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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 FDA 510(k) summary for the Paragon 28 APEX 3D Total Ankle Replacement System does not contain information related to AI/ML device performance or clinical studies using AI/ML. The document describes a traditional medical device (an ankle replacement system) and focuses on its mechanical performance testing and substantial equivalence to predicate devices based on physical properties, materials, and design.

Therefore, I cannot extract the requested information regarding acceptance criteria, study details, sample sizes, ground truth establishment, or expert involvement, as these elements are specific to the evaluation of AI/ML-driven medical devices, not the type of device described in this document.

The document details:

• Device Type: Total Ankle Replacement System (mechanical implant).
• Performance Testing: Focuses on mechanical characteristics like range of motion, contact stress, fatigue strength, polyethylene wear, etc.
• Substantial Equivalence: Based on intended use, indications, design, materials, and size range compared to predicate mechanical devices.

Thus, all specific questions regarding AI/ML device evaluation (e.g., test set, ground truth, experts, MRMC, standalone performance, training set) are not applicable to the content provided.

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