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510(k) Data Aggregation
(244 days)
The Largan DB (ocufilcon D) Daily Wear Soft (hydrophilic) Contact Lens/ Largan DB Color (ocufilcon D) Daily Wear Soft (hydrophilic) Contact Lens is a daily wear soft (hydrophilic) contact lens indicated for the correction of refractive ametropia (myopia and hyperopia) in aphakic or non-aphakic persons with non-diseased eyes who exhibit refractive astigmatism of 1.00D or less where the astigmatism does not interfere with visual acuity.
The Largan DB (ocufilcon D) Daily Wear Soft (hydrophilic) Contact Lens for Astigmatism/ Largan DB Color (ocuffilcon D) Daily Wear Soft (hydrophilic) Contact Lens for Astigmatism is indicated daily wear for the correction of amercopia (myopia and hyperopia) with astigmatism in aphakic persons with non-diseased eyes and whose powers are from -10.00 to +3.00 diopters and astigmatic corrections are from -0.25 to -5.00 diopters.
The Largan DB (ocufilcon D) Daily Wear Soft (hydrophilic) Contact Lens for Presbyopial Largan DB Color (ocufilcon D) Daily Wear Soft (hydrophilic) Contact Lens for Presbyopia is indicated daily wear for the correction of ametropia (myopia and hyperopia) and emmetropia with presbyopia in aphakic persons with non-diseased eyes and whose powers are from -10.00 to +3.00 diopters with add powers from +0.25 to +3.50 diopters. The lenses may be worn by persons who exhibit astigmatism of 1.00 diopters or less where the astigmatism does not interfere with visual acuity.
Eye care practitioners may prescribe the lens for either single-use disposable wear, or for frequent/planned replacement wear, with cleaning, disinfection, and scheduled replacement. When prescribed for single-use disposable wear, the lens is to be discarded after each removal, therefore no cleaning or disinfecting is required. When prescribed for frequent replacement, the lens may be disinfection system only. When prescribed for frequent replacement, it is recommended that the lenses be discarded and replaced with a new lens not more than every 1 month. However, the Eye Care Professional is encouraged to determine an appropriate replacement schedule based upon the response of the patient. The Largan DB Color (Ocufilcon D) Daily Wear Soft (hydrophilic) Contact Lens is also intended to enhance or alter the apparent color of the eye.
The Largan DB (Ocufilcon D) Daily Wear Soft (hydrophilic) Contact Lens/ Largan DB Color (Ocufilcon D) Daily Wear Soft (hydrophilic) Contact Lens is available as an aspherical lens, multifocal lens and as an astigmatic (toric) lens. The lens material (Ocufilcon D) is a hydrophilic co-polymer cross-linked with Ethylene Glycol Dimethacrylate (EGDMA). The hydrated lens consists of 45.0% (Ocufilcon D) and 55.0% water by weight of immersed in normal saline
The Largan DB (Ocufilcon D) Daily Wear Soft (hydrophilic) Contact Lens, Largan DB Color (Ocufilcon D) Daily Wear Soft (hydrophilic) Contact Lens, Largan DB (Ocufilcon D) Daily Wear Soft (hydrophilic) Contact Lens for ASTIGMATISM, Largan DB Color (Ocufilcon D) Daily Wear Soft (hydrophilic) Contact Lens for ASTIGMATISM, Largan DB (Ocufilcon D) Daily Wear Soft (hydrophilic) Contact Lens for PRESBYOPIA and Largan DB Color (Ocufilcon D) Daily Wear Soft (hydrophilic) Contact Lens for PRESBYOPIA is a hemispherical flexible shell, which covers the cornea and a portion of the adjacent sclera. UV absorbing monomer is used to filter UV radiation. Reactive Yellow 15 is used to tint the lens. The average transmittance characteristics (the thinnest lens measured by spectrophotometry as stated in ISO 18369) are less than 5% in the UVB range of 280 to 315 nm and less than 50% in the UVA range of 315 to 380 nm. The lenses are available with a visibility-handling tint or with a decorative tint intended to enhance or alter the apparent color of the eye.
This document describes a 510(k) premarket notification for contact lenses. No studies are presented that describe acceptance criteria and device performance in the context of AI/ML or image analysis. The document focuses on demonstrating substantial equivalence to a predicate device, which for contact lenses primarily relies on physicochemical and biocompatibility testing rather than clinical performance studies when the technological characteristics are comparable.
Therefore, I cannot provide a detailed answer to your request regarding acceptance criteria and study results in the context of device performance as you describe (e.g., sample size for test set, data provenance, number of experts, adjudication method, MRMC studies, standalone performance, training set sample size, ground truth establishment for AI/ML models) because this information is not present in the provided text.
The closest information provided related to "acceptance criteria" and "device performance" in this document is:
1. A table of acceptance criteria and the reported device performance
The document presents a comparison table between the new device and predicate devices. While not a strict "acceptance criteria" table with numerical thresholds for performance, it implicitly shows that the Largan DB (Ocufilcon D) Daily Wear Soft Contact Lenses meet the implied performance standards by being identical or highly similar to the legally marketed predicate devices across key technical and material characteristics.
| Item | Device (Largan DB Ocufilcon D) | Predicate (Largan 55 UV Ocufilcon D) |
|---|---|---|
| Manufacturer | Largan Medical Co. Ltd. | The same |
| Intended Use | Myopia, Hyperopia, astigmatism, Presbyopia | The same |
| Indication for use | Correction of refractive ametropia (myopia and hyperopia) in aphakic or non-aphakic persons with non-diseased eyes; correction of ametropia with astigmatism; correction of ametropia and emmetropia with presbyopia. Can be single-use disposable or frequent/planned replacement. Color version enhances/alters eye color. | The same |
| Lens Design | Aspherical, toric, or multifocal | The same |
| Replacement Schedule | Daily Wear | The same |
| Chemical composition | Ocufilcon D | The same |
| Classification | Group IV (Ionic, High water) | The same |
| Water Content | 55 % | The same |
| Oxygen Permeability (DK, 35°C) | 19.6 (Fatt method) | The same |
| Base Curve Range(mm) | 8.0~9.0 | The same |
| Diameter (mm) | 13.0~15.0 | The same |
| Center Thickness | Varies with power (e.g., 0.084 mm for -3.00D for spherical & astigmatism, 0.130 mm for -3.00D for presbyopia) | The same |
| Powers | -10.00D to +3.00D (Cylinder -0.25D ~ -5.00 D with Axis 10° to 180° for astigmatism; Add Powers +0.25D ~ +3.50D for presbyopia) | The same |
| Refractive Index | 1.405 | The same |
| Light Transmittance | 90% | The same |
| Color additives | Device: Phthalocyanine green, Carbazole violet, [Phthalocyaninato(2-)]copper, Titanium dioxide, Iron oxides, Chromium-cobaltaluminum oxide, Mica-based pearlscent pigment, Yellow 15Predicate K181232: Reactive Blue 246Predicate K182523: Phthalocyanine green, Carbazole violet, [Phthalocyaninato(2-)]copper, Titanium dioxide, Iron oxides, Chromium-cobaltaluminum oxide, Mica-based pearlscent pigment | Predicate K181232: Reactive Blue 246Predicate K182523: Phthalocyanine green, Carbazole violet, [Phthalocyaninato(2-)]copper, Titanium dioxide, Iron oxides, Chromium-cobaltaluminum oxide, Mica-based pearlscent pigment |
| Method of Manufacture | Cast Molded | The same |
| Packaging saline | Saline solution with sodium hyaluronate and poloxamer kolliphor P407 | The same |
Note: The color additives vary slightly between the new device and the predicate K181232, but are similar to K182523. This difference is addressed through nonclinical testing below.
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
Not applicable. The submission is for contact lenses, and no clinical test set for AI/ML performance is mentioned. The primary studies referenced are physicochemical and biocompatibility 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, as no clinical test set requiring expert ground truth is described.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable.
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, as no AI or diagnostic imaging component is involved.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable.
7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)
Not applicable in the context of an AI/ML algorithm. The "ground truth" for contact lenses is established by meeting specified physical, chemical, and biological safety standards.
8. The sample size for the training set
Not applicable, as no AI/ML training set is mentioned.
9. How the ground truth for the training set was established
Not applicable.
Studies that prove the device meets acceptance criteria:
The document states:
- Nonclinical Tests Performed:
- Physiochemical studies were conducted according to ISO 18369-4 second edition 2017-08, Ophthalmic optics -Contact lenses (Ophthalmic). The report states: "The physical, optical and chemical properties of the lens are within established specification for the lenses."
- Biocompatibility studies (cytotoxicity, acute ocular irritation, and acute systemic injection toxicity) of the subject lenses and primary package were conducted according to ISO 10993 series biocompatibility standard. The report states: "all of them are nontoxic and biocompatible." Specific standards referenced include:
- ISO 10993 Biological evaluation of medical devices- Part 5: Tests for in vitro cytotoxicity. (2009)
- ISO 10993 Biological evaluation of medical devices- Part 10: Tests for irritation and skin sensitization. (2010)
- ISO 10993 Biological evaluation of medical devices- Part 11: Tests for Systemic toxicity. (2006)
- ISO 10993 Biological evaluation of medical devices- Part 12: Sample preparation and reference materials. (2012)
- Clinical Studies: "The technical characteristics, formulation, manufacturing process of the subject device are equivalent to Largan 55 UV (Ocufilcon D) Daily Wear Soft (hydrophilic) Contact Lens (K181232) and Largan 55 UV Color (Ocufilcon D) Daily Wear Soft (hydrophilic) Contact Lens (K182523) current marketed by Largan Medical Co., Ltd, therefore no clinical data is required." This indicates that the equivalence to predicate devices, supported by nonclinical testing, is deemed sufficient to establish safety and effectiveness, meaning no new clinical trials were performed or required.
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