(274 days)
The Metro Soft, sphere (efrofilcon A) Silicone Hydrogel Soft Contact Lenses for daily wear are indicated for the correction of ametropia (myopia and hyperopia) in aphakic and non-aphakic persons with nondiseased eyes. The lens may be worn by persons who exhibit refractive astigmatism of .75 diopters or less where the astigmatism does not interfere with visual acuity.
The Metro Soft, toric (efrofilcon A) Silicone Hydrogel Soft Contact Lenses for daily wear are indicated for the correction of ametropia (myopia and hyperopia) in aphakic and non-aphakic persons with nondiseased eyes and/or possesses refractive astigmatism not exceeding 12 diopters.
The Metro Soft, multifocal (efrofilcon A) Silicone Hydrogel Soft Contact Lenses for daily wear are indicated for the correction of ametropia (myopia and hyperopia) in aphakic and non-aphakic persons with non-diseased eyes and/or possesses refractive astigmatism not exceeding .75 diopters and are presbyopic requiring add power of up to +4.00 diopters.
The Metro Soft, multifocal toric (efrofilcon A) Silicone Hydrogel Soft Contact Lenses for daily wear are indicated for the correction of ametropia (myopia and hyperopia) in aphakic and non-aphakic persons with non-diseased eves and/or possesses refractive astigmatism not exceeding 4 diopters and are presbyopic requiring add nower of up to +4.00 diopters.
The Metro Soft, irregular cornea (efrofilcon A) Silicone Hydrogel Soft Contact Lenses for daily wear are indicated for the correction of ametropia (myopia and hyperopia) in aphakic and non-aphakic persons and may be prescribed in otherwise non-diseased eyes that require a Soft Contact Lens for the management of irregular corneal conditions such as keratoconus and post graft fitting.
Eyecare practitioners may prescribe the lenses for frequent/planned replacement wear, with cleaning, disinfection and scheduled replacement. When prescribed for frequent/planned replacement wear, the lens may be cleaned and disinfected using a chemical (not heat) lens care system or hydrogen peroxide disinfection systems.
The Metro Soft Silicone Hydrogel Soft Contact Lenses are fabricated from efrofilcon A. which in the dry (unhydrated) state may be machined and polished. The hydrophilic nature of this material allows the lens to become soft and pliable when immersed in an aqueous solution.
The non-ionic lens material, (efrofilcon A) is a daily wear silicone hydrogel contact lens that is not surface treated and characterized by a high water content. The lens material is composed of silicone monomers cross linked with other monomers and optionally incorporates D&C Green 6 as an integrated handling tint. The lenses are made by lathe-cut for custom RX. It consists of 26% efrofilcon A and 74% water by weight when immersed in a buffered saline solution. The (efrofilcon A) name has been adopted by the United States Adopted Names Council (USAN).
In the hydrated state, the lens conforms to the curvature of the eye covering the cornea and extending slightly bevond the limbus forming a colorless, transparent optical surface. The (efrofilcon A) 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 provided text describes a 510(k) summary submission for a medical device, the Metro Soft Silicone Hydrogel Daily Wear Soft Contact Lens. This type of submission focuses on demonstrating substantial equivalence to existing legally marketed devices, rather than establishing entirely new safety and effectiveness through extensive standalone clinical trials.
Therefore, the requested information about acceptance criteria, a study proving device meets acceptance criteria, sample sizes for test/training sets, number/qualifications of experts, adjudication methods, MRMC studies, or specific ground truth for an AI/algorithm-based device is not applicable to this document. This document details a regulatory submission for a contact lens, which is a physical device, and not an AI or algorithm.
Instead, the document outlines the following:
1. Acceptance Criteria and Reported Device Performance:
The "acceptance criteria" in this context are the characteristics of the device that demonstrate its substantial equivalence to predicate devices. The performance is reported by direct comparison of its physical properties and intended use.
| Characteristic | Metro Soft (efrofilcon A) - New Device | Predicate (IntelliWave3, efrofilcon A) | Predicate (Metro Optics RevitalEyes, hioxifilcon B) | Predicate (Coopervision Biofinity, comfilcon A) | Predicate (Hydron Ltd. ActiFresh 400, lidofilcon A) |
|---|---|---|---|---|---|
| Intended Use | Daily wear for correction of ametropia, management of irregular corneal conditions. | Same as new device | Same as new device | Daily wear for correction of ametropia. | Daily wear for correction of ametropia. |
| Functionality | Same as predicate device | Focus light rays on retina | Focus light rays on retina | Focus light rays on retina | Focus light rays on retina |
| Indications | Daily wear, Silicone Hydrogel Soft | Daily wear, Silicone Hydrogel Soft | Daily wear, Soft | Daily wear, Silicone Hydrogel Soft | Daily wear, Soft |
| Production Method | Lathe-Cut, custom manufactured | Lathe-Cut, custom manufactured | Lathe-Cut, custom manufactured | Cast Molded, mass produced | Lathe-Cut, custom manufactured |
| USAN Name | efrofilcon A | efrofilcon A | hioxifilcon B | comfilcon A | lidofilcon A |
| Water Content | 74% | 74% | 48% | 48.0% | 74.0% |
| Oxygen Permeability | 60 x 10-11 cm2/sec | 60 x 10-11 cm2/sec | 15.89 x 10-11 cm2/sec | 128 x 10-11 cm2/sec | 28 x 10-11 cm2/sec |
| Specific Gravity | 1.139 | 1.139 | 1.142 | 1.142 | 1.060 |
2. Study Proving Device Meets Acceptance Criteria:
The study that "proves the device meets the acceptance criteria" in this context is the comparison demonstrating substantial equivalence to legally marketed predicate devices. The document explicitly states:
- Clinical Data: "The clinical performance of the (efrofilcon A) lens material has been previously established, and therefore was not required for this 510(k)." This indicates that clinical studies were performed for the material in a prior submission (likely K100221 for IntelliWave3).
- Non-clinical Testing: "A series of in vitro and in vivo preclinical toxicology and biocompatibility tests were performed to assess the safety and effectiveness of the Metro Soft (efrofilcon A) Silicone Hydrogel Soft Contact Lenses... All non-clinical toxicology tests were conducted in accordance with the GLP regulation. All other testing was conducted according to valid scientific protocols."
- Key Finding for Substantial Equivalence: "The Metro Soft, (efrofilcon A) Silicone Hydrogel Daily Wear Soft Contact Lens is identical to the cleared Intelliwave3 (efrofilcon A) Silicone Hydrogel Daily Wear Soft Contact Lens, cleared under K100221." And "The Metro Soft, (efrofilcon A) Silicone Hydrogel Daily Wear Soft Contact Lenses have the identical manufacturing process (lathe-cut versus lathe-cut) as the marketed Intelliwave3 (efrofilcon A) Silicone Hydrogel Daily Wear Soft Contact Lens, cleared under K100221."
No specific sample sizes for test sets, data provenance, number of experts, adjudication methods, MRMC studies, standalone algorithm performance, or training set details are provided because this is a 510(k) submission for a physical medical device, not an AI/ML algorithm requiring such specific performance validation methods. The "ground truth" for this submission relies on established safety and performance data of the predicate devices and general standards for biocompatibility and material properties of contact lenses.
§ 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.