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Delta Xtend™ Reverse Shoulder prosthesis is intended for use in total or hemi shoulder arthroplasty procedures in patients with non-functional rotator cuffs, with or without bone cement. HA coated components are for cementless use only.

Delta Xtend™ Reverse Shoulder prosthesis is indicated for use in a grossly rotator cuff deficient joint with severe arthropathy or a previous failed joint replacement with a grossly rotator cuff deficient 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.

In cases of bone defects in the proximal humerus, the monobloc implant should be used and then only in cases where the residual bone permits firm fixation of this implant.

Delta Xtend™ hemi-shoulder replacement is also indicated for hemi-arthroplasty if the glenoid is fractured intraoperatively or for revision of a previously failed Delta Xtend Reverse Shoulder.

The metaglene component is HA coated and is intended for cementless use with the addition of screws for fixation.

The modular humeral stem and epiphysis components are HA coated and intended for cementless use.

All other components are for cemented use only.

The Delta Xtend™ Reverse Shoulder System is a modular shoulder prosthesis designed for use in patients with non-functional rotator cuffs.

Since the provided text describes a 510(k) premarket notification for a medical device (Delta Xtend™ Reverse Shoulder Modular Stem) and explicitly states that the device's substantial equivalence is "substantiated by its similarity in intended use, indications for use, materials and design to legally marketed predicate devices," there is no mention of a study involving acceptance criteria or reported device performance in the context of the detailed AI/software specific questions.

The document is a regulatory submission for a physical implantable device, not a software or AI-based diagnostic tool. Therefore, the specific questions about acceptance criteria for AI models, sample sizes for test sets, expert ground truth, MRMC studies, standalone performance, training sets, etc., are not applicable to this document.

The "Basis of Substantial Equivalence" section {1} indicates that the device's approval relies on its similarity to previously approved predicate devices, not on a new clinical study with performance metrics as would be expected for a novel diagnostic or AI-driven system.

Therefore, an answer based on the provided text would have to state that this information is not present.

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