(148 days)
The Implex Ceramic Head is intended to provide articulation in cases of:
- Severely disabled joints as a result of degencrative arthritis or avascular 1 . necrosis.
- in Secondary revision of a previously unsuccessful femoral component or total hip replacement.
- Other hip problems where clinical experience has shown that alternative ਲ । modes of treatment are less likely to achieve satisfactory results.
- এ. Fracture dislocation of the hip or irreducible fractures in which adequate fixation cannot be obtained.
- ಗ Non-union of femoral neck or head fractures.
- ల్లో Salvage of a failed primary or secondary total or hemi hip.
The Implex Ceramic Head is intended to be used in either cemented or uncemented applications depending on the intended use of the femoral stem it is mated with.
The Implex Ceramic Head is a ceramic femoral head. It is a spherical ball made from zirconia ceramic which has a tapered bore on one end of it. It is provided in one external diameter (28mm) and two (2) neck lengths (+0 Short, +6 Standard).
I am sorry, but the provided text describes a medical device (Ceramic Head for hip replacement) and its intended use, rather than an AI/ML device. Therefore, it does not contain information about acceptance criteria for an algorithm, study designs for AI/ML performance, sample sizes for training/test sets, expert adjudication methods, or other details relevant to AI/ML device evaluation.
Consequently, I cannot extract the requested information regarding acceptance criteria and studies proving the device meets them in the context of an AI/ML device.
§ 888.3353 Hip joint metal/ceramic/polymer semi-constrained cemented or nonporous uncemented prosthesis.
(a)
Identification. A hip joint metal/ceramic/polymer semi-constrained cemented or nonporous uncemented prosthesis is a device intended to be implanted to replace a hip joint. This device limits translation and rotation in one or more planes via the geometry of its articulating surfaces. It has no linkage across-the-joint. The two-part femoral component consists of a femoral stem made of alloys to be fixed in the intramedullary canal of the femur by impaction with or without use of bone cement. The proximal end of the femoral stem is tapered with a surface that ensures positive locking with the spherical ceramic (aluminium oxide, A12 03 ) head of the femoral component. The acetabular component is made of ultra-high molecular weight polyethylene or ultra-high molecular weight polyethylene reinforced with nonporous metal alloys, and used with or without bone cement.(b)
Classification. Class II.