(114 days)
The Posey Bed 8070 is a hospital bed, canopy, and mattress system designed to help provide a safe, controlled environment for patients at extreme risk of injury from a fall or unassisted bed exit. The Posey Bed 8070 is a less restrictive alternative to physical restraints such as belts, vests, or jackets for patients at least 46 inches tall, weighing between 46 and 300 pounds. The Posey Bed 8070 is a restraint, and must be prescribed by a licensed physician (Rx Only).
The patented Posey Bed 8070 is an enclosed bed canopy system which includes and attaches to a fully automatic, AC-powered adjustable hospital bed (either the Joerns Healthcare, Inc., Stevens Point, Wisconsin, Easy Care® 2003DC, Model B684DC or the Invacare Corporation, Elyria, Ohio, Model SC900DLX Low Electric Bed), which has a six-inch enclosed mattress compartment to help reduce the risk of patient entrapment. The device also features a 70 cubic-foot rectangular green nylon canopy with four zippered access panels for easy access to patients and four ports for intravenous lines, call bells and drainage bag openings. The bed has a control that allows the frame to be raised to 30 inches for patient care or lowered to 19 inches for ease of wheelchair transfers. A perimeter guard is available as a temporary guard for use when patient care is being given. The Posey Bed 8070 does not have side rails, headboards or footboards. Contained within the canopy is a specialized compartment for the mattress to prevent the mattress from moving within the canopy and the patient from crawling under the mattress. These features provide a system that minimizes the potential for patient entrapment. Other safety features include a perimeter guard (reference: Soft Rails) that provides an additional measure to protect the patient from falling when the canopy is opened and a health care provider is attending to the patient. Optional accessories include filler cushions, cushions, cushions, bed support torso suface, incontinence pads, and travel covers.
The provided text is a 510(k) summary for the Posey Bed 8070, which is an enclosed bed system. It discusses the device's description, intended use, and substantial equivalence to a predicate device, but it does not contain information about specific acceptance criteria or a study proving the device meets those criteria in the format requested.
The document states that "Results of biocompatibility (ISO 10993), human factors, and performance testing (including to IEC 60601-2-38} have established that the Posey Bed 8070 is suitable for the intended use indicated and is substantially equivalent to the Soma Safe Enclosure." However, it does not provide the details of these tests, such as:
- Specific acceptance criteria for each test (e.g., maximum force, minimum durability, specific safety thresholds).
- Reported device performance against those criteria.
- Sample sizes for any of these tests (other than "caregivers" for human factors).
- Data provenance, number of experts, adjudication methods, MRMC studies, standalone performance, ground truth types, training set details, or ground truth establishment for training set.
Therefore, I cannot populate the requested table and answer the study-related questions based solely on the provided text. The document confirms that testing was done, but the specifics of that testing, particularly concerning quantitative acceptance criteria and detailed study methodology, are not present.
§ 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.