(83 days)
The AT550 is intended to measure intraocular pressure of the eye.
Not Found
The provided text is a 510(k) clearance letter for the Leica AT550 Non-contact Tonometer. It primarily addresses the regulatory approval process and states the device's intended use. However, it does not include information on acceptance criteria, a study proving device performance against those criteria, or details regarding ground truth establishment, sample sizes, or expert qualifications as requested. This document is a regulatory communication, not a clinical study report. Therefore, I cannot generate the requested table and study details based solely on the provided text.
§ 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.