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The Peristeen™ Anal Irrigation 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 Peristeen™ Anal Irrigation System is indicated for use by children (2 years - < 12 years old), adolescent (12 years - < 18 years old), transitional adolescent (18 - <21 years old) and adult patients with neurogenic bowel dysfunction who suffer from fecal incontinence, chronic constipation, and/or time-consuming bowel management procedures.

The Peristeen™ Anal Irrigation system is a Class II device, consisting of a single-use irrigation catheter with balloon for retention; a control unit with a manual switch that allows for addition of pressure to the water bag, and inflation and deflation of the balloon on the catheter; a bag with a lid to hold water, leg straps that may be used to fasten the control unit and tubing to the thigh, and tubes with connectors. The system is provided with a nylon storage case. The rectal catheter is single-use, but the other components may be used multiple times.

The provided FDA 510(k) summary for the Peristeen™ Anal Irrigation System (K112860) does not contain information about acceptance criteria or a study proving the device meets acceptance criteria in the context of an AI/ML device.

This document describes a medical device (a rectal catheter system) that underwent biocompatibility and mechanical testing. It does not mention any AI/ML components or algorithms, nor does it discuss performance metrics like sensitivity, specificity, or AUC, which are typically found in studies validating AI/ML devices.

Therefore, I cannot provide the requested information. The document explicitly states:

• SUMMARY OF CLINICAL TESTS SUBMITTED (AS APPLICABLE): Not applicable

This means no clinical trials were conducted or submitted as part of this 510(k) to evaluate the device's performance in human subjects, let alone an AI/ML component. The "nonclinical tests" listed are bench tests related to the physical properties and biocompatibility of the catheter.

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