Search Results

GEEN MEDI SOX GRADUATED COMPRESSI ON SOCKS HAVE BEEN DESIGNED TO PREVENT POOLING OF BLOOD I N THE LOWER EXTREMI TI ES BY APPLYI NG CONTROLLED GRADUATED COMPRESSION STARTING AT 20 MMHG AT THE ANKLE AND REDUCING TO 8 MMHG AT THE KNEE.

GEEN MEDISOX HELP IN THE TREATMENT AND PREVENTI ON OF VARI COSE VEINS, REDUCE THE FEELING OF HEAVINESS AND TIREDNESS IN LEGS, ESPECIALLY FOR THOSE STANDING OR WALKING ALL DAY, AND ALSO HELP TO REDUCE SWELLI NG IN THE LOWER EXTREMITIES.

Geen Medisox, a medical support stocking (21 CFR, 880.5780). Geen Medisox help prevent pooling of blood in the lower extremities by providing controlled graduated compression starting at 20 mmhg at the ankle and reducing to 8 mmhg at the knee. Geen Medisox are knit stockings made from cotton, Lycra, and polyamide, with gradual compression provided by the Lycra.

The provided text is a 510(k) summary for the Geen Medisox, a medical support stocking. It does not describe an AI medical device or a study with acceptance criteria and performance data as requested in the prompt. Instead, it focuses on demonstrating substantial equivalence to a predicate device.

Therefore, I cannot provide the requested information about acceptance criteria, device performance, sample sizes, ground truth establishment, or human-in-the-loop performance, as this information is not present in the provided document.

The document indicates that the device's substantial equivalence is based on:

• Similar materials: "Geen Medisox are knit stockings made from cotton, Lycra, and polyamide... Construction materials are similar to Jobst."
• Mode of action: "They both provide graduated compression of the lower extremities."
• Intended use: "help prevent pooling of blood in the lower Geen Nedison help pring controlled graduated compression excreating at 20 mmhg at the ankle and reducing to 8 mmhg at the knee." and "Geen Medisox help in the treatment and prevention of varicose veins, reduce the feeling of heaviness and tiredness in legs, especially for those standing or walking all day, and also help to reduce swelling in the lower extremities."

The document explicitly states: "The product being submitted, Geen Medisox, is substantially similar to the predicate product in the materials used, mode of action, and indications for use. It has a long history of use and has proven to be as safe and effective as the predicate product."

This 510(k) summary for Geen Medisox does not include any information regarding an AI algorithm, a standalone study, or a comparative effectiveness study with human readers, nor does it provide details about acceptance criteria and a study proving those criteria are met in the context of an AI device.

Ask a specific question about this device