(28 days)
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 is a spiral stent made from Nickel Titanium and fully covered with ePTFE sleeve. The ePTFE is sealed at the proximal and distal ends completely encapsulating the Nickel Titanium. The Controlled Expansion® Delivery Catheter is designed to allow the user to expand the stent within the stricture and confirm positioning prior to release.
This document is a 510(k) summary for a medical device (a stent) and does not describe an AI/ML powered device or a study involving such a device. Therefore, it is not possible to extract the requested information about acceptance criteria and a study proving device conformance using AI/ML specific metrics.
The document focuses on demonstrating substantial equivalence of a new stent length to a previously cleared predicate device, based on materials, mode of action, and intended use. The "Testing Summary" section mentions simulated use and performance testing to demonstrate mechanical integrity and device performance, but this is traditional bench testing, not an AI/ML study.
Therefore, I cannot provide the requested information.
§ 878.3720 Tracheal prosthesis.
(a)
Identification. The tracheal prosthesis is a rigid, flexible, or expandable tubular device made of a silicone, metal, or polymeric material that is intended to be implanted to restore the structure and/or function of the trachea or trachealbronchial tree. It may be unbranched or contain one or two branches. The metal tracheal prosthesis may be uncovered or covered with a polymeric material. This device may also include a device delivery system.(b)
Classification. Class II. The special control for this device is FDA's “Guidance for the Content of Premarket Notification Submissions for Esophageal and Tracheal Prostheses.”