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The Ascension® Modular Radial Head is intended for:

• Replacement of the radial head for degenerative or post-traumatic disabilities presenting pain, crepitation, and decreased motion at the radio-humeral 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
• Revision following failed radial head arthroplasty

The Ascension® Modular Radial Head is an anatomically designed, single-use, modular prosthesis designed for replacement of the proximal end of the radius. It is made from ASTM F1537 cobalt chromium alloy. Head components available in six sizes and stem components available in four sizes are interchangeable and achieve assembly by means of a taper connection.

The provided text describes a 510(k) premarket notification for the Ascension® Modular Radial Head, a radial head prosthesis. This submission focuses on demonstrating substantial equivalence to predicate devices rather than proving a device meets specific acceptance criteria through a clinical study with performance metrics.

Therefore, the following information is not applicable or extractable from the provided document:

1. A table of acceptance criteria and the reported device performance.
2. Sample size used for the test set and the data provenance.
3. Number of experts used to establish the ground truth for the test set and their qualifications.
4. Adjudication method for the test set.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done.
6. If a standalone (algorithm only without human-in-the-loop performance) was done.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc).
8. The sample size for the training set.
9. How the ground truth for the training set was established.

Explanation:

The 510(k) pathway, as indicated by the document (K032686), is for demonstrating that a new device is "substantially equivalent" to a legally marketed predicate device. This typically involves comparisons of:

• Intended Use: The Ascension® Modular Radial Head has an intended use as described in the document, which is compared to the predicate devices.
• Technological Characteristics: The device description details its materials (ASTM F1537 cobalt chromium alloy), design (anatomically designed, single-use, modular prosthesis, six head sizes, four stem sizes, taper connection), which are compared to the predicate devices (Avanta Orthopaedics, Inc., Radial Head Implant (K982288) and Wright Medical Technology, Inc., Modular Radial Head (K991915)).
• Performance Data: The document explicitly states "A comparison of materials and design features, as well as performance tests and analyses, demonstrate that the Ascension® Modular Radial Head is substantially equivalent to the predicate devices." However, it does not provide the details of these performance tests (e.g., acceptance criteria, test results, methodology, sample sizes, or ground truth establishment). The specific details of these "performance tests and analyses" are typically found in other sections of the 510(k) submission, such as the biocompatibility, mechanical testing, or sterility data, but are not present in this summary.

This kind of submission typically focuses on engineering and material performance tests (e.g., fatigue strength, wear, construct stability) relevant to an orthopedic implant, rather than clinical study-based performance metrics with expert ground truth or AI algorithms.

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