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BioTraceIO Lite 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.

BioTraceIO Lite 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 24 hours 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 Lite overlays the reference ablation zone (RAZ) provided by the ablation device manufacturer on the ultrasound image. BioTraceIO Lite is indicated for use in patients undergoing radiofrequency (RF) or microwave (MW) liver ablation procedures. BioTraceIO Lite is not intended for standalone prediction or for diagnostic purposes. BioTraceIO Lite does not support the use of multiple needles, either simultaneously or consecutively. The physician should not rely on BioTraceIO Lite BTM alone in decisions about patient management post treatment nor should BioTraceIO Lite serve as a substitute for any other assessment method, e.g., CT scans.

BioTraceIO Lite is a software application that uses a 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 BioTraceIO algorithm, providing a visual display of the expected ablation zone (calculated based on technical parameters provided by the ablation manufacturer datasheet), namely the Reference Ablation Zone (RAZ), during the procedure (Online Mode - Figure 1).

Thirty (30) minutes after the completion of the procedure, BioTraceIO Lite provides a visual display of the estimated ablation zone correlative to the 24-hour CECT, namely the BioTrace Map (BTM) (Offline Mode - Figure 2).

Once in Offline Mode, it is not possible to return to Online Mode. The BTM is displayed only in Offline Mode, 30 minutes after the ablation procedure has been completed, and cannot be visualized in Online Mode, during the procedure.

Information from the ultrasound system streams in only one direction, to the BioTracelO Lite software. BioTraceIO Lite utilized in either Online or Offline mode does not control or change the functions or parameters of the ultrasound system, or the ablation device used during the liver ablation procedure.

The BioTraceIO Lite application is installed on a dedicated, off-the-shelf, computer workstation with pre-defined minimal requirements and is controlled by the user via an independent user interface, which is separate from both the ablation system and the ultrasound system. The workstation is connected by video output to a compatible ultrasound system to be used during the liver tumor ablation procedure.

Here’s a breakdown of the acceptance criteria and the study that proves the device meets them, based on the provided text:

Acceptance Criteria and Device Performance

Acceptance Criteria

The acceptance criteria for the BioTraceIO Lite device are primarily based on demonstrating a statistically significant improvement in the correlation of the BioTrace Map (BTM) with the 24-hour post-procedure CECT (T=24 CECT) compared to the immediate post-procedure CECT (T=0 CECT). This is measured using the Dice similarity coefficient.

Specific Criteria for Effectiveness:

• Primary Effectiveness Objective: To demonstrate that the BTM available post-procedure is correlative to the area of the ablation zone as visualized on the 24-hours post-procedure (T=24) CECT scan. This is statistically assessed by comparing the Dice similarity coefficient of "BTM vs T=24 CECT" against "T=0 CECT vs T=24 CECT." The expectation is that the BTM's correlation will be significantly higher.

Specific Criteria for Safety:

• Primary Safety Objective: To demonstrate that the BioTraceIO Lite device is safe, based on an assessment of device-related Adverse Events (AEs) and serious adverse events (SAEs). The expectation is a low incidence of device-related AEs, with none being serious.

Reported Device Performance

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