Search Results

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 fo rhte 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 D and +4.00 D. The lenses may be disinfected using only a chemical disinfecting system compatible with both hydrogel and rigid gas pearmeable 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 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 text does not contain information about acceptance criteria and a study proving a device meets them. Instead, it is an FDA 510(k) premarket notification letter for SynergEyes™ contact lenses, detailing:

• Device Name: SynergEyes™ A, M, KC, and PS (paflufocon D hem-iberfilcon A) Hybrid Daily Wear Contact Lens.
• Regulation Number and Name: 21 CFR 886.5916, Rigid gas permeable contact lens.
• Regulatory Class: II.
• Product Code: HQD.
• Submission Date: January 25, 2008.
• FDA Determination: Substantially equivalent to legally marketed predicate devices.
• Indications for Use: Specific uses for correction of hyperopic, myopic, astigmatic refractive errors, presbyopia, irregular astigmatism in keratoconus, and refractive errors from corneal surgery or trauma.
• Disinfection Method: Compatible chemical disinfecting system for both hydrogel and rigid gas permeable lenses.

Therefore, I cannot provide the requested information about acceptance criteria, study details, sample sizes, expert qualifications, or ground truth establishment. The document focuses on regulatory approval based on substantial equivalence to existing devices, rather than presenting a performance study with detailed acceptance criteria and results.

Ask a specific question about this device