Search Results

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

The DeRoyal Industries, Inc. Wheelchair Belt is a protective restraint device that is intended for medical purposes to limit patient movements thereby helping prevent the patient from sliding in a wheelchair.

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

This is a 510(k) summary for a medical device (wheelchair belt) rather than a study report for a diagnostic or AI-powered device. Therefore, it does not contain the information required to answer the questions about acceptance criteria, study design, expert involvement, and ground truth establishment.

The provided document describes a device that is a physical restraint, and the 510(k) process for such devices typically focuses on demonstrating substantial equivalence to a legally marketed predicate device based on design, materials, intended use, and performance without requiring a clinical study with acceptance criteria in the way a diagnostic algorithm would.

Here's why the requested information cannot be extracted from the given text:

1. Acceptance Criteria and Reported Device Performance: This document doesn't define quantitative acceptance criteria for performance; instead, it compares the DeRoyal Wheelchair Belt's characteristics (materials, size, vehicles for attachment, length of use, level of patient activity) to "Other Devices" (predicate devices) and states they are the "Same." This is a qualitative comparison for substantial equivalence.
2. Sample Size and Data Provenance: No clinical study or performance data is mentioned. The comparison is based on device characteristics.
3. Number of Experts and Qualifications: No experts were used to establish ground truth because there's no diagnostic task or outcome being measured in a clinical study.
4. Adjudication Method: Not applicable.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study: Not applicable. This is not an AI-assisted diagnostic device.
6. Standalone Performance: Not applicable.
7. Type of Ground Truth Used: Not applicable.
8. Sample Size for Training Set: Not applicable, as there's no algorithm being trained.
9. How Ground Truth for Training Set Was Established: Not applicable.

In essence, the provided text does not describe a study that would generate the kind of data you are asking for. It's a regulatory submission demonstrating substantial equivalence for a physical medical device.

Ask a specific question about this device