(256 days)
Horizon 55 (methafilcon A), Horizon 55 (methafilcon A) soft Toric, Horizon 55 (methafilcon A) Bi-con, Horizon 55 (methafilcon A) Bi-con Toric, Horizon (methafilcon A) Progressive, Horizon (methafilcon A) Progressive Toric, Horizon 55 (methafilcon A) Westint (spherical), Horizon 55 (methafilcon A) Westint soft Toric, Horizon 55 (methafilcon A) Westint Bi-con, Horizon 55 (methafilcon A) Westint Bi-con Toric, Horizon (methafilcon A) Westint Progressive, Horizon (methafilcon A) Westint Progressive Toric are indicated for daily wear for the correction of refractive ametropia (myopia, astigmatism and presbyopia) in aphakic or not-aphakic persons with nondiseased eyes.
The color-enhanced version is indicated for daily wear to enhance or alter the apparent eye color. The lenses may be disinfected using chemical systems only.
The Horizon 38 (polymacon) (polymacon), Horizon 38 (polymacon) Westint (polymacon), Westhin 38 Soft Toric (polymacon) and Westhin 38 Soft Toric Westint (polymacon) are indicated for daily wear for the correction of refractive ametropia (myopia, hyperopic, astigmatism) in aphakic or not-aphakic persons with nondiseased eyes.
The color-enhanced version is indicated for daily wear to enhance or alter the apparent eye color. The color-enhanced lenses can be chemically disinfected only. The clear lenses may be disinfected using a heat o chemical disinfecting system.
The soft contact lenses that are manufactured from W-55 and W-38 lens blanks are lathe cut into a hemispherical shell that are designed to fit over the corneal surface of the eye. These lenses are designed with varying base curves that conform to the shape of the radius of the cornea and center over the apex of the cornea to provide correction of refractive ametropia (myopia, hyperopic, astigmatism and presbyopia) in aphakic or not-aphakic persons with nondiseased eves.
Each lens is designed with a base curve on the internal side of the lens and an optical zone in the center of the lens, generally of a diameter greater than 6 mm. The primary and secondary curves as well as beveled edge configurations are built into the lens for the purpose of aiding on the lens centration and comfort.
Adding color enhancement to the surface of the lens modifies the clear version of the Horizon 55 (methafilcon A) Contact Lens and Horizon 38 (polymacon) contact lens. The tinting process alters or changes the 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 color additives are used in the amounts not to exceed the minimum reasonably required to accomplish the intended coloring effect. The practitioner may also choose tint intensity and custom mix colors.
The Horizon Enhanced lenses are available in shades of the following: blue, green, brown and aqua.
Combining one or more reactive colors additives with distilled water forms the color enhancement. The reactive color additives that may be used either alone or in combination are: Reactive Blue 19, Reactive Black 5, Reactive Red 11, Reactive Orange 78, Reactive Yellow 15, Reactive Red 180.
The provided document describes a 510(k) submission for various contact lenses. It does not contain a study comparing the device's performance against acceptance criteria in the manner expected for diagnostic or AI-driven medical devices. Instead, the submission focuses on demonstrating substantial equivalence to previously cleared contact lenses and addresses the safety and effectiveness of adding color enhancement to the existing lens designs.
Therefore, many of the questions regarding acceptance criteria, study design, expert involvement, and statistical measures cannot be answered from the provided text, as these types of studies were not presented for this submission. The submission is primarily focused on safety and technological characteristics, especially for the new color-enhanced versions, and references prior 510(k) clearances for the core lens designs.
Here's a breakdown of what can and cannot be answered based on the provided text:
1. A table of acceptance criteria and the reported device performance
No explicit table of acceptance criteria and device performance is provided in the document in the context of a comparative clinical study for efficacy. The "performance" described relates to the safety and physical characteristics of the lenses.
| Acceptance Criteria (Implied) | Reported Device Performance (Implied) |
|---|---|
| No identifiable evidence of tint pigment leaching. | Showed no identifiable evidence. |
| No evidence of cellular toxicity. | Test results showed no evidence. |
| No evidence of systemic toxicity. | Test results showed no evidence. |
| No evidence of ocular irritation. | Test results showed no evidence. |
| Physical/Optical Characteristics remain same. | Remains the same as clear version. |
| No changes to validated microbiology process. | No changes. |
| Spectra measurement remains same after cleaning/disinfecting cycles. | Remained the same. |
2. Sample sized 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 specified. The studies mentioned (leachability, toxicology, microbiology, compatibility) are laboratory tests, not clinical performance tests with a "test set" of patient data in the typical sense.
- Data Provenance: Not specified. These are laboratory studies.
- Retrospective or Prospective: These appear to be laboratory studies conducted specifically for this submission, implying they are prospective for the aspects tested.
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 submission doesn't involve establishing ground truth from expert assessments of images or patient outcomes for a diagnostic device. The "ground truth" for the tests performed would be the results of the laboratory assays themselves and comparisons to established safety thresholds.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. There is no adjudication method described as this is not a study involving expert readers or interpretation of results that would require adjudication.
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 contact lens submission, not an AI-driven diagnostic device. No MRMC study was conducted.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
Not applicable. This is a contact lens submission, not an AI-driven diagnostic device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
The "ground truth" for the studies performed would be:
- Leachability: Chemical analysis results (absence of tint pigment in leachate).
- Toxicology: In vitro (cytotoxicity) and in vivo (systemic toxicity, ocular irritation) laboratory assay results compared to control or safety thresholds.
- Microbiology/Compatibility: Laboratory measurements comparing pre- and post-processing characteristics.
8. The sample size for the training set
Not applicable. This is not an AI/ML device that requires a training set.
9. How the ground truth for the training set was established
Not applicable. This is not an AI/ML device.
Summary of the Study that Proves the Device Meets Acceptance Criteria (as described in the document):
The submission demonstrates the safety and effectiveness of the color-enhanced versions of the contact lenses by showing they are substantially equivalent to their clear counterparts (K992010 and K963837) and do not raise new questions of safety or effectiveness. The core lenses themselves are already FDA-approved.
The studies performed for the color-enhanced lenses, as described in the "Summary of Safety and Effectiveness 6.0" and "7.0 Technical Summaries" sections, include:
- Leachability Studies: Showed "no identifiable evidence of tint pigment leaching." This addresses a critical safety concern for color additives in contact with the eye.
- Toxicology Studies: Included cytotoxicity, systemic toxicity, and ocular irritation studies. Results showed "no evidence of cellular or systemic toxicity, or ocular irritation." This confirms the biological safety of the materials, including the color additives.
- Physical/Optical Characteristics Review: Concluded that the "color-enhanced version remains the same as the clear version." This indicates no significant alteration to the lens's fundamental optical properties or fit due to the color.
- Microbiology Review: Stated that "There will be no changes to the validated process in 510(k) K954524," implying the sterilization and manufacturing processes for the color-enhanced lenses are consistent with previously validated methods, maintaining sterility.
- Compatibility Studies: Indicated that "The spectra measurement after the numerous cleaning and disinfecting cycles remained the same as the before measurement." This demonstrates that the color-enhanced lenses hold up to standard care routines without degradation.
- Shelf-life Study: Was started and would be completed later, based on relevant guidance documents. This is an ongoing study to confirm the stability of the lenses over time.
Conclusion: The submission relies on these laboratory and characteristic studies to support the claim that adding color enhancement does not negatively impact the safety and effectiveness established for the predicate clear lenses. The FDA's final decision letter (K031774) confirms that the device is "substantially equivalent" for the stated indications based on this presented data.
§ 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.