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The Arthrex UNIVERS REVERS COATED BASEPLATE is designed to be used as the glenoid component of the existing Univers Revers Shoulder Prosthesis System.

The Arthrex UNIVERS REVERS COATED BASEPLATE is indicated for use in a grossly rotator cuff deficient glenohumeral joint with severe arthropathy failed joint replacement with a gross rotator cuff deficiency. The patient's joint must be anatomically suited to receive the selected implant(s), and a functional deltoid muscle is necessary to use the device.

The Arthrex UNIVERS REVERS COATED BASEPLATE 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 Arthrex UNIVERS REVERS COATED BASEPLATE is coated and is intended for cementless use with the addition of screws for fixation.

The Arthrex UNIVERS REVERS COATED BASEPLATE is a coated titanium glenoid baseplate designed to be used as the glenoid component of the existing Univers Revers Shoulder Prosthesis System. The baseplate is centrally anchored by a barbed post with superior and inferior multi-directional screws to ensure optimal fixation. The baseplate comes in three sizes and is designed to be paired with the Univers Revers glenosphere.

The provided document is a 510(k) premarket notification for the "Arthrex UNIVERS REVERS COATED BASEPLATE." This document describes a medical device, specifically a shoulder prosthesis component, and not an AI/ML-driven medical device that would involve AI performance metrics.

Therefore, the requested information (acceptance criteria, study details, sample sizes, expert ground truth, adjudication methods, MRMC studies, standalone performance, training set details) related to AI/ML device performance is not applicable to this document.

The document focuses on demonstrating substantial equivalence to a predicate device through:

• Mechanical Testing: Mentioned as "Rocking Horse, Shear Force" to show equivalent performance to the predicate device.
• Coating Compliance: Non-clinical testing to demonstrate compliance with FDA Guidance for Industry on Testing of Metallic Plasma Sprayed Coatings on Orthopedic Implants.
• Bacterial Endotoxin Testing: To demonstrate the device meets pyrogen limit specifications.

These are standard engineering and biocompatibility tests for orthopedic implants, not performance studies for AI/ML algorithms.

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