(73 days)
The Soma™ Safe Transport Bed is to be used for the management of patients who are excessive in size and those who are the most difficult to care for. The use of this device will assure the prevention of personal injury to the patient and staff.
Soma 900 Transport Bed
I apologize, but the provided text from the FDA 510(k) K971546 approval letter for the "Soma 900 Transport Bed" (later referred to as "Soma Safe Transport Bed") does not contain information regarding acceptance criteria, device performance studies, sample sizes, ground truth establishment, or expert qualifications.
This document is a regulatory approval letter, specifically a "substantially equivalent" determination letter, which indicates the device can be marketed. It refers to the "indications for use" but does not detail the technical performance studies that would have been submitted as part of the 510(k) application.
Therefore, I cannot extract the information required to populate the table and answer the subsequent questions about acceptance criteria and the study that proves the device meets them from the provided text. The document focuses on regulatory compliance and approval, not on the technical performance data.
§ 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.