(140 days)
The Eni-Eye SH Sphere (Efrofilcon A) Soft (hydrophilic) Contact Lens for Daily Wear is indicated for daily wear for the correction of ametropia (myopia and hyperopia) in aphakic and non-aphakic persons.
Eni-Eye SH Sphere (Efrofilcon A) Soft (hydrophilic) Contact Lens for Daily Wear
This document is a 510(k) clearance letter from the FDA for a contact lens. It does not contain information about acceptance criteria or performance studies as typically requested for AI/ML device evaluations. Therefore, I cannot provide the requested information based on the given text.
The document states that the FDA reviewed a premarket notification for the "Eni-Eye SH Sphere (Efrofilcon A) Soft (hydrophilic) Contact Lens for Daily Wear" and determined it to be substantially equivalent to legally marketed predicate devices. It lists the indications for use as the correction of ametropia (myopia and hyperopia) in aphakic and non-aphakic persons for daily wear.
However, none of the specific details about acceptance criteria, study design, sample sizes, ground truth establishment, or expert involvement for AI/ML performance testing are present in this regulatory clearance letter.
§ 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.