(230 days)
The Unicon Hydrogel (etafilcon A) Soft (Hydrophilic) Daily Disposable Contact Lens is indicated for the optical correction of refractive ametropia (myopia and hyperopia) in phakic or aphakic persons with non-diseased eyes who may have 1.00 D or less of astigmatism. Eye care professionals may prescribe the lenses for daily disposable wear. Lenses shall be discarded upon removal.
The Unicon Hydrogel (etafilcon A) Soft (Hydrophilic) Daily Disposable Contact Lens is available as aspherical lenses manufactured by cast-molding method. The model illuminated with high water content (58 %). The hydrogel lens' material is a random copolymer composed of 2-hydroxyethyl methacrylate (HEMA) and methacrylic acid (MAA), which was cross-linked with Trimethylolpropane trimethacrylate (TMPTMA) and Ethylene Glycol Dimethacrylate (EGDMA) via UV photo-polymerization. The Unicon Hydrogel (etafilcon A) Soft (Hydrophilic) Daily Disposable Contact Lens with visible tint is light tinted blue using C.I Reactive Blue 246 to make the lens more visible for handling. The lenses also contain a UV absorber {2-[3-(2H-Benzotriazol-2-vl)-4-hydroxypheny]] ethyl methacrylate} which is included during the manufacturing process as an additive to block UV radiation. The average transmittance characteristics are less than 5% in the UVB range of 280 to 315 nm and less than 30% in the UVA range of 316 to 380 nm. With more specific explanation, the "Unicon Hydrogel (etafilcon A) Soft (Hydrophilic) Daily Disposable Contact Lens" is 58% water and 42% HEMA/MAA cast-molding aspherical soft contact lens. It is blister packaged and produced from +4.00D to -6.00D in 0.25D per step, from +4.50D to +6.00D in 0.50D per step, and from -6.50D to -13.00D in 0.50D per step.
The provided text describes the submission of a 510(k) premarket notification for the "Unicon Hydrogel (etafilcon A) Soft (Hydrophilic) Daily Disposable Contact Lens." This notification aims to demonstrate "substantial equivalence" to a predicate device, not necessarily to prove the device meets specific acceptance criteria as one might find for an AI/ML medical device.
Therefore, the requested information elements related to AI/ML device testing (sample sizes for test and training sets, data provenance, number and qualifications of experts, adjudication methods, MRMC studies, standalone performance, and ground truth types) are not applicable or mentioned in this document. This submission focuses on the physical and chemical properties and biocompatibility of a contact lens compared to a predicate device.
Below, I've extracted the closest relevant information regarding "acceptance criteria" (which are generally product specifications and compliance with standards) and "reported device performance" based on the provided text.
Acceptance Criteria and Reported Device Performance for Unicon Hydrogel (etafilcon A) Soft (Hydrophilic) Daily Disposable Contact Lens
This submission establishes substantial equivalence for the Unicon Hydrogel (etafilcon A) Soft (Hydrophilic) Daily Disposable Contact Lens to a predicate device (Tangible Hydrogel with Tangible Polymer (etafilcon A) ASPHERIC Soft (Hydrophilic) Daily Disposable Contact Lens). The "acceptance criteria" are implied by the product specifications and compliance with various international standards for contact lenses, which were met by the device.
1. A table of acceptance criteria and the reported device performance
The document provides a comparison of specifications between the subject device and the predicate device. The "reported device performance" are the physical and chemical properties of the Unicon Hydrogel contact lens. The acceptance criteria are essentially that these properties, or test results, meet established standards and are substantially equivalent to the predicate.
| Item / Property | Subject Device (Unicon Hydrogel) Performance | Predicate Device (Tangible Hydrogel) Performance | Substantial Equivalence Determination (Acceptance) |
|---|---|---|---|
| Intended Use | Optical correction of refractive ametropia (myopia and hyperopia) in phakic or aphakic persons with non-diseased eyes who may have 1.00 D or less of astigmatism. Daily disposable wear. | Optical correction of refractive ametropia (myopia and hyperopia) in phakic or aphakic persons with non-diseased eyes who may have 1.00 D or less of astigmatism. Daily disposable wear. | Same |
| Type of use | Prescription Use | Prescription Use | Same |
| Single Use | Yes | Yes | Same |
| UV Blocking | Yes (Avg98% | Different, but the specification meets the requirement; therefore it would not affect the equivalence. | |
| UV Transmittance (%) | At 280~315 nm: Avg. |
- Biocompatibility tests: Complies with ISO 10993-1:2009, ISO 10993-2:2006, ISO 10993-5:2009, ISO 10993-10:2010, ISO 10993-11:2017, and ISO 10993-12:2012 for In Vitro Cytotoxicity, White Rabbit Ocular Irritation, and Acute Systemic Toxicity.
- Performance tests (Humectant, Water Content, Transmittance, Refractive Index, Oxygen Permeability, Mechanical Properties, Extractables of Material Pigment, Extractables, pH Value, Osmolarity, Geometric Parameters, Specific Gravity): Complies with ISO 18369-2:2012, ISO 18369-3:2017, ISO 18369-4:2017, ANSI Z80.20-2004, ASTM D882:2002, and ASTM D1708-13.
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
The document states "A series of non-clinical studies were completed on this product." However, specific sample sizes for each test are not provided in this summary. The tests were performed according to FDA guidance "Premarket Notification [510(k)] Guidance Document for Class II Daily Wear Contact Lenses, Issued May 1994" and related recognized consensus standards. Data provenance (country of origin, retrospective/prospective) is not specified for these non-clinical tests.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
Not applicable. This is a contact lens submission primarily based on physical, chemical, and biological compatibility testing, not diagnostic AI/ML requiring expert ground truth for interpretation.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. This is not an AI/ML diagnostic device.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
Not applicable. This is not an AI/ML diagnostic device.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
Not applicable. This is not an AI/ML diagnostic device.
7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)
The "ground truth" for the non-clinical tests is based on established scientific and engineering principles, and validated measurement methods as described by the cited ISO, ASTM, ANSI, and USP standards. For example, water content is measured physically, and biocompatibility is assessed through standardized biological tests.
8. The sample size for the training set
Not applicable. This is not an AI/ML device that requires a training set. The device is a manufactured product tested for its inherent properties.
9. How the ground truth for the training set was established
Not applicable. This is not an AI/ML device that requires a training set.
§ 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.