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The ArthroCare System 12000 is indicated for resection, ablation, and coagulation of soft tissue and hemostasis of blood vessels in arthroscopic and orthopedic procedures:

The ArthroCare® System 12000 is a bipolar, high frequency, electrosurgical generator called the Controller that is intended to be used with a family of disposable, binolar, single use Wands.

This 510(k) summary for the ArthroCare System 12000 does not describe any acceptance criteria or a study that uses a quantitative test set to prove the device meets said criteria.

The document states:
"This Special 510(k) proposes a modification in the performance specifications and labeling for the ArthroCare System 12000, which was previously cleared in K071709 on August 7, 2007. The indications for use, technology, principle of operation, materials, packaging, and sterilization parameters of the ArthroCare System 12000 remain the same as in the predicate cleared 510(k). The modified ArthroCare System 12000, as described in this Special 510(k), is substantially equivalent to the predicate device. The proposed modifications in performance specifications and labeling are not substantial changes or modifications, and do not significantly affect the safety or efficacy of the System."

This indicates that the submission is for a modification to an already cleared device, and the basis for clearance is substantial equivalence to a predicate device (K071709), rather than a new study demonstrating performance against specific acceptance criteria using a test set. Therefore, the requested information regarding acceptance criteria, study details, sample sizes, ground truth establishment, expert involvement, and comparative effectiveness studies is not present in the provided text.

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