(366 days)
Calaview Color (Etafilcon A) Soft (hydrophilic) Contact Lens is indicated for daily wear for the correction of visual acuity in not-aphakic persons with non-diseased eyes that are myopic or hyperopic and may exhibit refractive astigmatism up to 2.00 diopters that does not interfere with visual acuity.
Eye care practitioners may prescribe the lenses for either single-use daily disposable wear or 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 contact lens may be disinfected using chemical (not heat) disinfection system.
Calaview Color (Etafilcon A) Soft (hydrophilic) Contact Lens for Daily Wear is available as aspherical lenses manufactured by spin-casting 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 1,1-trimethylolpropane trimethacrylate (TMPTMA) and Ethylene Glycol Dimethacrylate (EGDMA) via UV photo- polymerization. The Calaview Color (Etafilcon A) Soft (hydrophilic) Contact Lens for Daily Wear contains pigments around the non-optic area that will mask or enhance the color of the natural iris without blocking the light transmittance. The lens is colored with one or more of the FDA-approval color additives: iron oxides, titanium dioxide, phthalocyaninato copper, phtalocyanine green, vat orange 1. The Calaview Color (Etafilcon A) Soft (hydrophilic) Contact Lens for Daily Wear is available in the following opaque colors: Blue, green, violet, gray, hazel, white, yellow, gold, orange red and black. Lenses are supplied sterile in sealed glass vials containing sterile isotonic phosphate buffered saline solution.
The provided document is a 510(k) summary for the Calaview Color (Etafilcon A) Soft (hydrophilic) Contact Lens for Daily Wear. It is a submission for a labeling modification to a previously cleared predicate device (Calaview (Etafilcon A) Soft (hydrophilic) Contact Lens for Daily Wear cleared via K073060).
The core argument for substantial equivalence is that there are no changes to the lens material, manufacturing process, parameters, or properties between the predicate and the subject device. The only difference is the packaging vehicle (glass vials for the subject device vs. PP blister packaging for the predicate). Therefore, the clinical and non-clinical data previously submitted for the predicate device are used to support the safety and effectiveness of the subject device.
This means the study described is not a new clinical trial for the Calaview Color lens, but rather a demonstration that the new device's characteristics are equivalent to the predicate device, thereby relying on the predicate's established safety and effectiveness.
Here's an attempt to answer your questions based on the provided text, acknowledging that a direct "study" as you might expect for a new device's acceptance criteria won't be found here:
1. A table of acceptance criteria and the reported device performance
Since this is a labeling modification with no change in material or fundamental properties, the "acceptance criteria" are implied to be the established performance characteristics of the predicate device, which the subject device is shown to match.
| Characteristic | Acceptance Criteria (Predicate Device) | Reported Device Performance (Subject Device) |
|---|---|---|
| %Water content | 57 to 59 | 57 to 59 |
| Refractive index | 1.407 | 1.407 |
| Specific Gravity | 1.05 | 1.05 |
| Oxygen permeability (edged corrected) @ 35°C | $24 \times 10^{-11}$ [(cm2/sec)(ml O2/ml-mmHg)] | $24 \times 10^{-11}$ [(cm2/sec)(ml O2/ml-mmHg)] |
| %Light Transmission | >93 | >93 |
| Base Curve Radius, mm | 8.00~9.00 | 8.00~9.00 |
| Diameter, mm | 13.8~14.2 | 13.8~14.2 |
| Center Thickness @-3.0D, mm | 0.08~0.12 | 0.08~0.12 |
| Power, Diopters | +6.0D~-12.0D | +6.0D~-12.0D |
| Biocompatibility | Non-toxic, not irritating, not cytotoxic (predicate) | No biocompatibility risks (due to identical material) |
| Sterility | SAL of 10-6 (validated steam sterilization) | SAL of 10-6 (validated steam sterilization) |
| Leachables | No leachable monomers or additive residues (predicate) | No leachable monomers or additive residues |
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 does not detail a new "test set" or clinical study with a specific sample size for the Calaview Color lens. Instead, it relies on the data from the predicate device (K073060). The provenance of that original data is not stated in this summary, but the company is based in Taiwan, R.O.C. The type of data would have been for a prospective clinical trial and non-clinical testing to achieve clearance for the predicate device. For the current submission, the "test" involved physical and chemical characterization of the subject device to demonstrate equivalence to the predicate.
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)
This is not applicable to this 510(k) submission. No new ground truth establishment is described or required as the submission relies on the established safety and effectiveness of the predicate device.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set
Not applicable. The submission focuses on demonstrating technical equivalence, not clinical adjudication of outcomes for a new clinical study.
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 device is a contact lens, not an AI-assisted diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This device is a contact lens.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
For the predicate device, the "ground truth" would have come from standard clinical evaluations of contact lens wear, including visual acuity measurements, ocular health assessments by ophthalmologists/optometrists, and patient reported outcomes. However, for this specific submission, the "ground truth" is the established specifications and safety profile of the predicate device, against which the Calaview Color lens is compared for equivalence in its physical, chemical, and biological properties.
8. The sample size for the training set
Not applicable. This is not an AI or machine learning device requiring a training set.
9. How the ground truth for the training set was established
Not applicable. This is not an AI or machine learning device.
§ 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.