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The APEX 3D Total Ankle Replacement System is indicated as a total ankle replacement in primary surgery for patients with ankle joints damaged by severe rheumatoid, post-traumatic, or degenerative arthritis. Revision surgery for these patients is also indicated for patients with sufficient bone stock present. Components are intended for cemented use only.

The Paragon 28 APEX 3D Total Ankle Replacement device is a cemented, fixed-bearing device comprised of a tibial component, a talar component, and a UHMWPE component used for ankle joint replacement. Based on patient anatomy, a number of component sizes and design configurations can be selected for best fit.

The provided text is a 510(k) summary for the APEX 3D Total Ankle Replacement System. This document focuses on demonstrating substantial equivalence to a previously cleared device, rather than providing detailed acceptance criteria and performance studies for a novel AI/software medical device.

Therefore, the requested information regarding acceptance criteria, study details, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, and ground truth establishment for a device meets acceptance criteria cannot be extracted from this document.

The document states that the APEX 3D Total Ankle Replacement System is "substantially equivalent" to a predicate device (K192994). This means that the FDA has determined it is as safe and effective as a legally marketed device, but it doesn't involve the kind of rigorous performance testing against specific acceptance criteria that would be conducted for a new, unproven technology, especially software or AI.

The "Performance Data" section mentions "engineering analysis" to show that "the original testing and subsequent performance is not adversely affected by the modifications". This included "talar stability assessment and bacterial endotoxin testing." This is related to the physical device's integrity and biocompatibility, not software performance.

In summary, the provided text does not contain the information requested in your prompt as it pertains to a traditional medical device (total ankle replacement system) demonstrating substantial equivalence, not a software or AI-based device with specific performance metrics and acceptance criteria.

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