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Fluid/Gas Exchange and Viscous Fluid Delivery/Injection during ophthalmic surgery.

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This document is a 510(k) premarket notification letter from the FDA to SCIERAN TECHNOLOGIES, INC. for their device, CPD COMMANDER. It states that the device is substantially equivalent to legally marketed predicate devices and can be brought to market. However, it does not contain the specific information requested about acceptance criteria or a study proving the device meets those criteria. The letter primarily addresses regulatory approval and classification.

Therefore, I cannot extract the requested information from the provided text.

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Emulsification and aspiration of cataract

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The provided text is a 510(k) premarket notification approval letter for the PHACO COMMANDER system, dated February 24, 1998. It confirms the device is substantially equivalent to legally marketed predicate devices for the indication of "Emulsification and aspiration of cataract."

Unfortunately, this document does not contain any information regarding specific acceptance criteria, device performance studies, sample sizes, ground truth establishment, or expert qualifications. The letter is a regulatory approval, not a scientific study report.

Therefore, I cannot fulfill your request for a table of acceptance criteria and reported device performance or details about a study proving the device meets those criteria, as that information is not present in the provided text.

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For use in fragmentation and aspiration of the human lens

Frag Commander™ Phacofragmentation Device

This document, a 510(k) clearance letter, does not contain any information about acceptance criteria or a study proving device performance.

The letter from the FDA to Scieran Technologies for the "Frag Commander" device (K973749) indicates that the device has been found substantially equivalent to a legally marketed predicate device. This substantial equivalence determination means that the FDA believes the new device is as safe and effective as a device already on the market.

However, the letter only certifies the regulatory clearance and does not provide details about:

• Acceptance Criteria: What specific performance metrics were required for the device.
• Study Data: Any clinical or non-clinical study results demonstrating the device meets performance thresholds.
• Sample Sizes, Ground Truth, Expert Qualifications, Adjudication, MRMC studies, Standalone performance, or Training set details.

These types of details would typically be found in the 510(k) submission itself, which is not provided in the input. The provided text is solely the FDA's decision letter.

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Ask a specific question about this device

Ask a specific question about this device