(163 days)
The DeRoyal Industries, Inc. Pediatric Limb Holder is indicated for use, at the discretion of a responsible licensed healthcare professional, to limit pediatric patient limb movements thereby enabling examination of the patient or others. The Pediatric Limb Holder can be used with an OR table, gurney, bed, or stretcher.
The DeRoyal Industries, Inc. Pediatic Limb Holder is a protective restraint device that is intended for medical purposes to limit pediatric patient limb movements thereby enabling examination or protection of the patient or others.
Device Design/Materials UsedPhysical Properties: The DeRoyal Pediatric Limb Holder is designed similar to those marketed by other manufacturers. The Pediatic Limb Holder is primarily comprised of polyester straps with hook and loop fasteners.
I am sorry, but the provided text does not contain the information requested to describe acceptance criteria and associated studies for a medical device. The document is a 510(k) summary for the DeRoyal Industries, Inc. Pediatric Limb Holder, which is a submission to the FDA for market clearance. It focuses on demonstrating substantial equivalence to predicate devices rather than presenting detailed study results with acceptance criteria.
Specifically, the document does not include:
- A table of acceptance criteria and reported device performance.
- Details on sample sizes for test sets, data provenance, or ground truth establishment.
- Information regarding expert involvement, adjudication methods, or MRMC studies.
- Any standalone algorithm performance or training set details.
The summary primarily describes the device, its intended use, and a technological comparison to predicate devices, asserting that it is "substantially equivalent" based on materials, size, attachment vehicles, length of use, and level of patient activity. It does not provide any quantitative performance metrics against pre-defined acceptance thresholds.
§ 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.