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The MicroThermX Microwave Ablation System (MTX) delivers microwave energy for coagulation (ablation) of soft tissue. The system is not intended for use in cardiac procedures. The SynchroWave antennas may be used in open surgical as well as percutaneous ablation procedures. An optional temperature sensor may be used to monitor tissue temperatures.

The MicroThermX Microwave Ablation System (MTX-180 or MTX) delivers 915 MHz microwave energy for coagulation (ablation) of soft tissue. The delivery of microwave energy is controlled by time and power parameters set by the operator. The operator can select up to 3 applicators to ablate target tissue. The MTX-180 consists of a mobile cart with generator and closed-circuit antenna cooling system, microwave antennas, and an optional temperature sensor. The mobile generator is comprised of a computer, microwave generator, and thermistor-based temperature monitoring system. The operator interface is via the touchscreen monitor of the mobile generator. The cooling system consists of a bag of sterile isotonic saline (not supplied by BSD); peristaltic pump; cooling circuit tubing and connectors; and fluid pathway channels within the antenna. The MTX-180 is designed to: Deliver controlled microwave energy to induce coagulation of soft tissue; Provide repeatable ablation zone geometries for a given set of ablation parameters (repeatability demonstrated in ex-vivo studies performed in nonperfused animal tissue); Be used in an intraoperative or minimally invasive percutaneous procedure; Utilize a single SynchroWave antenna or synchronous operation of 2 or 3 antennas during a single procedure to induce larger zones of ablation .; and Utilize an optional sensor to monitor the temperature of non-target tissue during a procedure.

This document describes the MicroThermX® Microwave Ablation System (MTX-180 or MTX), a device that delivers 915 MHz microwave energy for the coagulation (ablation) of soft tissue. The 510(k) premarket notification (K100786) was submitted for changes in design from a predicate device (MicroThermX 100 Microwave Ablation System, K081042).

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria are not explicitly stated as quantitative values with clear pass/fail thresholds in the provided text. Instead, the document refers to conformance with various external standards and internal requirements, and equivalence with a predicate device. The "reported device performance" is a general statement of successful conformance.

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

The document does not explicitly state the sample size used for the test set or the data provenance (e.g., country of origin, retrospective/prospective). It mentions "ex-vivo studies performed in nonperfused animal tissue" for demonstrating repeatability of ablation zone geometries, but details on sample size for these or other tests are not provided.

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

Information regarding the number and qualifications of experts used to establish ground truth for the test set is not provided in the document. The study primarily focuses on engineering and performance verification against standards and predicate device equivalence.

4. Adjudication Method for the Test Set

The document does not describe any adjudication methods related to human interpretation or expert review of test results. The evaluation appears to be based on direct measurement and engineering verification against pre-defined standards and requirements.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, and the effect size of how much human readers improve with AI vs without AI assistance

A Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not performed as this device is not an AI/imaging diagnostic tool that assists human readers. It is a medical device for microwave ablation.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Study was done

This question is not applicable in the context of this device. The device is a physical medical system, not an algorithm. Its performance is evaluated through direct physical and electrical testing, and its function involves an operator controlling parameters. The device's "standalone" performance would be its ability to consistently deliver microwave energy and create ablation zones as designed, which was evaluated through "Verification and Validation Studies."

7. The Type of Ground Truth Used

The "ground truth" for the performance testing appears to be primarily defined by:

• Established industry standards: UL, IEC, and CISPR standards for medical electrical equipment, safety, and electromagnetic compatibility.
• Internal engineering specifications: Requirements for software control, alarms, cooling, ablation zone sizes, temperature measurement accuracy, and usability.
• Predicate device performance: Used as a benchmark for equivalence in safety and effectiveness.
• Direct physical measurements: For parameters like ablation zone geometries (e.g., through ex-vivo studies).

There is no mention of "expert consensus," "pathology," or "outcomes data" being used as ground truth in the context of this 510(k) submission, which focuses on device modifications and substantial equivalence.

8. The Sample Size for the Training Set

This question is not applicable. The MicroThermX Microwave Ablation System is a hardware device with software controls, not a machine learning or AI algorithm that requires a "training set" in the conventional sense. The "training" of the system would be its design, calibration, and manufacturing processes, rather than data-driven model training.

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

This question is not applicable, as there is no "training set" for an AI model in this context (see point 8). The device's "ground truth" for its design and manufacturing is established through engineering principles, relevant medical device standards, and the performance characteristics of predicate devices.

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