(83 days)
The metal backed acetabular component is intended for treatment of patients who are candidates for total hip arthroplasty because the natural femoral head and neck and/or acetabulum have been affected by osteoarthritis, inflammatory arthritis, traumatic arthritis, rheumatoid arthritis, avascular necrosis or femoral neck fracture, and revision arthroplasty where bone loss is minimal. These devices are intended to aid the surgeon in relieving the patient of hip pain and restoring hip motion.
The hemispherical metal shell is fabricated from wrought/forged or cast Ti-6Al-4V. The outside surface of the shell is plasma sprayed to provide a roughened surface for press-fit enhanced fixation. The metal shell has three spikes to provide enhanced press-fit fixation.
The poly liners are manufactured from ultra high molecular weight polyethylene and are available in a neutral and 10° hooded design. The hooded design is intended for those patients prone to subluxation because of soft tissue laxity.
The provided text describes a medical device, the Encore Orthopedics® Metal Acetabular Component, and its intended use, comparable features, and some test results. However, it does not include information about acceptance criteria or a study that proves the device meets specific performance criteria in a way that aligns with the structured request for AI/diagnostic device evaluation.
The "Test Results" section is very brief and states: "Testing on this device included porous attachment strength of liners to shell. All results are sufficient for in-vivo loading." This is a general statement about mechanical testing, not a detailed study of diagnostic accuracy or a comparison against an acceptance criterion in the way an AI/diagnostic device would be evaluated.
Therefore, I cannot fulfill your request as the necessary information for a study proving acceptance criteria, especially regarding AI/diagnostic device evaluation metrics, is not present in the provided text.
If you have a different document or an AI/diagnostic device summary, I would be happy to analyze it according to your criteria.
§ 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.