(51 days)
The iSee (roflufocon D, roflufocon E) Daily Wear Orthokeratology Contact Lenses are indicated for daily wear in an orthokeratology fitting program for the temporary reduction of myopia of up to 5.00 diopters in non-diseased eyes. To maintain the orthokeratology effect of myopia reduction, lens wear must be continued on a prescribed wearing schedule.
Eyecare practitioners may prescribe the lenses for frequent/planned replacement wear, with cleaning, disinfection and scheduled replacement. When prescribed for frequent wear, the lens may be cleaned and disinfected using a chemical (not heat) lens care system.
The iSee (roflufocon D, roflufocon E) Daily Wear Orthokeratology Contact Lenses are are lathe cut from one of the following hydrophobic, FDA Group #3 fluoro-silicone acrylate materials: roflufocon D or roflufocon E-with the following properties: Refractive Index, Light Transmission (clear), Light Transmission (tinted), Wetting Angle (Dynamic contact receding angle), Specific Gravity, Oxygen Permeability (Dk) ISO/FATT Method, Visitint lenses contain one or more of the following color additives conforming to: 21 CFR Part 73 & 74, Subpart D. The lenses are available in the following lens parameters: Base Curve, Center Thickness, Diameter, Spherical Power, Secondary Curves, Peripheral Curves, Multifocal Power.
The provided document is a 510(k) Premarket Notification for the iSee Daily Wear Orthokeratology Contact Lenses. It does not contain any information about acceptance criteria or a study proving the device meets acceptance criteria in the context of an AI/ML medical device.
Instead, the document focuses on demonstrating substantial equivalence to an already marketed predicate device (OPTIMUM GP OK Daily Wear Contact Lens). The basis for this equivalence is a comparison of technological characteristics, materials, production methods, and intended use.
Here's a breakdown of why this document doesn't provide the requested AI/ML device study information:
- Non-Clinical and Clinical Studies (Section VII): This section explicitly states:
- "The non-clinical performance data to establish the safety and effectiveness of contact lenses manufactured from roflufocon D and roflufocon E has been addressed by reference to the predicate devices."
- "Clinical performance data to demonstrate the safety and effectiveness of contact lenses manufactured from roflufocon D and roflufocon E have been addressed in previous applications."
This means that C&E GP Specialists, Inc. did not conduct new independent studies for this 510(k) submission. They are relying on existing data for the materials and the predicate device to establish safety and effectiveness.
Therefore, I cannot provide the requested information from this document for an AI/ML device since it is for a contact lens and references prior data rather than presenting a new study.
§ 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.