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510(k) Data Aggregation
(105 days)
The VASSEN COLOR (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 0.50 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 eye.
Daily wear replacement schedules may vary from patient and should be decided by eyecare practitioners in consultation with their patients.
Frequent/Planned Replacement Wear:
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.
Disposable Wear:
Eyecare practitioners may prescribe any of the above lenses for Daily Disposable Wear. When Prescribed for Daily Disposable Wear the lenses are not to be used with disinfecting systems as they are to be discarded after a single use.
The VASSEN COLOR soft contact lenses are hemispherical shells with molded spherical base curves and molded front surfaces. The VASSEN COLOR soft contact lenses are fabricated from polymacon, 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 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 saline solution. The (polymacon) name has been adopted by the United States Adopted Names Council (USAN).
VASSEN COLOR lenses are available clear, visibility tinted, and cosmetic tinted. Clear or color lens designs may be distributed under unique or "private label" trade names. VASSEN COLOR lenses are tinted with one or a combination of one or more of the following 'listed' color additives: D&C Yellow 10, D&C Green 6, Titanium Dioxide, Iron Oxide (Red), C.I. Reactive Blue 19, and C.I. Reactive black 5. 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. When producing the cosmetic tinted lenses, the manufacturing process alters and/or changes the specifications to the clear version of a contact lens by affixing a listed reactive color additive in the center of the contact lens (between layers of contact lens material) in a location that corresponds to the iris. As part of the manufacturing process, the lenses containing the color additives are thoroughly washed to remove unbound reactive color additives. The color additives used are not removed by lens handling and cleaning/disinfecting procedures. Except for affecting the amount of light transmittance through the lens, the coloring process does not alter the original characteristics of the pretinted lens. The cosmetic tinting pattern has a minimum Clear Pupil diameter of 6.0 mm.
In the hydrated state, the lens conforms to the curvature of the eve covering 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 provided text describes the VASSEN COLOR (polymacon) Daily Wear Soft (hydrophilic) Contact Lenses and their substantial equivalence to a predicate device. However, it does not contain a study that establishes clear acceptance criteria with reported device performance metrics in the format requested.
The document primarily focuses on demonstrating substantial equivalence based on material properties, manufacturing methods, and intended use, rather than presenting a performance study with specific acceptance criteria and results for the VASSEN COLOR lenses.
Here's a breakdown of what can be extracted and what is missing based on your requested information:
1. A table of acceptance criteria and the reported device performance
The document does not explicitly state "acceptance criteria" for a performance study in the traditional sense (e.g., sensitivity, specificity, accuracy thresholds). Instead, it lists physical properties of the lens and asserts that non-clinical testing demonstrated certain outcomes.
| Acceptance Criteria (Implied/General) | Reported Device Performance |
|---|---|
| Non-clinical Testing: | |
| Sterility for indicated shelf-life | Lenses supplied in blister packages and glass vials are sterile for the indicated shelf-life |
| Packaging material and extracts are non-toxic and non-irritating | The packaging material and extracts are not toxic and not irritating |
| Lens physical and material properties consistent with marketed lenses | Lens physical and material properties are consistent with currently marketed lenses |
| Physical Properties (Specifications): | |
| Refractive Index | 1.439 |
| Light Transmission (clear) | greater than 95% |
| Light Transmission (tinted, clear region) | greater than 95% (at clear region corresponding to pupil, minimum 6.0 mm diameter) |
| Light Transmission (tinted, iris region) | Opaque or 0-10% (at tinted region corresponding to iris) |
| Surface Character | hydrophilic |
| Water Content | 38±2% |
| Specific Gravity | 1.18 (hydrated) |
| Oxygen Permeability | 10.55 (cm²/sec)(mlO2)/(ml x mmHg @ 35°C)) (revised Fatt method) |
| Chord Diameter | 13.00 mm to 15.00 mm |
| Center Thickness | 0.06 mm to 0.17 mm |
| Base Curve | 8.0 mm to 9.0 mm |
| Power Range | -10.00D to +3.00D in 0.25D steps |
Crucially, the document states: "The clinical performance of the (polymacon) lens material has been previously established, and therefore was not required for this 510(k)." This indicates that no new clinical study was performed to demonstrate performance against specific clinical acceptance criteria for this device. The basis for safety and effectiveness relies on substantial equivalence to a predicate device and established performance of the polymacon material.
The following information is not provided in the document, as it focuses on substantial equivalence rather than a new performance study:
2. Sample sized used for the test set and the data provenance
- Not applicable as no new clinical performance study was conducted. Non-clinical toxicology tests were performed, but specific sample sizes for these in-vitro/in-vivo tests are not detailed with respect to a "test set" for performance evaluation.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Not applicable as no new clinical performance study requiring expert ground truth was conducted.
4. Adjudication method for the test set
- Not applicable as no new clinical performance study requiring adjudication was conducted.
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 as this is not an AI-assisted device and no MRMC study was mentioned.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable as this is not an algorithm-based device.
7. The type of ground truth used
- Not applicable for a performance study. For the non-clinical tests, "ground truth" would be the standard scientific methods and GLP regulations used to establish sterility, toxicity, and material properties.
8. The sample size for the training set
- Not applicable as no AI/algorithm training was performed or reported.
9. How the ground truth for the training set was established
- Not applicable as no AI/algorithm training was performed or reported.
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