(70 days)
The Alveolus TB-STS™ Tracheobronchial Stent System is indicated for use in the treatment of tracheobronchial strictures produced by malignant neoplasms.
The Alveolus Tracheobronchial Stent Technology System is comprised of two components: the radiopaque stent and the delivery system. The nitinol stent is completely covered with a biocompatible polyurethane (ChronoFlex™) membrane and is self-expanding. The stent expansion results from the mechanical properties of the metal and the proprietary geometry. The stent is designed with a slightly larger diameter near the distal and proximal ends to minimize the possibility of migration. The stent edges are significantly curved inwardly to minimize possible airway irritation. The overall stent geometry is designed to maintain a constant length over the entire range of possible diameters. As a result of this unique design the stent has virtually no foreshortening, thus facilitating the selection of the selection.
It looks like the provided text is a 510(k) summary for a medical device (Alveolus TB-STS™ Tracheobronchial Stent System) and focuses on establishing its substantial equivalence to previously cleared devices. It describes the device, its indications for use, and mentions that physical and biocompatibility test results were submitted.
However, the document does not contain the detailed information necessary to answer your specific questions regarding acceptance criteria and a study proving the device meets those criteria. Specifically, it lacks:
- A table of acceptance criteria and reported device performance.
- Details about a clinical study, including sample sizes, data provenance, ground truth establishment, expert qualifications, or adjudication methods.
- Information on MRMC comparative effectiveness studies or standalone algorithm performance.
The document primarily focuses on establishing substantial equivalence based on material properties, design, and general testing, rather than reporting on specific clinical performance against predefined acceptance criteria from a human-device interaction study.
Therefore, I cannot extract the requested information from the provided text.
§ 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.”