(181 days)
The Eni-Eye SH Toric (Efrofilcon A) Soft (hydrophilic) Contact Lens for Daily Wear is indicated for daily wear for the correction of refractive astigmatism with non-diseased eyes that may exhibit refractive and/or corneal astigmatism. The lens may be disinfected using a chemical disinfection system.
The Eni-Eye Q SH Multi (Efrofilcon A) Soft (hydrophilic) Multifocal Contact Lens for Daily Wear is indicated for daily wear for the correction of refractive ametropia (myopia and hyperopia) and presbyopia in aphakic and/or non aphakic persons with non-diseased eyes. The lenses may be disinfected using a chemical disinfection system.
The Eni-Eye Q SH Multi Toric (Efrofilcon A) Soft (hydrophilic) Multifocal Contact Lens for Daily Wear is designed to correct ametropia (myopia and hyperopia), presbiopia, and corneal astigmatism in aphakic and/or non aphakic persons with non-diseased eyes. The lenses may be disinfected using a chemical disinfection system.
The ENI-EYE SH Soft K (Efrofilcon A) Soft (hydrophilic) Keratoconus and irregular cornea Contact Lens for Daily Wear is indicated for daily wear for persons requiring keratoconus management and for the correction of refractive ametropia (myopia and hyperopia) in aphakic and non-aphakic persons that may exhibit refractive and/or corneal astigmatism, or post-refractive surgery corneal irregularity such as irreqular astigmatism up to 2.00 D that does not interfere with visual acuity. The lens may be disinfected with a chemical or heat disinfection system.
The Eni-Eye SH Soft K Toric (Efrofilcon A) Soft (hydrophilic) Keratoconus and irregular cornea Contact Lens for Daily Wear is indicated for daily wear for persons requiring keratoconus management and for the correction of refractive ametropia (myopia and hyperopia) in aphakic and non-aphakic persons that may exhibit refractive and/or corneal astigmatism, or post-refractive surgery corneal irregularity such as irregular astigmatism up to 2.00DS that does not interfere with visual acuity. The lens may be disinfected with a chemical or heat disinfection system.
Not Found
The provided document is a 510(k) premarket notification letter from the FDA for several contact lens products, including various "Eni-Eye SH" contact lenses. It confirms the substantial equivalence of these devices to legally marketed predicate devices.
However, the document does not contain information regarding acceptance criteria for device performance, or details of any specific study (such as clinical trials, AI studies, or comparative effectiveness studies) that would prove the device meets such criteria. It lists the device names, regulation numbers, regulatory class, and indications for use, but no performance data, test set details, ground truth establishment, or training set information.
Therefore, I cannot answer the requested questions based on the provided text. The document is primarily an administrative letter affirming substantial equivalence for market clearance, not a scientific report detailing device performance studies.
§ 886.5925 Soft (hydrophilic) contact lens.
(a)
Identification. A soft (hydrophilic) contact lens is a device intended to be worn directly against the cornea and adjacent limbal and scleral areas of the eye to correct vision conditions or act as a therapeutic bandage. The device is made of various polymer materials the main polymer molecules of which absorb or attract a certain volume (percentage) of water.(b)
Classification. (1) Class II if the device is intended for daily wear only.(2) Class III if the device is intended for extended wear.
(c)
Date PMA or notice of completion of a PDP is required. As of May 28, 1976, an approval under section 515 of the act is required before a device described in paragraph (b)(2) of this section may be commercially distributed. See § 886.3.