Keywords: AI, MRMC
Artificial intelligence (AI) are getting more and more applications in medical devices. Recently, AI related devices have been approved/cleared in multiple areas such as radiology imaging, ophthalmology, etc. Different guidance documents have been published about FDA’s recommendations for regulating AI related medical devices in various areas. This presentation reviews statistical issues when using Multi-Reader Multi-Case (MRMC) Studies to support AI related medical products in the areas of in vitro diagnostic and radiological devices.