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The sleeved jacket is intended for patients who require support while seated in a wheelchair.

The sleeved jacket with slider control is intended for patients who require support and additional support to prevent sliding forward while seated in a wheelchair.

Both are intended for patients who have a history of removing vest-style and poncho-style restraints.

Sleeved Jacket: The sleeved jacket is a polyester upper body garment, designed to be worn over clothing, with short sleeves, a brass back zipper, and 1 & 1/8 inch polyester webbing ties sewn across the back at the shoulder area and across the front at the waist. The ties are tied to the wheelchair push handles and kick spurs, respectively, to provide patients with postural support. The edges of the garment are finished with bias cut binding in a color to correspond with the garment size as described in the insert labeling.

Sleeved Jacket with Slider Control: The Sleeved Jacket with Slider Control has the same features as the sleeved jacket with the addition of a crotch pad sewn to the bottom center front. The pad is lined with 1/4 inch polyurethane foam and has a 1 & 1/8 inch polyester webbing strap sewn on that is either placed directly under the patient or under the seat of the wheel chair and secured to the wheelchair cross brace to prevent the patient from sliding down.

This document is a 510(k) summary for a medical device (Sleeved Jacket and Sleeved Jacket with Slider Control), which describes the device, its indications for use, and comparative information to a predicate device. It does not contain information about a study that assesses the device's performance against specific acceptance criteria.

Therefore, I cannot fulfill your request to describe the acceptance criteria and the study that proves the device meets them, as the provided text lacks this information.

Specifically, the document:

• Does not present a table of acceptance criteria.
• Does not report device performance data.
• Does not mention any studies conducted to evaluate the device's efficacy or safety against quantitative metrics.
• Does not discuss sample sizes, data provenance, expert involvement, adjudication methods, MRMC studies, standalone algorithm performance, or ground truth establishment.

The document primarily focuses on:

• Identifying the device and its manufacturer.
• Describing the device's physical characteristics and intended use.
• Stating that the device is a predicate device already legally marketed and exempt from certain regulations.
• Mentioning a change in labeling to align with FDA draft guidance.
• Discussing regulatory context regarding the use of restraints in healthcare settings.

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