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Avanta Orthopaedics Radial Head implant is intended for replacement of the proximal end of the radius:

• Replacement of the radial head for degenerative, or post-traumatic disabilities presenting pain, crepitation and decreased motion at the radiohumeral and or proximal radio-ulnar joint with:
  • joint destruction or subluxation visible on x-ray .
  • resistance to conservative treatment .
• Primary replacement after fracture of the radial head .
  • Symptomatic sequelae after radial head resection .

The radial head implant like the predicate device includes various sizes of implants and accessories including sizers. The implant allows for replacement of the proximal radial head.

The provided text is a 510(k) Summary for a Radial Head Implant (K023604). This document focuses on demonstrating substantial equivalence to a predicate device through comparison of design characteristics, intended use, and materials, rather than establishing acceptance criteria or reporting performance metrics from a clinical study as would be typical for artificial intelligence/machine learning (AI/ML) devices.

Therefore, the requested information, which is highly relevant to AI/ML device performance and testing, cannot be extracted from this document. This document describes a traditional medical device (implant) and its clearance process, which relies on a comparison to an already-marketed device and mechanical testing, not a study evaluating algorithm performance.

Specifically:

• No acceptance criteria or reported device performance in terms of diagnostic accuracy metrics (e.g., sensitivity, specificity, AUC) are present because this is a physical implant, not an AI/ML diagnostic tool. The "performance" discussed is in terms of material properties and mechanical strength, which are assessed through bench testing.
• No sample size for test set or data provenance is mentioned, as there is no "test set" of clinical cases for an algorithm.
• No number or qualifications of experts for ground truth, adjudication method, MRMC study, or standalone performance study is mentioned. These are all concepts related to evaluating diagnostic algorithms.
• No type of ground truth, training set size, or method for establishing training set ground truth is mentioned. Again, these are AI/ML specific details not applicable to this device submission.

The document indicates "Mechanical testing has been performed to demonstrate substantial equivalence." (p.2/2), implying the device's physical properties are comparable to the predicate. However, it does not detail the nature of this testing, specific metrics, or any defined acceptance criteria for these mechanical tests.

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