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This device is intended for use in total hip arthroplasty. The device is intended for uncemented, press-fit use only in cases of:

• Notably impaired hip joints due to osteoarthritis, rheumatoid arthritis and/or post traumatic arthritis.
• Previously failed hip surgery.
• Fractures of the femoral neck or head.
• Avascular necrosis of the femoral head.
• Congenital dysplasia or other structural abnormalities where stock exists to properly seat the prosthesis.

The Legend® Acetabular Shell is a one-piece, hemispherical shell prostheses, designed for single, uncemented use. Device fixation is achieved via press-fit into a prepared acetabulum, which maximizes contact between the shell and bone.

The Legend® Acetabular Shell is manufactured from titanium alloy Ti-6A1-4V ELI per ASTM F136. The outer surface of the shells are coated with commercially pure titanium (CPT)(ASTM F1580) sintered porous coating. The inner surface of the shell is designed to lock together with the Escalade® and Legend® Acetabular Liners which are made from extensively cross-linked polyethylene. The Legend® Acetabular Shell is also designed to be used with cancellous bone screws and apical plugs.

The existing Legend® Acetabular Shell (K161080) is coated with commercially pure titanium (CPT) sintered bead coating. This submission allows a similar sintered coating to be applied by an additional supplier: Avalign Thortex (MAF-2607) in addition to the original supplier.

This document is a 510(k) premarket notification for a medical device called the "Legend® Acetabular Shell." It describes a submission to add an additional supplier for a porous titanium coating that is applied to an existing device.

Therefore, the submission does not involve the development or testing of an AI/ML device. The performance data section refers to mechanical testing of the coating material to ensure it meets established orthopedic implant standards, not the performance of an AI model.

As such, I cannot provide details regarding acceptance criteria and studies for an AI/ML device, as this documentation pertains to a traditional orthopedic implant. There are no mentions of AI, machine learning, deep learning, algorithms, or any related terms.

The sections you requested (acceptance criteria table, sample sizes, expert qualifications, ground truth, MRMC, etc.) are applicable to AI/ML device submissions, which are not present in this document.

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