(42 days)
The Karl Storz Universal Twin Transilluminator and Universal Fiber Optic Twin Transilluminator are designed to transilluminate sinus tissue during ENT procedures.
The Karl Storz Universal Twin Transilluminator and Universal Fiber Optic Twin Transilluminator are manual, reusable, nonsterile medical devices. The body contact materials of these devices have a long history of biocompatibility with medical devices.
I am sorry, but the provided text is a 510(k) summary for a medical device called "Karl Storz Universal Twin Transilluminator". This document describes the device, its intended use, and claims substantial equivalence to predicate devices.
However, it does not contain any information about acceptance criteria, device performance studies, sample sizes, expert qualifications, ground truth establishment, or any other details related to a performance study as requested in your prompt.
Therefore, I cannot fulfill your request to describe the acceptance criteria and the study that proves the device meets them based on the given input.
§ 874.4350 Ear, nose, and throat fiberoptic light source and carrier.
(a)
Identification. An ear, nose, and throat fiberoptic light source and carrier is an AC-powered device that generates and transmits light through glass of plastic fibers and that is intended to provide illumination at the tip of an ear, nose, or throat endoscope. Endoscopic devices which utilize fiberoptic light sources and carriers include the bronchoscope, esophagoscope, laryngoscope, mediastinoscope, laryngeal-bronchial telescope, and nasopharyngoscope.(b)
Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 874.9.