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Help prevent edema and leg discomfort and help prevent deep vein thrombosis in individuals subjected to immobility or long distance travel. Over the counter use.

The FUTURO™ Travel Knee-Highs, Socks, Stockings and Pantyhose are made of a blend of nylon and spandex. The FUTURO™ Travel Knee-Highs, Socks, Stockings and Pantyhose provide graduated compression of the leg, with the higher compression in the ankle region and lower compression in the calf and the thigh (for the pantyhose only). Two compression ranges are available. Moderate. 15-20 mmHg. and Firm. 20-30mmHg. The compression hosiery products are produced on circular knitting machines. Performance testing of the products demonstrates that the compression hosiery meet the stated compression specification ranges and provide the same compression levels as the predicate devices.

The FUTURO™ Travel Knee-Highs, Socks, Stockings and Pantyhose are substantially equivalent to the predicate products in product materials, mode of action, compression levels, function and indication for use, and as such, can be considered safe and effective as the referenced, predicate products. Like the products, the FUTURO™ Travel Knee-Highs, Socks, Stockings and Pantyhose are available in a variety of colors and sizes for both men and women.

The FUTURO™ Travel Knee-Highs, Socks, Stockings and Pantyhose differ from the predicate devices in the following aspects. Tsung Hau Technology Company, Limited, Shape to Fit, compression hosiery utilizes a "fresh weave odor control". The 3M FUTURO™ hosiery does not. Jobst's Travel Sock contains cotton yarn for comfort. The 3M FUTURO™ hosiery does not contain any cotton (with the exception of the cotton lined crotch in the pantyhose). No other significant differences are noted.

The provided 510(k) summary for the FUTURO™ Travel Knee-Highs, Socks, Stockings, and Pantyhose does not contain the information requested regarding acceptance criteria and a study proving device performance in the format of AI/ML software validation.

This is a medical support stocking, which is a physical device, not an AI/ML algorithm. The submission focuses on demonstrating substantial equivalence to predicate devices based on materials, mode of action, and compression levels, which are mechanical performance characteristics and not related to AI/ML performance metrics like accuracy, sensitivity, or specificity.

Therefore, I cannot provide a table of acceptance criteria and reported device performance or answer the specific questions about sample sizes, ground truth establishment, expert adjudication, or MRMC studies, as these concepts are not applicable to the type of device and submission described.

The summary states: "Performance testing of the products demonstrates that the compression hosiery meet the stated compression specification ranges and provide the same compression levels as the predicate devices." However, it does not provide the specific acceptance criteria or the detailed results of this performance testing.

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