(76 days)
The indications for use include cemented or uncemented total hip arthroplasty for rheumatoid arthritis; osteoarthritis; post-traumatic arthritis; avascular necrosis; femoral neck fractures; osteomyelitis; fracture-dislocation of the hip; and unsuccessful cup arthroplasty, endoprosthesis, femoral osteotomy, or girdlestone resection.
The outer diameter of The Reflection Dual Dimension Shell has been modified to include an area with a larger diameter. This feature is a peripheral enhancement to the rim of the cup for improved press fit stability. The shell will be available in a no holed version (one apex hole for shell insertion) and a 3-holed version for some adjunctive screw fixations. In addition to the similarities to the previous Reflection Acetabular Component, The Dual Dimension Shell is similar to several shells currently marketed by other companies. The DePuy Duraloc and the Osteonics PSL shells. Since this modification is only to the outer geometry and the internal geometry and the locking mechanism remain the same as the previous Reflection Acetabular Component.
The provided text is a 510(k) summary for the "Reflection Dual Dimension Shell" and does not contain information about acceptance criteria, device performance, or any studies conducted to prove the device meets specific criteria. It primarily focuses on demonstrating substantial equivalence to previously marketed devices.
Therefore, I cannot provide a response to your request, as the necessary information is not present in the given text.
Here's why each point cannot be addressed:
- Table of acceptance criteria and reported device performance: No such criteria or performance data is mentioned.
- Sample size used for the test set and data provenance: No test set or study data is described.
- Number of experts used to establish the ground truth and qualifications: No ground truth establishment or expert involvement is described.
- Adjudication method: Not applicable as no study or ground truth establishment is described.
- Multi-reader multi-case (MRMC) comparative effectiveness study: No such study is mentioned.
- Standalone (algorithm only) performance: Not applicable; this is a medical device (hip prosthesis), not an algorithm.
- Type of ground truth used: No ground truth is described.
- Sample size for the training set: Not applicable; this is a medical device, not an AI/ML model with a training set.
- How the ground truth for the training set was established: Not applicable.
§ 888.3358 Hip joint metal/polymer/metal semi-constrained porous-coated uncemented prosthesis.
(a)
Identification. A hip joint metal/polymer/metal semi-constrained porous-coated uncemented 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 has a femoral component made of a cobalt-chromium-molybdenum (Co-Cr-Mo) alloy or a titanium-aluminum-vanadium (Ti-6Al-4V) alloy and an acetabular component composed of an ultra-high molecular weight polyethylene articulating bearing surface fixed in a metal shell made of Co-Cr-Mo or Ti-6Al-4V. The femoral stem and acetabular shell have a porous coating made of, in the case of Co-Cr-Mo substrates, beads of the same alloy, and in the case of Ti-6Al-4V substrates, fibers of commercially pure titanium or Ti-6Al-4V alloy. The porous coating has a volume porosity between 30 and 70 percent, an average pore size between 100 and 1,000 microns, interconnecting porosity, and a porous coating thickness between 500 and 1,500 microns. The generic type of device has a design to achieve biological fixation to bone without the use of bone cement.(b)
Classification. Class II.