(41 days)
The Saview Toric 55 (methafilcon A) Soft (hydrophilic) Contact Lens for Daily 'Vear is indicated for daily wear for correction of refractive ametropia (myopia, hyperopia and astigmatism) in aphakic or not-aphakic persons with non-diseased eyes that may exhibit refractive and/or corneal astigmatism up to 2.50 Diopters.
Saview 55 Toric (methifilcon A) Soft (hydrophilic Contact Lens for Daily Wear
I am sorry, but the provided text does not contain the detailed information required to answer your request about acceptance criteria and a study proving device performance. The document is an FDA 510(k) clearance letter for a contact lens, which primarily states that the device is substantially equivalent to a predicate device.
It does not include:
- A table of acceptance criteria or reported device performance metrics.
- Details about sample sizes, data provenance, or ground truth establishment for any studies.
- Information on expert involvement, adjudication methods, or MRMC studies.
- Information on standalone algorithm performance or training sets.
Therefore, I cannot fulfill your request for this specific document.
§ 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.