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The AltiVate® Anatomic Shoulder System is indicated as an anatomic shoulder joint replacement for patients suffering from pain and dysfunction due to:
• Non-inflammatory degenerative joint disease including osteoarthritis, avascular necrosis of the natural humeral head and/or glenoid, and post traumatic arthritis
· Rheumatoid and other inflammatory arthritis

• · Correction of functional deformity, including fracture malunion
• · Humeral head fracture
• · Revision of other devices if sufficient bone stock remains

The assembled humeral component may be used alone for hemiarthroplasty or combined with the glenoid component for a total shoulder arthroplasty.

Humeral components with a porous coated surface are indicated for either cemented applications. Glenoid components are indicated for cemented use only.

This application is to include the AltiVate® Anatomic Shoulder AG e+™ with Markers, as a component of the AltiVate® Anatomic Shoulder System. The AltiVate® Anatomic Shoulder AG e+™ with Markers are manufactured from ultra-high molecular weight polyethylene with vitamin E. The articulating surface has a radius of curvature greater than the compatible humeral heads to allow translation in the superior/inferior and anterior/posterior directions. The back surface(s) of the component is spherical in geometry and has four pegs for fixation in the glenoid. The central peg has three annular barbs and the peripheral pegs have machined fixation features, referred to as Tri-lobes, to provide immediate fixation to the patient's glenoid when inserted. Radiographic markers are found in all three peripheral pegs.

This document is a 510(k) summary for a medical device (AltiVate® Anatomic Shoulder AG e+™ with Markers), not a study report demonstrating device performance against specific acceptance criteria for AI/ML. Therefore, the information required to answer your specific questions about AI/ML device performance, ground truth, expert adjudication, or MRMC studies is not present in the provided text.

The closest relevant sections are:

• Mechanical and acoustic testing: "Dynamic evaluation of glenoid loosening or disassociation was performed per ASTM F2028-17." This refers to physical testing of the implant, not AI/ML performance.
• Clinical Studies: "Clinical data was not required." This explicitly states that clinical studies (which would involve human or AI/ML performance data) were not performed for this 510(k) submission.

Since the provided text does not describe an AI/ML device or its performance evaluation, I cannot generate the table or provide details about sample sizes, ground truth establishment, or expert involvement in such a study.

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