(141 days)
The DeRoyal Industries, Inc. Restrictive Limb Holder is indicated for use, at the discretion of a responsible licensed healthcare professional, to substantially limit patient limb movements thereby enabling examination or protection of the patient or others. The Restrictive Limb Holder can be used with a gurney, bed, or stretcher.
The DeRoyal Industries, Inc. Restrictive Limb Holder is a protective restraint device that is intended for medical purposes to limit limb movements thereby enabling examination or protection of the patient or others.
Device Design/Materials Used/Physical Properties: The DeRoyal Restrictive Limb Holder is designed similar to those marketed by other manufacturers. The Restrictive Limb Holder is primarily comprised of leather, neoprene, and soft kodel with nylon or polyester webbing straps. The types of fasteners include hook and loop, delrin, and various types that are steel nickel plated.
The provided text is a 510(k) summary for the DeRoyal Industries, Inc. Restrictive Limb Holder. It describes the device, its intended use, and compares it to predicate devices. However, this document does not contain information about acceptance criteria or a study proving the device meets acceptance criteria in the context of device performance metrics often associated with AI/ML devices (e.g., sensitivity, specificity, accuracy, etc.) or clinical endpoints derived from a clinical trial.
This submission is for a physical medical device (a limb holder/restraint) and appears to be based on substantial equivalence to existing legally marketed devices, rather than a novel technology requiring a performance study with specific acceptance criteria as you've outlined.
Therefore, I cannot provide the requested information. The document focuses on:
- Device Description: Materials, design, intended use.
- Comparison to Predicate Devices: Showing it's "substantially equivalent" in terms of materials, size, attachment vehicles, length of use, and target patient activity level.
There is no mention of:
- A table of acceptance criteria and reported device performance.
- Sample size of a test set or data provenance.
- Number or qualifications of experts.
- Adjudication method.
- MRMC comparative effectiveness study.
- Standalone performance study.
- Type of ground truth used.
- Sample size for a training set.
- How ground truth for the training set was established.
§ 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.