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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.

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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.

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