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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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