(51 days)
The Clearcolor 1- Day (hioxifilcon A) and Aryancolor 1-Day (hioxifilcon A) Daily Disposable Soft (hydrophilic) Contact Lens is indicated for daily wear single use only for the optical correction of refractive ametropia (myopia and hyperopia) in phakic or aphakic person with non-diseased eyes who may have 1.00 D or less of astigmatism. The lens is intended to be worn once and then discarded at the end of each wearing period on a daily basis. The patient should be instructed to start the next wearing period with a new lens. The lens is available clear or tinted and may be used to enhance or alter the apparent color of the eye.
The subject device, Clearcolor 1- Day (hioxifilcon A) Daily Disposable Device Soft (hydrophilic) Contact Lens and Aryancolor 1-Day (hioxifilcon A) Description Daily Disposable Soft (hydrophilic) Contact Lens is a Soft Hydrophilic Daily Disposable Color Soft Contact Lens. The subject device is made of a nonionic lens material, hioxifilcon A, which is a random co-polymer of 2-Hydroxyethyl methacrylate (2-HEMA) and glycerol methacrylate (HEMA/GMA) cross-linked with ethylene glycol dimethacrylate. The copolymer consists of 42% hioxifilcon A and 58% water by weight when immersed in normal buffered saline solution. The hioxifilcon A name has been adopted by the United States Adopted Names Council (USAN). The subject device is a cosmetically tinted contact lens and contains a pigmented area that will mask or enhance the color of the natural iris. The cosmetically tinted lenses contain one or more of the following US FDA approved colorants for contact lenses: D&C Yellow, No. 10, D&C Green, D&C Red No. 17, Phthalocyanine-2-Copper, Carbazole Violet, Titanium dioxides, reactive Black 5, C.I. Vat Orange 1, C.I. Vat yellow 3, C.I. Pigment Green, C.I. Vat Orange 5, C.I. Vat Brown 1, C.I. Vat Green 1, Pigment Blue 36, and Iron Oxides. These colorants will be used to make 1-tone, 2-tone and 3-tone color patterns on contact lenses. The cosmetically tinted lens is available in variety of opaque colors including: Gray, Brown, Tan Brown, Black, Green, and Blue.
The provided document is a 510(k) premarket notification for a contact lens, and as such, it does not describe an AI medical device. Therefore, the requested information regarding acceptance criteria and studies for an "AI device" is not applicable.
The document focuses on demonstrating the substantial equivalence of the "Clearcolor 1-Day (hioxifilcon A) Daily Disposable Soft (hydrophilic) Contact Lens and Aryancolor 1-Day (hioxifilcon A) Daily Disposable Soft (hydrophilic) Contact Lens" to a legally marketed predicate device (clearlab (hioxifilcon A) 1-day soft (hydrophilic) contact lens, clear and visibility tinted for spherical, single use daily wear contact lens, cleared under K080632).
The "acceptance criteria" presented in the document are primarily the characteristic specifications of the contact lens. The "study that proves the device meets the acceptance criteria" refers to non-clinical testing performed to show the equivalence of the subject device to the predicate device, not the performance of an AI algorithm.
Below is a breakdown of the requested information, adapted to the context of this contact lens submission:
1. A table of acceptance criteria and the reported device performance
The document lists various characteristics of the subject device (Clearcolor 1-Day (hioxifilcon A) and Aryancolor 1-Day (hioxifilcon A) Daily Disposable Soft (hydrophilic) Contact Lens) and states they are identical to the predicate device (clearlab (hioxifilcon A) 1-day). Therefore, the "acceptance criteria" are implied to be these specifications, and the "reported device performance" is that the subject device meets these specifications, as evidenced by non-clinical testing and comparison to the predicate.
| Feature / Acceptance Criteria (Implied) | Reported Device Performance (Subject Device) |
|---|---|
| Device Classification | Class II, 21 CFR 886.5925 (b) (1), CODE-LPL, MNV SOFT (HYDROPHILIC) CONTACT LENS |
| Intended Use | Vision Correction |
| Wearing Schedule | Daily Wear |
| Replacement Schedule | Single Use (daily disposable) |
| Method of Manufacture | Spun cast molding |
| USAN Name | Hioxifilcon A |
| FDA Contact Lens Group Number | Group 2 - Low Water (>50% H2O) Nonionic Hydrogel Polymer |
| Lens Design | Spherical |
| Power Range (Diopters) | -10.0 D to +6.0 D |
| Base Curve Range | 8.0 mm to 9.4 mm |
| Diameter Range | 12.8 to 15.0 mm |
| Center Thickness (varies with power) | 0.08 mm to 0.266 mm |
| Water Content | 58% |
| Oxygen Permeability (Dk) | 25.38 x 10-11 (cm2/sec) (O2/mL x mm Hg), revised Fatt Method |
| Refractive Index | 1.40 |
| Light Transmission | Greater than > 95% |
| Sterilization | Steam Sterilization, validated autoclave |
| Packaging | Buffered Saline |
| Package Storage Saline | Buffered Saline |
| Biocompatibility (ISO 10993) | Non-Toxic |
| Toxicology Testing | Favorable results (Cytotoxicity, Ocular Irritation, Systemic Toxicity) |
| Leachable Testing | Favorable results |
| Physical & Chemical Testing | Favorable results |
| Stability Testing | Favorable results |
"Study that proves the device meets the acceptance criteria":
The document explicitly states: "Toxicology, physical, chemical and stability testing confirm the subject device [...] is safe and effective." It also mentions specific tests conducted as recommended by the US FDA Premarket Notification (510(k)) Guidance Document for Daily Wear Contact Lenses, 12 May 1984:
- Toxicology Testing:
- Cytotoxicity testing using the Argose Overlay method
- ISO Ocular Irritation Study
- USP & ISO Systemic Toxicity in Mice
- Leachable Testing
- Physical & Chemical Testing
- Stability Testing
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
This information is not explicitly provided in the document for the non-clinical tests. The tests are mentioned generally (e.g., "Cytotoxicity testing"), without details on the number of samples or the experimental setup. Data provenance for such lab-based material testing is typically internal to the manufacturer and not specified in the 510(k) summary beyond the type of test.
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 as the document describes non-clinical testing of a physical product (contact lens materials and characteristics), not an AI algorithm requiring expert ground truth labeling.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This is not applicable for the same reason as point 3.
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
This is not applicable. This document is for a contact lens, not an AI medical device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This is not applicable. This document is for a contact lens, not an AI medical device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
For the non-clinical tests, the "ground truth" is typically established by physical and chemical standards, validated protocols (e.g., ISO standards, USP standards), and material properties, rather than expert consensus on medical images or pathology. For example, water content is a direct measurement, and biocompatibility is assessed against established toxicological benchmarks.
8. The sample size for the training set
This is not applicable. There is no AI model or "training set" involved in this submission.
9. How the ground truth for the training set was established
This is not applicable for the same reason as point 8.
§ 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.