(69 days)
Morrison Medical Stretcher/Cot and Backboard Restraints are intended to help secure a patient's body to a stretcher, cot or backboard.
The Morrison Medical Stretcher/Cot and Backboard Restraints are intended to be used by qualified and properly trained personnel to help secure a patient's body to a stretcher, cot or backboard.
The Morrison Medical Stretcher/Cot and Backboard restraints connect to or wrap around a stretcher, cot or backboard. The restraints are constructed by combining various webbing, buckles/closures and end styles. The webbing is available in nylon. polypropylene and vinyl coated polyester materials. The webbing that is used is dependent on user preference. The Morrison Medical Stretcher/Cot and Backboard Restraints are available as a reusable or disposable (series 139x) restraint. The restraint is available in either a one-piece length or two-piece lengths depending on user preference. The one-piece restraint wraps around a patient and the stretcher, cot or backboard and is secured with a buckle. The two-piece restraint is connected to the frame on both sides of the stretcher, cot or backboard with an end-style (end-style description below) and is secured together with a buckle/closure.
The provided text is a Safety and Effectiveness Summary for Morrison Medical Stretcher/Cot and Backboard Restraints and does not contain information about acceptance criteria or a study proving device performance against such criteria.
The document states: "The subject devices are identical in intended use, design, materials, manufacturing process, physical and mechanical specifications and issues of safety and effectiveness to the devices prior to the submission of this notification. The only difference is that the product labeling has been revised to comply with the Agency's labeling requirements set forth in the draft 'Guidance on the Content of Premarket Notification [510(k)] Submissions for Protective Restraints' dated December 1995."
This indicates that the submission is for a labeling change on an existing device, and not for a new device requiring performance testing against acceptance criteria. Therefore, the information requested in your prompt regarding acceptance criteria, performance studies, sample sizes, expert ground truth, adjudication methods, MRMC studies, standalone performance, training sets, and how ground truth was established is 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.