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The MicroThermX®-100 Microwave Ablation System (MTX-100) delivers microwave energy for coagulation (ablation) of soft tissue. The system is not intended for use in cardiac procedures.

The MTX-100 microwave applicators, which are inserted using the provided OTN catheters, may be used in open surgical as well as percutaneous ablation procedures. Optional temperature sensors may be used to monitor tissue temperatures.

The MicroThermX®-100 Microwave Ablation System (MTX-100) delivers 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 system consists of a mobile generator, generator cart, microwave applicators, Over-The-Needle (OTN) catheters for applicator can minorwing and optional temperature sensors and temperature sensor positioning tubes. The mobile generator is comprised of a computer, microwave generator, theoring the based temperature monitoring system, and thermal calibration well. The operator interface is via a touchscreen monitor.

The provided text describes the 510(k) summary for the BSD Medical Corporation MicroThermX®-100 Microwave Ablation System. It focuses on demonstrating substantial equivalence to predicate devices for regulatory approval, rather than a clinical study establishing specific acceptance criteria and detailed device performance metrics in a clinical setting.

Therefore, many of the requested elements (acceptance criteria table, sample size for test set, data provenance, ground truth establishment, MRMC study, effect size, standalone performance, training set details) are not present in the provided document. The document primarily outlines regulatory compliance and non-clinical testing.

Here's what can be extracted and inferred from the provided text:

1. Table of Acceptance Criteria and Reported Device Performance:

No specific, quantified acceptance criteria for performance (e.g., ablation zone size, success rate, complication rate) are provided in the document from a clinical efficacy perspective. The "acceptance criteria" discussed are largely related to regulatory standards, safety, and manufacturing.

2. Sample size used for the test set and the data provenance:

• Sample Size for Test Set: Not applicable/Not provided. The document states "No clinical data were necessary in order to support the safety and efficacy of the device." The "testing" mentioned refers to non-clinical verification and validation.
• Data Provenance: Not applicable/Not provided (as clinical data was not used).

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

Not applicable/Not provided, as no clinical test set with expert-established ground truth was detailed. The "ground truth" for the non-clinical tests would be defined by the specifications of the standards (e.g., electrical safety limits, biocompatibility requirements).

4. Adjudication method for the test set:

Not applicable/Not provided, as no clinical test set requiring adjudication was described.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:

Not applicable. This device is a microwave ablation system, not an AI-assisted diagnostic or interpretation tool. The document does not mention any AI component or MRMC study.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:

Not applicable. This device is a treatment system, not an algorithm. Its operation requires a human operator to set parameters and insert applicators.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):

For the non-clinical tests conducted (biocompatibility, electrical safety, accessory performance, usability), the "ground truth" was based on established industry standards, regulatory guidelines (FDA Memo G95-1e, ISO 10993-1), and internal protocols. These define the acceptable ranges and performance criteria for the specific types of tests.

8. The sample size for the training set:

Not applicable. This document describes a medical device, not a machine learning model. There is no concept of a "training set" in this context.

9. How the ground truth for the training set was established:

Not applicable, as there is no training set mentioned.

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