(222 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, traumatoid 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, arthrodesis, hemiarthroplasty, surface replacement arthroplasty, or total hip replacement.
The M-Vizion Femoral Revision System Extension implants are a range extension to the already cleared M-Vizion Femoral Revision System (K191816 and K170690). The range extension includes proximal bodies with holes and distal stems 4°.
The M-Vizion Femoral Revision System a is modular cementless stem intended to be used for hip arthroplasty, primary or revision. The system is composed of proximal body, distal stem and 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 locking screw provided with the subject proximal bodies is the same component cleared with the predicate devices. M-Vizion Femoral Revision System K191816 and K170690.
The proximal body is made of titanium alloy (Ti6A17Nb) according to ISO 5832-11 Second Edition 2014-09-15: Implants for Surgery - Metallic Materials - Part 11: Wrought Titanium 6-Aluminium 7-Niobium Alloy and coated with a titanium coating, TiGrowth®-C (Medacta commercial name: Mectagrip). The distal stem is made of titanium alloy while the locking screw is made of titanium alloy and coated with TiNbN.
This document is a 510(k) Premarket Notification from the FDA regarding a medical device called the "M-Vizion Femoral Revision System Extension." It is for a hip prosthesis.
The provided text does not contain information about acceptance criteria or a study proving device performance in the context of an AI/ML device. This document is for a traditional medical device (hip prosthesis) and focuses on demonstrating substantial equivalence to previously cleared predicate devices through materials, design, and mechanical testing, rather than algorithmic performance.
Therefore, I cannot fulfill your request for:
- A table of acceptance criteria and reported device performance for an AI/ML device.
- Sample size used for the test set and data provenance.
- Number of experts to establish ground truth and qualifications.
- Adjudication method for the test set.
- MRMC comparative effectiveness study results.
- Standalone performance.
- Type of ground truth used.
- Sample size for the training set.
- How ground truth for the training set was established.
The "Performance Data" section explicitly states:
- "No clinical studies were conducted."
- Performance data provided is related to "DESIGN VALIDATION and CHARACTERIZATION TESTING" for mechanical properties (e.g., fatigue tests) and "PYROGENICITY" testing, not AI/ML model performance.
This document clearly pertains to a physical orthopedic implant, not a software-driven device requiring performance evaluation based on AI/ML metrics.
§ 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.