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The Alveolus AERO™ Tracheobronchial Stent Technology System is indicated for use in the treatment of tracheobronchial strictures produced by malignant neoplasms.

The Alveolus AERO™ is comprised of two components: the radiopaque stent and the delivery system. The nitinol stent is completely covered with a biocompatible polyurethane membrane and is self-expanding. The stent expansion results from the physical 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 (2mm for bronchus stent sizes and 3mm for tracheal stent sizes). The stent ends are slightly vaulted inwardly in order to minimize possible airway injury from the stent edges. 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 appropriate stent length.

The provided text is a 510(k) summary for the Alveolus AERO™ Tracheobronchial Stent Technology System. It focuses on demonstrating substantial equivalence to previously cleared devices rather than presenting a study that establishes acceptance criteria and proves device performance.

Therefore, the requested information regarding acceptance criteria, study details, sample sizes, ground truth establishment, expert involvement, and MRMC studies is not available in the provided document.

The document primarily covers:

• Device Description: Details about the stent's components, materials (nitinol, polyurethane), design (self-expanding, slightly larger diameter ends, vaulted ends, constant length), and features (virtually no foreshortening).
• Intended Use/Indications: Treatment of tracheobronchial strictures produced by malignant neoplasms.
• Substantial Equivalence: Listing predicate devices (Alveolus TB-STS™, Boston Scientific Ultraflex™, Rusch International Polyflex, Novatech S.A. Endoxane®) and asserting equivalence based on similar applications and established material history.
• Regulatory Information: Classification (Class II), product code (JCT), and a warning regarding its use in the vascular system.

The document does not describe any specific clinical study conducted to establish acceptance criteria or demonstrate performance of the AERO™ Tracheobronchial Stent through quantitative metrics (e.g., success rates, complication rates, flow improvements) against defined criteria. The approval is based on substantial equivalence to existing devices, implying that their established safety and effectiveness profiles are sufficient.

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