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The HoverJack™ lifts a patient in a supine position, from the floor to the approximate height of a bed for a subsequent lateral patient transfer.

The HoverJack™ is made of four connected nylon air chambers, each measuring 32" x 70". When inflated, each chamber is 7" high. Each chamber has a dump valve for safety purposes. Each of these chambers has an air entry valve through which an external air supply is used to inflate the chamber against the floor is to be inflated first, then the other three chambers are inflated, in an upward succession, until the device is fully inflated. When fully inflated, the HoverJack™ feels hard and substantially supports the patient atop it, also providing a surface upon which emergency patient procedures can be performed, if necessary. Also in an emergency, dump valves are available to use for quick deflation. The HoverJack™ is constructed using 200 denier Nylon Oxford. Seams are RF welded (heat-sealed) to limit infection control issues. The bottom of the HoverJack™ has strips of a non-skid material attached for safety purposes. Fill-valves are self-sealing AND have caps that also screw on for additional closure. The HoverJack™ has two patient safety straps to buckle over the patient. The HoverJack™ does require the use of the Air Supply that is available as a separate unit. The Air Supply is CSA approved, meeting UL Standard #544. This Air Supply is also used to inflate other equipment such as the HoverMatt® which is an optional accessory to the HoverJack™.

While the provided text describes the HoverJack™ Air Patient Lift Device, its intended use, and a comparison to a predicate device, it does not contain the information needed to answer your specific questions regarding acceptance criteria and a study proving those criteria.

The document refers to "Non-Clinical, Volunteer, Safety Testing" and states that "Findings and feedback from all scenarios have resulted in safety and comfort improvements ultimately ending in the final design of the product." However, it does not provide details of this testing in a structured way that would allow for the extraction of acceptance criteria, reported performance against those criteria, or the methodology of a formal study.

Therefore, I cannot provide the requested information based on the input text. The information required for your questions (acceptance criteria table, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, ground truth types, and training set details) is not present in the provided document.

This document is a 510(k) summary, which typically focuses on demonstrating substantial equivalence to a predicate device rather than providing detailed clinical study reports or comprehensive performance data as you might find in an IDE or PMA submission.

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