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The Cath Caddie was developed by the grandmother of a pediatric cancer patient who received chemotherapy via a Hickman Catheter Constant removal of taped dressings placed in his chest. resulted in skin irritations to the youth. The inventor created the Cath Caddie for her grandchild to eliminate the need for tape. Subsequently, she provided Cath Caddies for several additional patients of Dr. David Rosen. She estimates that Dr.Rosen has issued as many as 1,500 of the covers through his practice and through the Children's Miracle Network. Additional prototypes of the Cath Caddie were provided to Dr. Jerry H. Feagan who in turn passed them on to the Endoscopy and Surgery Center of Topeka. This practice utilized the Cath Caddie to cover and secure PEG tubes of enteral feeding tubes in the abdomens of some of their patients.

This 510(k) summary for the Cath Caddie does not contain the information requested regarding acceptance criteria and a study demonstrating the device meets those criteria.

The document describes the origin and anecdotal use of the Cath Caddie, a device designed to cover and secure catheters (Hickman and PEG tubes). It highlights perceived benefits such as preventing skin irritation from tape, improving patient comfort, and potentially reducing healthcare costs.

However, the summary lacks any quantitative data, specific acceptance criteria, or details of a formal study that would be necessary to fulfill the request.

Therefore, I cannot provide:

1. A table of acceptance criteria and the reported device performance: No specific performance metrics or acceptance criteria are mentioned.
2. Sample size used for the test set and the data provenance: The document refers to "1,500 of the covers" issued by Dr. Rosen and use at the Endoscopy and Surgery Center, but these are not described as part of a formal test set with rigorous data collection. The data is observational and anecdotal, not from a controlled test.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: There is no mention of ground truth establishment or expert review in a study context.
4. Adjudication method for the test set: No adjudication method is described.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done: No such study is mentioned.
6. If a standalone performance (i.e. algorithm only without human-in-the-loop performance) was done: This is a physical device, not an algorithm, so this question is not applicable.
7. The type of ground truth used: No ground truth in an evaluative sense is described.
8. The sample size for the training set: No training set is applicable or mentioned.
9. How the ground truth for the training set was established: No training set or ground truth for it is applicable or mentioned.

The document is purely descriptive and testimonial in nature, focusing on the perceived benefits and the origin story of the device.

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