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The ERA Sheath is indicated for use during the resection and/or ablation of unwanted or diseased uterine tissue.

The ERA Sheath is a tubular sheath device incorporating an electrosurgical return electrode. The Sheath is designed to fit over the shaft of a standard gynecological resectoscope to act as an electrical return, thereby, obviating the need for an electrosurgical dispersive pad. The design of the Sheath enables a uterine tissue resection or ablation procedure to be performed in isotonic solution instead of hypotonic solutions which are currently used in these procedures, thereby eliminating the risk of hyponatremia.

The ERA Sheath is composed of four structural elements: 1) a non-conductive sheath material which is placed over a standard continuous flow resectoscope, 2) a return electrode located on the distal end of the sheath with a conductor that runs along the sheath's surface to the proximal end of the sheath, 3) a standard wire connector lead which is used to attach the sheath to the return/patient outlet on the electrosurgical generator, and 4) an insulating outer jacket which is configured to expose the distal electrodes.

The provided document describes a 510(k) summary for the "ERA Sheath," a medical device, but it lacks the detailed information typically found in a study report regarding acceptance criteria and performance data in the format requested. Specifically, it does not contain a discrete "study" proving acceptance criteria in the manner an AI algorithm study would and does not include the statistical metrics (e.g., accuracy, sensitivity, specificity, AUC) or study design elements (sample sizes for test/training sets, ground truth establishment, expert qualifications, adjudication methods, MRMC studies) directly applicable to an AI device.

The document states:

• "Results from clinical evaluations, electrical safety testing, and histopathological evaluation of extirpated uterine tissue resected/abulated with the sheath were supplied in support of substantial equivalence."

This indicates that clinical data and safety testing were conducted, but the specifics of acceptance criteria and performance metrics used to demonstrate "substantial equivalence" to predicate devices, especially in a quantitative table format with specific performance values, are not present in the provided text.

Therefore, for your request, I must state that the information is not available within the provided document. The document is a 510(k) summary for a legacy medical device (a resectoscope sheath), not a study report for an AI-powered diagnostic device, which typically includes the detailed sections you've outlined.

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