(72 days)
The DeRoyal Industries, Inc. Reusable Limb Holder is indicated for use, at the discretion of a responsible licensed healthicare professional, to limit limb movements thereby enabling examination of the patient or others. The Reusable Limb Holder can be used with a gurney, bed, or stretcher.
The DeRoyal Industries, Inc. Reusable Limb Holder is a protective restraint device that is intended for medical purposes to limit patient limb movements thereby enabling examination or protection of the patient or others.
Device Design/Materials Used/Physical Properties: The DeRoyal Reusable Limb Holder is designed similar to those marketed by other manufacturers. The Reusable Limb Holder is primarily comprised of a flannel and/or blue purr material. The straps are made of white webbing. The fasteners include a nylon hook and steel nickel plated buckles.
This 510(k) summary for the DeRoyal Industries, Inc. Reusable Limb Holder does not contain the information requested in your prompt regarding acceptance criteria, device performance studies, sample sizes, expert involvement, or ground truth establishment.
This document is a premarket notification (510(k)) submission to the FDA, which aims to demonstrate that a new device is substantially equivalent to a legally marketed predicate device. It primarily focuses on comparing the new device's characteristics and intended use to existing devices.
Here's why the requested information is absent:
- Acceptance Criteria and Device Performance: The summary compares the DeRoyal Reusable Limb Holder to other devices based on materials, size, attachment vehicles, length of use, and level of patient activity. It does not specify quantifiable acceptance criteria such as "the device must withstand X amount of force" or "the device must achieve Y level of securement." Consequently, there are no reported performance metrics against such criteria.
- Study Details (Sample Size, Data Provenance, Experts, Adjudication, MRMC, Standalone): The document does not describe any formal studies (like clinical trials, usability tests with human participants, or rigorous engineering tests with statistically significant sample sizes) to prove the device's performance against specific acceptance criteria.
- Ground Truth: Since there are no performance studies, there's no mention of ground truth being established for any test data.
- Training Set Information: As no AI or algorithm is mentioned, there's no training set information.
In essence, this document is a regulatory submission for substantial equivalence, not a scientific publication detailing performance studies and acceptance criteria as you've requested. The "performance" being demonstrated here is primarily conceptual equivalence to existing products in terms of design characteristics and intended use, rather than measured effectiveness or safety against predefined metrics.
§ 880.6760 Protective restraint.
(a)
Identification. A protective restraint is a device, including but not limited to a wristlet, anklet, vest, mitt, straight jacket, body/limb holder, or other type of strap, that is intended for medical purposes and that limits the patient's movements to the extent necessary for treatment, examination, or protection of the patient or others.(b)
Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 880.9.