IRISeg

“IRISeg is intended for use as a software application that receives DICOM compliant contrast-enhanced CT images, provides manual and machine learning-enabled tools for image analysis and segmentation, and creates an output file that can be used to render a 3D model for preoperative surgical planning and intraoperative display.”

“The auto-segmentation algorithm is a neural network based ML algorithm.”

“No imaging study used to verify performance was used for training; independence of training and testing data were enforced at the level of the scanning institution, namely, studies sourced from a specific institution were used for either training or testing but could not be used for both.”

“The cybersecurity verification and validation testing were conducted, and cybersecurity was evaluated per FDA's Guidance "Cybersecurity in Medical Devices: Quality System Considerations and Content of Premarket Submissions" (September, 2023). Specifically, addressing the following cybersecurity testing areas: security requirement testing, threat mitigation testing, vulnerability testing, and penetration testing. The cybersecurity verification and validation test results demonstrate the adequacy of the implemented cybersecurity controls.”