(79 days)
The BENZ hefilcon A SPHERICAL Soft (Hydrophilic) Contact Lenses in clear or with a light blue or light green visibility tint are indicated in daily wear for the correction of visual acuity in aphakic and non-aphakic persons with non-diseased eyes. The spherical lenses are available from +20.00 to -20.00 Diopters and may be worn by patients who can accomodate up to 1.5 Diopters of astigmatism.
The BENZ hefilcon A TORIC Soft (Hydrophilic) Contact Lenses in clear or with a light blue or light green visibility tint are indicated in daily wear for the correction of visual acuity in aphakic and non-aphakic persons with non-diseased eyes. The Toric lenses are available from +20.00 to -20.00 Diopters and up to 4.50 Diopters of astigmatic correction where it does not interefere with visual acuity.
The BENZ hefilcon A Spherical and Toric Contact lenses may be disinfected using either the heat (thermal) or the chemical (nonheat) disinfection system.
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I am sorry, but the provided text is a 510(k) clearance letter for contact lenses and does not contain the specific information requested in your prompt regarding acceptance criteria, study details, sample sizes, expert qualifications, or ground truth establishment for a medical device.
The document states that the BENZ Hefilcon A Soft (Hydrophilic) Daily Wear Contact Lenses are "substantially equivalent" to predicate devices, but it does not detail a study conducted to prove specific performance metrics against acceptance criteria. It focuses on regulatory clearance rather than a scientific study report.
§ 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.