BioTraceIO Vision (V1.7)
Techsomed Medical TechnologiesBioTraceIO Vision (V1.7) is a software tool designed for physicians to assist in planning and evaluating ablation treatments using CT and MR images. It helps with image import, anatomic segmentation (including liver and kidney), virtual needle placement, and confirmation of ablation zones, improving the accuracy and effectiveness of ablation procedures.
Intended Use
BioTraceIO Vision is a Computed Tomography (CT) and Magnetic Resonance (MR) image processing software package available for use with ablation procedures. It assists physicians in planning ablation procedures including target identification and virtual needle placement, and confirms ablation zones. It is not intended for diagnosis or to predict ablation success.
Technology
BioTraceIO Vision is a stand-alone software running on dedicated computers, performing image display, segmentation (liver, kidney, vessels, ablation targets/zones), needle placement planning for microwave and cryoablation, image registration, and treatment confirmation through quantitative analysis. It uses AI algorithms for segmentation and supports CT and MR images. The software facilitates manual and automated segmentation and registration with user intervention for accuracy confirmation.
Performance
Performance testing included segmentation accuracy, image registration, and measurement validation using clinical CT and MR datasets. AI segmentation algorithms achieved high Dice similarity coefficients (e.g., liver CT segmentation 0.98, kidney CT segmentation 0.91). Registration accuracy metrics showed mean corresponding distances around 3-5 mm. Testing confirmed that the device performs equivalently to its predicate with no new safety or effectiveness issues.
Predicate Devices
No predicate devices specified
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