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The Omni Foot and Ankle Plating System is intended for use in internal fixation of arthrodeses, osteotomies, fractures and nonunions of the small bones of the foot & ankle including the fore-, mid-, and hind foot and ankle applications.

The Omni Foot and Ankle Plating System is a bone fixation system consisting of unalloyed Titanium plates and Titanium Alloy (Ti-6AL-4V) locking and non-locking plate screws, which meet ASTM F67 and ASTM F136, and a set of instruments used for implant site preparation and delivery. The plates are available in various configurations, essentially differing by the lengths and number of holes. The plate screws are provided in diameters of 2.8mm and 3.5mm in lengths from 8mm to 50mm. The System offers 3.5mm cannulated screws and 4.0mm solid screws in various lengths to be used as adjunctive fixation. The 3.5mm cannulated screw can also be used with a specialized locking screw ("Post") which contains a locking feature at the distal end for compression/stabilization.

The provided text is for a 510(k) premarket notification for a medical device called the "Omni Foot and Ankle Plating System." This document does not describe the acceptance criteria or a study that proves the device meets those criteria in the context of an AI/ML powered device. Instead, it details the regulatory process for establishing substantial equivalence to previously cleared devices.

Therefore, I cannot extract the requested information regarding acceptance criteria, device performance, test set details, expert qualifications, adjudication methods, MRMC studies, standalone performance, ground truth types, or training set specifics for an AI/ML powered device from the provided text.

The document explicitly states: "No clinical testing was performed." and relies on "engineering analysis" for comparison to predicate devices, which is typical for non-AI/ML mechanical devices.

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