(41 days)
Horizon 59 Oasis (hioxifilcon A) Spherical, Horizon 59 Oasis (hioxifilcon A) Toric, Horizon 59 Oasis (hioxifilcon A) Bi-con, Horizon 59 Oasis (hioxifilcon A) Bi-con Toric, Horizon 59 Oasis (hioxifilcon A) Progressive, Horizon 59 Oasis (hioxifilcon A) Progressive Toric are indicated for daily wear for the correction of refractive ametropia (myopia, hyperopic, 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 eve color.
The lenses may be disinfected using chemical systems only.
The soft contact lenses that are manufactured from Hioxifilcon A 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 eyes.
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 59 Oasis (hioxifilcon A) 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 irris. 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 59 Oasis (hioxifilcon A) 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.
This document is a 510(k) premarket notification for a contact lens, not an AI/ML device. Therefore, the requested information about acceptance criteria, study details, ground truth, and training sets for an AI/ML device is not applicable and cannot be extracted from the provided text.
The document focuses on demonstrating substantial equivalence of the "Horizon 59 Oasis (hioxifilcon A)" contact lens to a previously approved device. The "studies" mentioned are related to the physical, optical, and biological safety of the contact lens material and design, not the performance of an AI/ML algorithm.
Here's a breakdown of why each requested point is not applicable:
- A table of acceptance criteria and the reported device performance: Not applicable. This device is a contact lens, not an AI/ML device with performance metrics like sensitivity, specificity, etc. The document assesses physical characteristics (light transmittance, expansion) and safety (leachability, toxicity).
- Sample size used for the test set and the data provenance: Not applicable. No test set for an algorithm is mentioned.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. There is no "ground truth" establishment in the context of an AI/ML algorithm. The safety and equivalence are determined through laboratory testing and comparison to a predicate device.
- Adjudication method: Not applicable. No expert adjudication is described in the context of an AI/ML device.
- 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 not an AI-assisted diagnostic device.
- If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is a contact lens, not an algorithm.
- The type of ground truth used: Not applicable. "Ground truth" in the AI/ML sense is not relevant here. The 'truth' for a contact lens involves meeting material specifications, biological safety standards, and functional requirements.
- The sample size for the training set: Not applicable. There is no AI/ML model to train.
- How the ground truth for the training set was established: Not applicable. No training set or ground truth for an algorithm is discussed.
Instead, the document describes the following for the contact lens:
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Acceptance Criteria/Performance Parameters (Implied):
- Leachability: No identifiable evidence of tint pigment leaching.
- Toxicology: No evidence of cellular or systemic toxicity, or ocular irritation (cytotoxicity, systemic toxicity, ocular irritation studies conducted).
- Physical/Optical Characteristics: Equivalent to predicate device (K031774) in light transmittance, linear expansion, and radial expansion.
- Microbiology: No changes to validated process in 510(k) K954524.
- Compatibility: Spectra measurement after cleaning/disinfecting cycles remained the same as before.
- Shelf Life: Study started and to be completed in 2005.
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Study That Proves the Device Meets the Criteria:
- Leachability studies were conducted.
- Cytotoxicity, systemic toxicity, and ocular irritation studies were conducted.
- Light transmittance, linear expansion, and radial expansion studies were conducted, and data was compared to the predicate device K031774.
- Compatibility studies were conducted (spectra measurement after cleaning/disinfecting cycles).
- Shelf life study initiated.
The primary method to "prove" the device meets acceptance criteria in this 510(k) is by demonstrating substantial equivalence to an existing FDA-approved predicate device (Westcon's own K031774 for the clear lens, and K954524 for manufacturing process and packaging). The studies mentioned above support this claim of equivalence and safety.
§ 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.