Description of use

Paige Prostate PNI 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, where necessary, 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 test set of 684 H&E stained prostate needle biopsy images. The dataset included 342 cancer slides (171 with PNI, and 171 without PNI) and 342 benign slides and resulted in an AUC of 0.96, Sensitivity of 91% and Specificity of 88%.