BioTraceIO Precision (2.0)
TechsoMed Medical Technologies Ltd.BioTraceIO Precision (2.0) is a medical software that assists physicians by analyzing ultrasound images captured during liver ablation procedures to visualize and predict the ablation zone. It helps clinicians assess the effectiveness of radiofrequency or microwave ablation treatments by correlating ultrasound data with contrast-enhanced CT scans obtained post-procedure, improving decision-making while providing adjunctive visual information during and after treatment.
Intended Use
BioTraceIO Precision is intended to provide physicians with adjunctive information in their clinical assessment of ablation zone created by liver tissue ablation, as part of their overall post-procedure clinical assessment.
Technology
A stand-alone software application using a proprietary computational algorithm to analyze streamed ultrasound images captured during liver ablation treatment (radiofrequency or microwave) to provide visualization of the expected ablation zone (Reference Ablation Zone, RAZ) during the procedure and the estimated ablation zone (BioTrace Map, BTM) after the procedure correlating with post-treatment contrast-enhanced CT.
Performance
Performance and algorithmic testing show that BioTraceIO Precision meets user needs and intended use, demonstrating equivalent accuracy to predicate device with a mean DICE coefficient of about 84.7 compared to 24-hour post-ablation CT, indicating accurate estimation of ablation zones. Testing included statistical analyses supporting non-inferiority to the predicate, and functional verification confirming safety and effectiveness.
Predicate Devices
No predicate devices specified
Device Timeline
- 1
Submission
9/30/2024
2 months - 2
FDA Approval
12/27/2024
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