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The NIVTS-P (Nexus IV Tubing Sets – Pre-Pierced) are intended for use to administer IV fluids/medication to the patient's vascular system through a needle.

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The provided text is a 510(k) premarket notification letter from the FDA to Nexus Medical, LLC, regarding their "Nexus Intravenous Tubing Sets-Pre-Pierced" device. This letter indicates that the device has been found substantially equivalent to a legally marketed predicate device.

However, the letter does not contain any information about acceptance criteria, device performance studies, sample sizes, expert qualifications, ground truth establishment, or any of the other specific details requested in the prompt for evaluating an AI/ML medical device.

This document is a regulatory approval letter for a physical medical device (intravenous tubing sets), not a software or AI/ML device. Therefore, the requested information (such as AI performance metrics, MRMC studies, or training set details) is not applicable and not present in the provided text.

Based on the input:

1. A table of acceptance criteria and the reported device performance: Not available. This document is a regulatory clearance letter, not a performance study report.
2. Sample size used for the test set and the data provenance: Not available. No information on a "test set" for performance evaluation is provided.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not available. The concept of "ground truth" as relevant to AI/ML performance evaluation is not discussed.
4. Adjudication method for the test set: Not available.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done: Not applicable. This is not an AI/ML device.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: Not applicable. This is not an AI/ML device.
7. The type of ground truth used: Not applicable.
8. The sample size for the training set: Not applicable.
9. How the ground truth for the training set was established: Not applicable.

In summary, the provided document is a regulatory clearance for an intravascular administration set and does not contain the type of information requested for evaluating an AI/ML medical device's performance study.

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