(34 days)
The Pelvic Holder is intended for patients who require both slider control and restraint while in the wheelchair.
The Pelvic Holder is a diaper-shaped device made from either woven polyester or polyester mesh. The device fits between the patient's legs and is secured by webbing around the waist. Webbing is 1 1/8-inch-wide polyester and secures to the wheelchair. The purpose of the device is to prevent patient from sliding down in the wheelchair. The edges are finished with bias cut binding that corresponds to a size chart included on the package insert. The device is intended for wheelchair use only.
The provided text is a 510(k) summary for a medical device called a "Pelvic Holder." It describes the device, its intended use, and compares it to a predicate device. However, it does not contain any information regarding acceptance criteria, performance studies, or ground truth establishment.
Therefore, I cannot provide the requested information in the format of a table or answer the specific questions about sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, or training set details.
The document focuses on regulatory compliance and device description, not on a detailed performance evaluation study.
§ 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.