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A Rigid Stent Introducer/Endoscope is a device used by a physician to insert Tracheal Stents.

Rigid Stent Introducer / Endose.ope

The provided document is an FDA 510(k) clearance letter for a "Rigid Stent Introducer/Endoscope" from 1999. This document does not contain information about acceptance criteria or a study proving the device meets those criteria.

FDA 510(k) clearance letters, particularly from this era, primarily focus on determining substantial equivalence to a predicate device based on indications for use and technological characteristics. They generally do not include detailed performance studies or specific acceptance criteria beyond what might have been submitted by the manufacturer as part of their 510(k) application. This letter simply states that the device is substantially equivalent to legally marketed predicate devices and can therefore be marketed.

Therefore, I cannot provide the requested information based solely on the provided text. To answer your questions, I would need access to the actual 510(k) submission (if it contained such a study) or other regulatory documentation that details the performance testing for this specific device.

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