(57 days)
The Medical Illumination International Inc. 150 - 300 Watt Medical Fiberoptic Light Source with Headlight is indicated for use in transmitting light for illumination purposes from an illuminator (150 - 300 Watt Lamp) to various instruments such as a Headlight, providing illumination in body cavities during examinations or minimal invasive surgical procedures.
Not Found
The provided text is a 510(k) clearance letter from the FDA for a medical fiberoptic light source with illuminating headlights. It does not contain information about acceptance criteria or a study that proves the device meets specific performance criteria. This type of document is a regulatory approval, not a scientific study report.
Therefore, I cannot extract the requested information regarding acceptance criteria, device performance, study details, sample sizes, ground truth establishment, or multi-reader multi-case studies from the provided text. The document primarily focuses on the substantial equivalence determination to a predicate device for regulatory purposes.
§ 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.