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The Medtronic Total Hip Arthroplasty System is indicated for cement-less use only in the following cases:

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

The Medtronic Total Hip Arthroplasty System Acetabular Screws are intended for supplemental fixation of the associated Medtronic Acetabular Cup.

The Medtronic Total Hip Arthroplasty System is a total hip system for the restoration of alignment, stability range of motion, and alleviation of pain, by replacing the articulating surfaces of the hip joint. The system includes femoral and acetabular components. The implants are available in a variety of sizes to accommodate varying patient anatomy.

New acetabular components including highly crosslinked UHMWPE acetabular liners and porous coated cups are the subject of this 510(k).

I am sorry, but the provided text does not contain information about an AI/ML-based medical device. The document is an FDA 510(k) clearance letter for the Medtronic Total Hip Arthroplasty System, a physical medical device (hip prosthesis).

Therefore, I cannot provide details on acceptance criteria, study methodologies, or performance related to AI/ML models as these elements are not present in the document. The document explicitly states: "Clinical Testing was not required for these products." and focuses on non-clinical (bench) testing for the hip implant's materials and wear characteristics.

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