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510(k) Data Aggregation
(281 days)
CALAVIEW COLORS (ETAFILCON A) SOFT (HYDROPHILIC) CONTACT LENS
Calaview Colors (Etafilcon A) Soft (hydrophilic) Contact Lens is indicated for daily wear 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.
The eye care practitioner may prescribe the contact lens for frequent replacement wear, with cleaning, rinsing and disinfection and scheduled replacement as prescribed by the eyecare professional. The contact lens may be disinfected using chemical (not heat) disinfection system.
Calaview Colors Soft (hydrophilic) Contact Lens are available as non-spherical lenses manufactured by spin-casting method. The model illuminated with high water content (58 ± 1%). The hydrogel lens' material is a random copolymer composed of 2-hydroxyethyl methacrylate (HEMA) and methacrylic acid (MAA), which was cross-linked with 1,1,1-trimethylolpropane trimethacrylate (TMPTMA) and Ethylene Glycol Dimethacrylate (EGDMA) via UV photo- polymerization. The Calaview Colors Contact lens 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 Colors (Etafilcon A) Soft (hydrophilic) Contact Lens 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 blister packers containing sterile isotonic phosphate buffered saline solution.
The provided text describes the safety and effectiveness of Calaview Colors (Etafilcon A) Soft (hydrophilic) Contact Lens for Daily Wear. This is a premarket notification (510(k)) submission, which aims to demonstrate that a device is substantially equivalent to a legally marketed predicate device. Therefore, the "acceptance criteria" are implied by the characteristics and performance of the predicate devices.
Here's a breakdown of the requested information based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria for the Calaview Colors (Etafilcon A) Soft (hydrophilic) Contact Lens are implicitly set by the characteristics and performance of its predicate devices: ACUVUE 2 colours Brand (Etafilcon A) Contact Lens (K010114) and Discon (Etafilcon A) Soft (hydrophilic) Contact Lens for Daily Wear (K051129). The study demonstrates substantial equivalence to these predicates rather than explicitly stating acceptance criteria for each metric.
| Characteristic | Acceptance Criteria (Predicate Range/Values) | Reported Device Performance (Calaview Colors) |
|---|---|---|
| %Water content | 57 to 59 (Discon) / 58 (Acuvue Colors) | 57 to 59 |
| Refractive index | 1.407 (Discon) / 1.40 (Acuvue Colors) | 1.407 |
| Specific Gravity | 1.05 (Discon & Acuvue Colors) | 1.05 |
| Oxygen permeability (edged corrected) @ 35°C | 24 x 10^-11 [(cm²/sec)(ml O₂/ml-mmHg)] (Discon) / 22.4 x 10^-11 [(cm²/sec)(ml O₂/ml-mmHg)] (Acuvue Colors) | 24 x 10^-11 [(cm²/sec)(ml O₂/ml-mmHg)] |
| %Light Transmission | >93 (Discon) / >85 (Acuvue Colors) | >93 |
| Base Curve Radius, mm | 8.00 | 8.00~9.00 |
| Diameter, mm | 13.8 | 13.8~14.2 |
| Center Thickness, mm | 0.08 | 0.08~0.20 |
| Power, Diopters | +6.0D~-20.0D (Discon) / +20.0D~-20.0D (Acuvue Colors) | +6.0D~-20.0D |
| Biocompatibility | Non-toxic, non-irritating, non-cytotoxic (based on predicate standards) | Irritation test in rabbit eye: non-irritated. Systemic toxicity: non-toxic. Cytotoxicity: not cytotoxic. |
| Sterilization | Minimum SAL of 10⁻⁶ (based on FDA Group IV requirement) | Steam sterilization validated to deliver minimum SAL of 10⁻⁶ |
| Leachability | No leachable monomers and addictive residues at detection levels (based on predicate standards) | No leachable monomers and addictive residues |
| Clinical performance | "Good and safe" with corrected vision and satisfaction (from predicate experience) | Nearly 100% vision corrected, nearly all satisfied, generally stable condition without severe complication. |
2. Sample Size Used for the Test Set and Data Provenance
The clinical study involved a test set of 65 human eyes.
The data provenance mentions "Calaview Colors lenses have been wide-used around the world, including Taiwan. China, Europe, etc." and implies the study participants were part of this usage. The study appears to be retrospective in the sense that the lenses "have been wide-used" and observed, although the "65 human eyes ... within 6 months" could also indicate a prospective observational study. Without further details, it's difficult to definitively classify. The country of origin for the 65 human eyes is not explicitly stated within the document for the specific clinical study, but the submitter is based in Taiwan.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
The document does not provide information on the number or qualifications of experts used to establish a "ground truth" for the test set in the clinical study. The assessment of "vision corrected," "satisfied with the lens wearing," and "stable condition without severe complication" likely comes from the "eye care practitioner" mentioned, but no specifics are given.
4. Adjudication Method for the Test Set
The document does not specify any adjudication method (e.g., 2+1, 3+1, none) for the clinical study's test set.
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
No MRMC comparative effectiveness study was done. This device is a contact lens; therefore, it's not an AI-assisted diagnostic tool for which an MRMC study would be relevant.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
No standalone algorithm performance study was done. Again, this is a physical medical device (contact lens), not an algorithm.
7. The Type of Ground Truth Used
For the clinical study, the "ground truth" was based on clinical observation and patient reported outcomes (e.g., visual acuity correction, patient satisfaction, lack of adverse events/complications). For the technical characteristics, the "ground truth" was established by laboratory measurements against defined standards or measurements from predicate devices.
8. The Sample Size for the Training Set
This submission is for a physical medical device (contact lens); it does not involve a "training set" in the context of machine learning algorithms. The manufacturing process and material properties are developed and validated through engineering and scientific principles, not machine learning training.
9. How the Ground Truth for the Training Set Was Established
As there is no training set in the machine learning sense, this question is not applicable. The device's design and manufacturing rely on well-established principles of polymer chemistry and optics, and its safety and effectiveness are confirmed through non-clinical laboratory testing and clinical observation against predicate devices and regulatory requirements.
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