(86 days)
The Endoscopic Fiberoptic Cable is used to conduct visible light from a light source to an endoscope during a surgical procedure.
Endoscopic Fiberoptic Cable
The provided text is a letter from the FDA regarding a 510(k) premarket notification for an "Endoscopic Fiberoptic Cable." This document is a regulatory approval letter, not a study report or technical documentation that describes acceptance criteria, device performance, and study details.
Therefore, the information requested in your prompt (acceptance criteria table, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, ground truth types, and training set details) cannot be extracted from the provided text.
The document primarily states that the FDA has reviewed the device and determined it is substantially equivalent to legally marketed predicate devices for the stated indications for use, thereby allowing it to be marketed. It does not contain the detailed technical performance data or study specifics you are looking for.
§ 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.