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The Klassic HD Hip System is intended for prosthetic replacement without bone cement in treatment of the following:

• · Patient conditions of non-inflammatory degenerative joint disease (NID): avascular necrosis, osteoarthritis, ankylosis, protrusio acetabuli and painful hip dysplasia.
• · Patient conditions of inflammatory joint disease (IJD): rheumatoid arthritis.
• · Those patients with failed previous surgery where pain, deformity, or dysfunction persists.
• Revision of a previously failed hip arthroplasty.
• · Patients who require a total hip replacement.

The Klassic HD® Hip System employs prostheses designed to help surgeons restore hip joint biomechanics intra-operatively. The +10.5mm offset option for the Femoral Head Adapter Sleeves is a line extension to the currently available predicate adapter head offsets (K100445). The subject device is fabricated from Ti6Al4V per ASTM F136. The subject device is compatible with 32mm and 36mm BIOLOX® OPTION Ceramic Femoral Heads (K143407), and also compatible with the Klassic HD® Femoral Stems (K100445) and the Klassic Blade Femoral Stems (K151440 and K171962). The subject components are provided sterile, for single use, by prescription only.

This document is a 510(k) summary for a medical device called "Adapter Sleeve for BIOLOX® OPTION Femoral Head, +10.5mm head length." It describes the device, its intended use, and the studies conducted to demonstrate its substantial equivalence to a predicate device.

1. Table of Acceptance Criteria and Reported Device Performance:

The document mentions that the subject components met predetermined acceptance criteria in Design Control Activities, demonstrating safety and effectiveness compared to predicate components. However, specific numerical acceptance criteria (e.g., minimum load, maximum displacement, pass/fail thresholds) and the exact performance values observed during each test are not explicitly provided in this summary. The table below represents the types of tests conducted and infers the general performance outcome as "met acceptance criteria."

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

The document describes non-clinical laboratory testing and engineering analysis. It does not involve a "test set" in the context of clinical data or AI model evaluation. It refers to physical samples of the device (adapter sleeves, femoral heads, femoral stems) that underwent mechanical and biological testing. The sample sizes for each specific mechanical test (e.g., number of units tested for fatigue, burst strength) are not provided in this summary.

Data provenance: The data is generated from laboratory testing. There is no information regarding the country of origin or whether it's retrospective or prospective, as these terms are typically applied to clinical studies.

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

This type of information is not applicable to this submission, as it deals with the mechanical and biocompatibility testing of a physical medical device, not the evaluation of an AI algorithm on a dataset with expert-defined ground truth.

4. Adjudication Method for the Test Set:

This is not applicable to this submission for the reasons stated above.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done:

This is not applicable to this submission. MRMC studies are used to evaluate the performance of diagnostic devices or AI algorithms when interpreted by multiple human readers, often with and without AI assistance. This submission is for a physical orthopedic implant.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done:

This is not applicable to this submission, as it does not concern an algorithm or AI.

7. The Type of Ground Truth Used:

The "ground truth" in this context refers to established engineering and biological standards and specifications. For mechanical tests, the ground truth is defined by the acceptance criteria specified in the relevant ISO and ASTM standards (e.g., ISO 7206, ASTM F2582), which dictate acceptable levels of load, displacement, and material integrity. For biocompatibility, the ground truth is established by AAMI-ST72 requirements for LAL testing.

8. The Sample Size for the Training Set:

This is not applicable to this submission, as it does not involve an AI algorithm with a training set.

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

This is not applicable to this submission.

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