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For use in cataract surgery to disrupt a cataract with ultrasound through emulsification and extract the cataract.

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The provided text is a 510(k) clearance letter from the FDA for a medical device (Odyssey Technologies Vista Universal Handpiece) and an "Indications For Use Statement." It does not contain information about acceptance criteria, device performance, study designs, sample sizes, ground truth establishment, or expert qualifications as requested.

Therefore, I cannot provide the information in the requested format based on the given text. The document is primarily a regulatory approval notice and a statement of the intended use of the device, not a technical report detailing performance studies.

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