(330 days)
FOR THE MEASUREMENTS OF INTRAOCULAR PRESSURE TO AID IN THE DIAGNOSIS OF GLAUCOMA.
Not Found
The provided text is a set of FDA correspondence regarding the 510(k) premarket notification for the Kowa Automated Tonometer KT-500. This document primarily focuses on regulatory approval based on substantial equivalence to a legally marketed predicate device.
Crucially, this document does NOT contain information about specific acceptance criteria for device performance, a study proving those criteria were met, sample sizes for test or training sets, expert qualifications, adjudication methods, MRMC studies, standalone performance, or ground truth establishment.
The document states that the FDA reviewed the premarket notification and determined the device is "substantially equivalent" to legally marketed predicate devices. This determination is based on the device meeting the same indications for use and having similar technological characteristics to a device already on the market. It does not provide details of a clinical study or performance data from the manufacturer's submission to demonstrate specific performance metrics against pre-defined acceptance criteria.
Therefore, I cannot fulfill your request for the detailed information you've outlined, as it is not present in 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.