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The Mentor Pathway Introducer is indicated for use as an operating port at the skin insertion site when instruments are utilized beneath the dermal layer for lipoplasty surgery applications. The Dilator is indicated for dilating the dermal layer and aiding in the insertion of the Pathway Introducer. The Plug is indicated for sealing the lumen of the Pathway Introducer when not in use.

The Mentor Pathway Introducer/Dilator system consists of three (3) primary components: Introducer, Dilator and Plug.

The Dilator consists of a dilating stem and a handle. It is used to facilitate the insertion of the Introducer.

The Pathway Introducer consists of a threaded distal end which is threaded into the skin at the insertion site, and a conical section which remains outside the skin. There is a longitudinal hole in the Introducer through which a cannula and sheath (or other similar surgical instrumentation) are inserted, and there is a seal inside the hole which wipes excess liquid from the cannula and sheath during withdrawal. The Introducer acts as an access port during the insertion of cannulae and other operating instruments to a desired surgical site beneath the dermal layer.

The Plug is used to seal the lumen of the Pathway Introducer when not in use.

The provided document is a 510(k) summary for the Mentor Pathway Introducer/Dilator, which outlines its intended use, design, and claims of substantial equivalence to other devices. However, this document does not contain any information regarding acceptance criteria, study designs, sample sizes, ground truth establishment, or expert involvement that would be required to answer your prompt.

Therefore, I cannot provide the requested information based on the text provided. This document is a regulatory submission for a medical device (an Introducer/Dilator for lipoplasty surgery), not a report on an AI/ML medical device's performance study.

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