(52 days)
The PASCAL™ Dynamic Contour Tonometer is a diagnostic device that serves for measuring intraocular pressure (IOP), according to the Contour Tonometry method. The device is also capable of measuring short term pressure fluctuations. PASCAL™ is specially indicated in Glaucoma.
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I am sorry, but the provided text does not contain the information required to answer your request. The document is an FDA 510(k) clearance letter for a tonometer, which details the regulatory approval of the device. It does not include information about acceptance criteria, study methodologies, sample sizes, expert qualifications, or ground truth establishment for a study proving device performance.
§ 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.