(143 days)
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:
- 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.
- Sample Size and Data Provenance: No clinical study or performance data is mentioned. The comparison is based on device characteristics.
- 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.
- Adjudication Method: Not applicable.
- Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study: Not applicable. This is not an AI-assisted diagnostic device.
- Standalone Performance: Not applicable.
- Type of Ground Truth Used: Not applicable.
- Sample Size for Training Set: Not applicable, as there's no algorithm being trained.
- 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.
§ 890.3910 Wheelchair accessory.
(a)
Identification. A wheelchair accessory is a device intended for medical purposes that is sold separately from a wheelchair and is intended to meet the specific needs of a patient who uses a wheelchair. Examples of wheelchair accessories include but are not limited to the following: armboard, lapboard, pusher cuff, crutch and cane holder, overhead suspension sling, head and trunk support, and blanket and leg rest strap.(b)
Classification. Class I (general controls). If the device is not intended for use as a protective restraint as defined in § 880.6760 of this chapter, it is exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in § 890.9. The device is also exempt from the current good manufacturing practice requirements of the quality system regulation in part 820 of this chapter, with the exception of § 820.180, regarding general requirements concerning records, and § 820.198, regarding complaint files.