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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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Indications For Use:

• 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 by 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 ioint biomechanics and stability. The short stem is designed to fit a broad range of patient anatomies for primary or revision cases. The features include a collarless, highly polished, doubletaper design, with a rectangular proximal geometry. The distal portion of the stem has a progressive diminishing cross-section. Each stem is packed with a winged and wingless centralizer, made of polymethylmethacrylate (PMMA), designed to help create a uniform mantle.. The size ranges are within the ranges of legally marketed predicates. The Sirius stem is made from Co-Cr-Mo, ASTM F799.

This document describes the Biomet Manufacturing Corp.'s Sirius Femoral Hip Stem, a medical device, and the non-clinical testing performed to establish its substantial equivalence to predicate devices. No clinical testing was conducted.

Here's the breakdown of the requested information:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria for the Sirius Femoral Hip Stem are implied by its demonstration of "substantial equivalence" to legally marketed predicate devices through non-clinical testing. The performance demonstrated that the device is "as safe, as effective, and performs as well as or better than the predicate devices."

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

This information is not provided in the document. The document refers to "nonclinical performance testing of the worst-case stem" and standardized tests (ISO 7206-4:2010, ASTM F2068-09, ISO 7206-6:1992, ISO 7206-10:2003, ISO 21535:2009) but does not specify the number of samples or data provenance (e.g., country of origin, retrospective or prospective) for these non-clinical tests.

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 study described is non-clinical (mechanical testing) and does not involve human expert evaluation for establishing ground truth in a clinical context.

4. Adjudication Method for the Test Set

This information is not applicable as the study described is non-clinical and does not involve human adjudication.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, and the effect size of how much human readers improve with AI vs without AI assistance

This information is not applicable. The document describes a medical device (femoral hip stem) and its non-clinical testing for substantial equivalence, not an AI or imaging-based device requiring human reader studies.

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

This information is not applicable as the device is a physical medical implant, not a software algorithm.

7. The Type of Ground Truth Used

The "ground truth" for the non-clinical testing was established by international and industry standards and guidance documents (e.g., ISO 7206 series, ASTM F2068-09, "Guidance for Industry and FDA Staff Non-clinical Information for Femoral Stem Prostheses"). The performance of the Sirius Femoral Hip Stem was compared against the requirements and performance characteristics outlined in these standards and the known performance of predicate devices.

8. The Sample Size for the Training Set

This information is not applicable. The device is a physical implant, not a learning algorithm that requires a training set.

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

This information is not applicable for the reasons stated in point 8.

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