Search Results

These products are intended to hinder egress of a patient and/or assist body alignment in a hospital bed, geriatric chair, wheelchair, or gurney,

The devices included in this 510(k) submission support the torso area. The product is closed around the patient by one or more of the following: criss crossing the fabric and straps, a zipper, hook and loop, or tie strings. The product is secured to the bed geriatric chair, wheelchair, or gurney via straps. These straps are securely connected to the bed, geriatric chair, or wheelchair by one or more of the following: knots, double D rings, hook and loop, standard buckles, or quick release buckles.

This document is a 510(k) summary for protective restraints (jackets and vests) manufactured by JT Posey Company. It describes the device, its intended use, and the regulatory context for its submission. However, it does not contain the specific information requested about acceptance criteria, device performance, study details, or ground truth establishment.

Therefore, I cannot provide a table of acceptance criteria and reported device performance, nor can I answer questions about sample sizes, data provenance, expert qualifications, adjudication methods, MRMC studies, standalone performance, or training set details based on the provided text.

The document states that the devices used for comparative purposes are "identical to the jackets and vests as described in this submission and produced or sold by the J.T. Posey Co." and that these products are "currently exempt from 510(k) Premarket Notification Procedures and Good Manufacturing Practice Regulations and are legally marketed by JT Posey Co. as of the date of this submission." This indicates that the submission is primarily for regulatory compliance of existing products rather than providing new performance data from a specific study designed to meet new acceptance criteria.

Ask a specific question about this device