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A Delta CTA™ Reverse Shoulder Prosthesis is indicated for use in
• 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.
• The metaglene component is HA coated and is intended for cementless application with the addition of screws for fixation. For US Use Only: All other components are intended for cemented use only.

The Delta CTA™ Reverse Shoulder is DePuy's first generation reverse shoulder system. In a reverse shoulder, the articulation is "inverted" compared to traditional, anatomical total shoulder prosthesis so that the "ball" of the articulation is incorporated into the glenoid prosthesis and the "cup" of the articulation is incorporated into the humeral prosthesis. This inverted design helps stabilize a shoulder in the absence of a functional rotator cuff.

The provided document is a 510(k) premarket notification summary for the DePuy Delta CTA™ Reverse Shoulder System. It focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than providing acceptance criteria and performance data for a new AI/software medical device.

Therefore, the requested information regarding acceptance criteria, study details, sample sizes, ground truth establishment, expert qualifications, adjudication methods, and MRMC studies for an AI/software device cannot be extracted from this document. This document describes a traditional medical device (shoulder prosthesis) and evaluates its substantial equivalence based on non-clinical performance and material characteristics, not AI performance.

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