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510(k) Data Aggregation
(74 days)
The SOFTCHROME TINTS, Color Enhanced Tinted Soft Contact Lens is indicated for daily wear to enhance and/or alter the apparent eye color. The SOFTCHROME TINTS visibility tinted lens provides for ease of patient handling and does not affect iris color.
Except for decreased light transmittance due to the tint intensity, the pre-tinted lens optical parameters remain the same as originally prescribed for the user prior to tinting. The lens may be disinfected using a chemical disinfection system only.
SOFTCHROME TINTS Transparent Tinted Soft Contact Lens are color enhanced soft contact lenses that have been previously prescribed for a specific patient. The lenses are tinted with utilization of the patented "In-Office Tinting System for Soft Contact Lenses". The tinting system consists of various tinting fixtures, calibrated mixing vessels, pre-mixed color additives, activator solution, neutralizer solution, tinting instructions, tips and recipes. The lens tinting process uses color additives that have been listed as safe for contact lenses in accordance with the FDA's color additive regulations. The color additives are used in amounts not to exceed the minimum reasonably required to accomplish the intended coloring effect. As part of the manufacturing process, the lenses containing the color additives are thoroughly washed to remove unbound reactive color additives. The manufacturing process alters and/or changes the specifications to the clear version of a contact lens by affixing a listed color additive on that portion of the anterior (front) surface of the lens that corresponds to the iris. The In-Office Tinting System for Soft Contact Lenses offers a variety of colors and intensity levels. The SOFTCHROME TINTS Transparent Tinted Soft Contact Lens is also available in a variety of colors for visibility-handling tint.
The color additive effect is formed by reacting one or more of the reactive color additives listed in this paragraph with (poly hydroxyethyl methacrylate). The reactive color additives that may be used either alone or in combination are: reactive black 5, reactive blue 19, reactive blue 19, reactive blue 4, reactive blue 163. reactive red 11. reactive red 180. reactive vellow 86. or reactive orange 78. The color additives used are not removed by lens handling and approved 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 pre-tinted lens.
This document is a 510(k) summary submission for a medical device, specifically the SOFTCHROME TINTS Transparent Tinted Soft Contact Lens. It provides information for establishing substantial equivalence to a predicate device.
It's important to note that this document does not describe a study to prove the device meets acceptance criteria in the typical sense of a performance study for a diagnostic or therapeutic medical device. Instead, it focuses on demonstrating substantial equivalence to an existing legally marketed device (the predicate device) based on shared characteristics, intended use, and safety/efficacy profile.
Therefore, many of the typical acceptance criteria and study details for AI/ML validation (like sample size for test sets, ground truth methodology, MRMC studies) are not applicable or present in this type of submission. The "acceptance criteria" here are essentially the shared characteristics and claims deemed equivalent to the predicate device.
Here's the information extracted based on your request, with clarifications where the concepts don't directly map to the provided content:
1. Table of Acceptance Criteria and Reported Device Performance
The "acceptance criteria" for this submission are based on demonstrating substantial equivalence to the predicate device. The performance is reported as being similar or identical to the predicate.
| Characteristic | Acceptance Criteria (based on Predicate Device: Adventure Tints) | Reported Device Performance (SOFTCHROME TINTS) |
|---|---|---|
| 1.) INTENDED USE | Daily wear, Soft (hydrophilic) contact lens | Daily wear, Soft (hydrophilic) contact lens |
| 2.) INDICATION | Indicated for daily wear to enhance and/or alter the apparent eye color. Provides ease of patient handling and does not affect iris color. Pre-tinted lens optical parameters remain the same except for decreased light transmittance. Disinfection using a chemical disinfection system only. | Indicated for daily wear to enhance and/or alter the apparent eye color. Provides ease of patient handling and does not affect iris color. Pre-tinted lens optical parameters remain the same except for decreased light transmittance. Disinfection using a chemical disinfection system only. |
| 3.) ACTIONS | In its hydrated state, when placed on the cornea, the lenses act as a refracting medium to focus light rays on the retina. | In its hydrated state, when placed on the cornea, the lenses act as a refracting medium to focus light rays on the retina. |
| 4.) FDA "listed" colored additives | Consist of reactive black 5, reactive blue 4, reactive blue 19, reactive 21, reactive blue 163, reactive yellow 15, reactive yellow 86, reactive orange 78, reactive red 11 and reactive red 180. | Consist of reactive black 5, reactive blue 4, reactive blue 19, reactive 21, reactive blue 163, reactive yellow 15, reactive yellow 86, reactive orange 78, reactive red 11 and reactive red 180. |
| 4. Uses and restrictions | Color additives may be used to color contact lenses in amounts not to exceed the minimum reasonably required to accomplish the intended coloring effect. | Color additives may be used to color contact lenses in amounts not to exceed the minimum reasonably required to accomplish the intended coloring effect. |
| 5.) Color Additive Characteristics | Not removed by lens handling and cleaning/disinfecting procedures. Optical and performance characteristics are not altered by the lens coloring process. | Not removed by lens handling and cleaning/disinfecting procedures. Optical and performance characteristics are not altered by the lens coloring process. |
| 6.) Colors Offered | Blue, Green, Aqua, Yellow, Lavender, Brown, Ultra Violet (hot pink) and Amber | Aqua, Blue, Sky Blue, Green, Brown, Black, Green, Yellow, Amber and Red (Note: This is the only characteristic where the two devices differ, having different color offerings, but the underlying safety and efficacy of the tinting process and additives are claimed to be equivalent.) |
2. Sample size used for the test set and the data provenance
- Not applicable in the context of this 510(k) submission. This submission asserts substantial equivalence based on device characteristics, intended use, and materials. It does not describe a clinical performance study using a "test set" of patient data for the device itself. The evidence is drawn from the established safety and efficacy of the predicate device and the materials/process used.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Not applicable. No such "ground truth" establishment for a medical data test set is described or required for this type of substantial equivalence submission for soft contact lenses.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not applicable. No adjudication method for a test set is described.
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 tinted soft contact lens, not an AI/ML-driven diagnostic or therapeutic device. Therefore, no MRMC study or assessment of human reader improvement with AI assistance was conducted or would be relevant.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
- Not applicable. This device is a physical medical device (contact lens), not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- Not applicable. The "ground truth" in this context is the regulatory acceptance and established safety/efficacy of the predicate device and the FDA-listed color additives.
8. The sample size for the training set
- Not applicable. There is no "training set" as this is not an AI/ML device.
9. How the ground truth for the training set was established
- Not applicable. There is no "training set." The closest concept is that information on the predicate device's safety and effectiveness, and the FDA's listing of the color additives, serves as the basis for the safety and effectiveness claims.
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