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The Vascular Architects aSpire® Covered Stent and Controlled Expansion® Delivery System are indicated for use in the treatment of tracheobronhial strictures produced by malignant neoplasms.

The Vascular Architects aSpire® Covered Stent and Controlled Expansion® Delivery I he vasound firemted the luminal diameter within tracheobronhial strictures produced by malignant neoplasms.

The provided document {0}-{4} is a 510(k) premarket notification for a medical device called the "Vascular Architects aSpire® Covered Stent and Controlled Expansion® Delivery System." This document primarily focuses on establishing substantial equivalence to a predicate device and does not contain information about clinical study results, acceptance criteria for device performance, or details about ground truth establishment.

Therefore, I cannot provide the requested information. The document only states:

• Testing Summary: "Simulated use and performance testing was conducted on the Vascular Architects aSpire® Covered Stent and Controlled Expansion® Delivery System. Results of the bench testing performed demonstrate the mechanical integrity and device performance of the subject device are substantially equivalent to that of the predicate device."

This statement confirms that testing was done to show equivalence, but it does not specify the acceptance criteria used for that testing, the actual performance metrics, or any details about a study involving human subjects or AI.

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