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This device is intended to be used for:

1. noninflammatory degenerative joint disease including osteoarthritis and avascular necrosis
2. rheumatoid arthritis
3. correction of functional deformity
4. revision procedures where other treatments or devices have failed
5. treatment of non-unions, femoral neck and trochanteric fractures of the proximal femur with head involvement, unmanageable using other techniques
6. treatment of osteomyelitis
7. endoprosthesis femoral osteotomy
8. use with a polyethylene cup with or without metal backed shell.

The Whiteside Biomechanics, Inc. Zirconia Ceramic Femoral Head will consist of a generally spherical, partially hollow (trunnion bore) ceramic ball. The implant will have a machined flat on the most distal surface with the trunnion centered and machined proximally into its center. The bore will be a Whiteside Biomechanics 12/14 taper intended to be seated on a trunnion compatible with this taper (see warning label). The head's outer perimeter is intended to articulate with a polyethylene acetabular component of compatible size. Labeling on the femoral head will be printed on a beveled surface machined around the periphery of the trunnion bore or on the top-inside flat of the bore.

This document does not contain information about acceptance criteria or a study proving the device meets those criteria for the Whiteside Biomechanics Zirconia Ceramic Femoral Head.

The provided text is a 510(k) premarket notification letter from the FDA to Whiteside Biomechanics, Inc., and a 510(k) Summary for a zirconia ceramic femoral head. It describes the device, its intended use, classification, and manufacturing information. The letter confirms that the device is substantially equivalent to a predicate device, allowing it to be marketed.

However, it does not include details on:

• A table of acceptance criteria or reported device performance.
• Sample size used for a test set, its provenance, or how ground truth was established for it.
• Number and qualifications of experts, or adjudication methods for a test set.
• Whether a multi-reader multi-case (MRMC) study was done, or any effect sizes of AI assistance.
• Standalone algorithm performance.
• Type of ground truth used (e.g., pathology, outcomes data).
• Sample size for a training set or how its ground truth was established.

Therefore, I cannot fulfill the request to describe the acceptance criteria and the study that proves the device meets the acceptance criteria based on the provided input.

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