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The EndoGator Endoscopy Irrigation Tubing (tubing and accessories to accommodate various endoscopes and irrigation pumps) is intended to provide irrigation via sterile water supply during GI endoscopic procedures when used in conjunction with an irrigation pump (or cautery unit).

The ENDOGATOR Endoscopy Irrigation Tubing is composed of the following: 1) EndoGator™ Irrigation Tubing, and 2) EndoGator™ Irrigation Accessories. The ENDOGATOR Endoscopy Irrigation Tubing is indicated for irrigation during endoscopic procedures by using it in conjunction with an irrigation pump or cautery units, irrigation accessory, endoscope and disposable sterile water bottle. All tubing sets contain a back flow valve at the distal tip that allows irrigation water to travel in one direction, and therefore the risk of cross contamination is significantly reduced. The irrigation tubing sets are for twenty-four hour use and are to be discarded daily. The accessories are single-use devices and are to be discarded between patients. Tubing sets do not come into direct contact with patient tissue.

The provided text describes the 510(k) Summary for the ENDOGATOR Endoscopy Irrigation Tubing. This document details a medical device and its comparison to a predicate device for substantial equivalence with the FDA. It does not contain information about the acceptance criteria and study design for an AI/ML powered device.

Therefore, I cannot provide the requested information about acceptance criteria for an AI/ML powered medical device, nor can I describe a study proving the device meets said criteria from this document. The document pertains to non-clinical performance testing of irrigation tubing, not an AI/ML diagnostic or therapeutic device.

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