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The Morrison Medical Products Cinch Strap with Buckle is intended to limit a patient's movement to the extent necessary for treatment, examination, or protection of the patient or others. The device can be used in the supine or sitting position. The device is also intended to be used as an assist in securing equipment.

The Morrison Medical Products Cinch Strap with Buckle is constructed of a nylon hook and loop material. Heat Sealed to one end is a nylon hook material that is used to secure the patient or equipment in the Cinch Strap with Buckle. The Cinch Strap with Buckle is available in the following sizes: Series 1142 - 1" x 42" Series 1150 - 11/2" x 18" Series 1160 - 11/2 x 30"

The provided document is a 510(k) summary for the "Morrison Medical Products Cinch Strap with Buckle." This document does not contain information about acceptance criteria, device performance studies, or any of the other specific details requested in the prompt related to evaluating the performance of a device using statistical methods, human readers, or AI.

The document states that "The subject devices are identical in intended use, design, materials, manufacturing process, physical and mechanical specifications and issues of safety and effectiveness to the devices prior to the submission of this notification." It also mentions "The only difference is that the product labeling has been revised to comply with the Agency's labeling requirements."

Therefore, I cannot extract the requested information from the provided text. The document's purpose is to demonstrate substantial equivalence to a predicate device, not to present a new performance study with acceptance criteria.

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