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The ArthroCare Dental Electrosurgery System is intended for use in dental and periodontal surgical procedures to remove soft tissue and to control bleeding in the oral cavity.

The ArthroCare Dental Electrosurgery System is comprised of three components: the Dental Probe, the Probe Cable, and an electrosurgical generator called the Controller. The Probe Cable connects the Controller to the Probe. The Probe is provided in a variety of models, ranging in diameters from 0.5 mm to 2.5 mm with the distal tip of the probe as straight or bent at angles up to 90 degrees. The distal tip may be configured with multi-electrodes or as a loop electrode. The Probe is supplied sterile and intended for single patient use. The Probe Cable is designed for repeat sterilization by either ethylene oxide gas or steam autoclaving methods, as selected by the user. The Controller is a high frequency electronic instrument. There is no software utilized in the operation of the Controller. The ArthroCare Dental Electrosurgery System is bipolar, incorporating a return electrode on the shaft of the device. This means that a return pad is not required for operation. The return energy in a bipolar device with an integral return electrode does not penetrate the tissue as in a monopolar device. In a monopolar device, the energy passes through the patient's body to reach the return pad.

I am sorry, but the provided text describes a medical device called the "ArthroCare Dental Electrosurgery System" and outlines its description, intended use, and technological characteristics, along with a statement of substantial equivalence to predicate devices.

However, the text does not contain any information regarding acceptance criteria, device performance metrics, clinical studies, sample sizes, ground truth establishment, expert qualifications, or adjudication methods. There is no data presented that would allow me to populate the requested table or answer the specific questions about a study proving the device meets acceptance criteria.

The submission is an FDA 510(k) summary from 1996, which typically focuses on demonstrating substantial equivalence to a predicate device rather than presenting detailed clinical study results with acceptance criteria.

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