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The Electrosurgery Wands are indicated for resection, ablation, and coagulation of soft tissue and hemostasis of blood vessels in open, laparoscopic, and endoscopic general surgery and general gynecology procedures. Representative procedures include the following: General Surgery: cholecystectomy, lysis of adhesions, upper GI, GI (other), splenectomy, thyroidectomy, herniorrhaphy, breast biopsy, bowel resection, pelvic adhesiolysis, removal of lesions, removal of polyps, tumor biopsy. Gynecological Surgery: lysis of adhesions, hysterectomy, salpingo-oophorectomy, burch colposuspension, myomectomy, endometriosis, ovariohysterectomy, removal of tumors.

The Wands are bipolar, single use, high frequency electrosurgical device designed for specific indications.

The provided document is a 510(k) Summary for the ArthroCare Electrosurgery Wands, which details a modification in material for an already cleared device. This type of submission relies on demonstrating substantial equivalence to a predicate device, rather than providing new clinical study data with acceptance criteria for device performance.

Therefore, the information typically requested regarding acceptance criteria, study design, sample sizes, expert ground truth, adjudication methods, MRMC studies, standalone performance, and training set details are not applicable to this specific submission.

The document states:
"The proposed modification in material is not a substantial change or modification, and does not significantly affect the safety or efficacy of the devices." (page 1)

And confirms:
"The indications for use, technology, principle of operation, design, performance and dimensional specifications, labeling, packaging, and sterilization parameters of the ArthroCare Electrosurgery Wands remain the same as in the predicate cleared 510(k)." (page 1)

This means that the device's performance characteristics (and any associated acceptance criteria) were established and accepted during the clearance of the predicate device (K020622). This 510(k) is specifically for a material change, not a new device requiring new performance data.

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