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The GE Sterile Disposable Equipment Cover is intended to protect equipment from fluids. Specifically, a coil used in the GE Magnetic Resonance Imaging (MRI) System.

An MRI system requires the use of a remote transmitting coil to generate the localized images. The coil is placed on the area of the patient where the operating incision is made. The coil itself resembles a window frame. These coils are very suspectible to damage caused by various fluids that may be release during an invasive procedure. To protect these coils, a Sterile Disposable Equipment Cover is used to seal the coil inside a wrapper preventing it from fluid contamination. The Sterile Disposable Equipment Cover is made from PVC Film and the strap is polynap of 100% nylon fabric with polyester foam core and nylon tricot backing.

I am sorry, but the provided text does not contain the information required to answer your request. The document is a 510(k) summary for a medical device (Sterile Disposable Equipment Coil Cover) and primarily focuses on its description, intended use, and comparison to a predicate device for regulatory clearance. It does not include acceptance criteria, performance studies, sample sizes, expert involvement, or any details about AI algorithms or ground truth establishment.

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