(90 days)
The soft contact lens for daily wear is indicated for the correction of visual acuity in aphakic persons with non-diseased eyes that are myopic or hyperopic. The spherical lens may be worn by persons who exhibit astigmatism of 0.75 Diopters or less that does not interfere with visual acuity. The toric lens may be worn by persons who exhibit astigmatism of up to 1.25 Diopters.
Eye care practitioners may prescribe the lens for frequent/planned replacement wear, with cleaning disinfection and scheduled replacement. When prescribed for frequent/planned replacement wear, the lens may be disinfected using a chemical disinfection system.
The soft contact lens with or without refractive power act to enhance or alter the apparent color of the eye.
Not Found
I am sorry, but based on the provided document, I cannot identify any information regarding acceptance criteria, device performance results, or details about a study that would include sample sizes, ground truth establishment, or expert qualifications.
The document is an FDA 510(k) clearance letter for "Toricolors (hioxifilcon D) Soft Contact Lenses," confirming its substantial equivalence to a legally marketed predicate device. It primarily discusses regulatory classifications, general controls, and compliance requirements. It also includes an "Indications for Use" section.
There is no mention of a clinical study, performance metrics, or statistical analysis that would typically be associated with proving a device meets specific acceptance criteria.
§ 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.