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The Arthrex TightRope™ Syndesmosis Device is intended as an adjunct in fracture repair involving metaphyseal and periarticular small bone fragments where screws are not indicated, and as an adjunct in external and intramedullary fixation systems involving plates and rods, with fracture braces and casting. Specifically, the Arthrex TightRope™ Syndesmosis Device is intended to provide fixation during the healing process following a syndesmotic trauma, such as fixation of syndesmosis (syndesmosis disruptions) in connection with Weber B and C ankle fractures.

The TightRope™ Syndesmosis Device is designed as two differently sized metal buttons, both stainless steel or both titanium, and FiberWire™ suture. The buttons are pre-threaded with FiberWire suture, looped twice through the buttonholes. A long straight needle with pull-through FiberWire suture is also looped through the leading button.

The provided text does not contain the information requested regarding acceptance criteria and a study proving the device meets those criteria.

This document is a 510(k) Summary of Safety and Effectiveness for the Arthrex TightRope™ Syndesmosis Device, dated February 16, 2005. The primary purpose of a 510(k) submission is to demonstrate substantial equivalence to a legally marketed predicate device, rather than to establish specific performance acceptance criteria through a dedicated study.

Here's why and what information is present in the document:

• Substantial Equivalence: The document explicitly states that Arthrex determined the TightRope™ Syndesmosis Device is "substantially equivalent to the predicate devices where basic features and intended uses are the same." This means its safety and effectiveness are established by showing it is as safe and effective as a device already on the market, not by meeting predefined performance targets in a primary clinical study.

Therefore, I cannot populate the table or answer the specific questions about acceptance criteria and a study as the provided text does not include this information.

The document does contain:

• Device Name: TightRope™ Syndesmosis Device
• Sponsor: Arthrex, Inc.
• Regulatory Information: Product codes, classifications, and identified predicate devices.
• Device Description: What the device is made of and how it works.
• Intended Use: The medical conditions and procedures for which the device is designed.
• FDA Clearance Letter: Confirmation of the 510(k) clearance based on substantial equivalence.

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