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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 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 introduce the AltiVate Anatomic Pegged Glenoid with Markers is a component that is 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 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 application also includes a material change from the currently cleared AltiVate Anatomic Pegged Glenoids.

It appears there has been a misunderstanding. The provided document is a 510(k) premarket notification clearance letter and summary for a medical device called the "AltiVate® Anatomic Pegged Glenoid with Markers," which is a shoulder joint prosthesis.

This document does not contain information about:

• Acceptance criteria for a device that relies on AI/ML or image analysis. The device in question is a physical implant, not a software or AI-driven diagnostic tool.
• Study data for AI/ML device performance. The "study" referenced in the document is non-clinical testing (material evaluation, dimensional comparisons, endotoxin assessment) to demonstrate substantial equivalence to predicate physical implants, not a performance study of an AI algorithm.
• Ground truth establishment, expert consensus, MRMC studies, or training/test set details. These concepts are relevant to AI/ML device evaluations, which are not applicable here.

Therefore, I cannot fulfill your request using the provided text. The information you're asking for (acceptance criteria, study details, expert involvement, etc., related to an AI/ML device) is simply not present in this document, as it pertains to a different type of medical device.

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