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510(k) Data Aggregation
(142 days)
VISION CARE DEVICES, INC.
The Velocity Advantage would be used by a physician in conjunction with standard vitrectomy equipment to cut and remove vitreous and other intraocular tissue.
Not Found
The provided text is a 510(k) clearance letter from the FDA for the "Velocity Advantage" device. It does not contain any information about acceptance criteria, device performance studies, sample sizes, expert qualifications, or ground truth methodologies.
The letter primarily confirms that the device is substantially equivalent to a predicate device and can therefore be marketed. It lists the device name, a brief indication for use, and regulatory information.
Therefore, I cannot extract the requested information from this document.
Ask a specific question about this device
(77 days)
VISION CARE DEVICES, INC.
Anterior Phaco emulsification cortex clean up.
Not Found
The provided document is a 510(k) clearance letter from the FDA for a medical device called "Bayers Bimanual I/A Handpieces." This document does not contain the information requested in your prompt regarding acceptance criteria, study details, sample sizes, expert qualifications, or ground truth establishment.
The 510(k) clearance process primarily focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than detailed performance studies with acceptance criteria as one might find for a novel or higher-risk device requiring a PMA.
Therefore, I cannot extract the requested information from the provided text.
Ask a specific question about this device
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