(198 days)
The FreshKon® Contact Lens is indicated for daily wear to enhance the color and/or the size and/or the definition of the natural iris and/or for the correction of refractive ametropia (myopia) in aphakic or not-aphakic persons with non-diseased eyes who may have 2.00 diopter (D) or less of astigmatism. It also helps protect against transmission of harmful UV radiation to the cornea and into the eye.
The Eye Care Professionals should prescribe the lenses for daily wear single use only. The lenses are to be discarded upon removal; therefore, no cleaning or disinfecting is required.
Soft (hydrophilic) contact lens
This document is an FDA 510(k) clearance letter for cosmetic contact lenses. It does not contain any information about acceptance criteria or a study proving device performance in the context of AI/ML or diagnostic accuracy.
The provided text is a regulatory approval document for a medical device (contact lenses) based on substantial equivalence to a predicate device. It confirms that the device can be marketed. It does not include:
- A table of acceptance criteria and reported device performance (in the context of analytical or clinical performance of a diagnostic or AI device).
- Information about sample sizes, data provenance, expert qualifications, or adjudication methods for a test set.
- Details about multi-reader multi-case (MRMC) comparative effectiveness studies.
- Information about standalone algorithm performance.
- The type of ground truth used to evaluate performance.
- Details about a training set or how its ground truth was established.
Therefore, I cannot fulfill your request for information regarding acceptance criteria and studies proving device performance, as the provided text relates to the regulatory approval of contact lenses, not a diagnostic or AI-driven device with such performance metrics.
§ 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.