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This device is a urological catheter, which is a tubular device that is inserted through the urethra and is used to pass fluids to or from the urinary tract.

The Rüsch SympaCath Hydrogel Coated Foley Catheter is a standard foley catheter, which has been coated with a coating known as hydrogel. The purpose of the coating is to make the catheter slippery on insertion, post activation with water.

The provided text is a 510(k) summary for a medical device (Rüsch SympaCath™ Hydrogel Coated Foley Catheter) and, as such, does not contain information about acceptance criteria, device performance studies with sample sizes, expert ground truth establishment, or clinical study methodologies like MRMC or standalone performance.

This document focuses on:

• Device identification: Submitter, device name (Rüsch SympaCath™ Hydrogel Coated Foley Catheter), common name (Foley Catheter), and classification.
• Equivalence to existing devices: Stating its equivalence to "Bard Biocath and Lubricath or the Curity Kendall Ultramer coated catheters."
• Description of the device: A standard Foley catheter with a hydrogel coating designed to be slippery upon activation with water.
• Intended use: A urological catheter inserted through the urethra to pass fluids.
• Summary of technological characteristics: Emphasizing the coating's function and the similarity of design, materials, and operating principles to competitors.

Therefore, I cannot provide the requested information regarding acceptance criteria and detailed study parameters because it is not present in the given text.

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