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Regulatory Science Tools Catalog

Digi Path
This regulatory science tool is a software program written in Python for analyzing whole slide images (WSIs) and assisting developers or pathologists in the assessment of machine learning algorithms used in digital pathology.
AI ML
This regulatory science tool is a synthetic mammography dataset that includes a variety of breast densities, breast sizes, and inserted lesions imaged with different exposure levels. The dataset is intended to be used for the comparative evaluation of AI tools used in mammography.
AI ML
This regulatory science tool presents a method (web-based decision tree) that may help developers select appropriate metric and endpoint for Artificial Intelligence (AI) / Machine learning (ML) classification algorithms in medical imaging.
AI ML
Tools that quantify wait-time-saving benefits for cases with positive diagnoses due to the adoption of Computer-Aided Triage and Notification devices in a radiology workflow
AI ML
Statistical tools (java GUI and R package) to analyze, size, and simulate multi-reader multi-case (MRMC) reader studies