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Intended for general use in the electrosurgical coagulation of tissue and intended for use specifically in the treatment of Gastroesophageal Reflux Disease (GERD).

The Stretta® Catheter is a single use monopolar electrosurgical device. The catheter connects to the Mederi RF Generator by means of a custom electrical connection. The catheter consists of a flexible shaft with a multi-arm basket at the distal end and a control handle at the proximal end. The catheter is introduced trans-orally. The catheter has depth of insertion indicators on the shaft to assist the user in inserting the device to the proper location. Inside the basket is a balloon that when inflated with sterile water or air to expands the basket during use. The basket arms support electrode needles which contact and penetrate esophageal tissue when the basket is expanded and the electrode needles are advanced. The basket arms also contain thermocouples to return temperature measurements to the generator during activation. The balloon is inflated by means of a syringe with an inline pressure relief valve. The procedure, delivery of energy, occurs in several steps where the catheter is positioned, activated, rotated and repositioned during the course of the treatment.

This document is a 510(k) summary for the Mederi Therapeutics Stretta® Catheter. It does not contain information about a study proving the device meets acceptance criteria in the format requested. The document describes the device, its intended use, and compares it to a predicate device to claim substantial equivalence. The "Performance Data" section briefly mentions design verification and validation testing but does not provide specific acceptance criteria, reported performance, sample sizes, ground truth details, or any information about AI or human reader studies.

Therefore, I cannot fulfill your request for the specific information regarding acceptance criteria and a study that proves the device meets them based on the provided text. The document focuses on regulatory approval through substantial equivalence, not on detailed clinical or performance validation studies with measurable acceptance criteria as you've outlined.

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