(79 days)
The Millennium Gold Series Surgical light is intended to be used by medical personnel for the purpose of illuminating surgical sites.
Not Found
This document is a 510(k) clearance letter from the FDA for the Millennium Gold Series Surgical Light. It confirms that the device is substantially equivalent to legally marketed predicate devices.
However, this document does not contain any information regarding acceptance criteria, device performance studies, sample sizes, expert qualifications, adjudication methods, or ground truth establishment. It is a regulatory clearance, not a scientific study report.
Therefore, I cannot provide the requested information based on this input.
§ 878.4580 Surgical lamp.
(a)
Identification. A surgical lamp (including a fixture) is a device intended to be used to provide visible illumination of the surgical field or the patient.(b)
Classification. Class II (special controls). The device, when it is an operating room lamp, a surgical instrument light, a surgical floor standing light, an endoscopic surgical light, a surgical light connector, a ceiling mounted surgical light, a surgical light carrier, surgical light accessories, a surgical lamp, a remote illuminator, or an incandescent surgical lamp, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 878.9.