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The ConMed Irrigation Nozzle is intended for colon cleansing when medically indicated, such as before radiological or endoscopic examinations.

The device is sterile, for single-use and is intended for use as an accessory with The device is stome, for clingie nomercial distribution and acts as a nozzle when inserted into a patient's recturn to direct water into and cleanse the lower colon when medically indicated, such as before radiological or endoscopic examination. The nozzle is designed as a one-piece, injection molded plastic handpiece having a slight curvature at the end intended for insertion into the rectum. At the opposite end the device has a barbed fitting for attachment to the tubing from the colonic irrigation system. Several tip configurations are made available to provide options for the clinician.

The provided text is a 510(k) Premarket Notification for a non-AI medical device (ConMed Irrigation Nozzle). As such, it does not contain information typically found in submissions for AI/ML-powered medical devices regarding acceptance criteria, performance studies, sample sizes, ground truth establishment, or expert involvement as requested in your prompt.

Therefore, I cannot extract the requested information.

The document discusses the device's substantial equivalence to predicate devices (Jimmy John III Rectal Nozzle and GC Irrigator) for its intended use in colon cleansing. It mentions that all devices are for similar use, made of similar materials, and have a similar design. This is a common approach for non-AI devices to demonstrate safety and effectiveness without needing extensive clinical trials in the same way an AI-powered device would.

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