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Total ankle arthroplasty is intended to give a patient limited mobility by reducing pain, restoring alignment and replacing the flexion and extension movement in the ankle joint. Total ankle arthroplasty is indicated for patients with ankle joints damaged by severe rheumatoid, post traumatic or degenerative arthritis in elderly individuals with reduced activity levels.

CAUTION: The Agility Ankle Prosthesis is intended for cemented use only.

The Agility™ LP Total Ankle Prosthesis proposed in this submission are a line extension to the Agility™ Total Ankle system components (cleared as DePuy Alvine Total Ankle Prosthesis under K920802, December 17, 1992). The Agility LP Ankle is a modular ankle prosthesis that is comprised of a tibial tray, a polyethylene tibial insert and a talar component.

The provided text is a 510(k) summary for the Agility™ LP Total Ankle Prosthesis. It describes the device, its intended use, and its substantial equivalence to a predicate device. However, this document does not contain information about acceptance criteria for device performance, nor details of a study demonstrating such performance.

The 510(k) process for this type of medical device (an ankle prosthesis) primarily focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than requiring extensive clinical trials or performance studies with specific acceptance criteria in the same way a diagnostic AI device or novel therapeutic might.

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

Specifically, the document states:

• "The substantial equivalence of the Agility LP Ankle Prosthesis is demonstrated by its similarity in indications for use, design, materials, sterilization and packaging to the Agility Ankle cleared in K920802 (formerly called the Alvine Ankle)."

This statement indicates that the regulatory clearance was based on similarity to a previously approved device, not on specific performance metrics established through a new study with acceptance criteria.

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