(82 days)
- Noninflammatory degenerative joint disease, including osteoarthritis and avascular . necrosis;
- . Rheumatoid arthritis (except the Osteolock™ HA Acetabular Cup):
- . Correction of functional deformity;
- Revision procedures where other treatments or devices have failed; and, .
- Nonunions, femoral neck fractures, and trochanteric fractures of the proximal femur . with head involvement that are unmanageable using other techniques.
This 510(k) submission is a line extension intended to add 36mm femoral heads to the PCA® Femoral Head Components.
The provided text describes a 510(k) submission for PCA® 36mm Femoral Heads. This is a medical device submission for a hip joint prosthesis component, and does not involve an AI/ML device.
Therefore, the requested information regarding acceptance criteria, study details, sample sizes, ground truth, experts, adjudication methods, MRMC studies, or standalone algorithm performance, as they relate to an AI/ML device, cannot be extracted from the provided text.
The document states: "An engineering analysis demonstrated the subject device falls within pre-established acceptance criteria of the predicate components and are substantially equivalent to these devices." This indicates that the predicate device's acceptance criteria were used, but the specific criteria and performance values are not detailed.
§ 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.