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The MTP Uropump Disposable Tubing Set is intended for use by qualified surgeons in the infusion of sterile irrigant solution into the ureter and urinary tract during ureterorenoscopic examinations.

The MTP Uropump Disposable Tubing Set is intended to be utilized with the Karl Storz Uropump Irrigation/Suction System for the infusion of sterile irrigant solution into the ureter and urinary tract during ureterorenoscopic examinations.

The MTP Uropump Disposable Tubing Set is intended for use by qualified surgeons in the infusion of sterile irrigant solution into the ureter and urinary tract during ureterorenoscopic examinations. The body contact materials are PVC, silicone, polyolefin, and Makrolon.

This document is a 510(k) summary for the MTP Uropump Disposable Tubing Set. It does not contain information about acceptance criteria or a study proving that a device meets acceptance criteria.

The document details the device's identification, indication for use, device description, and claims substantial equivalence to a predicate device. It also includes the FDA's clearance letter.

Therefore, I cannot fulfill your request for information regarding acceptance criteria and a study proving device performance from the provided text.

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