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These devices are indicated for use by incontinent persons with other medical conditions that warrant the use of a leg bag and are intended to collect urine. They may be connected to either an indwelling or non-indwelling catheter.

Medline Leo Bags are vinyl pouches with sterile fluid paths and adjustable comfort straps. This device is attached to the leg of an incontinent person and used to collect urine. This device may be used with an indwelling catheter or an external catheter. A leg bag provides the catheterized person with greater mobility and are usually worn during the day and are replaced at night with a standard urinary drainage bag.

The provided document is a 510(k) summary for a medical device: "Urine Collection Leg Bag for External Use Premium Leg Bag, Fabric-Bac Leg Bag, Urinary Leg Bag" by Medline Industries, Inc.

This document explicitly states: "There are no clinical studies that have been performed on these devices, both for the predicate and the new devices."

Therefore, based on the provided text, there is no study described that proves the device meets specific acceptance criteria as it relates to clinical performance. The submission rather relies on substantial equivalence to a predicate device already on the market, and the only difference noted is in the labeling.

Given this information, it is not possible to fill out the requested table and answer the study-related questions.

However, I can extract the information explicitly available:

1. A table of acceptance criteria and the reported device performance:

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
Not applicable, as no clinical studies were performed.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience):
Not applicable, as no clinical studies were performed.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
Not applicable, as no clinical studies were performed.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
Not applicable, as no clinical studies were performed, and the device is a urine collection bag, not an AI-assisted diagnostic tool.

6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
Not applicable, as no clinical studies were performed, and the device is a urine collection bag, not an algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
Not applicable, as no clinical studies were performed. The basis for approval is substantial equivalence to legally marketed predicate devices.

8. The sample size for the training set:
Not applicable, as no clinical studies were performed.

9. How the ground truth for the training set was established:
Not applicable, as no clinical studies were performed.

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