(420 days)
The Tono-Film Tonometer Tip Cover is intended to be used in conjunction with the Tono-Pen Tonometer, which is intended to be used to measure intraocular pressure and used in the diagnosis of glaucoma.
Tonometer Tip Covers
The provided text is a 510(k) clearance letter from the FDA for a device called "Tono-Pen Tonometer Tip Cover." This document confirms the device's substantial equivalence to a predicate device and allows it to be marketed.
However, the letter does not contain any information about acceptance criteria, device performance studies, sample sizes, ground truth establishment, or expert involvement. It is a regulatory clearance document, not a detailed study report.
Therefore, I cannot provide the requested information based on the given text.
To answer your request, I would need a different document, such as a study report, clinical trial results, or a more detailed section of the 510(k) submission that describes the testing and validation of the device.
§ 886.1930 Tonometer and accessories.
(a)
Identification. A tonometer and accessories is a manual device intended to measure intraocular pressure by applying a known force on the globe of the eye and measuring the amount of indentation produced (Schiotz type) or to measure intraocular tension by applanation (applying a small flat disk to the cornea). Accessories for the device may include a tonometer calibrator or a tonograph recording system. The device is intended for use in the diagnosis of glaucoma.(b)
Classification. Class II.