(174 days)
The ADVENTURE TINTS, Color Enhanced Tinted Soft Contact Lens is indicated for daily wear to enhance and/or alter the apparent eye color. The ADVENTURE TINTS visitint provides for ease of patient handling and does not effect 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.
ADVENTURE TINTS, Color Enhanced Tinted Soft Contact Lens are color enhanced soft contact lenses that have been previously prescribed for a specific patient. They have been supplied to Adventure in Colors to be modified by a tinting process using 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 reactive additive on that portion of the anterior (front) surface of the lens that corresponds to the iris. The ADVENTURE TINTS, Color Enhanced Tinted Soft Contact Lens are available in a light, medium or dark shade of the following enhance colors; Blue, Deep Blue, Green, Aqua, Yellow, Lavender, Brown, Ultra Violet (Hot Pink), and Amber. ADVENTURE TINTS. Color Enhanced Tinted Soft Contact Lens are also available in a standard blue 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 yellow 15, reactive yellow 86, or reactive orange 78. 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 pre-tinted lens.
The following are tint patterns available to the practitioner:
- Clear Pupil diameter (2.00mm to 8.00mm), standard is 4.5mm. ・
- Annular (iris) diameter (8.00mm to 13.5mm), standard is 11.5mm diameter. l
- Black pupil diameter (2.0mm to 12.5mm), standard is 4.0mm diameter. -
- Occluder diameter (2.00mm to 12.5mm). a
Here's an analysis of the provided text regarding the acceptance criteria and study information for the ADVENTURE TINTS, Color Enhanced Tinted Soft Contact lens:
1. Table of Acceptance Criteria and Reported Device Performance
The provided text does not explicitly state specific quantitative acceptance criteria or detailed study results for device performance beyond a comparison to a predicate device. The information focuses on establishing substantial equivalence based on intended use, indications, actions, color additives, characteristics, and colors offered.
The closest we can come to "reported device performance" are the characteristics presented in the Substantial Equivalence table (Table #1), which essentially state the device meets the same characteristics as the predicate.
| Characteristic | Acceptance Criteria (Implied by Predicate) | Reported Device Performance (ADVENTURE TINTS) |
|---|---|---|
| INTENDED USE | Daily wear, Soft (hydrophilic) contact lens | Daily wear, Soft (hydrophilic) contact lens |
| INDICATION | Enhance and/or alter apparent eye color, including ocular masking. | Enhance and/or alter apparent eye color. Visitint provides for ease of patient handling and does not affect iris color. Pre-tinted lens optical parameters remain the same except for decreased light transmittance. Disinfect using chemical disinfection system only. |
| 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. |
| FDA "listed" colored additives | Use of FDA-listed colored pigments (iron oxides, chromium oxide greens, titanium dioxide, [phthalo-cyaninato (2-)] copper, carbazole violet and phthalocyanine green). Amounts not to exceed the minimum reasonably required. | Use of FDA-listed reactive colored additives (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). Amounts not to exceed the minimum reasonably required. |
| Color Additive Characteristics | Color additives used are not removed by lens handling and cleaning/disinfecting procedures. Optical and performance characteristics are not altered by the lens coloring process. | Color additives used are not removed by lens handling and cleaning/disinfecting procedures. Optical and performance characteristics are not altered by the lens coloring process (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). |
| Colors Offered | Sky blue, Jade green, Aquamarine and Violet blue | Blue, Green, Aqua, Yellow, Lavender, Brown, Ultra Violet (hot pink) and Amber. Also available in a standard blue visibility-handling tint. |
Crucially, the document explicitly states: "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." This statement indicates that no specific optical performance metrics beyond light transmittance were assessed or reported as changed. The primary focus is on the safety of the tinting process and the color additives.
2. Sample Size Used for the Test Set and Data Provenance
The provided text does not mention any specific test set, its sample size, or data provenance (e.g., country of origin, retrospective/prospective). The submission focuses on substantial equivalence to a predicate device based on descriptive characteristics and regulatory compliance of materials and processes.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This information is not provided in the document. No "ground truth" establishment by experts for a test set is described, as there is no mention of a clinical or performance study with human subjects or a defined test set that required expert evaluation.
4. Adjudication Method for the Test Set
As there is no mention of a test set or expert evaluation, there is no information about an adjudication method.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and The Effect Size of How Much Human Readers Improve with AI vs. Without AI Assistance
This device is a tinted contact lens, not an AI-powered diagnostic or assistive tool. Therefore, no MRMC comparative effectiveness study was done, and the concept of "human readers improving with AI" does not apply to this product.
6. If a Standalone (Algorithm Only Without Human-in-the Loop Performance) Was Done
This device is a physical medical device (contact lens), not an algorithm or software. Therefore, no standalone "algorithm-only" performance study was done.
7. The Type of Ground Truth Used (Expert Consensus, Pathology, Outcomes Data, etc.)
The document does not describe a study involving "ground truth" as typically understood in the context of diagnostic device validation. The "ground truth" for this submission revolves around:
- Regulatory compliance: The listed color additives are FDA-approved for contact lenses.
- Material safety: The manufacturing process ensures unbound reactive color additives are removed.
- Equivalence to predicate: The assumption is that if the new device shares the same fundamental characteristics and uses approved materials/processes as a legally marketed predicate, it is safe and effective for its stated use.
8. The Sample Size for the Training Set
The concept of a "training set" is relevant to machine learning or AI models. Since this is a physical medical device, there is no training set in that context.
9. How the Ground Truth for the Training Set Was Established
As there is no training set, there is no information on how its "ground truth" was established.
Summary of Study Information:
The provided 510(k) summary is for a tinted contact lens where substantial equivalence is primarily established through a comparison of product characteristics, materials, and intended use to a legally marketed predicate device. It does not contain information about clinical trials, performance studies with human subjects, or any form of algorithmic testing. The "study" described is essentially a detailed comparison to a predicate device and a demonstration of compliance with relevant material safety and manufacturing regulations.
§ 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.