(57 days)
Measurement of the Intraocular Pressure
Not Found
The provided text is an FDA 510(k) clearance letter for the Keeler Pulsair 3000 Non Contact Tonometer. It generally confirms that the device is substantially equivalent to legally marketed predicate devices and states its intended use (measurement of Intraocular Pressure).
However, the document does not contain the specific information requested about acceptance criteria, detailed study results, sample sizes, ground truth establishment, or expert qualifications for the device's performance. These details are typically found in the 510(k) submission itself or in separate scientific publications, not in the clearance letter.
Therefore, I cannot provide the requested table and study details based solely on the given text.
To answer your request, I would need access to the actual 510(k) submission for the Keeler Pulsair 3000 or a summary of its performance studies.
§ 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.