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The Cure Ultra® is an intermittent urinary catheter that is inserted through the urethra and indicated for the purpose of bladder drainage for males and females. The urinary catheter comes in a variety of sizes and is packaged sterile for single-use.

The Cure Ultra® catheters, which include the Cure Ultra® Male, Cure Ultra® Female and Cure Ultra® Plus products are intermittent urinary catheters intended to be used by males and females for the purpose of bladder drainage. They are manufactured with conventional medical grade, biocompatible materials that are not made with natural rubber latex. The tip has been designed to eliminate trauma to the urethra and is provided in various sizes in easy-to-open, sterile, single-use packages.

The provided text describes the 510(k) summary for the ConvaTec Cure Ultra® urinary catheter. This document is a regulatory submission to the FDA, demonstrating substantial equivalence to a predicate device, rather than a clinical study proving device performance against specific disease-related acceptance criteria for an AI/algorithm.

Therefore, the prompt's request for information such as ground truth, expert adjudication, MRMC studies, or AI assistance is not applicable to this device and submission type. The Cure Ultra® is a physical medical device (intermittent urinary catheter), not an AI/algorithm-based diagnostic or therapeutic tool.

The "acceptance criteria" discussed in this document relate to the device meeting engineering and regulatory standards rather than clinical performance metrics in a diagnostic context.

Here's a breakdown of the available information based on the prompt's request, noting where information is not applicable:

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)

This information is not applicable as the document describes performance testing for a physical medical device (urinary catheter) against engineering and material standards, not a diagnostic algorithm evaluated on a clinical test set. The sample sizes would refer to the number of catheters tested for each performance criterion. The document does not specify the exact number of units tested for each performance test, but it states "Performance testing... was conducted per applicable sections of voluntary and FDA consensus standards," implying sufficient samples were used to meet those standards. Data provenance (country of origin, retrospective/prospective) is also not applicable in this context.

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)

This is not applicable. "Ground truth" in the context of clinical experts and test sets refers to diagnostic accuracy of an AI or algorithm. This document concerns a physical device tested against engineering and material safety standards.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

This is not applicable for the reasons stated above.

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

This is not applicable. This describes a physical medical device, not an AI-assisted diagnostic tool.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

This is not applicable. This is a physical medical device, not an algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

This is not applicable. The "ground truth" for this device would be its adherence to established engineering specifications and biocompatibility standards, verified through laboratory testing, rather than clinical diagnostic outcomes.

8. The sample size for the training set

This is not applicable. This device doesn't involve a "training set" in the context of machine learning.

9. How the ground truth for the training set was established

This is not applicable. This device doesn't involve a "training set."

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