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DeGasa Sterile USP Gauze Sponges are used in a hospital setting where sterile gauze is required. The instructions for use by physicians using gauze sponges are exactly the same as the instructions for use found on present labeling for similar products currently on the market.

DeGasa USP Gauze are sterile gauze sponges that are made with 100 % cotton, and are in the form of plain woven cloth conforming to the specifications of USP type VII.

The provided text describes a 510(k) summary for a medical device, the Protec Sterile Gauze Sponge. However, it does not contain information about acceptance criteria, device performance metrics, studies involving AI, sample sizes for test or training sets, ground truth establishment, or expert involvement as requested in the prompt.

The document primarily focuses on:

• Device identification: Trade name, classification, predicate device.
• Device description and comparison: Material (100% cotton), form (plain woven cloth conforming to USP type VII), and a comparison of physical specifications (threads per 2.54 cm warp/filling, average count per 6.45 sq. cm, weight per sq. meter) between the Protec gauze and its predicate device, Keilei. In all listed specifications, the Protec gauze is stated to be "Same" as the Keilei gauze.
• Intended use: "used in a hospital setting where sterile gauze is required."

Since the device is a simple sterile gauze sponge, the regulatory submission likely focused on demonstrating substantial equivalence to a predicate device based on material composition, physical characteristics, and intended use, rather than a performance study involving sensitivity, specificity, or AI algorithms.

Therefore, I cannot provide the requested table and study details based on the input text. The information is not present in the 510(k) summary.

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