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Duette™ SiH (petrafocon A hem-larafilcon A) Hybrid Contact Lenses for daily wear are indicated for use in the correction of hyperopic, myopic and astigmatic refractive error including presbyopia, in aphakic not aphakic, non-diseased eyes. The lenses are indicated for daily wear for the correction of up to +20.00 D in eyes with astigmatism up to 6.00 D. For presbyopia, add powers between +1.00 and +4.00 D. The lenses may be disinfected using only a chemical disinfecting system compatible with both hydrogel and rigid gas permeable lenses.

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This FDA document is a 510(k) clearance letter for the Duette SiH Hybrid Contact Lenses. It does not contain a detailed study description with acceptance criteria and device performance data.

The letter explicitly states: "We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976..."

This means the FDA reviewed data provided by the manufacturer to show the device is substantially equivalent to a predicate device already on the market, rather than requiring a detailed clinical study demonstrating the device meets specific acceptance criteria for performance as would be required for a novel device or a PMA application.

Therefore, I cannot extract the requested information regarding acceptance criteria, study details, sample sizes, ground truth establishment, or human reader effectiveness from this document. Such information would typically be found in the 510(k) submission itself, often in a section detailing clinical or non-clinical performance studies.

In summary, the provided document does not contain the information required to answer your request.

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