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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.

The Agility Ankle Revision Prosthesis is additionally indicated for patients with a failed previous ankle surgery.

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

The Agility Ankle Revision Prosthesis is a modular ankle prosthesis that is comprised of a tibial tray, a polyethylene tibial insert and a revision talar component. The Agility Ankle revision talar component is designed to replace the Agility Ankle primary talar component in revision ankle arthroplasty. It is designed for use with the existing Agility Ankle tibial tray and either the existing polyethylene tibial insert or revision (+2) tibial insert.

The distal surface of the Agility Ankle revision talar component is a rectangular shape and is designed with a fin in the anterior-posterior plane to be cemented into the bone. This distal surface and fin are porous coated with Porocoat. The superior surface is a convex shaped and highly polished to articulate with the polyethylene tibial insert.

The Agility Ankle revision (+2) tibial insert component is manufactured from Ultra High Molecular Weight Polyethylene. It is designed to slide into the existing Agility Ankle tibial tray and is designed to articulate with either the primary or revision Agility Ankle talar components. As with the current tibial insert, the revision insert is designed with lateral and medial ears that slide into the grooves of the tibial tray. The only difference is that the revision insert is 2mm thicker to allow the insert to be used in revision cases and in primary cases where the soft tissues surrounding the ankle are lax.

The provided text is a 510(k) summary for the Agility Ankle Revision Prosthesis. This type of submission is for demonstrating substantial equivalence to a predicate device, not for proving that a new device meets specific acceptance criteria through a study. Therefore, the document does not contain the information requested in your prompt regarding acceptance criteria and a study to prove device performance.

Specifically:

• No table of acceptance criteria and reported device performance is present. The document focuses on demonstrating equivalence to a previously cleared device (K920802, the Agility Ankle).
• No study data related to sample size, data provenance, number/qualifications of experts, adjudication methods, MRMC studies, standalone performance, or training set information is included.
• The document explicitly states that "The determination of substantial equivalence for this device was based on a detailed device description, and conformance with voluntary performance standards," rather than a new clinical or performance study demonstrating novel acceptance criteria.

The 510(k) process primarily relies on comparing a new device to an existing, legally marketed predicate device to establish that the new device is as safe and effective as the predicate. It generally does not require new clinical trials or studies to establish performance against novel acceptance criteria unless the device has significant differences in technological characteristics or indications for use from the predicate.

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