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The Jarvis Glenoid Reverse Shoulder Prosthesis is indicated for patients with severe shoulder arthropathy and a grossly deficient rotator cuff or a previously failed shoulder joint replacement with a grossly deficient rotator cuff.

The patient must be anatomically and structurally suited to receive the implants and a functional deltoid muscle is necessary. The glenoid baseplate is intended for cementless application with the addition of screws for fixation.

The JARVIS Glenoid Reverse Shoulder Prosthesis is used for reverse shoulder prosthesis, intendedfor primary, fracture or revision shoulder replacement. The JARVIS Glenoid Reverse Shoulder Prosthesis is made up of three components - glenophere, baseplate, and fixation component (screw or post) . All components are offered in varying sizes to accommodate patient anatomy. The baseplate and screw components are manufactured from medical grade titanium alloy (Ti6Al4V-ELI) per ASTM F-136/ISO 5832-3, while the glenophere is manufactured from wrought cobalt chromium molybdenum alloy per ASTM F1537/ISO 5832-12. All components are provided sterile via gamma irradiation.

This document is an FDA 510(k) summary for the JARVIS Glenoid Reverse Shoulder Prosthesis. It does not contain information about an AI/ML medical device. Therefore, I cannot provide the requested information regarding acceptance criteria and study details for an AI-powered device.

The provided text describes a traditional medical device (shoulder prosthesis) and its mechanical and biocompatibility testing, which are standard for such devices to demonstrate substantial equivalence to legally marketed predicates.

To answer your specific questions about an AI/ML device, the input document would need to describe such a device, its intended use, and the performance studies conducted to support its claims.

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