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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.

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