Interpretive software IVDs

Intended purpose

Franklin AI Digital Prostate (the Device) is an IVD Software as a Medical Device (SaMD) intended to assist pathologists to detect, localise and summarise prostate histopathological findings during the review of digitised Whole Slide Images (WSI) from prostate needle biopsies and transurethral resection of the prostate prepared from Hematoxylin & Eosin (H&E) stained formalin-fixed paraffin-embedded (FFPE) tissue. The Device is intended as a decision-support tool, not a primary diagnostic device. The Device is intended for use by Pathologists for patients over the age of 18 who have undergone prostate tissue sampling for histopathology diagnosis purposes.