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Electrodes Handpieces (VCT, RFTV, BMDT) are indicated for coagulation and ablation of tissue when used in conjunction with Mygen V-1000 RF generator (K193355) and M-3004 RF generator (K221277).

Electrodes Handpieces (VCT, RFTV, BMDT) are sterile, single-use electrosurgical electordes intended to be use in conjunction with with compatible radio frequency generator, mainly Mygen V-1000 RF generator (K193355) and M-3004 RF generator (K221277).

Electrodes Handpieces (VCT, RFTV, BMDT) consist of electrode tip, insulation part, handle.

Cooling of the electrode is provided by saline which is pumped (using the peristaltic pump) through the inflow tubing, the electrode and out through the outflow tubing. This is an enclosed system within the electrode and saline does not contact the patient. For the electrodes (VCT, RFTV, BMDT), dispersive electrodes are provided so that electrical current flows through the tip of the electrodes, through the target tissue and to the dispersive electrodes.

This document describes a 510(k) premarket notification for Electrode Handpieces (VCT, RFTV, BMDT) and does not contain information about the acceptance criteria or a study proving that an AI/ML device meets those criteria. The provided text is for a traditional medical device (electrosurgical electrodes) and focuses on substantial equivalence to a predicate device through non-clinical performance data.

Therefore, I cannot provide a response with the requested information about acceptance criteria and a study for an AI/ML device from this document.

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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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Electrodes Handpieces (BT, JET) are indicated for coagulation and ablation of soft tissue when used in conjunction with Mygen V-1000 radio frequency generator.

Electrodes Handpieces (BT, JET) are sterile, single-use electrosurgical electordes intended to be use in conjunction with Mygen V-1000 RF generator (K180999).

Electrodes Handpieces (BT, JET) consist of electrode tip, insulation part, handle.

Cooling of the electrode is provided by saline which is pumped (using the peristaltic pump) through the inflow tubing, the electrode and out through the outflow tubing. This is an enclosed system within the electrode and saline does not contact the patient. For the electrodes (BT, JET), dispersive electrodes are provided so that electrical current flows through the tip of the electrodes, through the target tissue and to the dispersive electrodes.

This document (K193355/S002) is not for an AI/ML medical device, but rather for "Electrode Handpieces (BT, JET)" which are electrosurgical electrodes used for coagulation and ablation of soft tissue. Therefore, the questions related to AI/ML device acceptance criteria, study details, and human-in-the-loop performance are not applicable.

However, I can extract the acceptance criteria and study details that were performed for this specific medical device from the provided text.

Here's a breakdown of the information found, specifically addressing the device's performance data and acceptance criteria:

1. Table of Acceptance Criteria and Reported Device Performance

Regarding the other questions, as this is not an AI/ML device, the following are not applicable or not mentioned in the document:

2. Sample size used for the test set and the data provenance: Not applicable in the context of an AI/ML algorithm. The "test sets" here refer to specific physical samples or experimental setups for the non-clinical tests (e.g., pig tissue for thermal effect, device components for biocompatibility). Specific numbers for these are generally not detailed in a 510(k) summary beyond the fact that testing was conducted.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable.
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.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable.
7. The type of ground truth used: For the non-clinical tests (e.g., thermal effect), the "ground truth" is derived from direct measurements, observations, and histological analysis of the treated biological tissue and physical properties of the device. For other tests like biocompatibility and sterility, it's adherence to international standards and validated methods.
8. The sample size for the training set: Not applicable (no AI/ML algorithm requiring a training set).
9. How the ground truth for the training set was established: Not applicable.

Additional Information from the document:

• No clinical studies were considered for this submission. This explicitly states that the substantial equivalence determination was based solely on non-clinical performance data and technological comparisons.

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The Mygen V-1000 RF system is intended for use in percutaneous and intraoperative coagulation and ablation of tissue.

Electrosurgical, cutting & coagulation device & accessories

I am sorry, but the provided text from the FDA 510(k) clearance letter for the "Mygen V-1000 RF System" does not contain any information regarding acceptance criteria, study details (like sample size, ground truth, expert qualifications, or MRMC studies), or performance metrics beyond the simple statement of "substantial equivalence" to a predicate device.

The document is a standard FDA clearance letter, which confirms that the device is substantially equivalent to a legally marketed predicate device and can therefore be marketed. It outlines regulatory requirements, but it does not delve into the specific technical studies or performance data typically found in a clinical study report or a detailed 510(k) summary (which might be a separate, more extensive document).

Therefore, I cannot fulfill your request for the detailed information regarding acceptance criteria and the study that proves the device meets them because that information is not present in the provided text.

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