(90 days)
Relief of pain and restoration of hip function following the effects of osteo, rheumatoid and Netier of pain and restoration of mip state effects, avascular necrosis, and total hip revision.
The C-Fit and DC-Fit plasma sprayed acetabular components are intended for use ONLY with bone cement.
Acetabular Cup System for use with previously cleared femoral stems and modular heads.
The acetabular cups are available in a range of diameters and are plasma sprayed.
The devices are used to resurface the acetabulum and are used in combination with UHMWPE inserts, femoral stems and modular heads to reinstate function following the degenerative effects of osteo and rheumatoid arthritis, post-trauma disease effects, avascular necrosis and septic or aseptic total hip revision.
The acetabular cups are manufactured from cobalt chrome alloy. The cobalt chrome plasma spray coating provides an increased surface roughness to act as a key for mechanical interlock with PMMA bone cement.
The provided text does not contain information about acceptance criteria or a study proving that a device meets acceptance criteria. Instead, it is a 510(k) summary and an FDA clearance letter for a medical device called the "C-Fit and DC-Fit Acetabular Cup System."
The document primarily focuses on establishing substantial equivalence to a predicate device (Mallory Head Acetabular Cup range) based on design, material, and intended use, rather than detailing specific performance acceptance criteria or a study designed to meet them.
Therefore, I cannot provide the requested information in the table format or answer the specific questions about sample sizes, experts, adjudication methods, MRMC studies, standalone performance, or ground truth for training/test sets.
§ 888.3350 Hip joint metal/polymer semi-constrained cemented prosthesis.
(a)
Identification. A hip joint metal/polymer semi-constrained cemented 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 includes prostheses that have a femoral component made of alloys, such as cobalt-chromium-molybdenum, and an acetabular resurfacing component made of ultra-high molecular weight polyethylene and is limited to those prostheses intended for use with bone cement (§ 888.3027).(b)
Classification. Class II.