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The Reverse® Shoulder Prosthesis (RSP®) is indicated for use in patients with a grossly rotator cuff deficient shoulder joint with severe arthropathy, a previously failed joint replacement with a grossly rotator cuff deficient shoulder joint. 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 glenoid baseplate is intended for cementless application with the addition of screws for fixation. The humeral stem is intended for cemented use only.

The Reverse® Shoulder Prosthesis Monoblock is indicated for patients with a functional deltoid muscle with a grossly deficient rotator cuff shoulder joint with severe arthropathy or a previously failed joint replacement with a grossly deficient rotator cuff shoulder joint:

• · In cases of 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. (For cemented implantation only)
• In cases of bone defect in proximal humerus.

The patient's joint must be anatomically and structurally suited to receive the selected implant(s).

The glenoid baseplate is intended for cementless application with the addition of screws for fixation. The humeral stem is intended for cemented or cementless use.

The RSP system is designed so that the "ball" of the articulation fits into the glenoid baseplate, and the "cup" of the articulations fits into a metal cup that is joined to the humeral stem. The components included in this system are a glenoid bead, a humeral stem. The component baseplate, and baseplate screws. The standard RSP system consists of a modular components which include a humeral stem, humeral socket inset, glenoid baseplate, glenoid baseplate, which screws. The RSP Monoblock stem includes a bument test glenoid baseplate, glenoid he screws. The RSP Monoblock socket hiser, greend baseplate, glenoid baseplate, and humeral socket and humeral socket

The modification outlined in this application consists of an addition of a humeral socket insert infused with pure liquid pharmaceutical grade alpha-tocopheral into the material.

I am sorry, but the provided text does not contain information on acceptance criteria or a study that proves a device meets such criteria. The document is a 510(k) premarket notification letter from the FDA regarding a shoulder prosthesis, focusing on its substantial equivalence to previously marketed devices. It outlines the device details, indications for use, and a list of non-clinical testing performed, but it explicitly states "Clinical Testing: None provided."

Therefore, I cannot extract any information to fulfill your request regarding:

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 results.
6. Standalone algorithm performance.
7. Type of ground truth used.
8. Sample size for the training set.
9. Method for establishing ground truth for the training set.

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