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1. Non-inflammatory 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 procedures where other treatment or devices have failed.

The Sirius Femoral Hip Stem is intended for cemented use only and may be used in partial and total hip arthroplasties.

The Sirius Femoral Stem is a highly polished, double-tapered, cemented stem designed to reduce hip pain for patients and restore joint biomechanics and stability. The femoral stem is designed to fit patient femoral anatomies for primary or revision hip arthroplasties.

The proposed device is made from CoCrMo per ASTM F799.The features include a collarless, highly polished, double taper design with a rectangular proximal geometry. The distal portion of the stem has a progressive diminishing cross-section.

This document outlines the 510(k) summary for the Sirius Femoral Hip Stem (K142295), asserting its substantial equivalence to a predicate device (K130610). The information provided focuses on the device's design, materials, and mechanical performance for regulatory approval rather than a study proving acceptance criteria in the sense of clinical effectiveness or algorithm performance. Therefore, many of the requested categories (e.g., sample size for test set, number of experts, adjudication methods, MRMC study, standalone performance, training set details) are not applicable or cannot be extracted from this type of regulatory submission.

1. Table of Acceptance Criteria and Reported Device Performance

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

• Sample Size for Test Set: Not specified in terms of number of devices tested. The document refers to "mechanical tests" without providing specific quantities for each test.
• Data Provenance: Not explicitly stated, but these are typically laboratory-based mechanical tests performed by the manufacturer (Biomet Inc.). The data is from prospective testing of the new device and comparative testing against the predicate's established performance.

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

• Not applicable. This is a premarket notification for a medical device (hip stem), focusing on mechanical testing and substantial equivalence, not on clinical performance evaluated by human experts reading images or making diagnoses.

4. Adjudication method for the test set:

• Not applicable. Mechanical tests for medical devices are evaluated against established engineering standards (e.g., ISO 7206-6, ISO 7206-4, ISO 21535), not through 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:

• Not applicable. This is a hip stem device, not an AI-powered diagnostic tool.

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

• Not applicable. This is a physical medical device.

7. The type of ground truth used:

• Engineering Standards and Material Specifications: The "ground truth" for this device's performance is adherence to recognized international standards for orthopedic implants (ISO 7206-6, ISO 7206-4, ISO 21535) and material specifications (ASTM F799). The performance of the predicate device (K130610) also serves as a benchmark for substantial equivalence.

8. The sample size for the training set:

• Not applicable. There is no "training set" in the context of mechanical testing for a physical device.

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

• Not applicable.

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