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The Microwave Ablation System is indicated for the coagulation (ablation) of soft tissue. The Microwave Ablation System is not intended for cardiac use.

The Microwave Ablation System is a microwave power (energy) source that can meet the needs of clinical soft tissue microwave thermal ablation therapy. The microwave energy is transmitted to the disposable microwave ablation needle through coaxial transmission cable, and the disposable microwave ablation needle is directly inserted into the targeted soft tissue, and the electromagnetic wave (microwave) is radiated from the front end of the disposable microwave ablation needle to cause the soft tissue to produce heat and rise. When it reaches the temperature of tissue coagulation and necrosis, in-situ inactivation is formed, that is, the purpose of microwave ablation therapy is achieved.

The Disposable Thermometer Needle and Foot Switch are accessories for the proposed device. And the proposed device is used in conjunction with the Disposable Microwave Ablation Needle made by our company.

The provided text describes a 510(k) premarket notification for a Microwave Ablation System. It focuses on demonstrating substantial equivalence to a predicate device rather than presenting a study to prove the device meets specific acceptance criteria in the way a clinical trial or performance study for a diagnostic device would.

Therefore, much of the requested information regarding acceptance criteria, reported performance, sample sizes, expert ground truth, adjudication, MRMC studies, standalone performance, and training set details are not applicable or available from this 510(k) summary. This document primarily focuses on engineering and regulatory compliance rather than clinical performance metrics as might be found in a diagnostic AI device submission.

Here's an attempt to answer the questions based on the provided text, indicating where information is not available:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not present specific quantitative performance acceptance criteria (e.g., accuracy, sensitivity, specificity) for a clinical outcome in the way an AI diagnostic device might. Instead, the "acceptance criteria" are implied by the conformance to various safety, performance, and software standards. The reported "performance" focuses on meeting these standards and demonstrating equivalence to a predicate device.

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

The document explicitly states: "No clinical study is included in this submission." This means there isn't a "test set" of patient data in the context of evaluating a diagnostic or AI-driven device's clinical performance. The testing mentioned (electrical safety, EMC, thermal effects) would involve laboratory setups and devices, not patient data.

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

Not applicable, as no clinical study or test set using patient data for ground truth establishment was conducted or reported.

4. Adjudication method for the test set

Not applicable, as no clinical study or test set requiring expert adjudication was conducted or reported.

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, which is a therapeutic device, not a diagnostic device that would typically involve human readers or AI assistance for interpretation.

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

Not applicable. This device is a therapeutic system, not an algorithm or AI product. Its performance is related to its physical functions and safety, not an AI's standalone interpretation capability.

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

For the engineering and safety tests, the "ground truth" would be the specifications and requirements defined by the relevant international standards (e.g., IEC 60601 series) and FDA guidance documents. For instance, an electrical safety test's ground truth is whether the device does or does not meet the leakage current limits. This is based on objective measurements against engineering standards, not clinical ground truth like pathology.

8. The sample size for the training set

Not applicable. There is no mention of a training set as this is not an AI/machine learning device.

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

Not applicable. There is no mention of a training set.

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The Microwave Ablation System is intended for coagulation (ablation) of soft tissue. It is not intended for use in cardiac procedures.

The Microwave Ablation System M150E is microwave-based system intended to deliver energy through an antenna inserted into soft tissue for the purpose of coagulating (ablation) of a defined volume of that tissue. The Microwave Ablation System utilizes a 2450MHz generator to deliver power to single microwave ablation antenna or double microwave ablation antennas. The Microwave Ablation Generator provides for user setting of ablation time and ablation power. The proposed device consists of Microwave Ablation Generator, Microwave Ablation Electrode Kits, Temperature Probe and Foot Switch.

1. Table of Acceptance Criteria and Reported Device Performance:

The document describes the device as a Microwave Ablation System. Rather than specific performance metrics like sensitivity/specificity for a diagnostic device, the acceptance criteria for this therapeutic device are based on demonstrating equivalent technical characteristics, safety, and performance to a predicate device.

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

   • Test Set Sample Size: Not applicable. The submission states, "Clinical studies were not required to demonstrate the substantial equivalence of the microwave ablation system and the predicated device." The testing primarily involved non-clinical bench and lab testing (e.g., electrical safety, EMC, performance, thermal effects, temperature monitoring, shelf life, package verification, sterilization validation, biocompatibility).
   • Data Provenance: Not applicable, as no clinical test set was used. The non-clinical testing data provenance is implied to be from the manufacturer's internal testing.

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

   • Not applicable, as no clinical test set was used that required expert ground truth establishment in this type of 510(k) submission.

4. Adjudication method for the test set:

   • Not applicable, as no clinical test set was used for adjudication.

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 therapeutic microwave ablation system, not a diagnostic imaging AI device that would involve human readers or AI assistance for interpretation.

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

   • Not applicable in the context of diagnostic AI performance. The device is a physically operated medical system. However, software validation was performed, indicating the internal algorithms and software governing the device's operation were tested in a standalone manner (without human intervention in the algorithm's execution during ablation).

7. The type of ground truth used:

   • For the non-clinical tests, the "ground truth" was established by adherence to recognized national and international standards (e.g., IEC 60601-1, IEC 60601-2-6, IEC 60601-1-2, ISO 11607-1, ISO 11135, ISO 10993), and engineering specifications for system performance, thermal effects, and temperature monitoring. These standards and specifications themselves represent a form of "ground truth" for acceptable device characteristics and safety.

8. The sample size for the training set:

   • Not applicable, as this device does not involve machine learning or AI models that require a training set in the conventional sense. The "training" here refers to the device's design, development, and adherence to established engineering principles and standards.

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

   • Not applicable, as no machine learning training set was used. The "ground truth" for the device's design and operational parameters was derived from existing medical device standards, predicate device characteristics, and established engineering and physiological principles related to microwave ablation.

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