(44 days)
The CANTOR & SILVER SX Tinted (hioxifilcon A) 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 leases may be worn by persons who exhibit refractive astigmatism of 1.50 diopters or less where the astigmatism does not interfere with visual acuity. The lenses are disinfected using a hydrogen peroxide lens care system only, and are available in a frequent replacement program.
The CANTOR & SILVER 5X Tinted (hioxifilcon A) Toric Soft Contact Lenses for daily wear are indicated for the correction of visual acuity in aphakic persons with non-disessed eyes with myopia or hyperopia and/or possesses refractive astigmatism up to 10.00 diopters. The lenses are disinfected using a hydrogen peroxide lens care system only, and are available in a frequent replacement program.
The CANTOR & SILVER 5X Tinted (hioxifilcon A) Soft (Spherical & Toric) Daily Wear Contact lens are fabricated from hioxifilcon 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 color enhanced soft contact lenses are tinted with "listed" color additives. 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 finted contact lenses are available in a light, medium or dark shade of the following enhance colors; Blue, Green, Aqua, Yellow, Lavender, Brown, Ultra Violet, and Amber.
The color additive (timing) effect is formed by reacting one or more of the "listed" additives with HEMA based (poly hydroxyethy) methacrylate) soft contact lens. The color additives used are not removed by lens handling and cleaning/disinfecting procedures as recommended. Except for affecting the amount of light transmitted through the lens, the coloring process does not alter the original characteristics of the pre-tinted lens.
In the bydrated state, the lens conforms to the curvature of the eye covering the comea and extending slightly beyond the limbus forming a transparent optical surface. The (hioxifilcon A) soft hydrophilic contact lens 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.
This document is a 510(k) premarket notification for a contact lens, which means it's focused on demonstrating substantial equivalence to existing devices rather than proving performance against specific acceptance criteria through a clinical study with detailed statistical outcomes.
Therefore, the information regarding acceptance criteria, specific study designs, sample sizes for training/test sets, expert adjudication methods, MRMC studies, or standalone algorithm performance, as typically sought for AI/ML device evaluations, is not present in this type of submission.
Instead, the submission focuses on comparing the new device's characteristics to a predicate device (Durasoft 2 Colors) to demonstrate that it does not raise new questions of safety or effectiveness.
Here's a breakdown of what is available, and what is not:
1. A table of acceptance criteria and the reported device performance:
- Acceptance Criteria (Implicit): The implicit acceptance criterion is "substantial equivalence" to the predicate device, meaning the new device's characteristics (materials, production method, lens function, color additives, and use restrictions) are similar enough to an already approved device that it's considered equally safe and effective.
- Reported Device Performance: Instead of performance metrics, the document provides the physical properties and characteristics of the CANTOR & SILVER 5X Tinted contact lens, and then compares them to the predicate device to show similarity.
Here's the table from the document, re-formatted to highlight the comparison for "performance" in this context:
| Characteristic | CANTOR & SILVER 5X TINTED (Reported) | DURASOFT 2 COLORS (Predicate) | Substantial Equivalence? |
|---|---|---|---|
| PRODUCTION METHOD | Lathe-Cut | Lathe-Cut | Yes |
| LENS FUNCTION | Refractive medium that focuses light rays from near and distant objects on the retina, while compensating for refractive error, including (astigmatism) | Refractive medium that focuses light rays from near and distant objects on the retina, while compensating for refractive error, including (astigmatism) | Yes |
| FDA "listed" colored additives | The reactive 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 | The colored pigments consist of iron oxides, chromium oxide greens, titanium dioxide, [phthalo-cyaninato (2-)] copper, carbazole violet and phthalocyanine green. | Note: Different additives, but the document claims equivalence in usage and restrictions. |
| Uses and restrictions | The color additives listed above may be used to color contact lenses in amounts not to exceed the minimum reasonably required to accomplish the intended coloring effect. | The color additives listed above may be used to color contact lenses in amounts not to exceed the minimum reasonably required to accomplish the intended coloring effect. | Yes |
| Color Additive Characteristics | The color additives used are not removed by lens handling and cleansing/disinfecting procedures. The optical and performance characteristics are not altered by the lens coloring process. | The color additives used are not removed by lens handling and cleansing/disinfecting procedures. The optical and performance characteristics are not altered by the lens coloring process. | Yes |
| Colors Offered | Blue, Green, Aqua, Yellow, Lavender, Brown, Ultra Violet and Amber | Sky blue, Jade green, Aquamarine and Violet blue | Note: Different range of colors, but this is a styling difference, not a functional one impacting safety/effectiveness. |
| Other Physical Properties | Refractive Index: 1.515 (dry) 1.404 (hydrated), Light Transmission: >70%, Water Content: 58% ± 2%, Specific Gravity: 1.308 (dry) 1.136 (hydrated), Oxygen Permeability: $20 X 10^{-11}$ (cm²/sec) (ml O₂/ml x mm Hg @ 35°C) | (Not explicitly listed for predicate, but assumed to be within acceptable ranges for soft contact lenses for equivalence claim) | Yes |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
- Not Applicable: This submission does not describe a clinical performance study with a test set in the way a modern AI/ML device would. The "study" here is essentially a technical comparison and declaration of equivalence.
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: There is no "ground truth" establishment in the context of expert consensus for a test set described. The ground truth for regulatory approval is the established safety and effectiveness of the predicate device and the new device's proven similarity to it through material science, manufacturing, and toxicology data.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not Applicable: No test set adjudication method 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:
- No: This is a contact lens, not an AI-powered diagnostic device. No MRMC study was conducted or is relevant.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not Applicable: This is a physical medical device (contact lens), not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- Implicit Ground Truth: The "ground truth" for this submission is the established safety and effectiveness profile of the predicate device (Durasoft 2 Colors) and general scientific understanding of contact lens materials and manufacturing. The manufacturer is demonstrating that their new device is functionally and materially similar enough to the predicate that it can rely on its established safety profile. This includes:
- Pre-clinical toxicology and manufacturing/chemistry data (K952620, referenced for BENZ-G 5X).
- Material properties (hioxifilcon A) being well-understood.
- Manufacturing processes (lathe-cut) being standard and controlled.
8. The sample size for the training set:
- Not Applicable: There is no machine learning "training set" for a contact lens.
9. How the ground truth for the training set was established:
- Not Applicable: As above, no machine learning training set or ground truth establishment in that context.
§ 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.