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Intended Use: The INFINITY™ Total Ankle System is intended to give a patient limited mobility by reducing pain, restoring alignment and replacing the flexion and extension movement in the ankle joint.

Indications For Use: The INFINITY™ Total Ankle is indicated for patients with ankle joints damaged by severe rheumatoid, posttraumatic, or degenerative arthritis.

The INFINITY ™ Total Ankle is additionally indicated for patients with a failed previous ankle surgery.

CAUTION: The ankle prosthesis is intended for cement use only.

The INFINITY™ Total Ankle System is a fixed-bearing total ankle prosthesis that restores mobility to a failing ankle joint. It encompasses three components (i.e., tibial insert, and talar dome) that are assembled to create a two-piece prosthesis. The device is composed of Titanium Alloy, Cobalt Chrome, Ultra High Molecular Weight Polyethylene, and commercially pure Titanium and each component is available in multiple sizes to accommodate variable patient anatomy.

The provided text is a 510(k) summary for the INFINITY™ Total Ankle System, a medical device. This type of document is a premarket notification to the FDA to demonstrate that the medical device is at least as safe and effective as a legally marketed device (predicate device).

However, the information provided does not contain details about acceptance criteria, a study proving device performance against those criteria, or any of the specific reader study methodologies requested.

The document primarily focuses on:

• Device Description: What the INFINITY™ Total Ankle System is made of and how it functions.
• Intended Use and Indications for Use: For whom and under what conditions the device is designed to be used.
• Technological Characteristics Comparison: A high-level statement that its features are similar to predicate devices.
• Non-Clinical Evidence: A list of types of non-clinical analyses performed (Bone interface stability, Component stability, Fatigue testing, Contact area/stress testing) and a conclusion that these results show the device performs "at least as well as" predicate devices. No specific performance metrics, acceptance criteria, or detailed study results are given.
• Clinical Evidence: Explicitly states "N/A", meaning no clinical evidence was presented for this 510(k) submission.
• Substantial Equivalence Conclusion: A general statement of safety and effectiveness based on non-clinical evidence and comparison to predicate devices.

Therefore, I cannot populate the requested table and answer the specific questions because the necessary data is not present in the provided text. The document aims to demonstrate substantial equivalence to existing devices through non-clinical testing and design comparison, rather than presenting a study with specific acceptance criteria and detailed performance metrics as one might find for an AI/software device.

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