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The Vital Concepts Irrigation Sets are intended for the delivery of irrigation solutions from the fluid container to the irrigation site during bladder irrigation or endoscopic procedures including cystoscopy, transurethral resection (TUR) and arthroscopic procedures.

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The provided text is a 510(k) clearance letter from the FDA for "Irrigation Sets" manufactured by Vital Concepts, Inc. This type of document does not contain information about acceptance criteria or a study proving that a device meets those criteria.

510(k) clearance is based on demonstrating substantial equivalence to a legally marketed predicate device, not on meeting specific performance criteria through a standalone study with defined endpoints.

Therefore, I cannot extract the information requested as it is not present in the provided document. The document primarily focuses on regulatory clearance, device classification, and indications for use.

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