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The Irrigation System (tubing and accessories to accommodate various endoscopes and irrigation pumps) is intended to provide irrigation fluids, such as sterile water, during gastrointestinal endoscopic procedures when used in conjunction with an irrigation pump or electrosurgical unit.

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This document is an FDA 510(k) clearance letter for the Torrent Irrigation System. It confirms that the device is substantially equivalent to legally marketed predicate devices.

However, this document does not contain any information regarding specific acceptance criteria, device performance metrics, or study details such as sample sizes, ground truth establishment, or expert qualifications. The letter primarily addresses regulatory compliance and market authorization.

Therefore, I cannot provide the requested table and study details based on the provided text. The information typically found in a 510(k) Summary or a more detailed biocompatibility/performance report would be necessary to answer your questions.

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