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The PROMOS Reverse Shoulder System 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 implants 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 and body components are intended for cementless use.

The implants of the PROMOS Reverse Shoulder System are single use device

Subject of this Traditional 510(k) premarket notification is the PROMOS Reverse Shoulder System. The glenohumeral articulation of the Promos Reverse Shoulder is inverted - when compared to traditional total shoulder prostheses. Unlike traditional fotal shoulder prostheses, the Promos Reverse Shoulder is designed so that the "ball" component of the shoulder is assembled to the glenoid baseplate and the "cup" component is assembled onto the humeral stem.

I am sorry, but I cannot provide the requested information because the document describes a medical device (PROMOS Reverse Shoulder System), not an AI/ML-driven device.

The document discusses the regulatory approval (510(k)) of a prosthetic shoulder system. It details the device's description, intended use, and substantial equivalence to existing predicate devices. However, there is no mention of any AI or machine learning component, nor any study involving performance metrics like sensitivity, specificity, or AUC, which would be relevant for establishing acceptance criteria for an AI-driven device.

Therefore, the requested information regarding acceptance criteria, study details, sample sizes, expert involvement, and ground truth establishment, as they pertain to an AI device's performance, is not available in the provided text.

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