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The Peristeen Anal Irrigation (PAI) System is intended to instill water into the colon through a rectal catheter - which incorporates an inflatable balloon - inserted into the rectum to promote evacuation of the contents of the lower colon. The PAI System is indicated for use by adolescent (12 years - < 18 years old), transitional adolescent (18 -< 21 years old) and adult spinal cord injury patients with neurogenic bowel dysfunction who suffer from fecal incontinence, chronic constipation, and/or time-consuming bowel management procedures.

The Peristeen Anal Irrigation system consists of a single-use irrigation catheter with a balloon for retention; a control unit with a manual switch to add pressure to the water bag, inflate and deflate the balloon on the catheter; a bag with a lid to hold water or isotonic saline solution, leg straps that may be used to fasten the control unit and tubing to the thigh, and tubes with connectors. The system may be purchased with a carrying case (toilet bag). The rectal catheter is single-use, but the other components may be used multiple times. Accessory kits are available for the components. The PAI System is provided nonsterile and is latex free. It is intended for single patient use only.

The provided text describes a medical device, the Peristeen™ Anal Irrigation System, and its substantial equivalence to predicate devices based on design, materials, intended use, and functional performance and biocompatibility testing. However, the document does not contain specific acceptance criteria or a detailed study description with performance metrics that would allow for the complete fulfillment of your request.

The document primarily focuses on obtaining 510(k) clearance by demonstrating substantial equivalence to existing devices. This type of submission often relies on a comparison of technical characteristics and safety data rather than a detailed comparative effectiveness study with specific performance thresholds.

Therefore, I cannot provide the requested table or detailed study information because it is not present in the provided text. The summary and conclusions from the nonclinical tests only state "acceptable results from functional performance and biocompatibility testing" without quantifying these results or defining acceptance criteria.

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