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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

Note: The primary acceptance criterion for the algorithmic performance was demonstrating equivalent performance of the optimized BTM algorithm to the predicate BTM algorithm when correlated with 24-hour CECT. The improved performance against T=0 CECT was a favorable additional finding.

2. Sample Size Used for the Test Set and Data Provenance

• Test Set Sample Size: The document does not explicitly state the exact number of cases or patients in the test set. However, it implicitly indicates that the test set included sufficient data to conduct statistical analyses (paired t-test, Wilcoxon Signed-Rank test) and generate 95% Confidence Intervals (CIs) for DICE coefficients, comparing the new algorithm with the predicate and T=0 CECT. This suggests a reasonably sized dataset.
• Data Provenance: Not explicitly stated in the provided text (e.g., country of origin). The document states the data was used for "algorithmic testing," implying it was collected from actual patient procedures. The data collected was retrospectively analyzed for this validation.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of those Experts

• Number of Experts: Not explicitly stated in the provided text.
• Qualifications of Experts: Not explicitly stated. The ground truth ("ablation zone visualized on the 24-hour post ablation CECT (T=24 CECT)") is itself an objective imaging finding. While interpretation of CECT images is done by radiologists, the document doesn't detail the role or number of human experts for ground truth establishment outside of "ablation zone visualized on the 24-hour post ablation CECT." It focuses more on the correlation between the device's output and this objective imaging finding.

4. Adjudication Method for the Test Set

• Adjudication Method: Not explicitly mentioned for the establishment of the 24-hour CECT ground truth. The ground truth is described as the "ablation zone visualized on the 24-hour post ablation CECT." It implies that this CECT visualization is the accepted reference standard.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size

• MRMC Study: No, the provided text does not describe an MRMC comparative effectiveness study where human readers improve with AI vs. without AI assistance. The study focuses purely on the equivalence of the device's algorithmic performance (BioTraceIO Precision 2.0 BTM) against a predefined ground truth (24-hour CECT) when compared to a predicate device. The device provides "adjunctive information" and is "not intended for standalone prediction or for diagnostic purposes," which aligns with the absence of an MRMC study assessing human reader improvement.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done

• Standalone Performance: Yes, the algorithmic testing described is a standalone performance evaluation of the BioTraceIO Precision (2.0) BTM algorithm. The DICE coefficient was calculated by comparing the algorithm's output directly to the 24-hour CECT images, without a human in the loop for the performance measurement itself.

7. The Type of Ground Truth Used

• Type of Ground Truth: The ground truth used was imaging data, specifically the "ablation zone visualized on the 24-hour post ablation CECT (T=24 CECT)." This is considered a clinical reference standard for assessing the success and extent of liver ablation.

8. The Sample Size for the Training Set

• Training Set Sample Size: The document does not provide the sample size for the training set. The focus of this 510(k) summary is on the validation of the updated device (BioTraceIO Precision 2.0) against its predicate, rather than the initial development and training specifics.

9. How the Ground Truth for the Training Set Was Established

• Ground Truth for Training Set: Not explicitly stated in the provided text. For a device like BioTraceIO Precision, it is highly likely that similar to the testing phase, the training set ground truth would have also been established using 24-hour CECT imaging to precisely delineate the ablation zones, potentially with expert radiologist annotations or consensus. However, the document does not elaborate on this.

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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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