(318 days)
The FreshKon® (methafilcon A) Soft (hydrophilic) Contact Lenses for Daily Wear are indicated for daily wear for the correction of refractive ametropia (myopia) in aphakic or not-aphakic persons with non-diseased eyes. The lenses may be used to enhance or alter the apparent color of the eye. The lenses may be disinfected using a chemical disinfection system.
Not Found
The provided text is an FDA 510(k) clearance letter for various FreshKon® contact lenses. It does not contain information about acceptance criteria or a study that proves a device meets those criteria, as typically found in a clinical study report or a 510(k) summary (which might include a section on performance data).
The document is a legal notification of substantial equivalence for a medical device, based on the comparison to a legally marketed predicate device. It confirms that the reviewed device is deemed substantially equivalent in terms of safety and effectiveness for its stated indications for use.
Therefore, I cannot extract the requested information regarding acceptance criteria and device performance evaluation, including sample sizes, expert qualifications, ground truth establishment, or specific study types like MRMC or standalone performance, because this information is not present in the provided text.
§ 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.