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The Reverse® Shoulder Prosthesis (RSP) is indicated for treatment of patients with a grossly rotator cuff deficient shoulder joint with severe arthropathy or 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.

During primary surgery, after the humerus is prepared for the RSP humeral stem (modular and monoblock), if purchase to the glenoid bone is insufficient to bear the load of the glenoid baseplate and alternative glenoid bone reconstruction and/or repair is inadequate, the corresponding RSP humeral stem adapter can be used to convert the RSP humeral stem to hemiarthroplasty prosthesis as a salvage procedure. During revision surgery of an RSP (modular or monoblock), if the glenoid bone stock appears to be "insufficient" to bear the load of the glenoid baseplate and alternative glenoid bone reconstruction and/or repair is inadequate, the corresponding RSP humeral stem adapter can be used to convert the RSP device to hemiarthroplasty prosthesis as a salvage procedure. For modular RSP stems, the Foundation Shoulder humeral head should be used. For the monoblock stem, the Turon humeral head should be used.

This stem/adapter construct is not approved for use as a surrogate for traditional hemiarthroplasty or anatomic replacement indications.

A monoblock humeral stem with socket that is joined with an adapter to mate with a humeral head for use in hemi-arthroplasty applications.

This document is a 510(k) premarket notification decision letter from the FDA regarding a medical device, the "Reverse® Shoulder Monoblock Stem with Hemi Adapter." It is not applicable to the request for acceptance criteria and study results for an AI/ML powered medical device.

Reasoning:

The document concerns a traditional implantable medical device (shoulder prosthesis) and its regulatory clearance process based on substantial equivalence to predicate devices. It explicitly states:

• "Clinical Testing: None provided." This directly indicates that no clinical study, of any kind, was conducted or provided for this submission.
• The entire document describes a 510(k) submission, which primarily relies on comparing the new device to existing legally marketed predicate devices, rather than exhaustive new clinical studies, especially for mechanical devices.
• There is no mention of any AI or Machine Learning component in the device or its function.

Therefore, the requested information regarding acceptance criteria, device performance tables, sample sizes, expert ground truth, adjudication methods, MRMC studies, standalone performance, and training set details for an AI/ML powered device cannot be extracted from this document.

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