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The AOS Humeral Nail is intended to treat stable and unstable proximal fractures of the humerus including two and three, and in some cases, four part humerus fractures. The Humeral Nail is also indented to treat proximal and distal one third fractures, midshaft fractures and pathological fractures.

The AOS Humeral Nail is a titanium humeral intramedullary nail that is design to enter the humerus through the greater tuberosity. It consists of an intramedullary nail, proximal and distal locking screws, compression screw and an end cap. The Humeral Nail is a cannulated nail with a 10° proximal bend and a proximal diameter of 10mm. The Humeral Nails are produced in 15cm, 20cm, 22cm, 24cm, 26cm and 28cm lengths and a distal diameters of 8mm. The proximal end of the nail has three holes to accept the 5 mm cancellous screw and one slot wich also accepts the 5.0mm cancellous screw. The Humeral Nail is produced in a left and a right configuration. The proximal end of the nail is threaded to accept an end cap. As medical judgment dictated addition angles, diameters and length may be added. The distal end of the nail contains two cross locking holes which are design to accept a 3,5mm cortical screw.

The provided text is a 510(k) summary for the AOS Humeral Nail, a medical device. It does not contain information about acceptance criteria or a study proving device performance against such criteria. Instead, it argues for substantial equivalence to existing devices. Therefore, I cannot extract the requested information concerning acceptance criteria, study details, sample sizes, ground truth, or expert qualifications from this document.

The document states: "Since the devices are substantial equivalent in design, geometry, construction and indications it was determine that no mechanical testing was necessary to demonstrate substantial equivalence." This indicates that no new performance studies, as you've described, were conducted for this 510(k) submission.

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