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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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