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Biolox® delta Ceramic Heads are indicated for use in total hip replacement with cemented or non-cemented femoral and acetabular components in cases of:

1. Non-inflammatory degenerative joint disease including osteoarthritis, avascular necrosis and traumatic arthritis.
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 by other techniques.
5. Revision procedures where other treatment or devices have failed.

Specific indications for compatible components that can be used with the above modular heads include:

Salvage/Oncology Hip and Total Femur System components are also indicated for cases of ligament deficiency, tumor resection, trauma and revision of unsuccessful osteotomy or arthrosis. (K974558, K002757, K021380, K033871)

Interlocking hip stems are indicated for non-cemented application in cases of revision, trauma, fracture, oncology or other situations where severe proximal bone loss may compromise the fixation and stability of a standard-type hip replacement prosthesis. (K990830, K042774)

The Biolox® delta component is a traditional, one-piece ceramic head indicated for hip arthroplasty. The material for the device is Transition-Toughened-Platelet Alumina (TTPA) 75% Alumina, 24% Zirconia and 1% Platelet. The highly polished spherical surface articulates with a polyethylene liner acetabular component. The modular head attaches to a metallic femoral stem with a Biomet Type I taper. The ceramic heads are available in three sizes, with several offsets.

The scope of this submission is:

• An inner taper change and distal face change requested by CeramTec for the purpose of increased burst strength and increased cost effectiveness.
• The one remaining size is previously cleared through K061312 and K073102. This submission seeks to incorporate all of Biomet's Biolox® delta Ceramic Heads (Monobloc) under unified Indications, Contraindications, Instructions for Use and labeling.

This document is a 510(k) Summary for the Biomet Biolox® delta Ceramic Heads, a medical device used in hip arthroplasty. The summary is intended to demonstrate substantial equivalence to legally marketed predicate devices.

1. Table of Acceptance Criteria and Reported Device Performance:

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

The document focuses on non-clinical testing of a physical medical device (ceramic femoral head). Therefore, the concept of a "test set" for data (like in software or AI models) and "data provenance" (country of origin, retrospective/prospective) is not directly applicable in the same way. The "test set" here refers to the samples of ceramic heads and associated components used for the physical and mechanical tests.

• Sample Size for Test Set: The exact sample sizes for each specific test (burst, fatigue, pull-off, rotational stability) are not explicitly stated in this summary. The document mentions "worst case" testing, which implies specific configurations or conditions were selected for testing.
• Data Provenance: Not applicable in the context of physical device testing. The tests are conducted on manufactured devices.

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

This information is not applicable as the document describes physical and mechanical testing of a medical device, not a diagnostic or AI-driven system that relies on expert interpretation for ground truth. The "ground truth" for these tests would be the established engineering standards and acceptable performance limits for orthopedic implants.

4. Adjudication Method for the Test Set:

This information is not applicable for the same reasons as point 3. Physical test results are objectively measured against established criteria, not subject to expert adjudication.

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 applicable. This document describes the 510(k) submission for a physical medical device (ceramic femoral head), not an AI or diagnostic imaging device. Therefore, no MRMC study, human readers, or AI assistance is involved.

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

This information is not applicable as the document is about a physical medical device, not an algorithm or software.

7. The Type of Ground Truth Used:

The ground truth used for this device's testing is based on established engineering standards, material science principles, and functional requirements for orthopedic implants. The tests (burst strength, fatigue, pull-off, rotational stability) are designed to verify that the device meets these pre-defined physical and mechanical performance characteristics relevant to its intended use and safety. The comparison is against predicate devices which have already been deemed safe and effective based on similar physical tests.

8. The Sample Size for the Training Set:

This information is not applicable as there is no "training set" in the context of physical medical device testing for 510(k) clearance. This is not an AI or machine learning device. The manufacturing process and quality control would involve ongoing testing, but not in the sense of a machine learning training set.

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

This information is not applicable for the same reasons as point 8.

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