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The DeRoyal Industries, Inc. Roll Belt is indicated for use, at the discretion of a responsible licensed healthcare professional, to limit patient movements thereby enabling examination or protection of the patient or others. The DeRoyal Industries, Inc. Roll Belt is intended to be used with a bed.

The DeRoyal Industries, Inc. Roll Belt is a protective restraint device that is intended for medical purposes to limit patient movements so that the patient remains in the bed while allowing the patient to move from side to side thereby enabling examination or protection of the patient or others.

Device Design/Materials Used/Physical Properties: The DeRoyal Roll Belt is designed similar to those marketed by other manufacturers. The Roll Belt is primarily comprised of nylon or polyester seat belt webbing and cotton flannel.

The provided text is a 510(k) summary for the DeRoyal Industries, Inc. Roll Belt, a protective restraint device. It describes the device, its intended use, and compares its characteristics to other similar devices.

*However, this document does not contain any information regarding acceptance criteria, device performance, a study to prove acceptance criteria, sample sizes, ground truth establishment, expert qualifications, or any details related to AI/ML performance or MRMC studies.

Therefore, I cannot provide the requested information. The 510(k) summary focuses on demonstrating substantial equivalence to a predicate device based on design, materials, and intended use, rather than a detailed performance study with defined acceptance criteria.

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The Roll Belt is intended for the patient who requires a safety belt while in bed and who requires a reminder not to leave the bed without assistance.

The Roll Belt has a cotton duck pad approximately 26 1/2 inches in length. At its narrowest end, the pad is approximately 6 1/2 inches wide, and at its widest end it is approximately eight inches wide. A 1 1/2-inch-wide, 88-inch-long strap made of polyester webbing is stitched to each end of the cotton duck pad. The wide end has a slot that is approximately 6 1/2 inches long and 1 1/2 inches wide. The webbing from the narrow end is inserted through the slot on the wide end, thereby closing the belt while it encircles the patient's waist. The straps criss-cross in front of the patient permitting him/her to roll from side to side. Both straps are secured to the bed frame. The edges of the device are finished with a bias cut binding.

This document is a 510(k) summary for a medical device (Roll Belt Bed Safety Belt, a protective restraint) and does not contain information about studies related to acceptance criteria or device performance in the way a modern AI/software as a medical device (SaMD) submission would.

Therefore, I cannot extract the requested information as it is not present in the provided text. The document focuses on regulatory aspects, device description, indications for use, and comparison with a predicate device, noting that the device itself has been marketed for many years and is exempt from certain regulations. The "comparative information" refers to regulatory comparisons, not performance studies.

Summary of missing information:

• Acceptance Criteria Table: Not present.
• Sample Size for Test Set and Data Provenance: No performance study described.
• Number of Experts and Qualifications for Ground Truth: Not applicable as no performance study is described.
• Adjudication Method: Not applicable.
• MRMC Comparative Effectiveness Study: Not present.
• Standalone Performance Study: Not present.
• Type of Ground Truth: Not applicable.
• Sample Size for Training Set: Not applicable (no AI/machine learning device).
• How Ground Truth for Training Set was Established: Not applicable.

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