(88 days)
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. BioTracelO Precision generates and depicts a map (BioTrace Map or BTM) post-procedure, that correlates with image findings seen with Contrast-enhanced Computed Tomography (CECT) obtained at 24hours post treatment. The information is provided in the 2D ultrasound plane. This is the only plane and location displayed. No imaging of other portions of the ablation zone is available.
During the ablation procedure BioTraceIO Precision overlays the reference ablation zone (RAZ) provided by the ablation device manufacturer on the ultrasound image.
BioTracelO Precision is indicated for use in patients undergoing radiofrequency (RF) or microwave (MW) liver ablation procedures.
BioTraceIO Precision is not intended for standalone prediction or for diagnostic purposes. BioTraceIO Precision does not support the use of multiple needles, either simultaneously or consecutively.
Manual ablation target contours and margins as defined by the user are not intended for diagnosis, to predict ablation volumes or predict ablation success.
The physician should not rely on BioTraceIO Precisions about patient management post treatment nor should BioTraceIO Precision serve as a substitute for any other assessment method, e.g., CT scans.
BioTracelO Precision is a stand-alone software application with tools and features designed to assist users in their clinical assessment of ablation zone created by liver tissue ablation, as part of their overall post-procedure clinical assessment.
BioTracelO Precision is a software application that uses a proprietary computational algorithm to analyze ultrasound images captured during liver ablation treatment (microwave ablation [MWA] or radiofrequency ablation [RFA]), as depicted in standard abdominal ultrasound imaging.
The streamed ultrasound images are captured and analyzed by the BioTracelO algorithm. providing a visual display of the expected ablation zone, namely the Reference Ablation Zone (RAZ), calculated based on technical parameters provided by the ablation manufacturer datasheet. The RAZ is displayed during the procedure (Online Mode). BioTracelO Precision also provides a visual display of the estimated ablation zone correlative to the 24-hour CECT, namely the BioTrace Map (BTM), after the completion of the procedure (Offline Mode).
Acceptance Criteria and Study for BioTraceIO Precision (2.0)
The BioTraceIO Precision (2.0) device is a software application designed to assist physicians in assessing the ablation zone created by liver tissue ablation procedures. The key functionality is to generate a "BioTrace Map" (BTM) that correlates with the ablation zone visualized on Contrast-enhanced Computed Tomography (CECT) obtained 24 hours post-treatment.
Here's a breakdown of the acceptance criteria and the study that proves the device meets these criteria:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Metric) | Target Performance | Reported Device Performance (BioTraceIO Precision 2.0) |
|---|---|---|
| Mean DICE coefficient vs. 24-hour CECT (BTM) | Equivalent to predicate device | 84.7 [95% CI: 83.07, 86.49] vs. 85.5 [95% CI: 83.63, 87.43] for predicate (p=0.2408; Wilcoxon p=0.11) |
| Mean DICE coefficient vs. 24-hour CECT (Optimized BTM vs. T=0 CECT) | Significantly higher than T=0 CECT | 7.9 [95% CI: 4.2, 11.7) higher (p |
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