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The INBONE and INFINITY Total Ankle is intended to give a patient limited mobility by reducing pain, restoring alignment and replacing the flexion and extension movement in the ankle joint. indicated for patients with ankle joints damaged by severe rheumatoid, post-traumatic, or degenerative arthritis.

The INBONE and 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 Inbone® and Infinity® Total Ankle Systems consist of tibial trays, talar domes and tibial inserts. The tibial trays and talar domes have modular stem connections. The tibial trays are manufactured from titanium alloy; the talar domes are manufactured from cobalt chrome; and the tibial inserts are manufactured from Ultra High Molecular Weight Polyethylene (UHMWPE).

The Inbone® and Infinity® Total Ankle Systems are intended to give a patient limited mobility by reducing pain, restoring alignment and replacing the flexion and extension movement in the ankle joint.

The design features of the Inbone® and Infinity® Total Ankle Systems are substantially equivalent to the design features of other-devices previously cleared for market.

This document is a 510(k) premarket notification for the INBONE and INFINITY Total Ankle System. It does not describe a study involving an AI device or present acceptance criteria in the typical format for AI performance. Instead, it is for a medical implant and focuses on demonstrating substantial equivalence to previously marketed predicate devices. Therefore, a direct answer to your request in the context of an AI device and its acceptance criteria as proven by a study is not possible from the provided text.

However, I can extract information related to the device and its intended use, which might be analogous to general "acceptance criteria" for a physical medical device. Also, I can explain why other requested information (like sample sizes for test/training sets, expert ground truth, MRMC studies, standalone studies, etc.) is not applicable here.

Here's a breakdown based on the provided document:

1. A table of acceptance criteria and the reported device performance

The document does not specify "acceptance criteria" in the format of quantitative performance metrics for the device itself, as would be expected for an AI algorithm. Instead, the "acceptance" is based on demonstrating substantial equivalence to predicate devices. The "performance" is described in terms of its intended function and safety under specific conditions.

2. Sample size used for the test set and the data provenance

• Not Applicable: This document describes a medical implant, not an AI device. There is no "test set" in the context of an AI algorithm's performance evaluation. The "testing" mentioned refers to physical and environmental testing (e.g., MR compatibility), not data-driven performance.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

• Not Applicable: As there is no "test set" for an AI algorithm, there are no experts establishing ground truth in this context. The "ground truth" for the device's safety and effectiveness is established through adherence to recognized standards, predicate device comparison, manufacturing quality systems, and clinical experience with similar devices, rather than expert labeling of data.

4. Adjudication method for the test set

• Not Applicable: No test set or associated adjudication method for an AI algorithm is described.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

• Not Applicable: This is a physical medical device, not an AI system. Therefore, no MRMC study, human readers, or AI assistance are involved in its evaluation as described in this document. The document explicitly states "N/A" under "Substantial Equivalence - Clinical Evidence."

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

• Not Applicable: This is a physical medical device, not an AI system.

7. The type of ground truth used

• For this 510(k) submission, the "ground truth" for demonstrating substantial equivalence relies on:
  • Predicate Device Comparison: The primary "ground truth" is the established safety and effectiveness of legally marketed predicate devices (K123059 Inbone® II Total Ankle System, K123954 and K140749 Infinity® Total Ankle System).
  • Material Science and Engineering Principles: The physical and mechanical properties of the device components.
  • Environmental Testing: Specifically, MR compatibility testing to ensure safety under those conditions.

8. The sample size for the training set

• Not Applicable: This is a physical medical device, not an AI system. There is no "training set."

9. How the ground truth for the training set was established

• Not Applicable: No training set or associated ground truth establishment is applicable to this medical implant device.

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