(51 days)
The Largan 55 UV (ocufilcon D) Daily Wear Soft (hydrophilic) Contact Lens is a daily wear soft contact lens indicated for the correction of refractive ametropia (myopia and hyperopia) in phakic 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 55 UV (ocufilcon D) Daily Wear Soft (hydrophilic) Contact Lens for Astigmatism is indicated daily wear for the correction of ametropia (myopia and hyperopia) with astigmatism in aphakic persons with nondiseased 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 55 UV (ocufilcon D) Daily Wear Soft (hydrophilic) Contact Lens for Presbyopia is indicated daily wear for the correction of ametropia (myopia) and emmetropia with presbyopia in aphakic and non-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 disinfected using a chemical disinfection system only.
The Largan 55 UV (ocufilcon D) Daily Wear Soft (hydrophilic) Contact Lens is in hemispherical flexible shells for myopia, hyperopia, astigmatisam and Presbyopia. The lens is made from HEMA containing UV blocker. The composition of the lens is 45% ocufilcon D and 55% water. The lens is tinted with "Reactive Blue 246" to make a light blue color for handling visibility purpose. A Benzophenone UV absorbing monomer is used to block UV radiation. The transmittance characteristics are less than 5% in the UVB range of 280-315nm and less than 50% in the UVA range of 316-380mm. It is supplied in a sterile package with buffered saline solution.
This document is a 510(k) Pre-Market Notification from Largan Medical Co. Ltd. to the FDA for their Largan 55 UV (ocufilcon D) Daily Wear Soft (hydrophilic) Contact Lenses. It seeks to demonstrate substantial equivalence to a predicate device, the Biomedics 55 (ocufilcon D) Soft (hydrophilic) Contact Lens (K091339) manufactured by CooperVision, Inc.
Here's an analysis of the acceptance criteria and the study that proves the device meets them, based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance:
The document doesn't explicitly state "acceptance criteria" in a quantitative performance metric for the device itself (e.g., a specific visual acuity improvement percentage). Instead, the acceptance is based on demonstrating substantial equivalence to a legally marketed predicate device. This means the new device must be as safe and effective as the predicate.
The comparison table below outlines key characteristics of the new device and the predicate device, highlighting their similarities and differences. The implied acceptance criteria for most metrics are that the new device's specifications should be comparable or within acceptable ranges to the predicate.
| Item | Acceptance Criteria (Implied by Predicate) | Reported Device Performance (Largan 55 UV) |
|---|---|---|
| Product Name | Biomedics Daily Wear Soft Contact Lens | Largan 55 UV daily wear soft contact lens |
| Manufacturer | Cooper Vision., Inc. | Largan Medical Co. Ltd |
| Intended Use | Myopia, Hyperopia, astigmatism, Presbyopia | Myopia, Hyperopia, astigmatism, Presbyopia |
| Lens Design | Spherical, aspherical, toric, multifocal | aspherical, toric, or multifocal |
| Replacement Schedule | Daily Wear | Daily Wear |
| Chemical composition | Ocufilcon D | Ocufilcon D |
| Classification | Group IV (ionic, High water) | Group IV (ionic, High water) |
| Water Content | 55% | 55 % |
| Oxygen Permeability (DK, 35°C) | 19.6 | 19.6 (Fatt method) |
| Base Curve Range (mm) | 6.50 to 10.8 | 8.0~9.0 |
| Diameter (mm) | 12.8 to 18.0 | 13.0~15.0 |
| Center Thickness | 0.025-0.40 mm (Varies with power) | Varies with design and power (0.084 mm at -3.00D) |
| Powers | -20.00 to +20.00D | -10.00D to +3.00D |
| Add Powers | +0.25D to +3.00D | +0.25E to +3.50D |
| Cylinder Power | -0.25D to -10.00D | -0.25D to -5.00D |
| Axis | 1° to 180° | 1° to 180° |
| Refractive Index | 1.41 | 1.405 |
| Light Transmittance | >95% | 90% |
| Blue handling tint | Entrapment Dye | Reactive Blue 246 |
| UV Block | (Implied by predicate's safety) | Less than 5% in UVB (280-315nm) and 50% in UVA (316-380nm) |
| Toxicology/Biocompatibility | Non-toxic and biocompatible in ocular environment (implied by predicate) | Non-toxic and biocompatibility acceptable |
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 explicitly states: "no clinical data is required." This indicates that there was no test set (as in, a set of subjects on whom clinical performance was specifically tested for this 510(k)). The determination of substantial equivalence was based on a comparison of characteristics to the predicate device and non-clinical laboratory testing. Therefore, there is no sample size for a test set, nor data provenance in the context of a clinical study.
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)
Since no clinical test set was used, there were no experts used to establish ground truth in the context of clinical performance data for the Largan 55 UV contact lenses. The ground truth for the safety and effectiveness is largely established by the predicate device's prior approval and the general understanding of contact lens materials and designs.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
As there was no clinical test set, there was no adjudication method employed.
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. The device in question is a contact lens, not an AI-powered diagnostic tool. Therefore, no MRMC study or assessment of human reader improvement with/without AI assistance was performed or reported.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This is not applicable. The device is a physical contact lens, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
The "ground truth" in this context is the established safety and effectiveness of the predicate device (Biomedics 55, K091339) and the scientific understanding of the materials (ocufilcon D) and design principles for contact lenses. The evaluation relies on:
- Physical and chemical properties: Assessed according to ISO 18369.
- Toxicology/Biocompatibility: Demonstrated through non-clinical studies.
- Comparison of characteristics: To a legally marketed predicate device.
Essentially, the ground truth is that if the new device is sufficiently similar to an already approved, safe, and effective device in its critical characteristics, then it is also considered safe and effective.
8. The sample size for the training set
This is not applicable. The device is a contact lens and does not involve AI or machine learning models that require a training set.
9. How the ground truth for the training set was established
This is not applicable, as there is no training set for an AI/ML algorithm involved with this medical device submission.
§ 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.