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The Fresenius CAPD stay.safe® Disposable Administration Sets with stay•safe® Connector is indicated for use in end stage acute and chronic renal disease.

The Fresenius CAPD stay•safe® Disposable Administration Sets with stay•safe® Connector consists of a circular housing designed with three, evenly spaced, outlet ports. Individual ports specifically provide for attachment either to the patient, to the peritoneal dialysis solution, or to a drain bag. The outlet port plugs allow the start or stop of solution flow; and prior to use the outlet port for the patient connection is covered with a cap. A knob is turned to different positions to initiate the various treatment steps of the peritoneal dialysis procedure.

The provided text is a 510(k) summary for a medical device called "Fresenius CAPD stay•safe® Disposable Administration Sets with stay•safe® Connector." 510(k) submissions typically focus on demonstrating substantial equivalence to a legally marketed predicate device rather than conducting extensive clinical studies with specific acceptance criteria and detailed performance metrics as might be found in a Premarket Approval (PMA) application.

Based on the provided text, here's an analysis of the requested information:

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)

The document explicitly states "Clinical Data: Not Applicable." The data provenance for the non-clinical tests (biocompatibility, pyrogenicity, sterility, functional/physical) is not specified. It can be inferred that these tests were conducted by the manufacturer, Fresenius Medical Care North America (headquartered in Lexington, MA). The retrospective or prospective nature of these tests is not mentioned, but they are typically conducted as part of the product development and manufacturing process.

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. The study did not involve human interpretation or subjective measurements that would require expert ground truth establishment.

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

Not applicable. There was no clinical study involving human interpretation requiring adjudication.

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. This device is a disposable administration set, not an AI-assisted diagnostic or interpretive tool. No MRMC study was conducted.

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

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

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

For the non-clinical tests, the "ground truth" is defined by established scientific standards and specifications:

• Biocompatibility: ISO 10993-1 standards.
• Pyrogenicity: LAL specification of 0.01 EU/mL.
• Sterility: Sterility Assurance Level (SAL) of ≥ 10⁻⁶.
• Functional and Physical Testing: Internal product release specifications.

8. The sample size for the training set

Not applicable. There is no mention of a training set as this is not an algorithm or AI-based device.

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

Not applicable, as there was no training set.

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