(131 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 persons with non-diseased eyes. The lens may be worn by persons who exhibit refractive astigmatism of 0.75 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 non-diseased 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) in aphakic and non-aphakic persons with non-diseased eyes and/or possesses refractive astigmatism not exceeding 0.75 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 eyes and/or possesses refractive astigmatism not exceeding 4 diopters and are presbyopic requiring add power of up to +4.00 diopters.
The Metro Soft, irregular cornea (efrofileon 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 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 Daily Wear 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 RB246 (1,4-Bis[4-(2-Methacryloxyethyl) phenylamino]-9, 10-Anthraquinone)as an integrated handling tint. The lenses are made by lathe-cut for individual patients. 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 beyond 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 hydrophilic characteristics allow aqueous solutions to enter the lens and in its fully hydrated state the lens is approximately 74% water by weight. The lenses will be manufactured in spherical, aspherical, toric, multifocal, multifocal toric and irregular cornea configurations.
The lens is supplied sterile in vials containing a buffered saline solution.
Here's an analysis of the acceptance criteria and supporting studies for the Metro Soft, Silicone Hydrogel Daily Wear Soft Contact Lens (efrofilcon A), based on the provided text:
Important Note: The provided document is a 510(k) summary for a contact lens. For medical devices like this, the "acceptance criteria" generally refer to established standards and benchmarks for safety and performance (e.g., ISO standards, physical property ranges), and the "study that proves the device meets the acceptance criteria" refers to the non-clinical and, if applicable, clinical testing performed to demonstrate compliance and substantial equivalence to a predicate device. This is different from the type of "acceptance criteria" and "study" typically associated with AI/ML-based diagnostic devices, which would involve metrics like sensitivity, specificity, AUC, and performance against a ground truth dataset.
Since this is a contact lens and not an AI/ML device, many of the requested fields regarding AI/ML-specific study design (test set sample size, data provenance, expert ground truth, adjudication, MRMC studies, standalone performance, training set) are not applicable to this submission.
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria for the Metro Soft contact lens are primarily defined by:
- Compliance with established ISO standards for biocompatibility and material properties.
- Meeting specified physical and optical parameter ranges with defined tolerances.
- Demonstrating similar performance characteristics (material properties, shelf life, solution compatibility) to the predicate devices.
- Having an equivalent Indications for Use statement to the predicate devices.
| Acceptance Criteria (General Category/Standard) | Specific Acceptance Criteria (Example) | Reported Device Performance (Metro Soft) |
|---|---|---|
| Material Properties: | ||
| Refractive Index (wet) | Not explicitly stated as an "acceptance criterion" value, but compared to predicate. | 1.3770 |
| Visible Light Transmission (%). | Not explicitly stated as an "acceptance criterion" value, but compared to predicate. | 94.4% |
| Specific Gravity (wet) | Not explicitly stated as an "acceptance criterion" value, but compared to predicate. | 1.049 |
| Water Content | 74 ± 2% | 74 ± 2% (Meets criterion) |
| Oxygen Permeability (Dk) | Not explicitly stated as an "acceptance criterion" value, but compared to predicate. | 56 x 10-11 (cm²/sec) (ml O₂/ml x mm Hg @ 35°C) |
| Device Parameters (with Tolerances): | ||
| Base Curve | Range: 8.0mm to 9.5mm; Tolerance: ± 0.20mm | All lenses manufactured to established finished product specifications within ANSI Z80.20 tolerance. (Implies all these parameters meet their respective tolerances.) |
| Center Thickness | Range: 0.01mm to 0.50mm; Tolerance: ≤ 0.10 mm → ±0.010 mm + 10%; > 0.10 mm → ±0.015 mm + 5% | All lenses manufactured to established finished product specifications within ANSI Z80.20 tolerance. |
| Diameter | Range: 12.00mm to 16.00mm; Tolerance: ± 0.20mm | All lenses manufactured to established finished product specifications within ANSI Z80.20 tolerance. |
| Spherical Power | Range: -20.00 D to +20.00 D; Tolerance: 0.00 4.00 D → ±1.00 D | All lenses manufactured to established finished product specifications within ANSI Z80.20 tolerance. |
| Cylindrical Power (Multifocal Toric) | Range: -0.25 D to -4.00 D; Tolerance: 0.00 |
§ 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.