(107 days)
The DeRoyal Industries, Inc. Pelvic Holder is indicated for use, at the discretion of a responsible licensed healthcare professional, to limit patient movement thereby enabling examination or protection of the patient or others. The Pelvic Holder is a protective restraint which can be used with a bed or wheelchair.
The DeRoyal Industries, Inc. Pelvic Holder is a protective restraint device that is intended for medical purposes to limit patient moyement thereby enabling examination or protection of the patient or others.
Device Design/Materials Used/Physical Properties: The DeRoyal Pelvic Holder is designed similar to those marketed by other manufacturers. The Pelvic Holder is primarily comprised of either cotton cloth, flannel, cool knit, or cotton sheeting.
This looks like a 510(k) summary for a medical device called the "DeRoyal Industries, Inc. Pelvic Holder". However, it does not contain any information regarding acceptance criteria, a study proving device performance, sample sizes, expert involvement, or any of the other specific details requested in your prompt.
The document is a regulatory submission outlining:
- Submitter and Device Information: Name, address, contact, date, device names.
- Predicate Devices: Identifying similar devices already on the market.
- Device Description: What the device is made of (cotton cloth, flannel, cool knit, cotton sheeting) and its general design.
- Intended Use: To limit patient movement for examination or protection, usable with a bed or wheelchair.
- Technological Comparison: A table comparing characteristics of the DeRoyal Pelvic Holder to "Other Devices" (predicates), noting they are largely "Same" across materials, style, attachment vehicles, length of use, and level of patient activity.
In essence, this document is a justification of substantial equivalence to predicate devices based on design and intended use, not a performance study. It falls under the regulatory process where a new device is shown to be as safe and effective as an already legally marketed device, often without needing new clinical studies if the technological characteristics are similar enough.
Therefore, I cannot fulfill your request for the tables and details about acceptance criteria, study methodologies, sample sizes, and ground truth, as none of that information is present in the provided text.
§ 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.