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Galen™ Second Read™ is a software only device intended to analyze scanned histopathology whole slide images (WSIs) from prostate core needle biopsies (PCNB) prepared from hematoxylin & eosin (H&E) stained formalin-fixed paraffin embedded (FFPE) tissue. The device is intentify cases initially diagnosed as benign for further review by a pathologist. If Galen™ Second Read™ detects tissue morphology suspicious for prostate adenocarcinoma (AdC), it provides case- and slide-level alerts (flags) which includes a heatmap of tissue areas in the WSI that is likely to contain cancer. Galen™ Second Read™ is intended to be used with slide images digitized with Philips Ultra Fast Scanner and visualized using the Galen™ Second Read™ user interface. Galen™ Second Read™ outputs are not intended to be used on a standalone basis for diagnosis, to rule out prostatic AdC or to preclude pathological assessment of WSIs according to the standard of care.

The Galen Second Read is an in vitro diagnostic medical device software, derived from a deterministic deep convolutional network that has been developed with digitized WSIs of H&E-stained prostate core needle biopsy (PCNB) slides originating from formalin-fixed paraffinembedded (FFPE) tissue sections, that were initially diagnosed as benign by the pathologist. The Galen Second Read is cloud-hosted and utilizes external accessories [e.g., scanner and image management systems (IMS)] for automatic ingestion of the input. The device identifies WSIs that are more likely to contain prostatic adenocarcinoma (AdC). For each input WSI, the Galen Second Read automatically analyzes the WSI and outputs the following: - Binary classification of the likelihood (high/low) to contain AdC based on a predetermined . threshold of the neural network output. - For slides classified with high likelihood to contain AdC, slide-level findings are flagged . and visualized (AdC score and heatmap) for additional review by a pathologist alongside the WSI. - For slides classified as low likelihood to contain AdC, no additional output is available. . Galen Second Read key functionalities include image upload and analysis, flag slides of high likelihood to contain AdC and display of all the WSIs uploaded to the system alongside their analysis results. Flagged findings constitute a recommendation for additional review by a pathologist.