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The Press-fit Porous Acetabular Component is intended for treatment of patients who are candidates for total hip arthroplasty because the natural femoral head and neck and/or acetabulum have been affected by osteoarthritis, inflammatory arthritis, traumatic arthritis, rheumatoid arthritis, avascular necrosis or femoral neck fracture, and revision arthroplasty where bone loss is minimal. These devices are intended to aid the surgeon in relieving the patient of hip pain and restoring hip motion.

The metal shell is fabricated from wrought/forged or cast Ti-6A1-4V. The outside surface of the shell is porous coated with commercially pure titanium beads to provide a porous surface for enhanced press-fit fixation.

The metal shell is hemispherical in shape and is available with and without screw holes. The screw holes are for the use of 6.5 mm cancellous bone screws for adjunct fixation. The geometry of the screw holes is such that a 12° angulation of the screws is possible.

The poly liners are manufactured from ultra high molecular weight polyethylene and are available in a neutral and 10° hooded design. The hooded design is intended for those patients prone to subluxation because of soft tissue laxity.

This document describes a medical device, the Foundation® Porous Press-fit Acetabular Component, and its safety and effectiveness. However, it does not describe an AI/ML powered device, nor does it detail a study involving AI/ML performance.

Therefore, I cannot provide the requested information regarding acceptance criteria, study details (sample sizes, ground truth establishment, expert qualifications, etc.), or AI performance metrics.

The "Test Results" section mentions testing on porous coating, tensile and shear strength, and attachment strength of liners to the shell, concluding that "All results are sufficient for in-vivo loading." This indicates traditional engineering/biomechanical testing, not an AI performance study.

To clarify, this document does not contain the information needed to answer the prompt's specific questions about AI/ML device validation.

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