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The Ocular Response Analyzer is intended to measure intra-ocular pressure of the eye and biomechanical response of the cornea.

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The provided text is a 510(k) clearance letter for the Ocular Response Analyzer (ORA). It confirms that the FDA has reviewed the device and determined it to be substantially equivalent to a legally marketed predicate device.

Critically, this document DOES NOT contain the acceptance criteria or a study proving the device meets those criteria.

510(k) clearance primarily focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than requiring the submission of new clinical efficacy or performance studies with detailed acceptance criteria in the same way a PMA (Premarket Approval Application) would.

Therefore, I cannot extract the requested information from the provided text. The document states the "Indications for Use" but does not detail performance metrics, study designs, sample sizes, ground truth establishment, or expert qualifications.

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