(56 days)
AIR OPTIX® COLORS (lotrafilcon B) spherical soft contact lenses with refractive power are indicated for daily wear for the optical correction of refractive ametropia (myopia) in phakic or aphakic persons with non-diseased eyes and up to approximately 1.50 diopters of astigmatism that does not interfere with visual acuity.
AIR OPTIX® COLORS (lotrafilcon B) toric soft contact lenses are indicated for daily wear for the optical correction of refractive ametropia (myopia and hyperopia) in phakic or aphakic persons with non-diseased eyes with 6.00 diopters (D) or less of astigmatism.
AIR OPTIX® COLORS (lotrafilcon B) multifocal soft contact lenses are indicated for daily wear for the optical correction of refractive ametropia (myopia and hyperopia) and/or presbyopia in phakic persons with nondiseased eyes who may require a reading addition of +3.00 diopters (D) or less and who may have up to approximately 1.50 diopters of astigmatism.
AIR OPTIX® COLORS (lotrafilcon B) lenses with or without refractive power act to enhance or alter the apparent color of the eye.
The lenses may be prescribed for frequent/planned replacement wear with daily removal for cleaning and disinfection (chemical, not heat) prior to reinsertion, as recommended by the eye care professional.
The lens material is 33% water and 67% lotrafilcon B. a fluoro-silicone containing hydrogel which is surface treated. Lotrafilcon B is classified as a Group V (silicone hydrogel) hydrogel contact lens material according to ISO 18369-1:2006/Amd.1:2009. A cosmetic pattern is embedded into the back surface of the lens, containing a combination of the following color additives: carbazole violet, iron oxides, [phthalocyaninato (2-)] copper, phthalocyanine green and titanium dioxide.
Lens designs for AIR OPTIX® COLORS (lotrafilcon B) lenses include spherical, toric, and multifocal lenses in the following parameter range:
Diameter Range: 13.0 to 15.0 mm
Base Curve Range: 8.0 to 9.2 mm
Power Range: -20.00D to +20.00D
Center Thickness: varies with design and power (0.08 mm for -3.00D spherical)
Lenses have the following properties:
• Refractive index: 1.42 (hydrated)
• Luminous transmittance: 95 ± 5%
• Water content: 33% by weight in normal saline
• Oxygen permeability 110 x 10 -11 (cm²/sec)(ml O2 /ml x mm Hg), measured at 35 °C (intrinsic Dk - Coulometric method)
Lenses are supplied sterile in sealed blister packs containing isotonic phosphate buffered saline solution (PBS), or PBS with 1% Copolymer 845 (labeled as buffered saline containing 0.2 % VP/DMAEMA Copolymer). The compatibility and package integrity of the blister pack packaging system has been demonstrated and successfully used for other marketed lens products, and packaged lenses are effectively steam sterilized in a validated autoclave. Blister pack containers are labeled with the lens parameters, lens color, lot number and product expiration date. The expiration date has been established through stability studies that have assessed the chemical stability of the lens and package integrity (ability to maintain sterility). Shelf-life studies are ongoing to further extend the labeled expiration date.
I'm sorry, but this document does not contain the detailed information necessary to complete your request. This document is an FDA 510(k) clearance letter and a 510(k) summary for AIR OPTIX® COLORS contact lenses.
Here's why I cannot fulfill your request:
- No Acceptance Criteria or Device Performance Table: The document states that "new color options are being added" and that "Key product characteristics remain unchanged," indicating that the performance would be substantially equivalent to the predicate device. However, it does not provide a table of specific acceptance criteria (e.g., minimum visual acuity improvement, maximum complication rate) or reported device performance against those criteria.
- No Detailed Study Description: While it mentions "Performance testing was conducted in consideration of the May 1994 FDA guideline titled Premarket Notification 510(k) Guidance Document for Class II Contact Lenses" and "Non-clinical biocompatibility testing was conducted in accordance with the GLP regulation (21 CFR Part 58)," it does not describe the studies in detail. It explicitly states: "The scope of the device modification did not require clinical testing to establish safety and effectiveness of the modified device." This means there aren't the types of clinical studies (with test sets, ground truth, experts, MRMC studies, standalone performance) you're asking about.
- Focus on Substantial Equivalence: The document is primarily focused on demonstrating substantial equivalence to a predicate device, meaning the new device is as safe and effective as a previously cleared device. This often involves showing that fundamental characteristics and performance remain the same, rather than conducting new, large-scale clinical trials with new acceptance criteria.
Therefore, I cannot extract information regarding:
- A table of acceptance criteria and reported device performance.
- Sample sizes for test sets, data provenance, number of experts, adjudication methods, MRMC studies, standalone performance, type of ground truth for test sets, sample size for training sets, or how ground truth for training sets was established.
The document indicates that the modification (adding new color options) did not necessitate new clinical studies to establish safety and effectiveness, as the key product characteristics and material remained the same as the predicate device. The performance data mentioned are non-clinical (physicochemical characteristics and biocompatibility) to show equivalence.
§ 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.