(53 days)
Medline Body Holders may be used either in a bed or wheelchair. They are intended to be used to help prevent patients from falling out of bed. They may be used to restrain the waist, chest, or legs. The Body Holders may be used in one of two ways in bed: First, the belts may be crossed in front of the wearer, providing the greatest amount of restraint and limiting the ability to roll. Second, the belts may be crossed in back of the wearer, allowing the ability to roll. The caregiver must determine the method which best suits the amount of mobility desired and provides the greatest comfort and security for the patient.
For use in a wheelchair, use the front side application ONLY.
Medline Patient Safety Products are intended to be used for those patients suffering from temporary medical related cognitive deficits, for agitated patients, or to help patients feel safer in a bed or wheelchair.
Medline Body Holders are designed for use with either a bed or wheelchair. When used in bed, it may be positioned to secure waist, legs or chest. Belts may be crossed on the front side of the wearer or the back side of the wearer. If limited movement is desired, the belts should be crossed on the front side of the wearer. If the belts are crossed on the back side of the wearer, they will be able to roll from side to side.
For use in a wheelchair, use the front side application ONLY.
I apologize, but the provided text describes a medical device, specifically a "Protective Restraint, Body Holder" manufactured by Medline Industries, Inc. The document is a 510(k) submission from 1996, which is a premarket notification demonstrating that a device is at least as safe and effective as a legally marketed predicate device.
The document does not contain any information about acceptance criteria or a study that proves the device meets specific performance criteria in the way you've outlined for a typical AI/software-as-a-medical-device (SaMD) submission.
Instead, the document focuses on:
- General Description and Intended Use: Explaining what the Medline Body Holder is, how it's used with beds or wheelchairs, and for what purpose (e.g., preventing falls, temporary cognitive deficits, agitated patients).
- Safety and Effectiveness Summary: This section summarizes a literature review of existing information on protective restraints. It identifies potential complications associated with their use (e.g., emotional desolation, fractures, decubitus ulcers, death, strangulation) but attributes these to incorrect supervision, handling, application, patient selection, or inadequate monitoring. It then highlights the benefits when used correctly.
- Citation: A list of thirteen articles reviewed for the 510(k) submission, primarily related to the safety and efficacy of protective restraints in general medical literature and FDA alerts.
Therefore, I cannot populate the table or answer the specific questions about acceptance criteria, study design, sample sizes, ground truth establishment, or multi-reader multi-case studies because this information is not present in the provided text. The document is for a physical medical device submitted under a regulatory pathway that relies on demonstrating substantial equivalence to pre-1976 or previously cleared predicate devices, rather than a de novo clinical study with quantitative performance metrics as you would typically find for a modern SaMD.
§ 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.