(94 days)
Indications for use :
The tonometer separation prisms is an accessory to the tonometer which is a manual device used to measure the intraocular pressure of the eye.
The Luneau tonometer separation prisms is an optical plastic monobloc piece which is transparent made of 1 plane surface in contact with the eye and of 2 small prisms allowing the ophthalmologists to observe 2 half circles.
The provided document is a 510(k) premarket notification letter from the FDA for a device called "Luneau tonometer separation prisms." This letter confirms that the device is substantially equivalent to legally marketed predicate devices.
However, the document does not contain any information regarding acceptance criteria, device performance studies, sample sizes, ground truth establishment, or any of the other specific details requested in your prompt.
The 510(k) clearance process primarily focuses on demonstrating substantial equivalence to a predicate device, meaning it has the same intended use and technological characteristics as a legally marketed device, or different technological characteristics but is as safe and effective as a legally marketed device and does not raise different questions of safety and effectiveness. It does not typically require the detailed performance studies or AI-specific information you've requested.
Therefore, I cannot fill in the table or answer the specific questions based solely on the provided text. The document is an FDA clearance letter, not a study report.
§ 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.