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The Checkmate Ankle Restraint System is intended to be used in situations requiring patient control while the patient is lying on a bed or gurney. The Checkmate Ankle Restraint System is intended to secure the patient's ankles by keeping them in a fixed position.

The Checkmate Ankle Restraint System is designed for situations requiring patient control. The Checkmate System is a restraint system that secures the patient's ankles in a fixed position. It consists of two individual quilted ankle restraints that are permanently attached at a specific distance apart from each other to a long security strap. The security strap is constructed from a woven polypropylene fabric that is 4 inches wide and 33 inches long. The webbed straps attached to both ends of the security strap secure the ankle restraint system to a bed or gurney. The individual ankle restraints are made of a soft polyester and polyurethane foam laminate that forms a cuff that closes around the patient's ankle. The ankle restraint is held securely closed with Velcro® (hook and loop) and a Double D-Ring closure with strap.

This document describes the Heelbo, Inc. Checkmate Ankle Restraint System and focuses on its safety and effectiveness relative to a predicate device. It primarily discusses the device's design, materials, and intended use.

Based on the provided text, there is no information about explicit acceptance criteria or a study that proves the device meets specific performance metrics in the way a medical diagnostic or AI device would. The document is a 510(k) submission, which aims to demonstrate substantial equivalence to a predicate device, rather than proving novel performance through a rigorous study with acceptance criteria.

The document states: "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. The only difference is that the product labeling has been revised to comply with the Agency's labeling requirements set forth in the draft 'Guidance on the Content of Premarket Notification [501(k)] Submissions for Protective Restraints' dated December 1995."

This indicates that the demonstration of safety and effectiveness for this submission relies on the established history and characteristics of the existing, substantially equivalent predicate device, with the only change being updated labeling. Therefore, the questions regarding acceptance criteria, sample sizes, expert ground truth, adjudication methods, MRMC studies, standalone performance, and training sets are not applicable to the information provided in this document.

In summary, the document does not contain the type of study or detailed performance metrics required to answer the specific questions posed for medical device performance evaluation. It's a regulatory filing focused on demonstrating equivalence and updated labeling.

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