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Aseptic Intermittent Self-Catheterization.

The Rüsch FloNeil (coated, with Water Pack) / Rüsch Flocath IntroGel (uncoated, without Water Pack) - consists of a tubular PVC catheter, a split introducer, a silicone introducer tip. introducer cap, lubrication jelly and a pack of 15ml saline (for FloNeil -coated product) inside a closed urine collection bag.

The provided text is a 510(k) Summary for a medical device (urinary catheters) and the subsequent FDA clearance letter. It does not contain information about acceptance criteria or a study proving that a device meets those criteria. The document focuses on demonstrating substantial equivalence to a predicate device, which is a regulatory pathway, not a performance study in the sense of accuracy, sensitivity, or specificity.

Therefore, I cannot fulfill your request for the detailed information because the source document does not provide it.

Here's a breakdown of what the document does include:

• Device Name: Rüsch FloNeil (coated, with Water Pack) and Rüsch FloCath IntroGel (uncoated, without Water Pack)
• Intended Use: Aseptic Intermittent Self-Catheterization
• Predicate Device: Rüsch MMG/O'Neil Catheter Set and the MMG O'Neil Urinary Catheter
• Substantial Equivalence: Claimed equivalence in materials, design, and use to the predicate.
• Classification: Class II medical device, 78 KOD, 21CFR 876.5130

To address your query regarding acceptance criteria and a study, these would typically be found in a performance study report, clinical trial summary, or a specific section of a 510(k) submission dedicated to performance testing (if non-clinical or clinical data were required to demonstrate substantial equivalence beyond material and design comparison). This document is a high-level summary.

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