(9 days)
Imaging and observation of the cellular layers of the anterior segment of the human eye, for the diagnosis and management of anterior segment diseases.
The system consists of the HRT II laser scanning camera, the Rostock Cornea Module optics, a mount with headrest, a power supply, and a personal computer. For an examination, the Rostock Cornea Module optics is placed on the laser scanning camera, positioned in front of the patient's eye, in contact with the cornea. The contact surface is a sterile PMMA plate. Images of the anterior segment are acquired, displayed on the computer monitor and stored on the hard drive of the computer from where the images can be retrieved at a later time.
The system operates by illuminating the cornea of the eye under examination and detecting the light reflected or backscattered from the cornea. The light detection system has a confocal optical arrangement, resulting in a shallow depth of focus. In consequence a two-dimensional image acquired with this system can be considered as an optical section through the corneal layer located at the current focal plane. In addition, by moving the focal plane step by step, a sequence of section images at different locations of the focal plane can be acquired. This sequence of section images provides a layer-by-layer three-dimensional image. The acquired images are displayed on the computer monitor and stored on the computer's hard disk for later use.
I'm sorry, but no information about acceptance criteria or a study proving that the device meets acceptance criteria is available in the provided text. The document is a 510(k) summary for the Heidelberg Retina Tomograph II / Rostock Cornea Module (HRT II / RCM), primarily focusing on its device description, intended use, comparison to predicate devices, and regulatory clearance. It confirms that the device was tested according to IEC 60601-1 and IEC 60601-1-2 and met all requirements, and is a Class 1 laser product. However, it does not detail specific acceptance criteria or a study with performance metrics for clinical efficacy.
§ 886.1850 AC-powered slitlamp biomicroscope.
(a)
Identification. An AC-powered slitlamp biomicroscope is an AC-powered device that is a microscope intended for use in eye examination that projects into a patient's eye through a control diaphragm a thin, intense beam of light.(b)
Classification. Class II (special controls). The device, when it is intended only for the visual examination of the anterior segment of the eye, is classified as Group 1 per FDA-recognized consensus standard ANSI Z80.36, does not provide any quantitative output, and is not intended for screening or automated diagnostic indications, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 886.9.