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AltiVate Reverse® Shoulder System, Reverse® Shoulder Prosthesis (RSP®), SMR Shoulder System, PRIMA Humeral System, and PRIMA Glenoid System are intended for various forms of partial or total, primary or revision shoulder joint replacement. Specific indications depend on the system and configuration (modular, monoblock, anatomic, reverse), addressing conditions such as:

• Grossly rotator cuff deficient shoulder joint with severe arthropathy
• Previously failed joint replacement with a grossly rotator cuff deficient shoulder joint
• Functional deltoid muscle is necessary to use the device
• Fracture of glenohumeral joint from trauma or pathologic conditions of the shoulder (including humeral head fracture or displaced 3- or 4-part fractures of proximal humerus)
• Bone defect in proximal humerus
• Non-inflammatory degenerative disease including osteoarthritis and avascular necrosis of the natural humeral head and/or glenoid
• Inflammatory arthritis including rheumatoid arthritis
• Correction of functional deformity
• Treatment of acute fractures of the humeral head that cannot be treated with other fracture fixation methods
• Revision of a failed primary implant (if sufficient bone stock remains)
• Cuff tear arthropathy (CTA Heads only)
• Glenoid arthrosis without excessive glenoid bone loss: A1, A2 and B1 according to Walch classification (SMR TT Hybrid Glenoid only)
• Massive irreparable rotator cuff tear

The patient's joint must be anatomically and structurally suited to receive the selected implant(s). Some components are intended for cemented and/or cementless application, often with the addition of screws for fixation. Revision surgery can include conversion from anatomic to reverse arthroplasty if the stem is stable, well positioned, and tissue integrated.

This 510(k) submission proposes updated labeling to reflect additional compatibility between previously cleared shoulder systems from Encore Medical, L.P. (AltiVate Reverse® Shoulder System) and LimaCorporate S.p.A. (SMR and PRIMA Shoulder Systems). The update allows for cross-system use of humeral and glenoid components for reverse total shoulder arthroplasty, where compatible sizes exist. There are no changes to the design, materials, function, or intended use of the devices, and no new implants or instruments are introduced. The proposed configurations include using an AltiVate Reverse® humeral stem and insert with SMR or PRIMA glenoid components, and vice versa.

It appears there might be a misunderstanding of the provided FDA 510(k) clearance letter. The document, K251184, is for orthopedic implants (shoulder prostheses, specifically reverse shoulder systems and related components), not for an AI/software as a medical device (SaMD) or diagnostic device that would typically have acceptance criteria, performance studies involving human readers, and ground truth establishment in the way described in your request.

The letter explicitly states:

• "Trade/Device Name: AltiVate Reverse® Shoulder System; Reverse® Shoulder Prosthesis (RSP®); SMR Shoulder System; PRIMA Humeral System; PRIMA Glenoid System"
• "Regulation Name: Shoulder joint metal/polymer semi-constrained cemented prosthesis"
• "Device Description: This 510(k) submission proposes updated labeling to reflect additional compatibility between previously cleared shoulder systems... The update allows for cross-system use of humeral and glenoid components for reverse total shoulder arthroplasty, where compatible sizes exist. There are no changes to the design, materials, function, or intended use of the devices, and no new implants or instruments are introduced."
• "Performance testing: Performance testing, including Wear Testing and Range of Motion Analysis, demonstrates substantial equivalence between the subject and predicate devices and did not raise different questions of safety and effectiveness."

This means the "device" in question is a physical medical implant, and the 510(k) is about demonstrating "substantial equivalence" to previously cleared implants, primarily regarding material compatibility and mechanical performance (wear, range of motion).

Therefore, the requested information about acceptance criteria for an AI/diagnostic device, sample sizes for test sets in medical imaging, number of experts for ground truth, MRMC studies, standalone algorithm performance, and training set details are not applicable to this specific 510(k) clearance letter. The testing mentioned ("Wear Testing and Range of Motion Analysis") would involve mechanical engineering and biomechanical testing, not clinical studies with human readers or AI performance metrics.

To answer your request based on the provided document would require fabricating information not present in the letter. If you have an FDA 510(k) clearance letter for an AI/SaMD or diagnostic device, I would be happy to analyze it against your criteria.

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