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Intended Use: The Delta CTA Reverse Shoulder System Humeral Head is intended for use in hemi arthroplasty procedures (without the humeral cup or glenoid components) if the glenoid is fractured intraoperatively or for revision surgery in cases with insufficient glenoid bone stock.

Indications for Use: A Delta CTA™ 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. The metaglene component is HA coated and is intended for cementless application with the addition of screws for fixation. All other components are intended for cemented use only.

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

The provided text describes a 510(k) summary for the DePuy Orthopaedics, Inc. Delta CTA™ Reverse Shoulder System Humeral Heads. A 510(k) submission is a premarket notification to the FDA to demonstrate that the device to be marketed is at least as safe and effective, that is, substantially equivalent, to a legally marketed predicate device.

Therefore, this document does not contain acceptance criteria for device performance or a study demonstrating that the device meets such criteria.

Instead, the "Basis of Substantial Equivalence" section explicitly states: "The substantial equivalence of the Delta CTA Reverse Shoulder System Humeral Head is substantiated by its similarity in intended use, indications for use, materials and design to the DePuy Delta CTA Reverse Shoulder System (K021478) and the DePuy Global Advantage CTA Head (K000575)."

This means the device's acceptance is based on its similarity to previously approved devices, not on specific performance metrics established through a new study. As such, the requested information about device performance, sample sizes, ground truth establishment, expert involvement, and comparative effectiveness studies is not available in this document.

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