(92 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 an additional method of porous coating currently conducted on the hip devices listed above.
The provided document, K072888, is a 510(k) summary for Encore Medical's Foundation® Porous Coated (FMPTM) Acetabular Shells. This document is a clearance summary for a medical device and not a study report demonstrating acceptance criteria for an AI/ML device. It focuses on demonstrating substantial equivalence to a predicate device, which is different from proving performance against specific acceptance criteria for a new AI/ML algorithm.
Therefore, the requested information regarding acceptance criteria, study details, sample sizes, expert involvement, and ground truth for an AI/ML device is not present in this document. The document describes a traditional orthopaedic implant and its indications for use.
No information regarding acceptance criteria or a study proving an AI/ML device meets them can be extracted from this document.
§ 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.