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The NFC Y-Site is for single patient use and intended for placement between the male Luer connection of a primary solution source and the patient's vascular access device. In this position, the y-site body provides unobstructed flow between the fluid source and the patient. The Needlefree side port of the y-site is swabbable and can be accessed multiple times using a male Luer for the purpose of administering general IV solutions or blood.

The Filtertek NFC Needlefree Y-Site is intended for single patient use and intended for placement between the male Luer connection of a primary solution source and the patient's vascular access device. In this position, the y-site body provides unobstructed flow between the fluid source and the patient. The needlefree side port of the y-site can be swabbed and then accessed multiple times. The closure system has been tested and has been found to maintain line patency throughout the labeled duration of use.

The Filtertek NFC Needlefree Y-Site is a sterile, non-pyrogenic component packaged in a Twek/polyethylene form, fill, and seal package. The materials used to manufacture the Filtertek NFC Needlefree Y-Site have been tested per tripartite guidelines and are safe for their intended use.

The provided text is a summary of safety and effectiveness information for a medical device (Filtertek NFC Needlefree Y-Site) and an FDA clearance letter. It does not contain the kind of detailed information about acceptance criteria, device performance metrics, study designs, sample sizes, expert qualifications, or ground truth establishment that would be required to complete the requested table and study description.

The document briefly mentions that:

• "The closure system has been tested and has been found to maintain line patency throughout the labeled duration of use."
• "The materials used to manufacture the Filtertek NFC Needlefree Y-Site have been tested per tripartite guidelines and are safe for their intended use."
• "The Filtertek NFC Needlefree Y-Site is sterilized per AAMI quidelines to a 10 sterility assurance level."
• "Each production lot is LAL tested per USP guidelines."

However, these are very high-level statements and do not provide specific acceptance criteria values, reported performance numbers, or details about the studies themselves (e.g., sample size, data provenance, expert involvement for ground truth).

Therefore, I cannot populate the table or provide the requested study details based on the provided text. The document is primarily focused on demonstrating substantial equivalence to a predicate device for regulatory clearance rather than a detailed reporting of a performance study.

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This device is intended to be used as a needless injection port that can be attre hed to any standard luer connector. It is a single patient use device that has an access port that can be swabbed and accessed multiple times.

The Filtertek NFC Needlefree Connector is a one-piece design. luer interfacing injection port. It is sterile, nonpyroqenic and packaged in a Tyvek/polyethylene form, fill, and seal package. The materials used to manufacture the Filtertek NFC Needlefree Connector have been tested per tripartite guidelines and are safe for their intended use.

This document is a 510(k) summary for the "Filtertek NFC Needlefree Connector". It outlines the device's intended use and claims substantial equivalence to existing devices.

Here's an analysis based on the provided text, focusing on the requested acceptance criteria and study information:

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample size used for the test set and the data provenance

The document does not explicitly mention a test set sample size or specific data provenance (e.g., country of origin, retrospective/prospective) for validating the performance criteria. The statements regarding performance are general assertions without specific study details.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

This information is not provided in the document. The filing focuses on substantial equivalence based on design, materials, and established testing guidelines rather than clinical expert evaluation for establishing ground truth for a new, independent test set.

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

This information is not provided. Given the nature of the device (a needlefree connector) and the type of submission (510(k) for substantial equivalence), a formal adjudication process akin to imaging algorithm validation is not detailed.

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 document describes a medical device (a needlefree connector), not an AI-powered diagnostic or assistive tool. Therefore, an MRMC study comparing human readers with and without AI assistance is not applicable and was not performed.

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

No. This device is a physical medical component, not an algorithm. Therefore, a standalone algorithm performance study is not applicable and was not performed.

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

The "ground truth" for this device's safety and effectiveness is primarily based on:

• Compliance with established industry guidelines and standards: e.g., AAMI guidelines for sterilization, USP guidelines for LAL testing, tripartite guidelines for material safety.
• Demonstrated performance in laboratory tests: "The closure has been tested and has been found to maintain line patency..."
• Substantial equivalence to legally marketed predicate devices: The document repeatedly asserts equivalence to existing devices (Douglas Medical Products Maxcess™ Connector and ICU Medical, Inc Clave™ Connector). The "ground truth" for the predicate devices' safety and effectiveness would have been established through their own regulatory pathways.

8. The sample size for the training set

Not applicable. This is a physical medical device, not a machine learning model. There is no concept of a "training set" in this context.

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

Not applicable. (See point 8).

Summary of Study Type:

This 510(k) filing presents a declaration of substantial equivalence rather than a detailed report of a single, comprehensive clinical or performance study. The "study" here refers to the collection of evidence demonstrating that the device meets safety and effectiveness criteria through adherence to established standards and comparison to predicate devices. The evidence includes:

• Material testing: "tested per tripartite guidelines."
• Functionality testing: "closure has been tested and has been found to maintain line patency."
• Sterilization validation: "sterilized per AAMI quidelines to a 10-6 sterility assurance level."
• Endotoxin testing: "LAL tested per USP guidelines."

These tests and validations are typically performed to demonstrate that the new device performs as expected and is as safe and effective as its predicate counterparts. Specific numerical results, sample sizes for these tests, or expert involvement beyond standard regulatory review are not detailed in this summary.

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