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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/reduce pain,
7. treatment of osteomvelitis.
8. endoprosthesis femoral osteotomy,
9. use determined by the physician using sound medical judgment.

The Whiteside Biomechanics 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 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.

The provided 510(k) statement (K964150) for the Whiteside Biomechanics Zirconia Ceramic Femoral Head does not contain the information requested regarding acceptance criteria and performance study details usually associated with AI/CADe systems or diagnostic devices.

The document describes a physical medical device: a zirconia ceramic femoral head for hip replacement. The information provided is typical for a premarket notification for a physical implant, focusing on:

• Device Description: Material (magnesia stabilized zirconia ceramic), physical characteristics (spherical, hollow, trunnion bore, specific taper), and articulation with a polyethylene acetabular component.
• Intended Use: Clinical conditions for which the device is indicated (e.g., osteoarthritis, avascular necrosis, rheumatoid arthritis, revision procedures, fractures, osteomyelitis, pain reduction, functional deformity correction).
• Sterilization: Method specified (ethylene oxide).
• Manufacturer Information: Company name and address.

Therefore, I cannot extract the requested information (acceptance criteria table, sample sizes, expert details, adjudication methods, MRMC studies, standalone performance, ground truth types, training set details) because it is not present in the provided text.

These types of details are typically found in regulatory submissions for software as a medical device (SaMD), AI/ML-powered devices, or diagnostic tests, where performance metrics like sensitivity, specificity, AUC, and their associated study designs are crucial for demonstrating safety and effectiveness. The K964150 document is for a mechanical implant, and its regulatory clearance would have focused on biocompatibility, mechanical strength, wear characteristics, and clinical equivalence to predicate devices, rather than the performance metrics listed in your request.

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