The PolyVue 43™ (ocufilcon A) Spherical, Toric and Aspherical Multifocal Hydrophilic Contact Lens (clear and visibility tinted) Is Indicated for dally wear for the correction of refractive ametropia (myopla and hyperopia), presbyopia and astigmatism In aphakic and non-aphakic persons with non-diseased eyes.

Eyecare practitioners may prescribe the lens for dally wear in a Frequent Replacement Program. The lenses may be disinfected using heat, chemical or hydrogen peroxide disinfection systems.

Device Description

Soft contact lenses are hemispherical shells manufactured of polymerized material of HEMA and methacrylic acid crosslinked with EGDMA, which yield the appearance of lenses, which are designed to fit over the corneal surface of the eyc. These lenses are designed with varying base curves which conform to the shape of the radius of the cornea and center over the apex of the cornea to provide corrective refi action of functional conditions of the eye including myopla (nearsightedness), hyperopia (farsightedness), presbyopia and astigmatism (multiple foci). Each lens provides corrective power, which is to correspond 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 which is generally of a diameter greater than 6mm. Spherical and aspheric curves as well as beveled edge configurations are built into the lens for alding in lens centration and comfort as well as providing additional add power for near and blocking spherical aberration.

AI/ML Overview

Here's an analysis of the provided text regarding the acceptance criteria and study for the PolyVue 43™ contact lenses:

1. Table of Acceptance Criteria and Reported Device Performance

The submission primarily focuses on demonstrating substantial equivalence to a predicate device rather than setting explicit, quantifiable "acceptance criteria" in the sense of performance thresholds to be met by the device itself in a clinical trial or benchmark study. Instead, the "acceptance criteria" are implied by showing the PolyVue 43™ device's properties are "substantially equivalent" to the predicate device, Specialty T Toric.

Parameter	Predicate Device Performance (Specialty T Toric)	PolyVue 43™ Performance	Acceptance Criteria (Implied)
Material	ocufilcon A	ocufilcon A	Same material
Indication for Use	myopia, hyperopia, astigmatism	myopia, hyperopia, presbyopia, and astigmatism	Broadly similar indications, with PolyVue adding presbyopia. This is justified by equivalence to other marketed presbyopic lenses.
Water Content	44.1%	43%	Within acceptable range for "substantially equivalent"
Light Transmittance	98.493	98.513	Very similar values
Dk (35°C)	$11.267 X 10^{-11}$	$11.340 X 10^{-11}$	Very similar values
Modulus	35.96 g/mm²	36.50 g/mm²	Very similar values
Tensile Strength	33.98 g/mm²	34.68 g/mm²	Very similar values
Elongation @ Break	165.27%	169.26%	Very similar values
Toughness	31.8488 g/mm²	31.9668 g/mm²	Very similar values
Color	clear	clear and visibility tinted	Addition of visibility tint is presented as a minor difference, falling within general controls.
Refractive Index	1.427	1.427	Identical
Powers	-20.00 to +20.00 D	-20.00 to +20.00D	Identical range
Biocompatibility	(Implied by predicate)	Non-toxic	Satisfy cytotoxicity, systemic injection, eye irritation tests.
Compatibility with lens care	(Implied by predicate)	Compatible	Compatible with standard lens care regimens (same lens group).
Preservative Uptake/Release	(Implied by predicate)	N/A	Same surface electric charge as predicate; no additional studies needed.
Leachability of color additives and residual monomers	(Implied by predicate)	Within acceptable limits	Within acceptable limits.

2. Sample Size Used for the Test Set and Data Provenance

The document does not describe a traditional "test set" in the context of clinical performance data in human subjects for the PolyVue 43™ device itself, as it relies heavily on substantial equivalence to the predicate device.

Physical, Optical, and Chemical Properties: The reported values (water content, Dk, modulus, etc.) are likely derived from laboratory testing of the device material and finished lenses. The sample sizes for these tests are not provided, nor is the data provenance in terms of specific laboratories or countries of origin.
Biocompatibility and Material Testing: The text mentions "Cytotoxicity Test," "Systemic Injection Test," "Eye Irritation Test," "Compatibility Testing," "Preservative Uptake and Release," and "Leachability of color additives and residual monomers." These are laboratory-based tests. The sample sizes for these specific tests are not provided. The data provenance is implied to be Optech, Inc. internal testing or testing by contract labs.
Manufacturing Verification: "We have also included in this submission the results of 10 multifocal lenses, manufactured to variety of prescribed specifications to verify ability of the manufacturer to make these lenses." This is a very small sample size for manufacturing verification, not a clinical test set. The provenance is internal manufacturing.

In summary, there is no clearly defined clinical "test set" or data provenance from patient studies provided in this 510(k) summary.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications

This information is not provided as the submission does not detail a clinical study with human subjects requiring ground truth established by experts. The "ground truth" for the physical and chemical properties would be established by validated laboratory measurement methods.

4. Adjudication Method for the Test Set

This information is not applicable/not provided as there is no described clinical test set requiring expert adjudication.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done

No, an MRMC comparative effectiveness study was not done or described. This type of study is more common for diagnostic imaging devices where human readers interpret results. For contact lenses, the primary focus is on physical and chemical properties, biocompatibility, and safety/effectiveness in patients, often through clinical trials if substantial equivalence cannot be fully demonstrated based on material and design. In this case, no clinical trial data are presented.

6. If a Standalone Study (algorithm only without human-in-the-loop performance) was done

This concept is not applicable here. "Standalone performance" or "algorithm only" refers to artificial intelligence/machine learning devices. The PolyVue 43™ is a physical medical device (contact lens), not an AI algorithm.

7. The Type of Ground Truth Used

The "ground truth" for the claims in this submission primarily relies on:

Laboratory Measurements: For physical, optical, and chemical properties (e.g., water content, Dk, modulus).
Standardized Biocompatibility Tests: For cytotoxicity, systemic injection, eye irritation, etc., which have predefined pass/fail criteria.
Predicate Device Equivalence: The foundation of the 510(k) process, where the "ground truth" for safety and effectiveness is largely drawn from the known performance and regulatory history of the legally marketed predicate device (Specialty T Toric).

8. The Sample Size for the Training Set

There is no mention of a training set in the context of artificial intelligence or machine learning. For contact lenses, the "training" would refer to the development and refinement of manufacturing processes and material science, rather than an AI training set.

9. How the Ground Truth for the Training Set was Established

As there is no "training set" in the AI sense, this question is not applicable. The "ground truth" for the development of medical devices generally involves extensive pre-clinical research, material science, engineering principles, and adherence to relevant standards and regulations.

Summary

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NOV 6 1998

510 (K) Summary

SUBMITTER:

Submitted on behalf of:

Company Name:	Optech, Inc.
Address:	6341 South Troy CircleEnglewood, CO 80111-6415

Phone! Fox:

303 708-1390 303 708-1392

CONTACT PERSON: Jarnes A. Brooks

DATE SUMMARY PREPARED: June 10, 1998

7 : 0 : 0 : 0000000

TRADE NAME: The PolyVue 43™ (ocufilcon A) Spherical, Toric and Aspherical Multifocal Hydrophilic Contact Lenses for Daily Wear (clear and - i ------------------------------------------------------------------------------------------------------------visibility tinted)

COMMON NAME: contact lens

SUBSTANTIALLY EQUIVALENT TO: -- ------

The PolyVue 43™ (ocufilcon A) Spherical, Toric and Aspherical Multifocal Hydrophlic Contact Lenses for Dally Wear (clear and visibility tinted) is equivalent to Specially UltraVision's Specialty T (ocufilcon A) Toric Hydrophlic Contact lens for daily wear as currently marketed in the U.S.

The PolyVue 43™ (ocurilcon A) Spherical, Toric and Aspherical Multifocal l lydrophille Contact Lenses for Dally Wear (clear and visibility tinted) are substantlally equivalent to Specialty UltraVision's Specialty T (ocufilcon A) Toric lens. PolyVue 43™ (ocufilcon A) Spherical, Toric and Aspherical Multifocal Hydrophilic Contact Lens (clear and visibility tinted) is the same lens " material that received marketing clearance pursuant to K963764 for Specialty UltraVision, Inc. This lens conforms to and Is substantially equivalent to spherical, aspherical, presbyopic and astigmatic lens designs that are currently marketed in the United States. The intended use and target population are substantlally equivalent.

This lens is in Group 'J lonic, low water content polymers as established by the FDA and located in the Guldance Document for Dally Wear Contact Lenses,

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Revised Edition May 1994. The physical, optical and chemical propertles of the PolyVue 43™ (ocufilcon A) Spherical, Toric and Aspherical Multifocal Hydrophilic Contact Lenses for Daily Wear (clear and visibility tinted) and the Specialty T (ocufilcon A) Soft (Hydrophilic) Toric Contact Lens for Dally Wear are substantially equivalent.

PARAMETER	PolyVue 43™	Specialty T Toric
material	ocufilcon A	ocufilcon A
indication for use	myopia, hyperopia, presbyopiaand astigmatism	myopia, hyperopia and astigmatism
water content	43%	44.1%
light transmittance	98.513	98.493
Dk (35°C)	$11.340 X 10^{-11}$	$11.267 X 10^{-11}$
modulus	36.50 g/mm²	35.96 g/mm²
tensile strength	34.68 g/mm²	33.98 g/mm²
elongation @ break	169.26 %	165.27%
toughness	31.9668 g/mm²	31.8488 g/mm²
color	clear and visibility tinted	clear
refractive index	1.427	1.427
Powers	-20.00 TO +20.00 d	-20.00 to +20.00 D

SIMILARITIES and DIFFERENCES:

DESCRIPTION of the DEVICE:

PERFORMANCE

Optech, Inc. has carried out a complete performance evaluation of the PolyVue 43™ (ocufilcon A) Spherical, Toric and Aspherical Multifocal Hydrophilic Contact

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Lenses for Daily Wear (clear and visibility tinted). This assessment addressed the following issues:

Cytotoxicity Tast 1.
SystemIc Injection I est 2.
1. Eye Irritation Test
1. Compatibility tasting
ഗ് Preservative Uptake and Release
Leachability of color additives and residual monomers 6.

These studies demonstrate that the material Is non toxic, compatible with standard lens care regimens and that the residual monomers and color additive leachability is within acceptable limits.

Concerning compatibility testing, the recommended lens care products (cleaning, rinsing and disinfection) have been approved for use with lenses of the same lens group. Therefore, no additional compatibility testing is Included.

with regard to preservalive uptake and release studies, since the subject contact lens has the same surface electric charge as the predicate device (same material being used) no additional studies need be conducted.

We have also included in this submission the results of 10 multifocal lenses, manufactured to variely of prescribed specifications to verify ablity of the manufacturer to make these lenses.

INDICATIONS FOR USE:

Device Name: PolyVue 43™ (ocufiicon A) Spherical, Toric and Aspherical Multifocal Hydrophilic Contact Lous (clear and visibility tinted)

The Polyvue 43m (ocutiicon A) Spherical, Toric and Aspherical Multifocal Hydrophlic Contact Lens (clear and visibility tinted) Is Indicated for dally wear for the correction of refractive ametropia (myopla and hyperopia), presbyopia and astigmatism In aphakic and non-aphakic persons with non-diseased eyes.

Lyecare practitioners may prescribe the lens for dally wear in a Frequent Replacement Program. The lenses may be disinfected using heat, chemical or hydrogen peroxide disinfection systems.

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PARAMETERS AVAILABLE:

PolyVue 43™ (ocufilcon A) Spherical, Toric and Aspherical Multifocal Hydrophlic Contact Lens (clear and visibility tinted)

・

Spherical and Aspherical Multifocal

Powers: Center Thickness: Diameter: Bose Curve: Cylinder Powers: Axis:

+20.00 to -20.00D 0.03 το 0.40mm 14.0, 14.5mm 8.3 to 8.6mm N/A N/A

Toric +20.00 to -20.00D 0.101 to 0.520mm 14.0, 14.5, 15.0mm 8.0 to 9.3mm -0.50 to -16.00 in 0.25 D steps 10 to 1800 in 10 sleps

For the Multifocal Design

Add Powers:

Continuous adds to 3.25 D

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Image /page/4/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized image of an eagle with three human profiles incorporated into its design. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

1998 6 NOV

James A. Brooks 6341 S. Troy Circle Unit E Englewood, CO 80111-6415

Re: K982110/S1

Trade Name: Poly Vue 43™ (ocufilcon A) Spherical, Toric and Aspherical Multifocal Hydrophilic Contact Lenses for Daily Wear (clear and visibility tinted, lathe cut from molded buttons) Regulatory Class: II Product Code: 86LPL Dated: August 25, 1998 Received: August 27, 1998

Dear Mr. Brooks:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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). 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 (Premarket Approval), 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 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

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Page 2 - Mr. James A. Brooks

This letter will allow you to begin marketing your device as described in your 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 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4613. 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" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".

Sincerely yours,

A. Ralph Rosenthal

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

Enclosure

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INDICATIONS STATEMENT

Device Name: PolyVue 43™ (ocufilcon A) Spherical, Toric and Aspherical Multifocal Hydrophilic Contact Lenses for Dally Wear (clear and visibility tinted)

The PolyVue 43™ (ocufilcon A) Spherical, Toric and Aspherical Multifocal Hydrophlilic Contact Lens (clear and visibility tinted) is indicated for daily wear for the correctlon of refractive ametropia (myopia and hyperopia), presbyopla and astigmatism in aphakic and non-aphakic persons with non-diseased eyes.

Eyecare practitioners may prescribe the lens for daily wear In a Frequent Replacement Program. The lenses may be disinfected using heat, chemical or hydrogen peroxide disinfection systems.

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

	Ming-chuen Shut(Division Sign-Off)Division of Ophthalmic Devices
Prescription Use
or Over-The-Counter Use	510(k) Number K982110

(Optional Format 1-2-9G)

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.