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The NAC™ PLUS Needleless Access Connector is an accessory to an Intravascular Ho NY O - - ES t reed as a secondary sterile injection site for delivery of fluids to a patient's vascular system through a cannula inserted into a vein or artery.

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I am sorry, but the provided text does not contain the information requested. The document is an FDA 510(k) clearance letter for a medical device called "The NAC™ PLUS Needleless Access Connector". It discusses the device's regulatory classification, substantial equivalence to predicate devices, and general regulatory requirements.

However, it does not include:

• A table of acceptance criteria or reported device performance.
• Details about a study proving the device meets acceptance criteria, including sample sizes, data provenance, expert qualifications, or adjudication methods.
• Information about multi-reader multi-case (MRMC) comparative effectiveness studies or standalone algorithm performance.
• Mention of ground truth types, training set sample sizes, or how training set ground truth was established.

This document is a regulatory approval letter, not a scientific study report or clinical trial summary.

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