(176 days)
Indications For Use:
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- Non-inflammatory degenerative joint disease including osteoarthritis and avascular necrosis.
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- Rheumatoid arthritis.
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- Correction of functional deformity.
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- Treatment of non-union, femoral neck fracture, and trochanteric fractures of the proximal femur with head involvement, unmanageable by other techniques.
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- 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."
| Acceptance Criteria (Implied from Substantial Equivalence to Predicates) | Reported Device Performance (as demonstrated by non-clinical testing) |
|---|---|
| Mechanical and physiological performance consistent with predicate devices for: | |
| Distal Stem fatigue strength | Met or exceeded |
| Proximal Stem fatigue strength | Met or exceeded |
| Cobalt Chrome Modular Head Pull-off from a Type 1 Reduced Taper strength | Met or exceeded |
| Range of Motion | Consistent with |
| Comparison/Justification for Modular Connections | Met or exceeded |
| Fretting and Corrosion resistance | Met or exceeded |
| Material composition (Co-Cr-Mo, ASTM F799) | Confirmed to be Co-Cr-Mo, ASTM F799 |
| Centralizer material (Polymethylmethacrylate (PMMA)) | Confirmed to be PMMA |
| Taper-slip principle effectiveness | Demonstrated to be effective |
| Rotational stability | Demonstrated to be effective |
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.
§ 888.3350 Hip joint metal/polymer semi-constrained cemented prosthesis.
(a)
Identification. A hip joint metal/polymer semi-constrained cemented prosthesis is a device intended to be implanted to replace a hip joint. The device limits translation and rotation in one or more planes via the geometry of its articulating surfaces. It has no linkage across-the-joint. This generic type of device includes prostheses that have a femoral component made of alloys, such as cobalt-chromium-molybdenum, and an acetabular resurfacing component made of ultra-high molecular weight polyethylene and is limited to those prostheses intended for use with bone cement (§ 888.3027).(b)
Classification. Class II.