PRAEVAorta®2

PRAEVAorta®2 is medical imaging software that automatically analyzes CT scan images to measure vessel diameters and identify anatomical features like aneurysms. It uses non-adaptive machine learning to calculate maximal transverse diameters of blood vessels (aorta and iliac arteries) and generates reports with measurements to support physician diagnosis. The software is intended for use by physicians and licensed healthcare practitioners in clinical settings and is not intended for standalone clinical decision-making.

PRAEVAorta®2 analyzes thoraco-abdominal-pelvic CT images to measure vessel diameters, whereas the predicate (CT Cardiomegaly) analyzes chest CT images to calculate cardiothoracic ratios of the heart. Both use non-adaptive machine learning algorithms on CT inputs and generate automated diameter measurements in PDF/JSON formats. PRAEVAorta®2 adds DICOM SC and DICOM GSPS output formats and targets a broader anatomical region, but the core functionality of automated segmentation and geometric measurement using machine learning on CT images is equivalent.

Testing referenced FDA guidance for Software as a Medical Device, IEC 62304:2015 (software life cycle), IEC 82304:2016 (health software safety), ISO 13485:2016 (quality management), ISO 14971:2019 (risk management), IEC 62366:2015 (usability engineering), ISO 20417:2021 (labeling), and 21 CFR Parts 820 and 860.

Both devices are Class II image analysis software using identical regulatory codes, inputs (CT images), and non-adaptive machine learning for automated measurement. Although PRAEVAorta®2 measures vessels instead of the heart and covers a larger anatomical area, these differences do not raise new safety or effectiveness concerns because the underlying technology and measurement principle are identical. Performance testing demonstrated equivalent accuracy (mean absolute error 2.04 mm, 96.9% within 5 mm limit, correlation coefficient 0.97 to ground truth), confirming the device performs as safely and effectively as the predicate despite the anatomical difference.