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510(k) Data Aggregation
(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 < F'v ≤ 10.00 D → ±0.25 D; 10.00 < F'v ≤ 20.00 D → ±0.50 D | All lenses manufactured to established finished product specifications within ANSI Z80.20 tolerance. |
| Cylindrical Power (Toric) | Range: -0.25 D to -12.00 D; Tolerance: 0.00 < F'v ≤ 2.00 D → ±0.25 D; 2.00 < F'v ≤ 4.00 D → ±0.37 D; F'v > 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 < F'v ≤ 2.00 D → ±0.25 D; 2.00 < F'v ≤ 4.00 D → ±0.37 D | All lenses manufactured to established finished product specifications within ANSI Z80.20 tolerance. |
| Cylindrical Axis | Range: 1º to 180º; Tolerance: ± 5º | All lenses manufactured to established finished product specifications within ANSI Z80.20 tolerance. |
| Add Power (Multifocal) | Range: +0.50 D to +4.00 D; Tolerance: ± 0.25D | All lenses manufactured to established finished product specifications within ANSI Z80.20 tolerance. |
| Biocompatibility: | ||
| In-Vitro Cytotoxicity | Not cytotoxic (ISO 10993-5) | Results indicate finished lenses are not cytotoxic. (Meets criterion). |
| Systemic Toxicity | Not acutely systemically toxic (ISO 10993-11) | Finished lenses meet requirements of systemic injection test and are considered not acutely systemically toxic. (Meets criterion). |
| Acute Ocular Irritation | No ocular irritation (ISO 10993-10) | Extracts from finished lenses produced no ocular irritation. (Meets criterion). |
| Skin Sensitization | No skin sensitization (ISO 10993-10) | Contact lens extracts did not produce skin sensitization. (Meets criterion). |
| 22-Day Ocular Irritation | No ocular irritation (ISO 9394) | Finished contact lenses produced no ocular irritation. (Meets criterion). |
| Shelf Life & Stability: | Demonstrate stability, sterility, and package integrity over labeled expiration date. | Data presented supports establishment of the proposed shelf life. (Meets criterion). |
| Preservative Uptake & Release: | Demonstrate sub-detection limit amounts of release at each time point evaluated (ISO 11986:2017). | Preservative uptake and release profiles of efrofilcon A contact lenses for the preservatives tested demonstrate sub-detection limit amounts of release at each time point evaluated. (Meets criterion). |
| Solution Compatibility: | Demonstrate physical compatibility with commonly available cleaning and disinfection solutions (ISO 11981:2017). | Physical compatibility with peroxide and MPDS solutions was confirmed. (Meets criterion). |
| Manufacturing Verification: | Ability to manufacture finished lenses to a variety of prescribed parameters, repeatably, and within ANSI Z80.20 tolerance. | Bench testing demonstrated the firm's ability to manufacture finished lenses on a repeatable basis to established finished product specifications within the ANSI Z80.20 tolerance. (Meets criterion). |
| Indications for Use (Equivalence): | Indications for Use for subject device should be substantially equivalent to predicate device(s). | The Indications for Use for the Metro Soft (Subject Device) are identical to the Metro Soft (Predicate Device: K100244) across all lens types (sphere, toric, multifocal, multifocal toric, irregular cornea). They are also almost identical to the IntelliWave³ (Predicate Device: K230824), with only minor wording variations (e.g., "IntelliWave3 sphere" vs. "Metro Soft, sphere"). This demonstrates substantial equivalence in intended use. |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Sample Size for Test Set: Not explicitly stated as a separate "test set" in the context of an AI/ML algorithm. For physical testing (e.g., tensile strength, Dk, water content, biocompatibility), samples are drawn from production batches according to statistical sampling plans relevant to the specific test method and ISO standards. For manufacturing verification, typically multiple lenses are measured.
- Data Provenance: Not specified, but the context implies laboratory testing and manufacturing data. It is not patient data from a specific country.
- Retrospective or Prospective: The testing described (bench testing, shelf life, toxicology, performance testing) is prospective testing conducted specifically for this submission.
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. This is not an AI/ML diagnostic device requiring expert interpretation for ground truth. Biocompatibility results are interpreted by toxicologists/biologists according to standard protocols. Physical property measurements are based on objective metrics.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not Applicable. No human adjudication method, as would be used for clinical interpretations, is described or required for this type of device submission. Results from bench tests and biocompatibility are objective measurements or interpretations of standard biological responses.
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 is a physical contact lens, not an AI-assisted diagnostic device. No human reader studies (MRMC or otherwise) are referenced in the provided text.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not Applicable. This is not an algorithm or software. It is a physical medical device (contact lens).
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- Ground Truth for Physical Properties: Established by validated laboratory measurement techniques and instrumentation (e.g., refractometers for refractive index, Dk sensors for oxygen permeability, calipers for dimensions, tensile testers for mechanical properties) against recognized scientific principles and standards (e.g., ISO, ANSI Z80.20).
- Ground Truth for Biocompatibility: Established by adherence to international standards (ISO 10993 series) and observation of biological responses in in vitro (cell culture) and in vivo (animal) models, interpreted by qualified personnel (e.g., toxicologists).
- Ground Truth for Clinical Performance: Clinical studies were explicitly stated as "not necessary for this application," implying that equivalence to the predicate (which has a known safety and effectiveness profile) based on material and physical characteristics was deemed sufficient.
8. The sample size for the training set
- Not Applicable. No "training set" in the context of AI/ML is relevant for this device. The phrase "training set" usually refers to data used to train an AI model.
9. How the ground truth for the training set was established
- Not Applicable. No "training set" or corresponding ground truth establishment method for AI/ML is relevant for this device.
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