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1. Noninflammatory degenerative joint disease, including osteoarthritis and avascular necrosis.
2. Rheumatoid arthritis.
3. Correction of functional deformity.
4. Treatment of non-union, femoral neck fracture and trochanteric fractures of the proximal femur with head involvement, unmanageable using other techniques.
5. Revision of previously failed total hip arthroplasty.
6. Dislocation risks.
   The ArComXL™ Active Articulation Head is a single-use implant, intended for uncemented applications.

The ArComXL™ Active Articulation belongs to the family of dual mobility acetabular implants: the presence of two articulating surfaces in the same joint device. The ArComXL™ Active Articulation Head fits over a femoral modular head, which articulates within the ArComXL™ Head. The resultant assembly then articulates within the acetabular metal shell. The ArComXL™ Head is designed to be used with several styles of acetabular shells that have been cleared in previous submissions: M²a Magnum™ (K042037), Magnum™ Tri-Spike (K062995), and M²a 38™ Flared Cups and Non-Flared Cups (K011110).
The ArComXL™ Active Articulation Heads are available in sizes 44-66mm (Note: Size 44-66mm references O.D. of mating shell; the actual head sizes are 38-60mm.) and are manufactured from highly cross-linked polyethylene, conforming to ASTM F648. ArComXL™ is not a new material; the material and manufacturing process were cleared in K042051, ArComXL™ Polyethylene Liners, as well as subsequent submissions. The ArComXL™ Active Articulation is designed for both primary and total revision surgeries, where all device components associated with the wear couple are removed and replaced. The system is intended for uncemented applications.

This document describes the Biomet ArComXL™ Active Articulation Head, a hip replacement component. This submission is for a material change from the predicate device.

Here's an analysis of the acceptance criteria and study information:

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample Size and Data Provenance

• Test Set Sample Size:
  • Push-In and Lever-Out: Six samples.
  • Wear Testing: Not explicitly stated, but typically multiple samples are used in ISO 14242 testing. The document states "the ArComXL™ Active Articulation heads were tested".
• Data Provenance: Not explicitly stated, but assumed to be from laboratory testing conducted by Biomet Manufacturing Corp. (the submitter). These are non-clinical tests.

3. Number of Experts and Qualifications for Ground Truth of Test Set

Not applicable. The reported studies are non-clinical mechanical tests (Push-In and Lever-Out, Wear Testing), not clinical studies requiring expert ground truth for interpretation.

4. Adjudication Method for Test Set

Not applicable. This section relates to clinical studies and expert review, which were not performed for the determination of substantial equivalence for this device.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

Not applicable. No clinical studies were conducted, and therefore, no MRMC studies comparing human readers with and without AI assistance were performed. The device is a medical implant, not an AI-assisted diagnostic tool.

6. Standalone (Algorithm Only) Performance Study

Not applicable. This device is a physical implant, not an algorithm or software. The performance studies are non-clinical hardware tests.

7. Type of Ground Truth Used

• Push-In and Lever-Out: Comparison to the performance of a legally marketed predicate device (K991990), establishing functional equivalence.
• Wear Testing: Comparison to the wear rates of a legally marketed predicate device, ArCom™ 36mm liners (K032396), as per ISO 14242 standards.

8. Sample Size for Training Set

Not applicable. This device is a physical implant; there is no "training set" in the context of an algorithm or AI model development.

9. How Ground Truth for Training Set Was Established

Not applicable, as there is no training set for this device.

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