validated on a set of 1,000 prostate images. Slide level ISUP/Grade Group classification linear-weighted Kappa concordance was 0.78, slide level tumor length Pearson correlation coefficient was 0.83 and slide level tumor percentage Pearson correlation coefficient was 0.91.