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The Anti-Embolism Stockings: Help prevent edema and leg discomfort, and help prevent deep vein thrombosis (DVT) in individuals subjected to immobility. Over-the-Counter (OTC) Use

The Anti-Embolism Stockings are compression stockings consisting of 90% nylon and 10% spandex. The thigh length stockings have a silicone band at the top. Knee length and thigh length models are each provided in three (3) different sizes. The Anti-Embolism Stockings are designed for the post-operative patient. The knee and thigh length models of these anti-embolism stockings are produced on a circular knitting machine. Nylon varns are knit into the fabric structure while the nylon covered spandex yarns are in-laid into the fabric structure. The stockings are designed with the higher compression in the ankle region (18 mmHg) and lower, graduated compression in the calf (11 mmHg) and thigh regions (8 mmHg - thigh length model) of the leg. The mechanism of action is achieved via the graduated compression design. The Anti-Embolism Stockings are not made with natural rubber latex.

The provided text is a 510(k) Summary for medical support stockings and contains no information regarding studies conducted, acceptance criteria, or performance data for a device in the context of AI or diagnostic accuracy studies. Therefore, I cannot generate the requested table or study details based on this input.

The document is a submission to the FDA for market clearance for "Anti-Embolism Stockings." It outlines the general information, predicate devices, indications for use, and a description of the device (compression stockings made of nylon and spandex). The FDA letter confirms the substantial equivalence determination.

To answer your request, I would need a different type of document, such as a clinical study report or a 510(k) summary that includes performance data and acceptance criteria for a device that has undergone such testing.

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