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IV/Catheter Extension Set with NAC Plus Needleless Access Connector is intended to administer drugs and solutions into a patient's vascular system. The NAC Plus (integral or stand-alone) allows the user to administer or withdraw solutions. The NAC Plus Needleless Access Connector, available as a stand-alone accessory or as part of the IV/Catheter Extension set, may aid in the prevention of needlestick injury.

The IV/Catheter Extension Set with NAC Plus Luer Access Connector constitutes a set for continuous and intermittent fluid delivery into the vascular system. The extension set has luer locks, tubing, slide clamps, tip protectors, and NAC Plus Luer Access Connectors.

The NAC Plus Needleless Access Connector is a Luer activated device cleared under K011193 (Medegen) April 10, 2001. This component is purchased bulk, non-sterile and is packaged by Baxter as both a stand-alone accessory device and as a component integral to IV/Catheter sets. The devices are subsequently packaged, gamma irradiated and distributed to the end user in a cardboard carton.

The provided text is a 510(k) summary for a medical device (IV/Catheter Extension Set with NAC Plus Needleless Access Connector and NAC Plus Needleless Access Connector). It outlines the device description, intended use, and comparison to predicate devices, along with some nonclinical testing information.

However, the document does not contain the specific information required to answer your detailed questions about acceptance criteria and a study proving those criteria are met. The 510(k) summary is a regulatory document focused on demonstrating substantial equivalence to a predicate device, not typically a detailed report of individual performance studies and their specific acceptance criteria.

Here's a breakdown of why I cannot provide the requested information from the given text:

1. A table of acceptance criteria and the reported device performance: The document states, "The results indicate that the proposed device meets or exceeds all functional requirements," but it does not list the specific functional requirements (acceptance criteria) or quantify the reported device performance against those criteria in a table or any other format.
2. Sample size used for the test set and the data provenance: This information is not present.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: This information is not present.
4. Adjudication method: This information is not present.
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: This device is a physical medical device (IV/catheter extension set), not an AI-powered diagnostic or interpretive system. Therefore, an MRMC study comparing human readers with and without AI assistance is not applicable and not mentioned.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: As a physical device, this concept does not apply.
7. The type of ground truth used: This information is not present.
8. The sample size for the training set: As a physical device, this concept does not apply.
9. How the ground truth for the training set was established: As a physical device, this concept does not apply.

What the document does state regarding testing:

• Nonclinical Tests:
  • Biological and chemical reactivity of materials assessed using ISO Standard 10993-1 and USP physicochemical tests. "The material was found to be acceptable for its intended use."
  • "Results regarding the functional performance of the proposed NAC Plus have been submitted."
  • "The results indicate that the proposed device meets or exceeds all functional requirements."

In summary: The provided 510(k) summary affirms that nonclinical tests were conducted and that the device met functional requirements and material biocompatibility standards. However, it does not detail the specific acceptance criteria, test methodologies, sample sizes, or the quantitative results of those tests. These granular details would typically be found in the full test reports submitted to the FDA, not necessarily in the publicly available 510(k) summary.

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