(141 days)
The DeRoyal Industries, Inc. Tuxedo Vest Restraint is indicated for use, at the discretion of a responsible licensed healthcare professional, to limit movements thereby enabling examination or protection of the Tuxedo Vest Restraint is a protective restraint that is intended to be used with a bed or wheelchair.
The DeRoyal Industries, Inc. Tuxedo Vest Restraint device that is intended for medical purposes to limit movements thereby enabling examination or protection of the patient or others.
Device Designition Undering: The DeRoyal Tuxedo Vest Restraint is designed similar to those marketed by other manufacturers. The Tuxedo Restraint is primarily comprised of white or plaid tietex with polyester straps. The fasteners are made of a nylon hook and loop or plastic.
This 510(k) premarket notification describes a medical device, the DeRoyal Industries, Inc. Tuxedo Vest Restraint. However, it does not contain the information required to answer your request regarding acceptance criteria and a study proving device performance.
Here's why:
- Type of Device: This is a physical restraint device, not a diagnostic or AI-based device. The criteria you've asked for (such as sensitivity, specificity, sample sizes for test/training sets, ground truth establishment, expert review, MRMC studies, standalone performance) are typically applied to diagnostic algorithms or AI systems that analyze data (e.g., medical images, lab results) to provide an output.
- 510(k) Premarket Notification vs. Clinical Study Report: A 510(k) is a premarket submission made to the FDA to demonstrate that the device to be marketed is at least as safe and effective, that is, substantially equivalent, to a legally marketed predicate device. It typically focuses on design, materials, intended use, and technological comparison with existing devices. It does not routinely include detailed clinical study performance metrics or AI algorithm validation data like what you are requesting.
- "Study" in this context: The "study" mentioned informally in the prompt's request refers to a clinical study or a technical validation study for performance metrics of an algorithm. For a physical restraint, proof of safety and effectiveness relies on demonstrating substantial equivalence to a predicate device, which usually involves a comparison of design, materials, and intended use, potentially supported by internal testing (e.g., tensile strength of materials) or literature review, rather than a clinical trial measuring diagnostic accuracy.
Therefore, I cannot provide the requested information because it is not present in the provided 510(k) document for this type of device.
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K963474
Jan. 22, 1997
DeRoyal Industries, Inc. Tuxedo Vest Restraint
510(k) Summarv
SUMMARY OF THE SAFETY AND EFFECTIVENESS INFORMATION UPON WHICH AN EQUIVALENCE DETERMINATION COULD BE BASED
SUBMITTER INFORMATION
NAME: DeRoyal Industries, Inc. 200 DeBusk Lane ADDRESS: Powell, TN 37849
TELEPHONE: CONTACT: DATE OF PREPARATION: (423) 938-7828 Camille Matlock August 30, 1996
DEVICE NAMES
NAME: COMMON/USUAL NAME: CLASSIFICATION NAME (if known): DeRoval Industries. Inc. Tuxedo Vest Restraint Tuxedo Vest Restraint Restraint, Protective (80FMO)
PREDICATE OR LEGALLY MARKETED DEVICES
J.T. Posey Company DeRoyal Industries, Inc.
DEVICE DESCRIPTION
The DeRoyal Industries, Inc. Tuxedo Vest Restraint device that is intended for medical purposes to limit movements thereby enabling examination or protection of the patient or others.
Device Designition Undering: The DeRoyal Tuxedo Vest Restraint is designed similar to those marketed by other manufacturers. The Tuxedo Restraint is primarily comprised of white or plaid tietex with polyester straps. The fasteners are made of a nylon hook and loop or plastic.
DEVICE INTENDED USE
The DeRoyal Industries, Inc. Tuxedo Vest Restraint is indicated for use, at the discretion of a responsible licensed healthcare professional, to limit movements thereby enabling examination or protection of the Tuxedo Vest Restraint is a protective restraint that is intended to be used with a bed or wheelchair.
TECHNOLOGICAL COMPARISON WITH PREDICATE OR LEGALLY MARKETED DEVICE(S)
| Characteristic | DeRoyal Device | Other Devices |
|---|---|---|
| Materials | Primarily comprised of plaid or white tietex and polyesterstraps. Fasteners are made of hook and loop or plastic. | Same |
| Size | X-Small, Small, Medium, Large, X-Large, XX-Large, XXX-Large | Same |
| Vehicles for Attachment | Bed or Wheelchair | Same |
| Length of use | Doctor must prescribe every 24 hours | Same |
| Level of Patient Activity | Moderately agitated or disorientedProne to slidingActively trying to get out of bed or wheelchair | Same |
§ 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.