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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 or a previously 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 Univers Revers Shoulder Prosthesis 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 Shoulder Prosthesis is indicated for primary, fracture, or revision total shoulder replacement for the relief of pain and significant disability due to gross rotator cuff deficiency.

(Humeral) Stems are intended for cementless applications for use with the Arthrex Humeral Suture Cups. The glenoid baseplate is CaP coated and is intended for cementless use with the addition of screws for fixation.

The Arthrex Univers Revers CA Heads and Adapters are indicated for salvage of a failed reverse total shoulder, with an irreparable rotator cuff tear and a well-fixed humeral stem, to an anatomic hemi-shoulder replacement; or conversion of a primary reverse total shoulder. for the relief of pain secondary to severe rotator and an irreparable rotator cuff tear, to anatomic hemi-shoulder replacement when insufficient glenoid bone stock is encountered intraoperatively after the humeral stem has been implanted.

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 Shoulder Fracture Prosthesis is indicated for severe pain or significant disability resulting from degenerative, theumatoid, or traumatic disease or injury of the glenohumeral joint. This included traumatic or pathological conditions of the shoulder resulting in fracture of the glenohumeral joint, including impression fractures. comminuted fracture, humeral head fracture, displaced 3-or4-fragment proximal head fractures, of the humeral head, and fractures of the anatomical neck.

The Arthrex Univers Shoulder Fracture Prosthesis is designed for cemented use. This device may be used for hemi or total shoulder repair, utilizing the appropriate Arthrex Univers Glenoid component, which is to be cemented in place.

The Arthrex UNIVERS II and UNIVERS APEX Shoulder Prosthesis is indicated in replacement(s) when conditions including severe pain or significant disability resulting from degenerative, traumatic disease, or injury of the glenohumeral joint; non-union humeral head fractures of long duration; irreducible 2- and 4-part proximal humeral fractures; avascular necrosis of the humeral head, or other difficult clinical management problems where arthrodesis or resectional arthroplasty is not acceptable.

The glenoid components are intended fixation in the joint and must only be used with appropriate bone cement.

The Arthrex Shoulder Systems encompass the following FDA cleared devices:
• Arthrex Univers II Should Prosthesis
• Arthrex Univers Apex
• Arthrex Univers Revers Shoulder Prosthesis System
These systems are comprised of humeral and glenoid components for use in shoulder prosthesis.

This document is a 510(k) premarket notification for the Arthrex Shoulder System, seeking clearance for a modification to the device labeling to include an "MR Conditional" statement. It does not contain information about a study proving the device meets acceptance criteria related to clinical performance or an AI/algorithmic medical device.

Therefore, I cannot provide details on:

1. A table of acceptance criteria and reported device performance.
2. Sample size and data provenance for a test set.
3. Number and qualifications of experts for ground truth.
4. Adjudication method for the test set.
5. MRMC comparative effectiveness study or its effect size.
6. Standalone algorithm 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 demonstrating substantial equivalence for an existing device with a labeling change for MR compatibility. The "Performance Data" section specifically mentions non-clinical testing and in-vivo electromagnetic simulation to demonstrate MR Conditional status and bacterial endotoxin testing. This is not the type of clinical performance study typically described by the detailed questions you've posed, which are more relevant to the validation of AI/ML-based medical devices or new device types requiring clinical efficacy studies.

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