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

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

The provided document is a 510(k) premarket notification letter from the FDA regarding the DePuy Delta Xtend Reverse Shoulder System. This document does not contain information about acceptance criteria or a study proving that a device meets those criteria.

Instead, this document focuses on:

• Substantial Equivalence: The FDA's determination that the DePuy Delta Xtend Reverse Shoulder System (specifically the High Mobility Cup) is substantially equivalent to previously cleared devices (Delta Xtend Reverse Shoulder System, K062250 and K071379). This means the FDA believes the new device is as safe and effective as existing legally marketed predicate devices.
• Indications for Use: The medical conditions for which the device is intended.
• Device Description: A brief overview of the device's design and components.
• Regulatory Classification: The device's classification (Class II) and associated regulations.

Therefore, I cannot provide the requested information regarding acceptance criteria, reported device performance, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, or ground truth establishment based on the provided text. This type of detailed study information is typically found in a clinical study report or a more comprehensive technical document, not in a 510(k) clearance letter.

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