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

Odyssey Technologies P3 Universal Handpiece

The provided documents do not contain information about acceptance criteria or a study that proves a device meets such criteria. The documents are an FDA 510(k) clearance letter for the "Odyssey Technologies P3 Universal Handpiece," which is used in cataract surgery.

Specifically, the letter from the FDA to Mr. Glenn A. Dunki-Jacobs of Odyssey Technologies states that the device has been found substantially equivalent to devices marketed prior to May 28, 1976. This is a regulatory clearance based on equivalence, not necessarily on a performance study with acceptance criteria.

The information requested in the prompt, such as acceptance criteria table, sample sizes, ground truth establishment, expert qualifications, adjudication methods, MRMC studies, or standalone performance, is not present in these documents.

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