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The water bottle cap irrigation system (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.

The EndoChoice Water Bottle Cap Irrigation System is a sterile, consumable, 24-hour multi-patient use device designed to fit commercially available sterile water bottles and irrigation pumps for providing sterile water during endoscopic procedures.

The EndoChoice water bottle cap system is comprised of a polycarbonate standard water bottle cap, medical grade PVC tubing that extends from the endoscope connector into the water bottle, and a medical grade stainless steel cylinder that serves as both the water intake portion of the disposable water bottle cap and a weight to hold the tubing down while in the water bottle.

The bottle tubing is added into the sterile water bottle and the irrigation system is fastened via the tubing system cap.

Flexible pump tubing connected to the top of the water bottle cap runs to the tubing connector reducer. This flexible tubing is the part of the device that is placed into the irrigation pump. A tubing connector reducer joins the flexible tubing and rigid tubing. The rigid tubing runs to the tubing Luer connector. The tubing Luer connector has the first one-way check valve which prevents potential backflow of fluid from the endoscope into the tubing set. The separately packaged, single-use endoscope connectors (used to connect the tubing set to the auxiliary water channel) also contain one-way valves used to prevent potential backflow.

As with the predicate, the separately packaged, single-use connectors are used to connect to different endoscope models, and all include the second one-way valve to prevent contamination due to potential backflow.

Between patients, the endoscope connectors must be changed to ensure that there is no risk of cross contamination. EndoChoice water bottle irrigation tubing fits standard threaded lid disposable sterile water bottles of approximately 33 mm diameter.

The water bottle cap system is supplied sterile and can be used up to 24 hours.

The provided document is a 510(k) summary for the EndoChoice Water Bottle Cap Irrigation System. It discusses the device's equivalence to a predicate device based on non-clinical testing. However, the document does not contain information about acceptance criteria, device performance metrics, sample sizes for test sets (as this is not an AI/algorithm-based device and thus doesn't have a "test set" in that context), ground truth, or MRMC studies.

Therefore, I cannot fulfill the request for a table of acceptance criteria and reported device performance, or details about the other points, as the necessary information is not present in the provided text.

The document only states that:

• Non-clinical testing (benchtop funcional performance testing, post-aging; and biocompatibility testing per ISO 10993-1) was performed.
• "All test results passed, demonstrating that the device is safe and effective in comparison with the predicate device."

This indicates that internal acceptance criteria for these tests were met, but the specific criteria and detailed results are not provided.

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