(267 days)
The hip prosthesis M-Vizion is designed for cementless use in total or partial hip arthroplasty in primary or revision surgery.
Hip Replacement is indicated in the following cases:
- Severely painful and/or disabled joint as a result of arthritis, traumatic arthritis, rheumatoid polyarthritis, or congenital hip dysplasia.
- Avascular necrosis of the femoral head.
- Acute traumatic fracture of the femoral head or neck.
- Failure of previous hip surgery: joint reconstruction, internal fixation, arthrodesis, hemiarthroplasty, surface replacement arthroplasty, or total hip replacement.
The M-Vizion Femoral Revision System is a modular cementless stem intended to be used for hip arthroplasty in primary or revision surgery. The system is composed of the proximal body, the distal stem, and the locking screw. The proximal body and the distal stem are intended to be assembled together on a conical coupling and tightened by the locking screw.
The proximal body is made of titanium alloy and coated with a titanium coating, TiGrowth -C (Medacta commercial name: Mectagrip). The distal stem is a straight stem made of titanium alloy and the principal feature consists of shard fins that potentially increase the rotation stability. The locking screw is made of titanium alloy and coated with TiNbN.
The provided text describes the M-Vizion Femoral Revision System, a medical device, and its demonstrated substantial equivalence to predicate devices. However, it does not include specific acceptance criteria with numerical values for performance, nor does it detail a standalone study that directly proves the device meets such criteria in a comparative effectiveness manner with effect sizes or human reader performance.
The document primarily focuses on non-clinical performance tests performed to demonstrate substantial equivalence, rather than establishing acceptance criteria or reporting performance against them in a table format.
Therefore, much of the requested information cannot be extracted directly from the provided text. Below, I will present the information that can be inferred or directly stated, and clearly indicate what is not available.
1. A table of acceptance criteria and the reported device performance
The document lists performance tests conducted but does not specify the numerical acceptance criteria for these tests or provide specific reported numerical performance values. It only states that the tests "met the acceptance criteria that were based on standards."
| Test Parameter | Acceptance Criteria (from Standards) | Reported Device Performance |
|---|---|---|
| Range of Motion (ROM) | Based on EN ISO 21535:2009 | Met acceptance criteria |
| Shaft Fatigue Testing | Based on ISO 7206-4 Third Edition 2010-06-15 | Met acceptance criteria |
| Modular Conical Connection Fatigue Test | Based on ISO 7206-4 Third Edition 2010-06-15 | Met acceptance criteria |
| Post Fatigue Fretting Corrosion Analysis | Based on ISO 7206-4 Third Edition 2010-06-15 | Met acceptance criteria |
| Neck Fatigue Testing | Based on ISO 7206-6 Second edition 2013-11-15 | Met acceptance criteria |
| Pull-off Force Testing | Based on ASTM F2009-00 (Reapproved 2011) | Met acceptance criteria |
| Coating Characterization Tests | Based on characterization reports | Met acceptance criteria |
| Bacterial Endotoxin Test (LAL test) | Endotoxin limit of |
§ 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.