Mosaic (V1.0.1)

Mosaic V1.0.1 is a medical image analysis software that processes CT angiography scans to help trained medical professionals evaluate arterial diseases, including atherosclerosis and aneurysms in the aorta, carotid, iliac, femoral, and popliteal arteries. It provides tools for vessel measurement, visualization, and analysis including diameter, length, volume, stenosis, and positive remodeling calculations, but is not intended to provide diagnosis or replace clinical judgment.

Mosaic V1.0.1 shares all major technological features with the predicate ElucidVivo A.3: Windows OS compatibility, DICOM image input, CT acquisition source, Hounsfield Unit-based segmentation, 2D and 3D imaging, multiplanar reformatting, 2D measurements, vessel stenosis analysis, volumetric measurements, positive remodeling index calculation, and PDF reporting. A minor difference is Mosaic uses calcified tissue threshold >350 HU (versus >250 HU in predicate) and employs an adaptive algorithm for low-attenuating plaque detection.

Not stated in this summary. The document references FDA guidance on General Principles of Software Validation, Guidance for Content of Premarket Submissions for Software Contained in Medical Devices, and Content of Premarket Submission for Management of Cybersecurity in Medical Devices, but does not cite specific ISO, IEC, or ASTM consensus standards.

Mosaic is substantially equivalent because it performs the identical intended function as ElucidVivo A.3 (post-processing CT images for arterial disease analysis) using the same fundamental technological approach and features. Validation testing demonstrated measurements from Mosaic are substantially equivalent to ElucidVivo across diameter, tissue volume, stenosis, and positive remodeling index with comparable bias and root mean square error across the intended clinical ranges. The minor threshold adjustments for tissue characterization represent refinements rather than functional differences.