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The Mygen M-3004 RF system is intended for use in percutaneous and intraoperative coagulation and ablation of tissue.

Mygen M-3004 RF System consists of a microprocessor based RF generator, a cooling pump and tubing, electrodes, and ground pads. The generator, pump and electrodes are designed to produce local tissue heating at the tip of the electrodes causing the coagulation (ablation) of the tissue. Mygen M-3004 RF System generator is capable of delivering up to 200 waits (into a 50 Ohm resistive load) while monitoring tissue impedance and electrode tip temperature during the RF energy. The generator includes manual and impedance control and displays/monitors impedance, current, power and temperature.

The radiofrequency (RF) energy, which is delivered to an electrode, makes frictional heat for coagulation and ablation on diseased tissue by ionic agitation. The patient can receive safe therapy as leakage current is extremely low. Mygen M-3004 continually measures and displays RF output power, tissue impedance, and elapsed time of RF delivery. Tissue temperature is measured by the thermocouple embedded in the electrode tip and is displayed on the touch screen. This equipment automatically adjusts the output to maximize the delivery of high-frequency energy and displays the measured temperature from the treatment site during high-frequency emission.

Mygen M-3004 automatically adjusts the output to optimize radiofrequency output and displays the measured temperature from the treatment area while delivering radiofrequency energy.

This is a 510(k) summary for a medical device called the "Mygen M-3004 RF System," an electrosurgical cutting and coagulation device. The document primarily focuses on establishing substantial equivalence to a predicate device, not on clinical performance or diagnostic accuracy. Therefore, the information requested in your questions, particularly regarding acceptance criteria for diagnostic accuracy, expert review, and training/test set details, is largely not present in this type of submission.

Here's an breakdown of the available information based on your questions:

1. A table of acceptance criteria and the reported device performance

The document does not provide a formal table of acceptance criteria for diagnostic accuracy or performance metrics like sensitivity, specificity, or AUC. Instead, it details performance tests conducted to ensure the device functions as intended and is safe. The "acceptance criteria" here are implicit in the successful completion of these engineering and safety tests, demonstrating compliance with relevant standards.

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

The document describes in vivo animal testing using micropig models.

• Sample size: Not explicitly stated as a number of animals. It mentions "micropig models" in plural, implying more than one but a specific count is not provided.
• Data provenance: Prospective, animal study (micropig models). No country of origin is specified for the animal testing, but the submitter's HQ is in South Korea.

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

This information is not provided. The animal study was conducted to obtain "histological data of values for depth and zone of ablation and thermal damage." This "ground truth" would typically be established by veterinary pathologists, but their number and qualifications are not mentioned.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

This information is not provided. Given the nature of histological evaluation in animal studies, it might involve a single expert or multiple without a formal adjudication protocol listed in this summary.

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

This device is an electrosurgical generator, not an AI-powered diagnostic or assistive tool for human readers. Therefore, an MRMC comparative effectiveness study involving human readers and AI assistance is not applicable and was not performed.

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

This device is a hardware electrosurgical system, not a software algorithm. Therefore, "standalone (algorithm only)" performance is not applicable.

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

For the in vivo animal testing, the ground truth was histological data (depth and zone of ablation and thermal damage immediately post treatment; 7 days post treatment; and 14 days post treatment).

8. The sample size for the training set

This information is not applicable. The device is a hardware system, not a machine learning model that requires a training set. The "tests" mentioned are for hardware performance and safety verification.

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

This information is not applicable, as there is no training set for this type of device.

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