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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

Study Details

2. Sample Size and Data Provenance

• Test Set Sample Size:
  • Effectiveness Analysis Set: 50 patients with 51 ablations. (One patient had two ablations; the remaining 49 patients had a single ablation).
  • Safety Analysis Set: 59 patients.
• Data Provenance:
  • Country of Origin: United States (multi-center prospective single-arm pivotal clinical study conducted at six clinical sites in the United States).
  • Retrospective or Prospective: Prospective.

3. Number of Experts and Qualifications for Ground Truth

• Number of Experts: More than one, as stated "performed independently by certified interventional radiology experts, blinded to each other." The exact number is not explicitly stated, but the plurality suggests at least two.
• Qualifications of Experts: Certified interventional radiology experts. They were trained on CECT segmentation and registration processes specific to this study. The document does not specify their years of experience.

4. Adjudication Method for the Test Set

• Adjudication Method: The analysis of imaging data (T=0 and T=24 CECT) was performed independently by certified interventional radiology experts, blinded to each other. This suggests an independent reading paradigm where each expert provided their segmentation/assessment without knowledge of others' results. There is no mention of a formal adjudication process (e.g., 2+1, 3+1 where a third or fourth expert resolves discrepancies). The ground truth appears to be based on these independent analyses, which were then used to calculate metrics like Dice coefficient.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

• Was an MRMC study done? No, not in the traditional sense of comparing human readers' diagnostic performance with and without AI assistance on a per-reader basis.
  • This study focused on the device's performance (BioTraceIO Lite's BTM) in correlating with the T=24 CECT as an adjunctive information source, and comparing the BTM's correlation to T=24 CECT against the T=0 CECT's correlation to T=24 CECT. It was not a reader study to assess improvement in human diagnostic performance.
  • The experts were involved in establishing the ground truth (segmenting T=0 and T=24 CECTs), not as readers whose performance was being evaluated.
• Effect size of human reader improvement: Not applicable, as this was not an MRMC study designed to measure human reader improvement with AI assistance.

6. Standalone Performance

• Was standalone (algorithm only without human-in-the-loop) performance done? Yes, the primary effectiveness objective evaluated the BioTrace Map (BTM), which is generated by the BioTraceIO Lite algorithm, against the T=24 CECT. This can be considered a standalone performance assessment of the algorithm's output (BTM) in predicting the ablation zone.
  • The device is intended to provide adjunctive information and is not intended for standalone prediction or for diagnostic purposes, reinforcing that while its performance is evaluated alone, its clinical use is always with a physician.

7. Type of Ground Truth Used

• Type of Ground Truth: Expert consensus with pathology/outcomes data is most analogous, but specifically, the ground truth for the ablation zone was established by certified interventional radiology experts segmenting the 24-hour post-procedure Contrast-enhanced Computed Tomography (CECT) scans (T=24 CECT). This is considered the reference method for the ablation zone.

8. Sample Size for Training Set

• Training Set Sample Size: Not explicitly stated in the provided text. The document describes a pivotal clinical study used for testing the device's performance, but does not specify details about the training data used to develop or train the BioTraceIO Lite algorithm.

9. How Ground Truth for Training Set Was Established

• Ground Truth for Training Set: Not explicitly stated in the provided text. The document focuses on the test set's ground truth and the pivotal study results. Standard practice would suggest that training data also requires some form of expert segmentation or clinically confirmed labels, but details are not provided here.

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