Mosaic (V1.0.1)
Navier MedicalMosaic V1.0.1 is a medical image analysis software that processes CT angiography images to help trained clinicians analyze arterial diseases such as atherosclerosis and aneurysmal disease. It offers 3D vessel visualization, measurements of vessel diameter, stenosis, and tissue volumes, supporting clinical decision-making though it does not provide direct diagnoses.
Intended Use
Mosaic V1.0.1 is intended to assist trained medical professionals in stratifying patients suspected or identified with atherosclerosis or aneurysmal disease of the aorta, carotid, iliac, femoral, and popliteal arteries by post-processing multidetector CT images and providing tools for measurement and visualization of arterial vessels and disease.
Technology
Mosaic is a post-processing software operating on Windows OS that analyzes CT angiography images using Hounsfield Unit-based segmentation to measure vessel diameter, distance, volume, stenosis, plaque volumes, and arterial wall remodeling. It provides visualizations such as 3D vessel views and multiplanar reformatting, with outputs including analysis files and PDF reports to assist clinical management.
Performance
Performance testing included software verification and validation according to FDA guidance, with validation using phantom and clinical images comparing measurements of vessel diameter, length, tissue volumes, stenosis, and positive remodeling to ground truth. Results showed small bias and RMSE values across tested ranges, demonstrating substantial equivalence to the predicate device ElucidVivo.
Predicate Devices
No predicate devices specified
Device Timeline
- 1
Submission
12/26/2024
5 months - 2
FDA Approval
6/16/2025
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