(176 days)
Corneal Topographer: Indicated for use for measuring the shape and curvature of the anterior surface of the eye and for displaying the topographical maps of the surface of the cornea. This information can be used to analyze, monitor and evaluate the shape and symmetry of the comea following refractive surgery, to assist in the diagnosis of keratoconus, to assist in the fitting of contact lenses, to assist in the understanding of various corneal irregularities such as those induced by post operative sutures and wounds, and to assist in the understanding of various refractive conditions of the cornea, such as myopia, hyperopia, and astigmatism.
Not Found
The provided document is an FDA 510(k) clearance letter for the Euclid Systems Corneal Topographer Model ET800. It does not contain information about acceptance criteria, device performance, study details (sample size, provenance, ground truth, experts, adjudication, MRMC, standalone performance), or training set information.
Therefore, I cannot provide the requested information based solely on this document. The letter signifies that the device has been found substantially equivalent to a legally marketed predicate device, but it does not include the detailed technical study results that would typically contain the requested criteria and performance data.
§ 886.1350 Keratoscope.
(a)
Identification. A keratoscope is an AC-powered or battery-powered device intended to measure and evaluate the corneal curvature of the eye. Lines and circles within the keratoscope are used to observe the corneal reflex. This generic type of device includes the photokeratoscope which records corneal curvature by taking photographs of the cornea.(b) The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 886.9. The battery-powered device is exempt from the current good manufacturing practice requirements of the quality system regulation in part 820 of this chapter, with the exception of § 820.180 of this chapter, with respect to general requirements concerning records, and § 820.198 of this chapter, with respect to complaint files