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The NMI PICC II and NMI PICCIV are indicated for short- or long-term peripheral access to the central venous system for intravenous therapy, including but not limited to, the administrations and nutrients, the sampling of blood, for central venous pressure monitoring and for power injection of contrast media.

The NMI PICC III with PASV Valve Technology is indicated for short- or long-term peripheral access to the central venous system for intravenous therapy, including but not limited to, the administration of fluids, medications and nutrients, the sampling of blood, and for power injection of contrast media.

The proposed device has similar design, components and technological characteristics as the predicate intravascular catheters; the only difference between the predicate and proposed devices is the type of ink used on the markings of the catheter shaft.

This document describes a 510(k) premarket notification for the NMI PICC III and NMI PICC IV devices. It focuses on demonstrating substantial equivalence to predicate devices, rather than a clinical study proving device meets acceptance criteria through performance. As such, information regarding a study with acceptance criteria, sample sizes, ground truth establishment, or expert involvement is not available in the provided text.

Specifically, the document states:

• "The proposed device has similar design, components and technological characteristics as the predicate intravascular catheters; the only difference between the predicate and proposed devices is the type of ink used on the markings of the catheter shaft."
• "Biocompatibility testing per ISO 10993-1 demonstrates that the new ink on the proposed device does not affect safety and/or effectiveness."
• "The NMI PICC III and NMI PICC IV are substantially equivalent to Navilyst predicate devices based on comparison of technological characteristics and the results of non-clinical tests..."

Therefore, I cannot provide the requested information about acceptance criteria and a study demonstrating device performance as would be found in a clinical trial or performance study report. The provided text outlines a regulatory submission demonstrating equivalence based on non-clinical testing and similar technological characteristics.

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