Search Results

The ADAPt™ Open Access Port is indicated for use in thoracic, abdominal, and gynecologic minimally invasive surgical procedures to provide a pathway for the introduction of endoscopic surgical devices.

ADAPt™ Open Access Port, Model 41233

I apologize, but the provided text is a 510(k) clearance letter from the FDA concerning the "Adapt™ Open Access Port, Model 41233." This document does not contain information about acceptance criteria, device performance studies, sample sizes, expert qualifications, or ground truth establishment.

A 510(k) clearance determines if a new medical device is "substantially equivalent" to an existing, legally marketed device (predicate device). It generally doesn't require new clinical studies or detailed performance data comparing the new device against specific acceptance criteria in the way you've described for an AI or diagnostic device. Instead, the manufacturer provides information showing that their device has the same intended use and technological characteristics as a predicate device, or if there are differences, that those differences do not raise new questions of safety and effectiveness.

Therefore, I cannot fulfill your request for information regarding acceptance criteria and study details based on the provided text.

Ask a specific question about this device