(35 days)
The Osteonics® Acetabular Wedges, because they are accessory components to an existing total hip replacement system, are subject to the general indications of their mating acetabular shell components, as follows:
General Indications for Total Hip Replacement Components
- Painful, disabling joint disease of the hip resulting from degenerative arthritis, rheumatoid arthritis, post-traumatic arthritis or late stage avascular necrosis.
- Revision of previous unsuccessful femoral head replacement, cup arthroplasty or other procedure.
- Clinical management problems where arthrodesis or alternative reconstructive techniques are less likely to achieve satisfactory results.
- Where bone stock is of poor quality or is inadequate for other reconstructive techniques as indicated by deficiencies of the acetabulum.
Indications Specific to the Acetabular Wedges
- As an alternative to structural allograft in cases of superior and superior/posterior segmental acetabular deficiencies.
The assembled acetabular wedge-to-shell construct can be affixed to the acetabulum either with or without bone cement, according to the specific fixation methods already determined substantially equivalent by FDA for the commercially available, mating acetabular shell components.
The Osteonics® Acetabular Wedges are characterized by the following design features.
- Basic Wedge Shape: The Osteonics® Acetabular Wedges feature a basic wedge (or crescent) shape that conforms to the outer geometry of the mating acetabular shell.
- Size range: The Osteonics Acetabular Wedges are available in a wide range of outer diameter sizes.
- Thickness Options: The Osteonics® Acetabular Wedges come in thicknesses of 8, 12, or 16mm.
- Interior Normalizations: The interior face of the acetabular wedges features machined steps that correspond to the normalizations featured on the exterior of the mating shells.
- Screw Hole Availability: The Osteonics® Acetabular Wedges feature 6.5mm bone screw holes that are compatible with commercially available Osteonics 6.5mm Cancellous Bone Screws.
- Surface Treatments: The exterior surface of the Osteonics® Acetabular Wedges features Osteonics' AD-HA Coating.
Here's an analysis of the provided text regarding the acceptance criteria and study for the Osteonics® Acetabular Wedge System:
Based on the provided 510(k) summary for the Osteonics® Acetabular Wedge System, the information available for acceptance criteria and the supporting study is limited, as this is a medical device submission focused on substantial equivalence rather than a clinical AI/software study.
Here's a breakdown of the requested information based only on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Withstand anticipated in-vivo loading conditions for the wedge-to-shell assembly. | All specimens successfully endured 10 million cycles of physiologically relevant loading, with no signs of impending wedge/shell interface failure. |
2. Sample Size Used for the Test Set and Data Provenance
The document does not specify a numerical "sample size" for the test set beyond stating "All specimens." It also does not explicitly state the data provenance (e.g., country of origin, retrospective or prospective) as this was a mechanical test, not a clinical data study.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
Not applicable. This was a mechanical engineering performance test, not a study requiring expert clinical assessment for ground truth establishment.
4. Adjudication Method
Not applicable. This was a mechanical engineering performance test.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
Not applicable. This is not a study involving human readers or AI assistance.
6. Standalone (Algorithm Only Without Human-in-the-Loop Performance)
Not applicable. This is a physical medical device, not an algorithm. The performance test describes the mechanical integrity of the device itself.
7. Type of Ground Truth Used
The ground truth for the mechanical testing was the absence of "signs of impending wedge/shell interface failure" after being subjected to "physiologically relevant loading" for 10 million cycles. This is a simulated mechanical failure/durability test, not a clinical ground truth.
8. Sample Size for the Training Set
Not applicable. This is a physical medical device, not a software/AI system that requires a "training set." The design and materials are based on existing predicate devices and engineering principles.
9. How the Ground Truth for the Training Set Was Established
Not applicable.
Summary of Limitations:
It's crucial to understand that the provided text is a 510(k) summary for a physical medical device, not a study evaluating an AI algorithm or a diagnostic tool based on clinical data. Therefore, many of the requested categories (especially those related to expert reviewers, test sets, training sets, and AI performance metrics) are not relevant or addressed in this type of submission. The focus here is on demonstrating the mechanical integrity of the device compared to its predicate.
§ 888.3353 Hip joint metal/ceramic/polymer semi-constrained cemented or nonporous uncemented prosthesis.
(a)
Identification. A hip joint metal/ceramic/polymer semi-constrained cemented or nonporous uncemented prosthesis is a device intended to be implanted to replace a hip joint. This device limits translation and rotation in one or more planes via the geometry of its articulating surfaces. It has no linkage across-the-joint. The two-part femoral component consists of a femoral stem made of alloys to be fixed in the intramedullary canal of the femur by impaction with or without use of bone cement. The proximal end of the femoral stem is tapered with a surface that ensures positive locking with the spherical ceramic (aluminium oxide, A12 03 ) head of the femoral component. The acetabular component is made of ultra-high molecular weight polyethylene or ultra-high molecular weight polyethylene reinforced with nonporous metal alloys, and used with or without bone cement.(b)
Classification. Class II.