(59 days)
The Vail 1000 Enclosed Bed is a soft-sided enclosed bed for patients who are at risk to harming themselves or others by intentionally or unintentionally leaving the bed unasisted
Vail 1000 Enclosed Bed
I am sorry, but based on the provided text, there is no information about acceptance criteria, device performance tables, sample sizes, expert qualifications, adjudication methods, multi-reader multi-case studies, standalone performance, ground truth types, or training set details.
The document is a US FDA 510(k) clearance letter for a device called "Vail 1000 Enclosed Bed". It states that the device is substantially equivalent to a legally marketed predicate device and outlines the general controls provisions of the Act it falls under. It also includes the "Indications For Use" for the device, which describes its intended purpose.
Therefore, I cannot fulfill your request to describe the acceptance criteria and the study that proves the device meets them from this document.
§ 880.5100 AC-powered adjustable hospital bed.
(a)
Identification. An AC-powered adjustable hospital bed is a device intended for medical purposes that consists of a bed with a built-in electric motor and remote controls that can be operated by the patient to adjust the height and surface contour of the bed. The device includes movable and latchable side rails.(b)
Classification. Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 880.9.