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The Rüsch Urodynamic Rectal Balloon 2-way Catheter is intended to provide a fluid conduit for urodynamic studies, where the detrusor pressure is to be calculated from rectal pressure.

The Rusch Urodynamic Rectal Balloon 2-way Catheter consists of a double lumen polyvinyl chloride tube upon which is affixed a latex balloon, with a radiopaque stripe.

To use, the balloon is inflated with sterile water using a luer taper syringe. The catheter is then connected to a transducer, and can be used in conjunction with equipment for calculating the detrusor pressure necessary to open the urinary sphincter).

The provided text describes a 510(k) summary for the Rüsch Urodynamic Rectal Balloon 2-way Catheter. However, it does not contain information about acceptance criteria or specific study results involving a device's performance against such criteria in the manner requested. Instead, it focuses on the device's characteristics, comparison to predicate devices, and a general statement about biocompatibility and bench testing without numerical performance data or detailed study methodology.

Therefore, I cannot fulfill the request for a table of acceptance criteria and reported device performance, nor details about sample sizes, ground truth establishment, expert qualifications, adjudication methods, or MRMC studies, as this information is not present in the provided text.

The closest information available that might be interpreted in the context of "performance" is the statement:

"The device's performance in these tests [Tensile Testing, Balloon Burst Testing] is comparable with that of the Rüsch Urodynamic Rectal Balloon Catheter (K952573)."

This indicates that some form of performance evaluation was done through bench testing, and the outcome was "comparable" to a predicate device. However, it does not provide the specific numerical acceptance criteria for these tests or the reported numerical performance of the device.

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