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Hip components are indicated for individuals undergoing primary and revision surgery where other treatments or devices have failed in rehabilitating hips damaged as a result of trauma or noninflammatory degenerative joint disease (NIDJD) or any of its composite diagnoses of osteoarthritis, avascular necrosis, traumatic arthritis, slipped capital epiphysis, fused hip, fracture of the pelvis, and diastrophic variant.

Hip components are also indicated for inflammatory degenerative joint disease including rheumatoid arthritis, arthritis secondary to a variety of diseases and anomalies, and congenital dysplasia; treatments of nonunion, femoral neck fracture, and trochanteric fractures of the proximal femur with head involvement that are unmanageable using other techniques; endoprosthesis, femoral osteotomy, or Girdlestone resection; fracture-dislocation of the hip; and correction of deformity.

Total hip systems may be indicated for use (i) with bone cement , (ii) without bone cement , or (ii) for use with or without bone cement.

The subjects OXINIUM DH Femoral Heads are metal alloy devices processed via a proprietary oxidation process and are designed as a component to replace a hip joint. The subject OXINIUM DH Femoral Heads are designed for use with existing 510(k) cleared products consisting of Smith & Nephew hip stems, acetabular shells and liners and will articulate against existing acetabular shell and liner constructs. The subject Femoral Heads are comprised of Oxidized Zirconium manufactured from wrought Zirconium (Zr) -2.5 Niobium (Nb).

The purpose of this 510(k) submission is to add additional OXINIUM DH femoral heads to the Smith & Nephew Total Hip System.

This document is a 510(k) Summary for the OXINIUM DH Femoral Heads, and thus, does not contain information typically found in an AI/ML device submission, such as detailed acceptance criteria tables, sample sizes for test/training sets, expert qualifications or ground truth establishment methods for AI/ML models, or MRMC studies. The content focuses on demonstrating substantial equivalence to predicate devices through material properties and mechanical testing.

Therefore, many of the requested items cannot be extracted directly from the provided text.

However, I can provide information based on the mechanical performance tests described, which include "acceptance criteria" for the device's functional integrity.

Here's an attempt to answer based only on the provided text, while acknowledging that many AI/ML specific questions cannot be answered:

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample size used for the test set and the data provenance:

• Test Set Sample Size: Not specified in the document. For mechanical and biocompatibility testing, sample sizes are typically determined by the specific ASTM/ISO standards referenced, but these numbers are not disclosed.
• Data Provenance: The testing was conducted by Smith & Nephew, Inc. It is internal testing performed for FDA submission. The country of origin for the data is implicitly the USA, where the company is located. The nature of the data is prospective, in that the tests were performed to evaluate the new device.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

• This question is not applicable to this type of device submission. This document pertains to physical medical devices (femoral heads) and their material/mechanical properties, not an AI/ML algorithm requiring expert establishment of ground truth.

4. Adjudication method for the test set:

• This question is not applicable. Adjudication methods are typically used in clinical studies or for interpreting diagnostic outputs, not for direct mechanical or biocompatibility testing of a physical device. Test results are compared against predefined criteria in the standards.

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 question is not applicable. This is not an AI/ML device.

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

• This question is not applicable. This is not an AI/ML device.

7. The type of ground truth used:

• For Biocompatibility: The "ground truth" is defined by established international standards (ISO-10993) and FDA guidance for biological evaluation of medical devices, which dictate acceptable material behavior in a biological environment.
• For Mechanical Testing: The "ground truth" is defined by the technical specifications and performance requirements outlined in the referenced ASTM and ISO standards (e.g., ASTM F2009-00, ASTM F2068-15, ISO 7206-6). The device's performance is measured against these established engineering and safety criteria.

8. The sample size for the training set:

• This question is not applicable as this is not an AI/ML device that requires a training set. The device itself is manufactured from well-characterized materials and processes.

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

• This question is not applicable as this is not an AI/ML device.

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