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This device is composed of 100% natural cotton fiber. The intended uses of an operating room towel are the absorption of fluids, including blood and body fluids while being used as patient drape at the incision site, or serving as a general use sterile towel for drying hands. The product is intended for single use and is disposable. This product is not intended to be used as a protective barrier.

This device is composed of 100% natural cotton fiber.

This document is a 510(k) premarket notification letter from the FDA to Broadline Medical Industries, Incorporated, regarding their "Broadline O.R. Towels." It indicates that the device has been found substantially equivalent to legally marketed predicate devices.

Crucially, this document does not contain information about acceptance criteria, device performance, study details, or ground truth establishment for a medical device that uses an algorithm or AI functionality.

The "Broadline O.R. Towels" are described as being made of 100% natural cotton fiber and intended for absorption of fluids during surgery (blood, body fluids as a patient drape at the incision site, or a general use sterile towel for drying hands). They are for single use and disposable. The document explicitly states: "This product is not intended to be used as a protective barrier."

Therefore, I cannot answer your specific questions related to acceptance criteria, study methodologies, sample sizes, expert qualifications, or ground truth for an AI/algorithm-based device, as this product does not appear to be such a device.

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The intended uses of gauze sponges are absorption of blood and body fluids, wound dressing, prepping and scrubbing, and debridement. This product is patient contacting material.

GAUZE SPONGES

I am sorry, but the provided text is a 510(k) premarket notification letter from the FDA regarding Broadline Gauze Sponges. This document does not contain information about the acceptance criteria or a study proving the device meets acceptance criteria.

Therefore, I cannot fulfill your request to describe the acceptance criteria and the study that proves the device meets them, as this information is not present in the provided text. The document is a regulatory approval notice, not a scientific study report.

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