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The Electrosurgery System is intended 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 may 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 Electrosurgery System is a bipolar, high frequency electrosurgical system consisting of three components: an electrosurgical generator called the Controller; a family of disposable, bipolar, single use Wands; and a reusable Patient Cable.

The provided text is a 510(k) summary for the ArthroCare Electrosurgery System. It focuses on demonstrating substantial equivalence to a predicate device rather than presenting a study with specific acceptance criteria and performance metrics for a new device's efficacy or safety.

Therefore, the requested information regarding acceptance criteria, device performance, sample sizes, expert involvement, and ground truth establishment cannot be extracted from the given document.

Here's a breakdown of why this information is missing:

• Type of Submission: This is a "Special 510(k)" which proposes a modification to an already cleared device (K012519). The primary goal of such a submission is to show that the modifications do not significantly affect the safety or efficacy of the device, rather than to prove new performance criteria.
• Focus on Substantial Equivalence: The document explicitly states: "The proposed modifications in performance specifications, dimensional specifications, and labeling are not substantial changes or modifications, and do not significantly affect the safety or efficacy of the System." This means the assessment is comparative to the predicate, not a de novo evaluation against new, pre-defined acceptance criteria.
• Lack of Clinical Study Details: There is no mention of any clinical study, performance study, or human-in-the-loop study in the provided text. The "summary of safety and effectiveness" refers to the comparison to the predicate, not the results of a specific trial.
• Absence of Performance Metrics: The document does not provide any quantitative or qualitative performance metrics (e.g., accuracy, precision, sensitivity, specificity, or specific outcomes) for the modified device itself.

In summary, the provided document does not contain the information requested to fill out the table and describe a study proving the device meets acceptance criteria. It is a regulatory document focused on demonstrating equivalency of minor modifications, not a scientific publication detailing a device's performance validation.

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