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The Biomet Biaxial Total Elbow is indicated for use in Rheumatoid Arthritis, Non-Inflammatory Degenerative Joint Disease including Osteoarthritis and Avascular Necrosis, correction of severe functional deformity, revision procedures where other treatments or devices have failed., and treatment of acute or chronic fractures with humeral epicondyle involvement which are unmanageable using other treatment methods. This linked constrained elbow prosthesis is indicated for joints with both intact and limited soft tissue structures about the elbow.

This device is a single use implant. It is intended for use with bone cement.

The Biomet Biaxial Total Elbow Prosthesis is a constrained hinge elbow prosthesis used to replace the humeral-ulnar articulation of the human elbow. The implant consists of two main components, an ulnar and a humeral component which are ioined by a modular connecting piece.

The biaxial elbow is a "loose hinge" type that has a parallel acting second axis of articulation between the ulnar and humeral stems. An inheirent characteristic of the biaxial articulation is that it can vary the anterior-posterior offset between the intramedullary stems. The Biaxial Elbow allows the stem offset to vary because of varying amounts of flexion between the displaced axes of the prosthesis.

The humeral component is a titanium allov stem. The humeral stem incorporates a flange on the anterior side for additional fixation. A portion of the stem and flange are plasma sprayed coated. The remainer of the stem is a bead blast finish. The humeral component utilizes a polyethylene humeral bearing (saddle bearing) to prevent metal on metal contact with the connecting segment.

The ulnar component is titanium alloy stem. A portion of the surface of the ulnar component is textured with a thin layer of Biomet's plasma spray coating (Bondcoat) and the remainer is a bead blast finish. The ulnar component utilizes a polyethylene ulnar bearing (saddle bearing) to prevent metal on metal contact with the connecting segment.

The modular connecting segment is a cobalt chromium allov metallic piece with a polished finish. The connecting segment is joined to the humeral and ulnar stems by means of a sleeve bearing metal reinforcing rod and saddle bearing. The metal reinforcing rod or axle assembly is manufactured from cobalt chromium. The axles are sleeved by axle bearings, which are manufactured from ArCom® (ultra high molecular weight polyethylene (UHMWPE)). The axle retaining clips are manufactured from titanium alloy. The saddle bearings of the humeral and ulnar component are manufactured from Arcom.

The provided text describes a medical device, the Biomet Biaxial Total Elbow, and its substantial equivalence to other marketed devices. It outlines the intended use, device description, and potential risks. However, the document does not contain information typically found in acceptance criteria or studies proving device performance for most of the requested parameters. This kind of information is usually detailed in pre-clinical testing reports (e.g., mechanical tests, biocompatibility tests) or clinical studies, which are not included in this summary of safety and effectiveness.

Here's an analysis based on the available text:

Acceptance Criteria and Device Performance Study Information

1. A table of acceptance criteria and the reported device performance

The document does not provide specific acceptance criteria or reported device performance data in a quantitative or tabular format. It generally states that the device is "substantially equivalent" to predicate devices, implying it meets similar safety and effectiveness standards, but it doesn't detail what those standards are or how it explicitly performs against them.

2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)

This information is not provided in the document. The document describes the device and its intended use but does not present data from a test set or clinical study.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g., radiologist with 10 years of experience)

This information is not provided in the document. No test set or ground truth establishment is described.

4. Adjudication method (e.g., 2+1, 3+1, none) for the test set

This information is not provided in the document. No test set or adjudication method is described.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

This information is not provided in the document. The device is a physical elbow prosthesis, not an AI-assisted diagnostic or therapeutic tool, so an MRMC study related to AI assistance would not be applicable.

6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done

This information is not provided in the document. As mentioned above, this is a physical implant, not an algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

This information is not provided in the document. No specific ground truth related to device performance is discussed. The "substantial equivalence" determination by the FDA is based on a review of the device's design, materials, and intended use compared to legally marketed predicate devices, not typically on a new ground truth evaluation through clinical trials for 510(k) clearances unless specific performance data is required for a novel aspect.

8. The sample size for the training set

This information is not provided in the document. No training set is mentioned as this is a physical medical device clearance, not an AI model development.

9. How the ground truth for the training set was established

This information is not provided in the document. No training set or ground truth establishment for a training set is discussed.

Summary of what is present:

The document is a FDA 510(k) Summary of Safety and Effectiveness for a medical device. It provides:

• Device Name: Biomet Biaxial Total Elbow
• Intended Use: Rheumatoid Arthritis, Non-Inflammatory Degenerative Joint Disease, correction of severe functional deformity, revision procedures, and treatment of acute/chronic fractures with humeral epicondyle involvement.
• Device Description: A constrained hinge elbow prosthesis with humeral and ulnar components joined by a modular connecting piece, designed as a "loose hinge." Details on materials (titanium alloy, polyethylene, cobalt chromium) are provided.
• Potential Risks: Standard risks associated with joint replacement (e.g., reaction to bone cement, fracture of components, infection, loosening).
• Substantial Equivalence: States the device is substantially equivalent to predicate devices like the Coonrad III Total Elbow (Zimmer) and Osteonics Elbow Prosthesis. This is the primary "proof" for 510(k) clearance – demonstrating that the new device is as safe and effective as a legally marketed predicate device.

What is generally expected for acceptance criteria and performance evidence for this type of device (though not present in this document):

For a joint prosthesis like the Biomet Biaxial Total Elbow, acceptance criteria and performance studies typically involve:

• Mechanical Testing: Benchtop tests for fatigue, wear, strength, range of motion, and constraint, adhering to ISO or ASTM standards. Acceptance criteria would be specific load cycles, wear rates (e.g.,

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