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This device is intended for medical purposes in hospitals or nursing homes for use by the staff to adjust the surface contour of the bed using built-in electric motors and wheels for movement of the bed to different locations.

The device includes bed using built-in electric motors and wheels for movement of the bed to different locations.

The provided text is a 510(k) premarket notification letter from the FDA regarding a hospital bed (Volker Hospital Bed, Model K-960). This type of document is an approval for a medical device to be marketed, based on its substantial equivalence to a legally marketed predicate device.

It does not contain any information about acceptance criteria, device performance studies, sample sizes, ground truth establishment, expert qualifications, adjudication methods, or multi-reader multi-case studies.

Therefore, I cannot provide the requested information from this document. The letter explicitly states that the device is approved "subject to the general controls provisions of the Act," confirming its substantial equivalence rather than providing detailed performance study results against specific acceptance criteria.

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