(104 days)
- PEGAVISION Aquamax (Etafilcon A) Daily Disposable Soft (Hydrophilic) Contact Lenses are indicated for daily wear for vision correction of refractive ametropia in aphakic or not-aphakic persons with non-diseased eyes that are myopic or hyperopic. The lens may be worn by persons who exhibit refractive astigmatism of 2.00 diopters (D) or less where the astigmatism does not interfere with visual acuity. The lens may be prescribed in spherical powers ranging from 0.00D to -12.00D. Eye Care Practitioners may prescribe the lens for single-use daily disposable wear. The lens is intended for single-use disposable wear.
- PEGAVISION Aquamax (Etafilcon A) Bi-weekly Disposable Soft (Hydrophilic) Contact Lenses are indicated for daily wear for vision correction of refractive ametropia in aphakic or not-aphakic persons with non-diseased eyes that are myopic or hyperopic. The lens may be worn by persons who exhibit refractive astigmatism of 2.00 diopters (D) or less where the astigmatism does not interfere with visual acuity. The lens may be prescribed in spherical powers ranging from 0.00D to -12.00D. The lens is intended for frequent/planned replacement wear with cleaning, rinsing, disinfection and scheduled replacement as prescribed by the eye care professional. When prescribed for frequent/planned replacement wear, the lens may be disinfected using a chemical (not heat) lens care system only.
Aquamax (Etafilcon A) Bi-Weekly Disposable Soft (Hydrophilic) Contact Lenses and Aquamax (Etafilcon A) Daily Disposable Soft (Hydrophilic) Contact Lenses are available as spherical lenses manufactured by cast molding method. The model illuminated with high water (58 %). These hydrogel lens materials are random copolymer of 2-hydroxyethyl methacrylate (HEMA) and methacrylic acid (MAA), which were crosslinked with ethylene glycol dimethacrylate (EGDMA) and 1.1.1-trimethylolpropane trimethacrylate (TMPTMA) via photo-polymerization. These lenses are tinted blue using C.I. reactive blue 19 to make them more visible for These lenses contain UV blocker, a benzotriazole UV absorbing monomer handling. to block UV radiation. The average transmittance characteristics of theses lenses are less than 5 % in the UV range of 280-315 nm and less than 30% in the UVA range of 315-380mm. Lenses are supplied sterile in sealed blister package containing sterile isotonic borate buffered saline solution.
This is a 510(k) premarket notification for cosmetic contact lenses, not an AI/ML device. Therefore, the requested information about acceptance criteria and study design for an AI/ML device is not applicable here.
The document discusses the substantial equivalence of the Aquamax (Etafilcon A) contact lenses to existing predicate devices (ACUVUE and Discon Plus contact lenses) based on non-clinical performance tests and technological characteristics.
The document does not contain information about:
- Acceptance criteria for an AI/ML device.
- A "study that proves the device meets the acceptance criteria" in the context of AI/ML performance metrics.
- Sample sizes for test sets and data provenance for AI/ML.
- Number of experts, their qualifications, or adjudication methods for ground truth in an AI/ML context.
- Multi-reader multi-case (MRMC) comparative effectiveness studies.
- Standalone algorithm performance.
- Training set information for an AI/ML model.
Instead, it focuses on demonstrating substantial equivalence through:
- Technological characteristics comparison: This involves comparing physical and chemical properties of the lenses (e.g., water content, refractive index, oxygen permeability, transmittance) to predicate devices.
- Biocompatibility tests: Standard tests for cytotoxicity, sensitization, and ocular irritation with negative responses.
- Microbiology tests: Validation of steam sterilization process and shelf-life stability to ensure sterility.
- Bacteriostatic validation: Verification of sterilizer effectiveness and lens sterility over time.
- Leachability studies: Confirmation of no leachable monomers or additive residues from the finished lenses.
The document states, "Clinical studies for Aquamx Bi-Weekly Disposable Soft (Hydrophilic) Contact Lenses and Aquamax (Etafilcon A) Daily Disposable Soft (Hydrophilic) Contact Lenses are not required for the premarket notification as the USAN name and process are the same as the above mentioned predicate devices." This further confirms that no clinical studies (and by extension, no AI/ML specific performance studies) were conducted or reported for this submission.
§ 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.