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 .

Device Description

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.

AI/ML Overview

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):

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.
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.
Adjudication method for the test set:
- Not applicable. This was a series of laboratory tests, not a clinical trial with human observers and adjudication.
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.
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.
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.
The sample size for the training set:
- Not applicable. This is not a machine learning or AI algorithm.
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).

Summary

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1.0	Name andaddress ofsubmitter	Westcon Contact Lens Company, Inc.611 Eisenhauer StreetGrand Junction, CO. 81503
	Contact Person	Carol Noble970-245-3845
	Fax	970-245-4516
	Date Prepared	10/14/02
NOV 2 6 2002

2.0 Name of Device

♦ Trade Name:
Spherical: Horizon 38 (polymacon) and Horizon 38 Westint (polymacon)

Toric:

Westhin 38 Soft Toric (polymacon) and Westhin 38 Soft Toric Westint (polymacon)

Common Name: Daily Wear Soft Contact Lens �
� Generic (USAN) Name: Polymacon
Classification Name: Soft Hydrophilic Contact Lens �

3.0 Indications

The lens may be disinfected using either a heat or chemical system .

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Traditional 510(k)-Submission

8.0 510 (k) Summary

Device Description 4.0

5.0 Substantially Equivalent To:

Westcon will be claiming equivalency to our own contact lenses that are currently FDA approved in 510(k) K963837.

Summary of Safety and Effectiveness 6.0

W-38 (polymacon) lens blanks were subjected to leachability studies and showed no identifiable evidence of tint pigment leaching.

7.0 Technical Summaries

7.1 Toxicology:

Cytotoxicity, systemic toxicity and ocular irritation studies were. Test results showed no evidence of cellular or systemic toxicity, or ocular irritation.

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Physical/Optical Characteristics 7.2
Light transmittance, refractive index, water content, linear expansion, radial expansion and tensile strength were determined. A comparison of data from these studies showed that the W-38 polymacon is equivalent in physical and optical characteristics as 510(k) K963837
7.3 Microbiology
There will be no changes to the validated process in 510(k) K954524
7.4 Compatibility
The spectra measurement after the numerous cleaning and disinfecting cycles remained the same as the before measurement.
7.5 Shelf Life
The three year shelf life study has been started on the lenses manufactured from W-38 and will be completed later this year. The packaging remains the same as 510(k) K954524 and 510(k) K963837.

8.0 Conclusion

In conclusion, it is Westcons' conviction that the data submitted shows that manufacturing with W-38 polymacon instead of Benz's polymacon material does not raise different questions of safety and effectiveness.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Westcon Contact Lens Co., Inc. c/o Ms. Carol Noble Management Representative 611 Eisenhauer Street Grand Junction, CO 81505

Re: K023530

Trade/Device Name: The Horizon 38 (polymacon), Horizon 38 Westint (polymacon), Westhin 38 Soft Toric (polymacon) and Westhin 38 Soft Toric Westint (polymacon) Soft (hydrophilic) Contact Lenses for Daily Wear Regulation Number: 21 CFR 886.5925 Regulation Name: Soft (hydrophilic) Contact Lens Regulatory Class: Class II Product Code: LPL Dated: October 14, 2002 Received: October 21, 2002

Dear Ms. Noble:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations. Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

Image /page/3/Picture/11 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized caduceus symbol, which is a staff with two snakes coiled around it. The symbol is enclosed in a circle with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. The text is written in all capital letters and is evenly spaced around the circle.

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Page 2 – Ms. Carol Noble

forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050. This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at (301) 594-4692. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html

Sincerely yours,

A. Ralph Rosenthal

A. Ralph Rosenthal, M.D. Director Division of Ophthalmic and Ear, Nose and Throat Devices Office of Device Evaluation Center for Devices and Radiological Health

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INDICATIONS FOR USE STATEMENT

Device Name:

Horizon 38 (polymacon), Horizon 38 Westint (polymacon), Westhin 38 Soft Toric (polymacon) and Westhin 38 Soft Toric Westint (polymacon)

Indication of Use:

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 lenses may be disinfected using either a heat or chemical system .

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Division Sign-Off
Division of Ophthalmic Ear, Nose and Throat Devices
510(k) Number	K023530
Prescription Use	X
	OR
	Over-The-Counter Use
(Per 21 CFR 801.109
(Optional Format 1-2-96)

Regulation Number and Section

§ 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.