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The GelPort Blunt Tip Trocar System is indicated for use in general, abdominal, gynecological and thoracic minimally invasive surgical procedures to establish a path of entry or to gain access through tissue planes, extraperitoneal spaces and/or potential spaces for endoscopic instruments.

The GelPort Blunt Tip Trocar System is a sterile single use device, intended for use in conjunction with Applied's currently marketed Trocar products. A standard trocar assembly consists of an obturator, a seal and a cannula system.

The provided text is a 510(k) summary for a medical device (GelPort Blunt Tip Trocar System) and related FDA correspondence. It does not contain information about acceptance criteria, device performance metrics, or study details (like sample sizes, ground truth establishment, expert qualifications, or MRMC studies) for demonstrating the device meets performance criteria.

Instead, this document focuses on demonstrating substantial equivalence to a predicate device based on performance and functional testing. The key statement is:

"The performance and functional testing of the GelPort Blunt Tip Trocar System compared to its predicate device demonstrated that the GelPort Blunt Tip Trocar System is substantially equivalent to its predicate device and it introduces no new safety and effectiveness issues when used as instructed."

This implies that the device was tested to ensure it functions similarly to the predicate device, but the specific acceptance criteria and results of these tests are not detailed in this summary. The FDA's 510(k) clearance process often relies on demonstrating equivalence rather than establishing new performance benchmarks with clinical studies, especially for devices like trocars.

Therefore, I cannot provide the requested information from the given text.

To answer your prompt, I would need a document that specifically outlines the performance study, its methodology, and its results against predefined acceptance criteria.

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