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The sterile, disposable cable or tube holder is intended to limit the amount of excess cable or tubing that extends into the surgical field. The holders are offered in 1/2" and 3/4" sizes to allow for a variety of diameters. Pressure sensitive adhesive is attached to the back of both sizes to allow for easy attachment to a clean, dry surface.

The cable or suction tube holder is a sturdy nylon construction available in 1/2" or 3/4" diameter. Pressure sensitive adhesive backing allows for the holders to be positioned on a clean, dry surface. Flexible lock and release loops allow the cable or tube to be retained and held in place.

The provided text is a 510(k) summary for a "Cable Holder / Suction Tube Holder." It describes the device, its intended use, and identifies a predicate device. However, it does not contain any information about acceptance criteria, device performance studies, sample sizes, ground truth establishment, or expert involvement.

Therefore, I cannot provide the requested information. The 510(k) summary provided pertains to a simple medical device (a cable/suction tube holder) and not a diagnostic or AI-powered device that would typically undergo the kind of performance evaluation described in your request. Such detailed performance studies are usually associated with devices that generate, process, or interpret data, or make diagnostic recommendations.

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