The PolyVue Silver Chord, Unisoft (methafilcon A) Spherical, Aspherical, Toric and Multifocal Hydrophilic Contact Lens (clear and tinted) is indicated for daily wear for the correction of refractive ametropia (myopia and hyperopia), presbyopia and astigmatism in not-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.

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 eye. These lenses are designed with varying base curves which conform to the shape of the radius of the comea and center over the apex of the cornea to provide corrective refraction of functional conditions of the eye including myopia (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 aiding in lens centration and comfort as well as providing additional add power for near and blocking spherical aberration.

AI/ML Overview

The provided text is a 510(k) Summary for a contact lens device, not a study report for an AI/ML medical device. Therefore, the information requested in the prompt, which is specific to AI/ML device studies and acceptance criteria (e.g., sample size for test set, number of experts for ground truth, MRMC study, standalone performance, training set details), is not present in the given document.

The document primarily focuses on establishing substantial equivalence to a predicate device based on material, properties, and indications for use.

Here's what can be extracted from the document in relation to acceptance criteria and device performance, rephrased to fit the context of device characteristics rather than AI model performance:

1. Table of Acceptance Criteria and Reported Device Performance

For contact lenses, "acceptance criteria" are typically defined by the physical, optical, and chemical properties that demonstrate the device is safe and effective and comparable to legally marketed predicate devices. The "reported device performance" are the measured values for these properties.

Parameter	PolyVue Silver Chord, Unisoft (methafilcon A) Spherical, Aspherical, Toric and Multifocal Hydrophilic Contact Lenses for Daily Wear (clear and tinted) (Subject Device)	Acceptance Criteria (implied by predicate device)
Material	methafilcon A	methafilcon A
Indication for Use	myopia, hyperopia, presbyopia and astigmatism (in non-aphakic persons with non-diseased eyes)	myopia, hyperopia, presbyopia and astigmatism
Water Content	55%	55%
Light Transmittance	>95%	>95%
Dk (35°C)	$18.83 X 10^{-11}$	$18.83 X 10^{-11}$
Powers	-20.00 to +20.00 D	-20.00 to +20.00 D
Color	clear and green tinted	clear (predicate)
Color Additive Used	Phthalocyanine Green	N/A (predicate)
Specific Gravity	1.09	1.09
Refractive Index	1.415	1.415
Center Thickness	0.17 mm	Not explicitly stated in table, but part of device description.
Diameter	14.5 mm	Not explicitly stated in table, but part of device description.
Base Curve	8.3 mm and 8.6 mm	Not explicitly stated in table, but part of device description.
Multifocal Add Powers	Continuous adds to +3.25	Not explicitly stated in table, but part of device description.

Study that proves the device meets the acceptance criteria:

The document states that the PolyVue Silver Chord, Unisoft (methafilcon A) Spherical, Aspherical, Toric and Multifocal Hydrophilic Contact Lenses for Daily Wear (clear and tinted) is substantially equivalent to a previously cleared device (K953807), which serves as the "study" or justification for meeting acceptance criteria.

The substantial equivalence is argued based on:

Identical material (methafilcon A), implying identical biocompatibility.
Similar intended use and target population.
Equivalent physical, optical, and chemical properties (as shown in the table above).
Labeling modifications only for the color additive, following FDA's guidance document.
Manufacturing methods: While an alternative manufacturing method (molded button with lathe-cut front surface) is introduced, it is stated that "The process shall be validated to demonstrate that the finished product is equivalent to a standard lathe cut lens. Samples will be periodically taken to continually assure that the finished lens specifications are complied with." This describes the validation plan rather than completed study results within this summary.

The remaining points (2-9) are not applicable to this document as it does not describe an AI/ML device study.

Sample size used for the test set and the data provenance: Not applicable. This is a contact lens submission, not an AI/ML study.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable.
Adjudication method: Not applicable.
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.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable.
The type of ground truth used: Not applicable. The "ground truth" for contact lenses is established through material characterization, clinical trials for safety and effectiveness (which this 510(k) references by substantial equivalence to an already cleared device), and adherence to manufacturing specifications.
The sample size for the training set: Not applicable.
How the ground truth for the training set was established: Not applicable.

Summary

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K980818

510 (k) Summary

SUBMITTER:

MAR 30 1998

Submitted on behalf of:

Company Name:	Stephen A. Dunn, Inc.
Address:	1329 Lusitana StreetHonolulu, HI 96813

Telephone: Fax:

(808) 599-2742 (808) 521-2823

CONTACT PERSON: Martin S. Knopf

DATE SUMMARY PREPARED: February 27, 1998

TRADE NAME: The PolyVue Silver Chord, Unisoft (methafilcon A) Spherical, Toric and Multifocal Hydrophilic Contact Lenses for Daily Wear (clear and tinted

COMMON NAME: contact lens

SUBSTANTIALLY EQUIVALENT TO:

The PolyVue Silver Chord, Unisoft (methafilcon A) Spherical, Aspherical, Toric and Multifocal Hydrophilic Contact Lenses for Daily Wear (clear and tinted) is equivalent to PolyVue Silver Chord, Unisoft (methafilcon A) Spherical, Aspherical, and Toric Hydrophilic Contact Lenses for Daily Wear which received marketing clearance pursuant to K953807 as currently marketed in the U.S.

The PolyVue Silver Chord, Unisoft (methafilcon A) Spherical, Aspherical, Toric and Multifocal Hydrophilic Contact Lenses for Daily Wear (clear and tinted) are substantially equivalent to Stephen A. Dunn, Inc.'s currently marketed PolyVue Silver Chord, Unisoft (methafilcon A) Spherical, and Toric Hydrophilic Contact Lenses for Daily Wear. PolyVue Silver Chord, Unisoft (methafilcon A) Spherical, Toric and Multifocal Hydrophilic Contact Lens (clear and tinted) is the same lens material that Stephen A. Dunn, Inc. received marketing clearance pursuant to K953807. 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 substantially equivalent.

This lens is in Group 4 ionic, high water content polymers as established by the FDA and located in the Guidance Document for Daily Wear Contact Lenses, Revised Edition May 1994. The physical, optical, and chemical properties of the PolyVue Silver Chord, Unisoft (methafilcon A) Spherical, Aspherical, Toric and Multifocal Hydrophilic Contact Lenses for Daily Wear (clear and tinted) and the PolyVue Silver Chord, Unisoft (methafilcon A) Spherical, Aspherical, and Toric Hydrophilic Contact Lenses for Daily Wear which received marketing clearance pursuant to K953807 are substantially equivalent.

025 s
C

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SIMILARITIES and DIFFERENCES:

PARAMETER	PolyVue Silver Chord, Unisoft (methafilcon A) Spherical, Aspherical, Toric and Multifocal Hydrophilic Contact Lenses for Daily Wear (clear and tinted)	PolyVue Silver Chord, Unisoft (methafilcon A) Spherical, Aspherical and Toric Hydrophilic Contact Lenses for Daily Wear
material	methafilcon A	methafilcon A
indication for use	myopia, hyperopia, presbyopia and astigmatism	myopia, hyperopia, presbyopia and astigmatism
water content	55%	55%
light transmittance	>95%	>95%
Dk (35°C)	$18.83 X 10^{-11}$	$18.83 X 10^{-11}$
powers	-20.00 to+20.00 D	-20.00 to+20.00 D
color	clear and green tinted	clear
Color additive used	Phthalocyanine Green	N/A
specific gravity	1.09	1.09
refractive index	1.415	1.415

DISCUSSION OF SIMILARITIES AND DIFFERENCES

The PolyVue Silver Chord, Unisoft (methafficon A) Spherical, Toric and Multificcal Hydrophlic Contact Lenses for Daily Wear (clear and linted) has the same intended use and target population as the company's referenced predicate device.

PolyVue Silver Chord, Unisoft (methallicon A) Sohencal, Aspherical, Toric and Multifocal Hydrophilic Contact Lenses for Daily Wear (clear and tirted) differs from some of the predicate devices characteristics with respect to the addition of an approved color additive and the additional, alternative manufacturing process. These issues will now be discussed in turn.

1. Materials

methafilcon A. This is identical for both the subject and predicate device

2. Blocompatibility

Identical, since the material is the same

ri Labeling Compared to Predicate Labeling

Labeling for daily wear soft contact lenses has been provided by reference in the predicate application for Stephen A. Durn, Inc., pursuant to K950807. The only modification to this labeling is the inclusion of the color additive, phthalocyanine green to the device description. This labeling follows the recommended labeling which is supplied in the Guidance Document for Daily Wear Soft Contact Lenses issued by FDA May 1994. Each of the labeling elements, the Vial Label, Package Insert, Professional Fitting and Information Guide and Patient Instruction Booklet.

026 ో ప్ర

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4. Manufacturing Method

In a standard lathing process for a soft lens, the lenses are fully lathe cut from cast molded buttons. This is the currently cleared manufacturing method for the predicate lens. The subject lens will be either fully lathed from these buttons or may alternatively be manufactured from a molded button, which incorporates a molded base curve. The front surface will then be lathe cut. The process shall be validated to demonstrate that the finished product is equivalent to a standard lathe cut lens. Samples will be periodically taken to continually assure that the finished lens specifications are complied with.

DESCRIPTION of the DEVICE:

INDICATIONS FOR USE:

Device Name: PolyVue Silver Chord. Unisoft (methafilcon A) Spherical, Aspherical, Toric and Multifocal Hydrophilic Contact Lens (clear and tinted

Evecare 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.

PARAMETERS AVAILABLE:

PolyVue Silver Chord, Unisoft (methafilcon A) Spherical, Aspherical, Toric and Multifocal Hydrophilic Contact Lens (clear and tinted

powers:	20.00 to -20.00D
Center Thickness:	0.17 mm
Diameter:	14.5 mm
Base Curve:	8.3 mm and 8.6 mm

For the Multifocal Design: Add Powers:

Continuous adds to +3.25

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Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized depiction of a human figure in profile, composed of three curved lines that suggest a head, torso, and legs. The figure is positioned to the right of a circular arrangement of text that reads "DEPARTMENT OF HEALTH & HUMAN SERVICES USA".

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MAR 3 0 1998

Stephen A. Dunn, Inc. c/o Mr. Martin S. Knopf President and CEO Knopf Associates, Inc. 90 West Main Street Freehold, NJ 07728

Re: K980818

Trade Name: Poly Vue, Silver Chord and Unisoft (methafilcon A) Spherical, Aspherical, Toric and Multifocal Hydrophilic Contact Lenses for Daily Wear (clear and visibility tint)

Regulatory Class: II Product Code: 86 LPL Dated: February 27, 1998 Received: March 3, 1998

Dear Mr. Knopf:

We have reviewed your Section 510(k) notification of intent to market the devices referenced above and we have determined the devices are 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 devices, 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 devices are 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 devices 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 devices 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. Martin S. Knopf

This letter will allow you to begin marketing your devices as described in your 510(k) premarket notification. The FDA finding of substantial equivalence of your devices to a legally marketed predicate device results in a classification for your devices and thus, permits your devices to proceed to the market.

If you desire specific advice for your devices 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 devices, 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 Silver Chord, Unisoft (methafilcon A) Spherical, Aspherical, Toric and Multifocal Hydrophilic Contact Lenses for Daily Wear

The PolyVue Silver Chord, Unisoft (methafilcon A) Spherical, Aspherical, Toric and Multifocal Hydrophilic Contact Lenses is indicated for daily wear for the correction of refractive ametropia (myopia and hyperopia), presbyopia and astigmatism in aphakic and not-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)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use

X	OR Over-The-Counter Use
---	-------------------------

Daniel W. C. Breton Ph.D (Optional Format 1-2-96)

(Division Sign-Off)

Division Imin Devices

510(k) Number	K980818
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Signature

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.