Search Results

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.

Ask a specific question about this device