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The Self Cath® Catheter is intended for use in male, female, and pediatric patients (neonates, infants, children, adolescents, and transitional adolescents) requiring bladder drainage as determined by their physician. This device is indicated for those individuals unable to promote a natural urine flow or for those individuals who have a significant volume of residual urine following a natural bladder-voiding episode

The Self Cath Catheter consists of a flexible PVC tube. One end of the tube has two holes (eyelets) punched into the tube. These eyelets allow urine to enter the tube and be drained from the bladder. A piece of PVC connector tubing (drain funnel) is attached to the opposite end of the PVC tube.

The provided text is a 510(k) summary for a urological catheter (Self Cath® Catheter) and primarily focuses on demonstrating substantial equivalence to a legally marketed predicate device (Self Cath Plus). It does not contain information about acceptance criteria or specific studies detailing device performance against such criteria in the manner requested.

Therefore, I cannot provide a detailed answer to your request. The document describes the device, its intended use, and states that substantial equivalence is supported by a comparison of design, materials, and intended use, as well as "acceptable results from functional performance and biocompatibility testing." However, it does not specify what these "acceptable results" are, what acceptance criteria were used, or the details of the studies conducted. It also lacks information on sample sizes for test or training sets, ground truth establishment, expert qualifications, or multi-reader multi-case studies.

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