(60 days)
Lotrafilcon B spherical soft contact lenses are indicated for the optical correction of refractive ametropia (myopia and hyperopia) 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.
Lotrafilcon B toric soft contact lenses are indicated for the optical correction of refractive ametropia (myopia and hyperopia) in phakic or aphakic persons with non-diseased eyes and up to 6.00 diopters (D) or less of astigmatism.
Lotrafilcon B multifocal soft contact lenses are indicated for the optical correction of presbyopia with or without refractive ametropia (myopia and hyperopia) in phakic persons with non-diseased 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.
Lotrafilcon B multifocal toric soft contact lenses are indicated for the optical correction of refractive ametropia (myopia and hyperopia) and presbyopia in phakic persons with non-diseased eves and up to 6.00 diopters (D) or less of refractive and/or corneal astigmatism.
Eye care professionals may prescribe the lenses for daily disposable wear (lenses are discarded upon removal from the eye) or daily wear with removal for cleaning and disinfection (chemical, not heat) prior to reinsertion and frequent replacement, 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. Contact lenses contain the color additive phthalocyanine blue, a light blue handling tint, which helps make them easier to see when handling.
Lotrafilcon B lens designs include spherical. toric, multifocal toric lenses in the following parameter ranges:
• 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 (Example: 0.08 mm for -3.00D spherical)
Lenses have the following properties:
- . Refractive index: 1.42 (hydrated)
- Light transmittance: > 94 % ●
- Water content : 33% by weight in normal saline
- Oxygen permeability 110 x 10-11 ●
[(cm2 /sec)(ml O2 /ml mmHg)] measured at 35°C (intrinsic Dk-Coulometric method)
Lotrafilcon B contact lenses are supplied sterile in sealed blister packs containing isotonic phosphate buffered saline solution (PBS) with or without additives [1% Copolymer 845, or 1% Copolymer 845 and 0.04% (400 ppm) polyoxyethylene-polyoxybutylene copolymer (EO45BO10)]. The compatibility and package integrity of the blister pack packaging system have 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, 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).
This document from the FDA is a 510(k) premarket notification for a medical device -- a soft contact lens. It serves to demonstrate substantial equivalence to a predicate device, not necessarily to provide detailed acceptance criteria and a study report designed to prove the device meets these criteria in a typical clinical trial format for AI/ML devices. Therefore, a direct response to all your questions in the requested format for acceptance criteria and a study proving it meets them may not be fully extractable as this is not the primary purpose of this type of regulatory document.
However, I can extract information related to the device and its claimed equivalence.
Here's an attempt to answer your questions based on the provided document, recognizing the limitations of the document's nature:
Acceptance Criteria and Study for AIR OPTIX plus HydraGlyde (lotrafilcon B) Soft Contact Lenses
Given that this is a 510(k) premarket notification for a contact lens, the "acceptance criteria" are not presented as numerical thresholds for an AI/ML device's performance metrics (e.g., sensitivity, specificity, AUC). Instead, the acceptance criteria are implicitly that the new device, when packaged in modified saline, performs equivalently to or better than the predicate device across critical safety and performance characteristics for contact lenses. The "study" here refers to a series of nonclinical tests demonstrating this equivalence.
1. Table of Acceptance Criteria and the Reported Device Performance
| Acceptance Criteria (Implicit) | Reported Device Performance (AIR OPTIX plus HydraGlyde in modified saline) |
|---|---|
| Biocompatibility: Non-toxic and non-irritating | The lens material, lens extracts, and package saline are equivalent to the predicate and remain non-toxic and non-irritating. (Nonclinical biocompatibility testing conducted in accordance with GLP 21 CFR Part 58). |
| Physical and Material Properties: Consistent with industry-marketed lenses and equivalent to or better than the predicate lens | Lens physical and material properties are consistent with industry-marketed lenses and equivalent to or better than the predicate lens. Specific properties are listed in "Device Description" and "Substantial Equivalence Comparison," including: |
- Refractive Index: 1.42 (hydrated)
- Light Transmittance: > 94 %
- Water Content: 33% by weight
- Oxygen Permeability (Dk): 110 x 10^-11 [(cm^2/sec)(ml O2/ml mmHg)] (intrinsic Dk-Coulometric method)
- Other: Plasma-treated surface, double-side molding manufacturing, visibility tint (copper phthalocyanine blue). These match the predicate device. |
| Compatibility with Lens Care Products: Compatible with commonly available lens care products | The device in modified saline is compatible with commonly available lens care products, like the predicate device. |
| Packaging & Sterilization: Maintains sterility and integrity, and lenses are effectively sterilized | Compatibility and package integrity of the blister pack packaging system have been demonstrated. Packaged lenses are effectively steam sterilized in a validated autoclave. Stability studies assessed chemical stability of the lens and package integrity. The packaging (global blister pack) and sterilization method (steam sterilization, validated autoclave) are the same as the predicate. The package storage saline solution is Phosphate buffered saline with 1% Copolymer 845 and 0.04% (400 ppm) ethylene oxide-butylene oxide (EO45BQ10) copolymer, which is a key difference from the predicate (which was Phosphate buffered saline with or without 1% Copolymer 845). The nonclinical tests confirm equivalence despite this change. |
| Indications for Use: Matches predicate for various lens types (spherical, toric, multifocal, multifocal toric) | Spherical: Optical correction of refractive ametropia (myopia and hyperopia) in phakic persons with non-diseased eyes and ~1.50D astigmatism.
Toric: Optical correction of refractive ametropia (myopia and hyperopia) in phakic/aphakic persons with non-diseased eyes and
§ 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.