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The Univers Revers Modular Glenoid System is indicated for use in a grossly rotator cuff deficient glenohumeral joint with severe arthropathy or a previously failed joint replacement with a gross rotator cuff deficiency. The patient's joint must be anatomically and structurally suited to receive the selected implant(s), and a functional deltoid muscle is necessary to use the device.

The Univers Revers Modular Glenoid System is indicated for primary, fracture, or revision total shoulder replacement for the relief of pain and significant disability due to gross rotator cuff deficiency.

The Univers Revers Modular Glenoid System is porous coated and is intended for cementless use with the addition of screws for fixation.

The subject devices are augmented baseplates made of titanium with BioSync coating. The baseplates are available in sizes 24 and 28 with full and half augments. The subject devices are designed to be used cementless with peripheral screws and glenosphere devices cleared under K193372, K191960 and K173900.

This document is a 510(k) summary for the Univers Revers Modular Glenoid System, Standard Augment Baseplates. It does not contain information related to software performance or AI/ML acceptance criteria and studies.

Therefore, I cannot provide the requested information regarding:

1. A table of acceptance criteria and the reported device performance.
2. Sample sizes or data provenance.
3. Number of experts or their qualifications for establishing ground truth.
4. Adjudication method.
5. MRMC comparative effectiveness study or effect size.
6. Standalone (algorithm-only) performance.
7. Type of ground truth used.
8. Sample size for the training set.
9. How ground truth for the training set was established.

The document focuses on the mechanical and material equivalence of a medical implant (shoulder prosthesis) to previously cleared predicate devices. The "Performance Data" section specifically mentions:

• Mechanical testing: "Rocking horse testing per ASTM F2028 was performed to demonstrate that the subject device meets the standards requirements."
• Bacterial Endotoxin test: Conducted in accordance with various USP and EP standards.
• MRI testing: Conducted in accordance with FDA guidance and ASTM F2182.

These tests are standard for implantable hardware and are not related to artificial intelligence or machine learning performance.

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