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Radial head arthroplasty

The Axia Radial Head System is intended to reduce or relieve pain and restore function and motion to the elbow.

• Radial head replacement for degenerative or post-traumatic disabilities when presenting with . pain, crepitation, and decreased motion at the radio-humeral and or proximal radio-ulnar joint with:
  • 0 Joint destruction and/or subluxation
  • Resistance to conservative treatment O .
  • Primary radial head replacement after fracture
• Symptomatic sequelae after radial head resection ◆
• Revision following failed radial head arthroplasty .

CAUTION: This device is intended for uncemented use only.

The Axia Radial Head System is a 2-part system comprised of a radial head implant and a radial stem implant. There are 6 sizes of radial heads and 6 sizes of stem implant is available in 3 offset sizes. The large combination of implant sizes and the amount size interchangeability in the system allows for better reproduction of individual patient anatomy.

The Axia Radial Head System radial head implants are made from cobalt-chromium-molybdenum (Co-Cr-Mo) alloy. The radial head stems are made from titanium alloy (Ti-6Al-4V).

The provided text describes the Axia Radial Head System, a medical device, and its regulatory submission (K132735). It details the device's technical specifications, intended use, indications for use, and a single performance test conducted. However, the document does not contain information typically associated with acceptance criteria and a study to prove a device meets those criteria in the context of diagnostic or AI-driven medical devices.

The information provided pertains to the substantial equivalence of a physical orthopedic implant (radial head prosthesis) to a legally marketed predicate device, as part of a 510(k) submission to the FDA. The "acceptance criteria" here are defined by the FDA's regulatory requirements for substantial equivalence, primarily focusing on materials, design, and performance characteristics compared to a predicate.

Therefore, many of the requested sections (e.g., sample size for test set, data provenance, number of experts, adjudication method, MRMC study, standalone performance, training set sample size, ground truth for training set) are not applicable as they relate to studies for diagnostic devices or AI algorithms that predict or classify outcomes. This document describes a mechanical device for joint replacement.

Below is an attempt to structure the available information as requested, with explicit notes about what information is not present or not applicable given the nature of the device.

Acceptance Criteria and Device Performance Study (K132735 - Axia Radial Head System)

1. Table of Acceptance Criteria and Reported Device Performance

For this medical device, "acceptance criteria" are interpreted as demonstrating substantial equivalence to a predicate device (Evolve® Radial Head System - K060731) through shared technological characteristics and indications for use, and confirming the mechanical integrity of a critical component.

2. Sample Size Used for the Test Set and the Data Provenance

• Sample Size: The document does not specify a "sample size" in the context of patient data or clinical cases. The performance testing was a mechanical bench test on device components.
  • For the Modular Connection Testing (ASTM F 2009), the test used "worst case test components and worst case assembly conditions." The exact number of components tested for this mechanical evaluation is not provided.
• Data Provenance: Not applicable in the context of patient data. The "data" comes from laboratory bench testing of physical device components.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts

• Not applicable as this is a mechanical device performance test, not a diagnostic study requiring expert ground truth for interpretation of clinical data.

4. Adjudication Method for the Test Set

• Not applicable. The "test set" was mechanical components undergoing physical stress testing, not clinical cases requiring expert adjudication.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done

• No, an MRMC study was not done. This type of study is relevant for diagnostic performance, typically for medical imaging devices or AI algorithms that assist human readers. The Axia Radial Head System is a physical orthopedic implant.

6. If a Standalone Study (i.e., algorithm-only performance) was done

• No, a standalone study was not done. This is relevant for AI algorithms. The performance test conducted was for the mechanical integrity of the device components.

7. The Type of Ground Truth Used

• The "ground truth" for the Modular Connection Testing was implicitly defined by the ASTM F2009 standard for determining axial disassembly force and comparison to "loads reported in the clinical literature for high demand patient activities." This is a measured mechanical property compared against established biomechanical data, not a clinical pathology, expert consensus, or outcomes data.

8. The Sample Size for the Training Set

• Not applicable. This device is not an AI algorithm, and therefore does not have a "training set."

9. How the Ground Truth for the Training Set was Established

• Not applicable. This device is not an AI algorithm, and therefore does not have a "training set."

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