(76 days)
Joint replacement is indicated for patients suffering from disability due to:
- noninflammatory degenerative joint disease including osteoarthritis and avascular necrosis of the natural femoral head;
- rheumatoid arthritis;
- correction of functional deformity;
- femoral fracture;
This device may also be indicated in the salvage of previously failed surgical attempts.
The modification consists of a change to the Instructions for Use to minimize the necessity for multiple IFU's and to update the contents to reflect current practice.
This submission (K121024) is a 510(k) premarket notification for a modification to the Instructions for Use (IFU) for several hip stem devices. The intent is to minimize the necessity for multiple IFUs and to update their content to reflect current practice.
Based on the provided document, there are no acceptance criteria or studies related to device performance in the context of AI/ML or diagnostic accuracy. This submission explicitly states "Non-Clinical Testing: None Provided" and "Clinical Testing: None provided."
The modifications relate to the labeling and administrative aspects of the device's usage instructions, not to any new or changed functional aspects that would require performance criteria or testing. The FDA's review in this case is focused on substantial equivalence to predicate devices based on indications, sterilization, and intended use, as documented on page 2.
Therefore, I cannot provide the requested information about acceptance criteria, device performance, sample sizes for test/training sets, expert qualifications, adjudication methods, MRMC studies, standalone performance, or ground truth types because these concepts are not applicable to the nature of this 510(k) submission.
§ 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.