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• Noninflammatory degenerative joint disease, including osteoarthritis and avascular . necrosis;
• . Rheumatoid arthritis (except the Osteolock™ HA Acetabular Cup):
• . Correction of functional deformity;
• Revision procedures where other treatments or devices have failed; and, .
• Nonunions, femoral neck fractures, and trochanteric fractures of the proximal femur . with head involvement that are unmanageable using other techniques.

This 510(k) submission is a line extension intended to add 36mm femoral heads to the PCA® Femoral Head Components.

The provided text describes a 510(k) submission for PCA® 36mm Femoral Heads. This is a medical device submission for a hip joint prosthesis component, and does not involve an AI/ML device.

Therefore, the requested information regarding acceptance criteria, study details, sample sizes, ground truth, experts, adjudication methods, MRMC studies, or standalone algorithm performance, as they relate to an AI/ML device, cannot be extracted from the provided text.

The document states: "An engineering analysis demonstrated the subject device falls within pre-established acceptance criteria of the predicate components and are substantially equivalent to these devices." This indicates that the predicate device's acceptance criteria were used, but the specific criteria and performance values are not detailed.

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