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• Noninflammatory degenerative joint disease including osteoarthritis and avascular necrosis.
• Rheumatoid arthritis.
• Correction of functional deformity.
• Treatment of non-union, femoral neck fracture, and trochanteric fractures of the proximal femur with head involvement, unmanageable by other techniques.
• Revision procedures where other treatment or devices have failed.
• Dislocation risks.
  Dual Mobility Hip Bearings are single-use implants, intended for uncemented applications.

The G7 Dual Mobility System and Active Articulation System are dual articulation systems wherein there are two articulating surfaces in the same joint space. The systems include a polyethylene (UHMWPE) bearing which is assembled over a femoral head. The femoral head articulates on the inner, concave surface of the bearing. The resultant assembly then articulates within a metal liner (G7 Dual Mobility System) or acetabular shell (Active Articulation System). The G7 Dual Mobility and Active Articulation Systems are designed for both primary and revision surgeries, where all device components associated with the wear couple are removed and replaced.

It seems there is a misunderstanding. The provided text is a 510(k) premarket notification letter from the FDA regarding a medical device, "Dual Mobility - Longevity and Vivacit-E Polyethylene Hip Bearings."

This document does not describe the acceptance criteria and study proving a device meets those criteria in the context of an AI/Machine Learning device, as implied by the detailed questions about ground truth, expert adjudication, MRMC studies, training sets, and standalone performance.

Instead, this document is for a traditional medical implant (hip bearings) and the "performance data" referred to are related to mechanical and material properties of the physical implant, not algorithmic performance.

Therefore, I cannot extract the information requested for acceptance criteria and study design related to AI/ML device performance from the provided text. The questions you've asked are applicable to AI/ML-based medical devices, which this product is not.

If you can provide a text that describes the evaluation of an AI/ML medical device, I would be happy to help.

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