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The ArthroCare Orthopedic Electrosurgery System is indicated for resection, ablation, and coagulation of soft tissues and hemostasis of blood vessels in orthopedic, arthroscopic, and spinal procedures.

The ArthroCare Orthopedic Electrosurgery System is a bipolar, high frequency electrosurgical system designed for use in orthopedic procedures where ablation and coagulation of soft tissue and hemostasis of blood vessels is desired. The System consists of three components: an electrosurgical generator called the Controller, the disposable Wand, and the reusable Cable. The Controller utilizes radio frequency (RF) energy as a power source. RF energy is delivered to the patient via the Cable and the Wand. The Cable is designed to attach to the Controller and Wand for patient treatment. The single use, sterile Wand is the patient contacting component of the System. The Wand configuration ranges from single to multiple electrodes incorporating straight, screen, loop, and sheet shaped electrodes. The ArthroCare Orthopedic Electrosurgery System uses bipolar technology in the design of the Wand eliminating the need for a patient contacting dispersive pad used in monopolar devices.

This 510(k) submission (K992581) for the ArthroCare Orthopedic Electrosurgery System is for a Class II electrosurgical device, not an AI/ML powered device. As such, the information you've requested regarding acceptance criteria, study details, expert involvement, and training/test set specifics for AI/ML performance is not applicable to this document.

The submission focuses on establishing substantial equivalence to previously cleared predicate devices (K943450, K963123, K973478, K980170) by demonstrating that it has not modified the technology, principle of operation, design, manufacturing operations, and/or sterilization, and that the expanded indication (to include orthopedic and spinal procedures) does not raise new safety or efficacy issues.

Therefore, I cannot provide a table of acceptance criteria for AI performance, sample sizes for test/training sets, details on expert ground truth establishment, or information on MRMC studies. These concepts are not relevant to the regulatory approval process described in this document.

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