(68 days)
The VES 3001/w use is indicated in the following situations:
- Whenever there is a need for head lamp illumination of the fiber-optic type .
- When ever there is a need for a fiber-optic illuminator for an endoscope .
- . When ever there is a need to use video either as a visual aid for as a method of recording or both.
- When ever there is a requirement for any or all of the above at the same . time.
Not Found
I am sorry, but the provided text is a 510(k) clearance letter from the FDA for a medical device called the "VES 3001/2 Dual Output Video Illuminator."
This document does not contain the kind of information requested in your prompt regarding acceptance criteria, a study proving device performance, sample sizes, expert qualifications, ground truth methods, or details about training sets. The letter is a regulatory approval document confirming substantial equivalence to a predicate device.
Therefore, I cannot extract the requested information from this text.
§ 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.