TeraRecon Aorta.CT (1.1.0)

TeraRecon Aorta.CT is medical imaging software engineered for automatic 3D segmentation and anatomical landmark labeling of the Aorta from CT Angiography images, supporting trained professionals in clinical assessment. Its scientific methodology involved a retrospective cohort study that demonstrated high accuracy in lumen and aorta segmentation and precise landmark identification, establishing its substantial equivalence to a predicate device.

TeraRecon, Inc. received a determination for its medical imaging software, TeraRecon Aorta.CT (1.1.0). This software is designed to provide automatic 3D segmentation and label anatomical landmarks of the Aorta using CT Angiography with contrast DICOM images. The device outputs DICOM result files for viewing by trained professionals and is intended to be used with other patient information, not to provide a diagnosis or alter original input data. It is indicated for adult patients, with specific exclusions for those with certain pre-existing aortic conditions. The review concluded that the device is substantially equivalent to a legally marketed predicate device. The determination of substantial equivalence was supported by a comparison to a predicate device, AutoSeg-H, which highlighted similar core functionality despite some differences in additional features and patient exclusions. Non-clinical testing was conducted through a retrospective cohort study involving adult patient CT scans. This study evaluated the device's accuracy in lumen and aorta segmentation, achieving mean DICE scores of 88% and 90% respectively, exceeding the 80% acceptance criterion. Additionally, the accuracy of 22 anatomical landmarks was assessed, with all landmarks successfully meeting the specified acceptance criteria for precision. These test results affirm that TeraRecon Aorta.CT is as safe, as effective, and performs as well as the predicate device.

AI Regulatory Concerns

Powered by

Jev reads the full FDA letter and returns calibrated concern probabilities per regulatory category. These are AI estimates, not regulatory advice.

• Q1. What specific pre-existing aortic conditions are listed as exclusions, and how do they impact the device's performance or safety?; How does TeraRecon Aorta.CT's performance compare to manual segmentation by expert radiologists, particularly in complex or atypical aortic anatomies?; What are the clinical implications of the observed DICE scores for lumen and aorta segmentation, and how might minor discrepancies affect treatment planning?; Beyond the 22 assessed anatomical landmarks, are there other critical landmarks or measurements that could enhance the device's utility for specific clinical applications?; What is the long-term plan for post-market surveillance or real-world evidence collection to further validate the device's performance and safety in diverse patient populations?