(173 days)
The Hidrocor, Hidrocharme, and Natural Colors Soft (hydrophilic) Contact Lenses are indicated for daily wear to enhance or alter the apparent color of the eye, including ocular masking, either in sighted eyes that require a prosthetic contact lens for the cosmetic management of conditions such as scleral, corneal, iris, or lens abnormalities.
Daily wear replacement schedules may vary from patient and should be decided by eyecare practitioners in consultation with their patients.
Frequent/Planned Replacement Wear:
Eyecare practitioners may prescribe any of the above lenses 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 disinfecting system.
Disposable Wear:
Eyecare practitioners may prescribe any of the above lenses for Daily Disposable Wear. When Prescribed for Daily Disposable Wear the lenses are not to be used with disinfecting systems as they are to be discarded after a single use.
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This is a premarket notification for contact lenses, not a medical device driven by AI/ML. Therefore, the questions regarding acceptance criteria and study details for an AI/ML device are not applicable to the provided document.
The document discusses the substantial equivalence of Hidrocor, Hidrocharme, and Natural Colors Soft (hydrophilic) Contact Lenses to legally marketed predicate devices. It covers the regulatory classification, indications for use, and compliance with general controls provisions of the Act.
There is no information about an AI/ML device, performance studies, test sets, ground truth establishment, or expert reviews 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.