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Both devices are indicated for use in the collection of free flowing urinary drainage. Both devices function in the same manner: they collect and contain urine.

ProSys™ Bedside Drainage Bag (Sterile) is available with a 2000 ml volume capacity. Each stèrile bag is fitted with a permanently welded 55 inch inlet tube containing a universal connector which connects to an indwelling or external catheter. The Bedside Drainage Bag (Sterile) has a T-tap drainage valve. The inlet tube contains an anti-reflux valve to reduce the risk of urine backflow and infection and, a sample port used for urine sampling is integrated into the universal connecter.

The provided text is a 510(k) summary for a medical device called the "ProSys™ Bedside Drainage Bag (Sterile)". It describes the device, its intended use, and claims substantial equivalence to a predicate device.

However, the information required to answer your specific questions about acceptance criteria, device performance, and study details (sample size, experts, ground truth, MRMC, standalone performance, training set details) is not present in this document.

This 510(k) summary focuses on general device description, biocompatibility, and process validation testing, but it does not provide the detailed study results or specific quantitative performance metrics that would be typically found in a clinical study report or a more comprehensive technical document.

Therefore, I cannot provide a table of acceptance criteria and reported device performance, nor can I answer your specific questions about sample sizes, experts, ground truth, or MRMC/standalone studies, as this information is not available in the provided text.

The document mentions "Process validation testing performed on ProSys™ Bedside Drainage Bag (Sterile) included tests for resistance to bursting, resistance to impact, and for leakage. Additionally, the anti-reflux valve, tensile strength and outline weld integrity were also tested. All components performed at an acceptable level and the test results appear in Item 5a."

This indicates that some testing was done, and that the results were deemed "acceptable," but it does not provide the quantitative acceptance criteria or the reported performance values. It also refers to "Item 5a" for the test results, which is not included in the provided text.

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