(280 days)
The MiGwang Comfort 38 (polymacon) Spherical Soft Contact Lenses for daily wear are indicated for the correction of visual acuity in aphakic and not aphakic persons with non-diseased eyes with myopia or hyperopia. The lens may be worn by persons who exhibit refractive astigmatism of .50 diopters or less where the astigmatism does not interfere with visual acuity. The lens is available clear or tinted and may be used to enhance or alter the apparent color of the eye.
The MiGwang Comfort 38 (polymacon) Toric Soft Contact Lenses for daily wear are indicated for the correction of visual acuity in aphakic and not aphakic persons with non-diseased eyes with myopia or hyperopia and/or possesses refractive astigmatism not exceeding 5.00 diopters. The lens is available clear or tinted and may be used to enhance or alter the apparent color of the eye.
Eyecare practitioners may prescribe any of the above lenses for frequent/planned replacement wear, with cleaning disinfection and scheduled replacement. When prescribed for frequent/planned replacement wear, the lens may be disinfected using a chemical disinfecting system.
The MiGwang Comfort 38 (polymacon) Soft Contact Lenses are hemispherical shells with molded spherical base curves and lathe-cut front surfaces. The MiGwang Comfort 38 soft contact lens is fabricated from a nonionic polymer,
The nonionic lens material, (polymacon) is a hydrophilic polymer of 2- Hydroxyethyl methacrylate (2-HEMA) and cross-linked with ethylene glycol dimethacrylate (EGDMA), plus an initiator. The copolymer consists of 62% polymacon and 38% water by weight when immersed in normal buffered saline solution. The lenses are available clear or tinted. Lenses are tinted with one or a combination of one or more of the following 'listed' color additives: C.I. Reactive black 5, C.I. Vat orange 5, Iron oxides, C.I. Pigment green 7, C.I. Vat brown 1, C.I. Vat yellow 3, C.I. Vat blue 6, C.I. vat orange 1, C.I. Vat green 1, C.I. Pigment blue 36, C.I. Pigment violet 23, D&C Green No.6, phthalocyanato (2) copper, D&C Yellow No. 10. D&C Red No. 17 and Titanium dioxide. Lenses that contain a unique tinting pattern are subsequently processed to incorporate the 'listed' color additives, and contain only the amount of color additive needed to accomplish the intended coloring effect.
In the hydrated state, the lens conforms to the curvature of the cornea and extending slightly beyond the limbus forming a transparent or colored optical surface. The (polymacon) soft hydrophilic contact lens has a spherical back surface. The hydrophilic properties of the lens require that it be maintained in a fully hydrated state in a solution compatible with the eye. If the lens dries out, it will become hard and appear somewhat warped however, it will return to its proper configuration when completely rehydrated in the proper storage solution.
The hydrophilic characteristics allow aqueous solutions to enter the lens and in its fully hydrated state the lens is approximately 38% water by weight. The physical properties of the lens are:
Refractive Index: 1.43 (hydrated)
Light Transmission (clear): greater than 90%
Light Transmission (tinted): greater than 90%
Water Content: 38% ± 2%
Oxygen Permeability: 9.77 X 10-11 (cm2/sec) (ml O2/ml x mm Hg @ 35°C), (revised Fatt method).
The provided text describes a 510(k) submission for a soft contact lens and focuses on demonstrating substantial equivalence to already marketed predicate devices. It does not contain information about a study that measures device performance against specific acceptance criteria using a test set, expert ground truth, or statistical analysis.
Therefore, I cannot provide the requested information in the format described, as the document does not include a performance study with detailed acceptance criteria and outcome metrics for the new device.
However, I can extract the information that is present regarding the device's properties and its comparison to predicate devices, which served as the basis for its substantial equivalence claim.
Acceptance Criteria and Device Performance (Based on Substantial Equivalence)
The acceptance criteria are not explicitly stated as performance targets, but rather as substantial equivalence to predicate devices based on material, properties, and intended use. The "reported device performance" is essentially its physical characteristics and safety profile, which are declared equivalent to the predicates.
1. Table of Acceptance Criteria and Reported Device Performance
| Criterion / Property | MiGwang Comfort 38 (Proposed Device) | Predicate Device (Advantage 38) | Predicate Device (Contaflex 38) | Acceptance (Substantial Equivalence) |
|---|---|---|---|---|
| Manufacturer | MiGwang Contact Lens Company | Preferred Optics | Contamac Ltd. | N/A (Manufacturer identity) |
| Intended Use | Daily Wear, Soft (hydrophilic) Contact Lens | Daily Wear, Soft (hydrophilic) Contact Lens | Daily Wear, Soft (hydrophilic) Contact Lens | Equivalent |
| Indications for Use | Correction of visual acuity in aphakic/not aphakic persons with non-diseased eyes with myopia or hyperopia, and/or refractive astigmatism not exceeding 5.00 diopters. Spherical lenses: astigmatism 90% | Not specified for predicates | Not specified for predicates | N/A (Industry standard for clear) |
| Light Transmission (tinted) | > 90% | Not specified for predicates | Not specified for predicates | N/A (Industry standard for tinted) |
| Oxygen Permeability | 9.77 X 10-11 (cm2/sec) (ml O2/ml x mm Hg @ 35°C) (revised Fatt method) | Not specified for predicates | Not specified for predicates | N/A (Characteristic of polymacon) |
| Toxicity (safety) | Non-Toxic | Non-Toxic | Non-Toxic | Equivalent |
2. Sample size used for the test set and the data provenance
Not applicable. The document does not describe a clinical performance study with a test set. The submission relies on demonstrating substantial equivalence to already approved devices rather than presenting new clinical study data for device performance. The "data provenance" mentioned in the document refers to the established safety profile (preclinical toxicology and manufacturing/chemistry data) of the polymacon material, deemed equivalent to that of the predicate devices.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable. No such test set or expert ground truth establishment is described in this document.
4. Adjudication method for the test set
Not applicable. No such test set or adjudication method is described in this document.
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-powered diagnostic tool, so an MRMC study comparing human readers with and without AI assistance is irrelevant and was not performed.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This device is a contact lens, not an algorithm, so a standalone performance study in this context is irrelevant and was not performed.
7. The type of ground truth used
The "ground truth" in this context is the established safety and effectiveness of the polymacon material, as demonstrated by its long-standing use in the "Advantage 38" and "ContaFlex 38" predicate devices. This implicitly refers to:
- Historical clinical data/usage: The predicate devices have been safely and effectively used in the market.
- Material properties data: Scientific and manufacturing data supporting the safety and performance characteristics of the
polymaconpolymer.
8. The sample size for the training set
Not applicable. No training set for an algorithm is discussed. The "training" for this device would be the extensive prior use and testing of the polymacon material in similar contact lenses.
9. How the ground truth for the training set was established
Not applicable. Similar to point 8, no training set in the AI sense is relevant. The "ground truth" for the material (polymacon) was established through years of research, manufacturing, and clinical use of contact lenses made from this polymer, leading to its FDA approval in predicate devices. This includes:
- Preclinical toxicology studies: To ensure the material is non-toxic to ocular tissues.
- Physical and chemical characterization: To determine properties like water content, oxygen permeability, refractive index, and light transmission.
- Clinical experience: The history of safe and effective use of contact lenses made from
polymaconin the market.
§ 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.