(90 days)
The intended use of Nova Technologies, Inc.'s Novabed System is to transfer a patient from or to the bed.
The cleared model of the Novabed System, which consists of a bed, a wheelchair, and a footrest attachment, is used to transfer a patient from or to a bed. The bed has a conveyor sheet which is pulled by rollers towards the foot of the bed during a patient transfer from the bed and towards the head of the bed during patient transfer to the bed. Each end of the conveyor sheet is connected to a motorized roller at each end of the bed. During transfer, the patient is moved to the end of the bed and, when partially on the pivoted wheelchair seat and legrest and partially on the bed, the patient is elevated to a vertical sitting position by the elevation of the bed against which the patient's back is resting. As the patient is elevated to a sitting position by the bed, the wheelchair automatically pivots until the seat is horizontal and the legrest vertical. The transfer is complete when the attendant disconnects the wheelchair from the bed and mounts the backrest to the wheelchair.
Nova is seeking clearance to modify the cleared Novabed System and market four models of the device with the modifications. Nova intends to make the following modifications to the cleared Novabed System: (1) integrate the tilt table's footrest into the bed; (2) replace the discrete logic in the bed's electronic control unit with a microprocessor; (3) replace the motor used to automatically pivot the wheelchair ("the pivot motor") with a lever that an attendant can use to manually pivot the wheelchair: (4) replace the pivot motor and linkage mounted on the wheelchair with a motor and draw-bar mounted on the bed; (5) replace the wire cable driven by a linear actuator with a parallel linkage with a cantilever driven by a linear actuator to raise or lower the bed; (6) replace the wire cable that is used to create a data link between the bed and wheelchair with optical couplers; and (7) replace circuits in the sheet motor with reversible motor drive circuitry.
The provided text does not contain information about acceptance criteria or a study that proves a device meets such criteria. Instead, it describes a 510(k) summary for the "Novabed Patient Transfer System," focusing on its intended use, substantial equivalence to a predicate device, and proposed modifications.
Therefore, I cannot fulfill your request to describe the acceptance criteria and the study that proves the device meets them based on the given input. The requested details such as sample sizes, data provenance, expert qualifications, adjudication methods, MRMC studies, standalone performance, types of ground truth, and training set information are not present in 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.