(74 days)
The Staurenghi Wide Field Scanning laser lens is indicated for use whenever a wide field scanning laser ophthalmoscope is indicated.
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The provided text is a 510(k) premarket notification letter from the FDA regarding a medical device, the "Staurenghi Wide Field Scanning Laser Lens." This document does not contain any information about acceptance criteria, device performance studies, sample sizes, ground truth establishment, or expert qualifications.
The letter is a regulatory approval document stating that the device is substantially equivalent to legally marketed predicate devices. It discusses regulatory classifications, general controls, and compliance requirements.
Therefore, I cannot fulfill your request for the specific information regarding acceptance criteria and the study proving the device meets those criteria based solely on the input provided. The input solely focuses on regulatory approval, not on the technical performance study details.
§ 886.1385 Polymethylmethacrylate (PMMA) diagnostic contact lens.
(a)
Identification. A polymethylmethacrylate (PMMA) diagnostic contact lens is a device that is a curved shell of PMMA intended to be applied for a short period of time directly on the globe or cornea of the eye for diagnosis or therapy of intraocular abnormalities.(b)
Classification. Class II.