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The INBONE™ Total Ankle System, the INFINITY™ Total Ankle System and the INVISION™ Total Ankle Revision System are indicated for patients with ankle joints damaged by severe rheumatoid, post-traumatic, or degenerative arthritis.

The INBONE™ Total Ankle System, the INFINITY™ Total Ankle System and the INVISION™ Total Ankle Revision System are additionally indicated for patients with a failed previous ankle surgery.

CAUTION: In the United States, the ankle prosthesis is intended for cement use only.

The subject INBONE™ Total Ankle System, INFINITY™ Total Ankle System and INVISION™ Total Ankle Revision System are fixed-bearing, bone-sparing ankle replacement prostheses that restore mobility to a failing ankle joint. The systems include three components (i.e., tibial tray, poly insert, and talar dome) that are assembled together to create the two-piece prosthesis.

This is a 510(k) summary for a medical device (an ankle replacement system), not an AI/ML device. Therefore, the requested information about acceptance criteria, study details, sample sizes, ground truth establishment, expert qualifications, and MRMC studies is largely not applicable in the context of AI/ML performance evaluation.

However, I can extract the information that is present regarding the non-clinical performance and a general conclusion of equivalency:

Device Name: The INBONE™ Total Ankle System, the INFINITY™ Total Ankle System and the INVISION™ Total Ankle Revision System

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

The document lists "Applicable Standard" for various non-clinical performance bench tests. The specific acceptance criteria (e.g., minimum tensile strength value) are not explicitly stated within this summary, nor are the reported performance values. The study concludes that the device performs "at least as well as the predicate devices," implying it met the standards.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

This information is not provided. The study relies on non-clinical bench testing, not patient data.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

Not applicable, as this is a non-clinical bench testing report for a physical device, not an AI/ML diagnostic system. The "ground truth" here is adherence to engineering standards.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not applicable.

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

No, an MRMC study was not done. This is a 510(k) for a physical medical device.

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

Not applicable.

7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)

The "ground truth" for this submission are the performance specifications outlined in established ASTM/ISO standards for material properties and device performance. The testing aims to demonstrate that the device meets these engineering standards.

8. The sample size for the training set

Not applicable. There is no AI/ML model that requires a training set in this submission.

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

Not applicable.

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