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SynergEyes® A and M (paflufocon D hem-iberfilcon 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 and not aphakic, non-diseased eyes. The lenses are indicated for daily wear for the correction of up to +20.00 and -20.00 D in eyes with astigmatism up to 6.00 D. For presbyopia, add powers between +1.00 and +4.00D. The lenses may be disinfected using only a chemical disinfecting system compatible with both hydrogel and rigid gas permeable lenses.

SynergEyes™ KC (paflufocon D hem-iberfilcon A) Hybrid Contact Lenses for keratoconus are indicated for use in the correction of eyes with refractive errors that include hyperopia and myopia that manifest irregular astigmatism, in aphakic and not aphakic, and otherwise non-diseased eyes. The lenses are indicated for daily wear for the correction of up to +20.00 and -20.00 D in eyes with irregular astigmatism up to 10.00 D. The lenses may be disinfected using only a chemical disinfecting system compatible with both hydrogel and rigid gas permeable lenses.

SynergEyes™ PS (paflufocon D hem-iberfilcon A) Hybrid Contact Lenses are indicated for use in the correction of eyes with refractive errors resulting from corneal surgery or trauma including hyperopia and myopia, astigmatism, and irregular astigmatism in aphakic and not aphakic, nondiseased eyes. The lenses are indicated for daily wear for the correction of up to +20.00 and -20.00 D in eyes with irregular astigmatism up to 6.00 D. The lenses may be disinfected using only a chemical disinfecting system compatible with both hydrogel and rigid gas permeable lenses.

Not Found

The provided document is a 510(k) premarket notification letter from the FDA to SynergEyes, Inc. for their hybrid contact lenses. This type of document declares substantial equivalence to a predicate device, allowing the device to be marketed.

Crucially, this document is not a study report or clinical trial summary. It does not contain information about acceptance criteria, device performance metrics (like sensitivity, specificity, accuracy), sample sizes for test or training sets, expert qualifications, or details about ground truth establishment. These are typically found in the submission itself or associated clinical reports.

Therefore,Based on the provided document, I cannot fulfill your request as the information regarding acceptance criteria, device performance, study details, and ground truth establishment is not present within this FDA clearance letter. This document only confirms the FDA's determination of substantial equivalence for the device.

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