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The Welcon Hue-Vu™ Urinary drainage Bag is indicated for use for the collection of urine when used with an indwelling catheter.

The Welcon Hue-Vu™ Urinary Drainage Bag is a 2000 ml capacity vented vinyl urine collection receptacle intended to be used with an indwelling catheter. The bag has a hanging hook at the top, and is equipped with a sampling port near the catheter connector. The inlet tubing has an anti-reflux valve to prevent backflow. A vent allows air to escape the bag as urine enters. A Hue-Vu™ color strip label is affixed to the front of the bag, and is used to compare and record the color of the urine collected in the bag.

The provided document is a 510(k) premarket notification for the Welcon Hue-Vu™ Urinary Drainage Bag. It explicitly states that no performance or safety data was included in this submission. Therefore, it is not possible to describe acceptance criteria or a study proving the device meets those criteria from the information given.

The document states:
"Substantial equivalence for this device was based solely on design and performance characteristics; no performance or safety data was included in this premarket notification. The materials, performance specifications and essential design characteristics of the Welcon Hue-Vu™ device are identical to those of the predicate devices."

As a result, I cannot provide the requested information, including:

1. A table of acceptance criteria and the reported device performance
2. Sample size used for the test set and the data provenance
3. Number of experts used to establish the ground truth
4. Adjudication method
5. MRMC comparative effectiveness study results
6. Standalone performance study
7. Type of ground truth used
8. Sample size for the training set
9. How the ground truth for the training set was established

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