(64 days)
The indicated use of these Vests and Jackets is to be used as a mild restraint. To help prevent the patient from falling, sliding or getting out of bed. The Vests and Jackets can be used in a hospital bed, wheelchair or geriatric chair. These Vests and Jackets should not be used on violent patients.
Not Found
The provided text is a 510(k) clearance letter and an "Indications For Use" statement for a medical device: Restraints (Vests and Jackets). This document does not contain any information about acceptance criteria, device performance studies, sample sizes, expert ground truth establishment, adjudication methods, or comparative effectiveness studies.
The letter is a regulatory approval, stating that the device is "substantially equivalent" to legally marketed predicate devices, which allows the manufacturer to market the product. It primarily focuses on regulatory compliance rather than clinical performance data from studies.
Therefore, I cannot fulfill your request for the specific details outlined, as they are not 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.