(90 days)
The Sunsoft (methafilcon A) Soft ( Hydrophilic) Contact Lens is a random copolymer of 2-hydroxyethylmetharcylate and methacrylic acid. When hydrated, the lens consists of 45% methafilcon A and 55% water by weight when immersed in normal saline. It is indicated for the correction of visual acuity.
The Sunsoft (methafilcon A) Soft ( Hydrophilic) Contact Lens is a random copolymer of 2-hydroxyethylmetharcylate and methacrylic acid. When hydrated, the lens consists of 45% methafilcon A and 55% water by weight when immersed in normal saline.
This document is a 510(K) summary for a contact lens and does not contain the information required to populate the fields of "acceptance criteria" or a "study that proves the device meets the acceptance criteria" in the context of AI/ML device performance. This document describes the biocompatibility, physical/optical characteristics, and manufacturing process validation of a contact lens, comparing a new manufacturing method to an existing one. It is not about the performance of a device that uses an algorithm or AI.
Therefore, I cannot provide the requested information from the given 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.