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The Cushion Belt is intended for patients who require a safety belt when in the wheelchair or bed. It is also used as a reminder not to leave the wheelchair or bed without assistance.

The Cushion Slider Belt is intended for patients who require a safety belt while in the wheelchair and who also need added control to prevent sliding down in the wheelchair.

The Adjusta-Loop Cushion Belt is intended for patients who require a safety belt while in the wheelchair and who require a reminder not to leave the wheelchair without assistance.

The Quick-Release Cushion Belt is intended for patients who require a safety belt while in the wheelchair and who require a reminder not to leave the wheelchair without assistance.

Cushion Belt: A 26-inch-long, 6 1/2-inch wide cushion comprised of polyester on the outside and 3/4-inch-thick polyurethane foam inside. It has 1 1/2-inch-wide webbing and webbing loops sewn to each end. Webbing is polyester. Edges are finished with a bias cut binding. Webbing criss-crosses behind patient and secures to wheelchair or bed. Device is made in one size.

Cushion Slider Belt: Identical to above with the addition of a crotch pad sewn to the bottom center front. The pad is lined with 1/4-inch-thick polyurethane foam and has a 1 1/8-inch-wide strap sewn on that is either placed directly under the patient or under the wheelchair seat and secured to the cross brace under the wheelchair to prevent he patient from sliding down. This device is designed for wheelchair use only.

Adjusta-Loop Cushion Belt: Identical to the Cushion Belt except that the webbing is fitted with slider buckles that permit it to form adjustable loops that slip over the wheelchair kickspurs. The product is used by care givers who do not want to tie the webbing ends to the wheelchair. The device is intended for wheelchair use only.

Quick Release Cushion Belt: Identical to the Cushion belt except that one section of webbing is terminated with a "male" Delrin buckle component and the other end with a "female" Delrin buckle component. The buckle secures behind the wheelchair backrest.

This document is a 510(k) Pre-market Notification for a medical device (Cushion Belts), but it does not contain the information requested in your prompt regarding acceptance criteria and a study proving the device meets those criteria.

The document describes different types of cushion belts, their intended use, and states that they are similar to currently marketed devices from the same company. It primarily focuses on the regulatory aspects of introducing the devices, mentioning that labeling will be changed and discussing the existing regulations around restraint use.

Therefore, I cannot provide a table of acceptance criteria and device performance, or details about sample sizes, experts, ground truth, or specific study types based on the provided text. The document explicitly states that these devices are exempt from 510(k) Premarket Notification Procedures and Good Manufacturing Practice Regulations, and have been marketed for approximately 18 years. This suggests that extensive new studies comparing performance against specific acceptance criteria might not be part of this particular submission for devices that are already legally marketed and exempt.

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