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The Nipro Disposable Stopcocks are intended for use to change the direction of flow of fluids through a tubing set.

The subject devices can be classified as stopcocks as described in 21 CFR 880.5440. Among the types described here are: click - stop; 3W-R; 3W-L; and, NCN. Both slip tip and luer lock are included.

This document is a 510(k) premarket notification for a Class II medical device (Nipro Disposable Stopcocks) and does not contain the details of a study with acceptance criteria and reported device performance in the manner typically associated with clinical or standalone performance studies for more complex devices.

The approval is based on a determination of substantial equivalence to a previously marketed predicate device, not on a new performance study demonstrating the device meets specific numerical acceptance criteria.

Therefore, many of the requested fields cannot be directly extracted from this document as the information simply isn't present for a device of this type and regulatory pathway.

Here's a breakdown based on the provided text, indicating where information is present and where it is not:

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)

• Sample size for test set: Not mentioned.
• Data provenance: Not mentioned. Given the nature of a 510(k) for this type of device, performance tests would likely be in-vitro engineering tests (e.g., flow rate, pressure resistance, leak testing), not human clinical data.

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. This device does not involve expert interpretation or ground truth establishment in the way an AI diagnostic device would.

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

• Not applicable.

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

• No. This is not an AI-assisted diagnostic device, so an MRMC study is not relevant or described.

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

• No. This is a physical medical device (stopcock), not an algorithm.

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

• Not applicable. The "ground truth" for a device like a stopcock is its adherence to engineering specifications and performance within safe parameters, typically verified through physical and mechanical testing rather than clinical "ground truth" as defined for diagnostic systems.

8. The sample size for the training set

• Not applicable. This is not a machine learning or AI device that requires a training set.

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

• Not applicable. This is not a machine learning or AI device that requires a training set.

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