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The Aequalis Reversed Shoulder Prosthesis is indicated for patients with a functional deltoid muscle as a total shoulder replacement for the relief of pain and significant disability following arthropathy associated to massive and non repairable rotator cuff-tear. This device is also indicated for the prosthetic revisions with massive and non repairable rotator cuff-tear. Only the humeral components are for cemented use. The glenoid implant is anchored to the bone with 4 screws and is for non-cemented fixation.

When during the primary surgery the glenoid bone stock appears to be insufficient to bear the reversed glenoid components or when glenoid bone fracture occurs during the surgical procedures, the hemi-prosthesis adaptor and the union screw can be adapted to the humeral components in order to transform the Aequalis Reversed prosthesis into a non reversed hemi-prosthesis.

When, in case of revision of a Aequalis Reversed prosthesis, the glenoid bone stock appears to be insufficient to implant a base plate and a sphere of Aequalis Reversed range again, the use of the hemi-prosthesis adaptor and the union screw allows for the transformation of the Aequalis Reversed prosthesis into a non reversed hemi-prosthesis in order to avoid the revision of the humeral components.

The Aequalis Reversed Shoulder Prosthesis is intended to relieve pain and significant disability following massive and non repairable cuff-tear associated to arthropathy and following massive cuff-tear arthropathy. In this case, the rotator muscles of the shoulder (supraspinatus, teres minor and long head of the biceps) are no more useful for mobility, and only the deltoid (for abduction and external rotation) and the subscapularis (for internal rotation) are functional.

Therefore, the usual goal of such surgery is to restore the shoulder joint to facilitate its working condition and to recuce or eliminate pain. The Aequalis Reversed Shoulder Prosthesis is intended to accomplish these goals. Its reversed design allows to medialize the center of rotation of the shoulder, lengthening the deltoid muscle lever arm.

The Aequalis Reversed Shoulder Prosthesis is a semi-constrained system composed of a humeral and a glenoid parts.

The present device modification submission consists in :

• addition of glenoid baseplates and glenoid spheres, .
• addition of polyethylene inserts.

The provided text is a 510(k) premarket notification letter and a summary of safety and effectiveness information for a medical device. It does not contain information about acceptance criteria or a study that proves the device meets those criteria, as typically seen in performance studies for diagnostic or AI-based devices.

The document describes the device, its indications for use, materials, and classification within the FDA's regulatory framework. It primarily focuses on demonstrating substantial equivalence to predicate devices, which is a regulatory pathway for certain medical devices. This type of submission does not usually include detailed performance studies with acceptance criteria in the way a clinical trial or AI algorithm validation would.

Therefore, I cannot provide the requested information based on the given text.

To address the specific points you asked for:

1. A table of acceptance criteria and the reported device performance: This information is not present in the document.
2. Sample sized used for the test set and the data provenance: Not applicable/not present. The document is for a physical orthopedic implant, not a diagnostic device that uses a test set of data.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable/not present.
4. Adjudication method for the test set: Not applicable/not present.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance: Not applicable. This device is an orthopedic implant, not an AI-assisted diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is not an algorithm or AI device.
7. The type of ground truth used: Not applicable. For an orthopedic implant, "ground truth" in the context of device performance usually refers to clinical outcomes, wear testing, mechanical properties, etc., which are not detailed in this summary.
8. The sample size for the training set: Not applicable. This is not an AI/ML device that requires a training set.
9. How the ground truth for the training set was established: Not applicable.

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