(36 days)
The Horizon 38 (polymacon). Horizon 38 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 and astigmatism) in aphakic and/or not-aphakic persons with nondiseased eyes.
The lens may be disinfected using either a heat or chemical system .
The soft contact lenses that are manufactured from W-38 lens blanks, clear or tinted, can be 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 ametropia (myopia, hyperopic and astigmatism). Each lens provides corrective power, which corresponds to the refractive power of the eye to which it is being treated.
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, as well as, beveled edge configurations are built into the lens for the purpose of aiding on the lens centration and comfort.
This document describes the premarket notification (510(k)) for Westcon Contact Lens Company's Horizon and Westhin contact lenses. It focuses on demonstrating substantial equivalence to previously approved devices, rather than presenting a study with specific acceptance criteria and performance data in a traditional sense. Therefore, many of the requested elements for an AI/device performance study are not applicable or directly available in this document.
However, I can extract the relevant information regarding their "acceptance criteria" (or more accurately, the tests performed to demonstrate substantial equivalence) and what the document reports.
Here's an attempt to structure the available information according to your request, with significant caveats for clarity:
Acceptance Criteria and Device Performance for Westcon Horizon and Westhin Contact Lenses (Based on 510(k) K023530)
Note: This 510(k) submission is for demonstrating substantial equivalence to existing predicate devices (K963837 and K954524) for contact lens material change (from Benz's polymacon to W-38 polymacon). It is not a clinical study to prove the performance of a novel device against specific clinical endpoints or acceptance criteria in the typical modern sense. The "acceptance criteria" here are implied by the tests performed to show that the new material is equivalent and does not raise different questions of safety and effectiveness.
| Acceptance Criteria Category (Implied) | Reported Device Performance / Outcome |
|---|---|
| Material Safety | |
| Leachability Studies | No identifiable evidence of tint pigment leaching. |
| Cytotoxicity Studies | No evidence of cellular toxicity. |
| Systemic Toxicity Studies | No evidence of systemic toxicity. |
| Ocular Irritation Studies | No evidence of ocular irritation. |
| Physical/Optical Characteristics | |
| Light Transmittance | Equivalent to 510(k) K963837 |
| Refractive Index | Equivalent to 510(k) K963837 |
| Water Content | Equivalent to 510(k) K963837 |
| Linear Expansion | Equivalent to 510(k) K963837 |
| Radial Expansion | Equivalent to 510(k) K963837 |
| Tensile Strength | Equivalent to 510(k) K963837 |
| Microbiology | |
| Changes to Validated Process | No changes to the validated process in 510(k) K954524. |
| Compatibility (Cleaning/Disinfection) | Spectra measurement remained the same after numerous cleaning and disinfecting cycles as before measurement. |
| Shelf Life | 3-year shelf life study started, to be completed later. Packaging remains same as 510(k) K954524 and K963837. |
Information on the "Study" (Demonstration of Substantial Equivalence):
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Sample size used for the test set and the data provenance:
- The document does not specify sample sizes for any of the studies (leachability, toxicity, physical/optical characteristics, compatibility).
- Data Provenance: Not explicitly stated, but it would be laboratory testing conducted by or for Westcon Contact Lens Company. It is "prospective" in the sense that these tests were performed for this specific submission to characterize the W-38 polymacon material.
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Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable/mentioned. The "ground truth" here is the outcome of standardized laboratory tests and comparisons to predicate device data, not expert consensus on medical images or clinical observations.
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Adjudication method for the test set:
- Not applicable. This was a series of laboratory tests, not a clinical trial with human observers and adjudication.
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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 510(k) for contact lenses, not an AI-powered diagnostic device.
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If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- Not applicable. This is a 510(k) for contact lenses, not an AI algorithm.
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The type of ground truth used:
- The "ground truth" here refers to laboratory test results (e.g., cytotoxicity assays, spectrophotometer readings for leachability and compatibility, physical property measurements) and comparative data from the predicate device (K963837) for physical/optical characteristics.
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The sample size for the training set:
- Not applicable. This is not a machine learning or AI algorithm.
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How the ground truth for the training set was established:
- Not applicable. This is not a machine learning or AI algorithm.
Summary of the Submission's Conclusion:
Westcon Contact Lens Company concluded, and the FDA agreed, that the data submitted demonstrated that manufacturing with W-38 polymacon instead of Benz's polymacon material "does not raise different questions of safety and effectiveness." This established substantial equivalence to their previously approved devices (K963837 and K954524).
§ 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.