(38 days)
The bifocal/multifocal designs of the HYDRO2 (filofocon A) contact lens are indicated for daily wear correction of visual acuity in non-aphakic persons with non-diseased presbyopic eyes that are myopic or hyperopic. The lens may be disinfected with chemical disinfection only.
Bifocal/Multifocal HYDRO2 (filofocon A) Daily Wear RGP Contact Lens
The provided document is a 510(k) clearance letter from the FDA for a contact lens, not a study report or a document describing acceptance criteria and device performance. Therefore, it does not contain the specific information requested in your prompt regarding acceptance criteria, study details, ground truth, or expert qualifications.
The document states that the FDA reviewed a "Section 510(k) notification of intent to market the device" and found it to be "substantially equivalent" to a legally marketed predicate device. This process involves comparing the new device to an existing one, but the specific performance data and criteria used for that comparison are not detailed in this clearance letter.
Therefore, I cannot extract the requested information from the provided text.
§ 886.5916 Rigid gas permeable contact lens.
(a)
Identification. A rigid gas permeable contact lens is a device intended to be worn directly against the cornea of the eye to correct vision conditions. The device is made of various materials, such as cellulose acetate butyrate, polyacrylate-silicone, or silicone elastomers, whose main polymer molecules generally do not absorb or attract 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.