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The X O Odontosurge 4 is intended for use in removing soft tissue and controlling bleeding in the oral cavity in all phases of dentistry, including prosthodontics, periodontics, endodontics, pedodontics, orthodontics, oral surgery, and routine restorative dentistry.

The X O Odontosurge 4 is a high frequency electrosurgery unit that is comprised of the following three principal components: Control Box, Handpiece and Cord, and seven different Electrodes contained in a separate case. The X O Odontosurge 4 is compact and easily portable. The X O Odontosurge 4 is a reusable electrosurgical unit that is used to cut and to coagulate soft tissue during procedures in all disciplines of dentistry. There is no software utilized in the operation of the X O Odontosurge 4.

This document describes a 510(k) premarket notification for a dental electrosurgical unit, not a device with AI or software components requiring performance criteria based on studies, ground truth, or expert consensus. Therefore, I cannot fill in the requested table and details related to such studies.

Specifically, the document states: "There is no software utilized in the operation of the X O Odontosurge 4." This means the device does not employ Artificial Intelligence or machine learning, and thus, does not have "acceptance criteria" or "study that proves the device meets the acceptance criteria" in the context of diagnostic accuracy, algorithm performance, or human-AI effectiveness.

Instead, the submission focuses on establishing substantial equivalence to a predicate device (ArthroCare Dental Electrosurgery System K962445) based on intended use, sterilization method, mode of operation, and general design. The only difference noted is the frequency of operation, which the manufacturer claims offers advantages.

Therefore, the questions regarding acceptance criteria, reported device performance, sample sizes, data provenance, expert ground truth, adjudication methods, MRMC studies, standalone performance, and training set information are not applicable to the information provided in this 510(k) summary.

The device's "acceptance criteria" for regulatory purposes would have been related to engineering specifications, safety standards, and performance benchmarks common for electrosurgical units, which are not detailed in this summary. The "study" mentioned would refer to non-clinical bench testing or electrical safety testing rather than clinical performance studies of diagnostic accuracy.

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