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The FLUENCY® Tracheobronchial Stent Graft is indicated for use in the treatment of tracheobronchial strictures produced by malignant neoplasms.

The FLUENCY™ Tracheobronchial Stent Graft includes a self-expanding Nitinol Stent encapsulated with ePTFE pre-loaded on a flexible "pull-back" delivery system. It is a single use prosthetic device designed to maintain the patency of the tracheobronchial tree in patients with tracheobronchial strictures produced by malignant neoplasms or in benign strictures after all alternatives have been exhausted. Highly radiopaque Tantalum markers on the stent graft ends facilitate stent graft placement. The FLUENCY™ Tracheobronchial Stent Graft is available in various lengths and diameters. It is preloaded into various size delivery catheters, depending on the size of the stent graft.

This looks like a 510(k) premarket notification for a medical device called the FLUENCY™ Tracheobronchial Stent Graft. However, the provided text does not contain any information about acceptance criteria or a study that proves the device meets specific performance criteria.

The document primarily focuses on:

• Device identification: Trade name, common name, classification, and submitter information.
• Predicate devices: Listing similar legally marketed devices used for comparison.
• Device description: Explanation of the stent graft's components and function.
• Intended use/Indications for Use: The medical conditions the device is designed to treat.
• Substantial equivalence claim: Arguments that the new device is substantially equivalent to existing predicate devices based on composition, design, intended use, and performance attributes.
• FDA correspondence: A letter from the FDA confirming the 510(k) clearance and the device's classification.

Therefore, I cannot fulfill your request to describe acceptance criteria and a study proving the device meets them because this information is not present in the provided text.

To answer your request, I would need a different type of document, such as:

• A clinical study report.
• A design verification and validation report.
• A risk analysis document that specifies performance requirements and acceptance criteria.
• A more detailed premarket submission that includes performance test data.

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