Frequency 55 UV and Frequency 55 UV Aspheric lenses are indicated for daily wear for the correction of refractive ametropia (myopia and hyperopia) in aphakic and not-aphakic persons with non-diseased eyes. The lenses may be worn by persons who exhibit astigmatism of 2.00 diopters or less that does not interfere with visual acuity.

Frequency 55 UV Toric lenses are indicated for daily wear for the correction of refractive ametropia (myopia, hyperopia, and astigmatism) in aphakic and not-aphakic persons with nondiseased eyes. The lenses may be worn by persons who have astigmatism of 12.00 diopters or less.

FREQUENCY 55 LENSES WITH UV ABSORBING MONOMER HELPS PROTECT AGAINST TRANSMISSION OF HARMFUL UV RADIATION TO THE CORNEA AND THE EYE.

Note: Only chemical (not heat) and hydrogen peroxide disinfection systems may be used with Frequency 55 UV lenses.

Frequent/Planned Replacement Wear

When prescribed for Frequent/Planned Replacement Wear, the Frequency 55 UV and Frequency 55 UV Toric lenses are to be cleaned, rinsed and disinfected each time they are removed from the eye and discarded after the recommended wearing period prescribed by the eye care practitioner.

Disposable Wear

When prescribed for Disposable Wear, the wearing time prescribed by the eye care practitioner is for daily wear (single use). Patients should be instructed to discard the lenses at each removal.

Device Description

Frequency 55 UV and Frequency 55 UV Aspheric (methafilcon A) soft (hydrophilic) contact lenses are available as spherical lenses. Frequency 55 UV Toric (methafilcon A) soft (hydrophilic) contact lenses are available as astigmatic (toric) lenses. The lens material, methafilcon A, is a random copolymer of hydroxyethylmethacrylate and methacrylic acid. A benzophenone UV absorbing monomer is used to block UV radiation. The average transmittance characteristics are less than 10% in the UVB range of 280 to 315 nm and less than 40% in the UVA range of 315 to 380 nm. The lenses are tinted aqua from edge to edge for visibility purposes with the color additives, C.I. Reactive Blue No. 4 and C.I. Reactive Yellow 86.

Frequency 55 UV. Frequency 55 UV Aspheric and Frequency 55 UV Toric contact lenses are hemispherical shells with the following dimensions:

Diameter: 14.0mm to 15.0mm
Base Curve: 8.0mm to 9.5mm
Center Thickness: 0.03mm to 0.60mm (varies with power)
Spherical Powers: -20.00 to +20.00D
Cylindrical Powers: plano to -12.00
Axis: 1° to 180°

The physical/optical properties of the Frequency 55 UV and Frequency 55 UV Aspheric and Frequency 55 UV Toric contact lenses are:

Refractive Index: 1.40
% Transmittance @ 590nm: >90%
% Transmittance @ 280-315nm: <10%
%Transmittance 316-380nm: <40%
Water Content; 55%
Oxygen Permeability: 22.0 x 10.11 (cm2/sec)(ml 02/ml x mmHg) at 35°C Fatt Method for determination of oxygen permeability)

AI/ML Overview

The provided text is a 510(k) Premarket Notification for contact lenses. It describes the device, its indications for use, and a comparison to predicate devices to establish substantial equivalence.

Based on the nature of this document (a 510(k) for contact lenses), it focuses on demonstrating equivalence to existing legally marketed devices, rather than a clinical study evaluating the performance of an AI-powered diagnostic device against specific acceptance criteria in the way you've outlined. Therefore, many of the requested data points (sample sizes for test/training sets, number/qualifications of experts, adjudication methods, MRMC studies, standalone performance, ground truth types) are not applicable or not present in this type of submission.

However, I can extract information related to the device's technical specifications and how they compare to the predicate devices, which serves as the "acceptance criteria" in this context for demonstrating substantial equivalence.

Here's the closest interpretation of your request based on the provided document:

Acceptance Criteria and Device Performance (for Substantial Equivalence)

For a 510(k) submission, "acceptance criteria" are generally met by demonstrating that the new device is as safe and effective as a legally marketed "predicate device," without raising new questions of safety or effectiveness. This is done by comparing various attributes. The table below outlines key comparative data presented to establish substantial equivalence rather than explicit "acceptance criteria" in the context of a clinical study.

Acceptance Criteria (Predicate Device Value)	Reported Device Performance (Frequency 55 UV)	Interpretation / Conclusion
Lens Material: Methafilcon A (Equivalent)	Methafilcon A	Equivalent
Material Classification: Group 4 >50% ionic polymer (Equivalent)	Group 4 >50% ionic polymer	Equivalent
Indication: Myopia, hyperopia, and astigmatism (for Frequency 55 UVAM predicate)	Myopia, hyperopia, and astigmatism	Equivalent
Water Content: 55% (Equivalent)	55%	Equivalent
Light Transmittance (%) @ 590nm: 94.61% (for Sauflon 55 UV) / 93.58% (for Frequency 55 UVAM)	94.61%	Within range of predicates
UVA region (316-380nm): 36.00% (for Sauflon 55 UV) / 4.09% (for Frequency 55 UVAM)	36.00%	Matches Sauflon 55 UV, higher than Frequency 55 UVAM, but within acceptable range for UV blocking.*
UVB region (280-315nm): 9.41% (for Sauflon 55 UV) / 6.00% (for Frequency 55 UVAM)	9.41%	Matches Sauflon 55 UV, higher than Frequency 55 UVAM, but within acceptable range for UV blocking.*
Dk (35° C): 15.8 x 10-11 (for Sauflon 55 UV) / 14.0 x 10-11 (for Frequency 55 UVAM)	15.8 x 10-11	Matches Sauflon 55 UV, higher than Frequency 55 UVAM
Powers: +20.00 to -20.00 D (Equivalent)	+20.00 to -20.00 D	Equivalent
Tint: Aquamarine (for Sauflon 55 UV) / Clear or Aquamarine (for Frequency 55 UVAM)	Clear or Aquamarine	Consistent with predicates
Manufacturing Method: Fully Molded (Equivalent)	Fully Molded	Equivalent
Lens Design: Spherical, Aspheric, Back Surface Toric (consistent with predicates)	Spherical, Aspheric, Back Surface Toric	Consistent with predicates
Packaging: Blister Pack (Equivalent)	Blister Pack	Equivalent

*Note on UV Transmittance: The document states "The average transmittance characteristics are less than 10% in the UVB range of 280 to 315 nm and less than 40% in the UVA range of 315 to 380 nm." The reported values are 9.41% for UVB and 36.00% for UVA, which meet these internal specifications. The comparison table shows the Frequency 55 UV matching the Sauflon 55 UV for these characteristics.

Study Information (as applicable for a 510(k) for contact lenses)

Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
- Test Set Sample Size: Not applicable in the context of an "AI test set." The "test" for this device is primarily a comparison of its physical, chemical, and optical properties, and safety (toxicology), rather than a clinical performance study with a patient population and ground truth.
- Data Provenance: The data primarily comes from laboratory testing (e.g., transmittance measurements, Dk, toxicological assays) and engineering specifications. Country of origin not specified, but the submitter is in Scottsville, NY, USA. The data is prospective as it pertains to the newly developed device and its characteristics.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience):
- Not applicable. "Ground truth" in the clinical sense is not established by experts for this type of device comparison. The "truth" is based on objective scientific measurements and established safety standards.
Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not applicable. There is no adjudication in the sense of expert consensus on diagnostic outcomes.
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-powered diagnostic device.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not applicable. This is not an algorithm. The device's standalone performance is its physical and chemical properties and safety.
The type of ground truth used (expert consensus, pathology, outcomes data, etc):
- The "ground truth" for the device comparison is based on objective laboratory measurements (e.g., refractive index, % transmittance, water content, oxygen permeability, cytotoxicity, ocular irritation, systemic toxicity, leachability, extractables) and adherence to established material and design specifications that have been previously deemed safe and effective for predicate devices.
The sample size for the training set:
- Not applicable. This is not an AI/ML device that requires a training set.
How the ground truth for the training set was established:
- Not applicable.

Summary

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Image /page/0/Picture/0 description: The image shows the logo for CooperVision. The logo consists of the company name in a stylized font, with the "C" in "Cooper" being a double circle. To the right of the name is a square containing a stylized eye.

K020392

APR 2 6 2002 Frequency 55 UV Methafilcon A

Premarket Notification

510(k) SUMMARY OF SAFETY AND EFFECTIVENESS

1. Submitter Information:	CooperVision, Inc.711 North RoadScottsville, NY 14546
Contact Person:	Bonnie TsymbalManager, Regulatory Affairs
Telephone:	(585) 264-3210
Fax:	(585) 889-5688
Date Prepared:	February 5 th , 2002
2. Device Name:
Common Name:	Soft (hydrophilic) Contact Lens
Trade/Proprietary Name:	Frequency 55 UV (methafilcon A) Soft (hydrophilic)Contact Lens for Daily Wear
Device Classification:	Class II

3. Predicate Device:

The predicate devices are the Sauflon 55 UV (methafilcon A) Soft (hydrophilic) Visibility Tinted Contact Lens marketed by Sauflon Pharmaceuticals Ltd. and Frequency 55 with UVAM (methafilcon A) (Sphere, Asphere and Toric) Soft (hydrophilic) contact lenses for daily wear manufactured by Aspect Vision. The predicate devices were cleared under K013649 and K982997 respectively. The devices were selected as the predicate devices based on the material, intended use and design.

4. Device Description:

Frequency 55 UV. Frequency 55 UV Aspheric and Frequency 55 UV Toric contact lenses are hemispherical shells with the following dimensions:

14.0mm to 15.0mm

0.03mm to 0.60mm (varies with power)

8.0mm to 9.5mm

Diameter: .
Base Curve: ●
Center Thickness: .
Spherical Powers: .
. Cylindrical Powers:
Axis: .
-20.00 to +20.00D plano to -12.00 1° to 180°

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The physical/optical properties of the Frequency 55 UV and Frequency 55 UV Aspheric and Frequency 55 UV Toric contact lenses are:

• Refractive Index:	1.40
• % Transmittance @ 590nm:	>90%

% Transmittance @ 590nm: .
% Transmittance @ 280-315nm: <10% . <40%
%Transmittance 316-380nm .
Water Content; .
Oxygen Permeability: .

22.0 x 10.11 (cm2/sec)(ml 02/ml x mmHg) at 35°C Fatt Method for determination of oxygen permeability)

Transmittance Curves

55%

The figure below shows transmittance curves comparing the Frequency 55 UV (methafilcon A) contact lens with visibility tint and UV blocker, against those for a 24 yr. old human cornea and 25 yr. old human crystalline lens.

Image /page/1/Figure/13 description: The figure shows a plot of % Transmission vs. Wavelength (nm). The x-axis ranges from 200 to 800 nm, while the y-axis ranges from 0 to 100 % Transmission. There are three different lines plotted on the graph, each representing a different sample. One sample has a sharp increase in transmission around 350 nm, reaching nearly 100% transmission, while another sample has a gradual increase in transmission starting around 350 nm, reaching around 75% transmission.

Data was obtained from measurements taken thru the central 3-5mm portion of a Frequency 55 UV (methafilcon A with UV blocker) soft contact lens with visibility tint and UV blocker. Curve shown is for a -6.75D lens with a center thickness of 0.06 mm which represents the transmittance characteristics of the thinnest version of this UV-absorbing lens to marketed.

..............................................................................................................................................................................

-------- 25 year old crystalline lens *2

N.B.

Lerman, S., Radiant Energy and the eye, MacMillan, New York, 1980, p.58, Fig 2-21 1.
Waxler, M. Hitchins, V.M., Optical Radiation and Visual Health, CRC Press, Boca Raton, Florida, 1986, 2. p. 10 Fig. 5

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5. Indications for Use:

Frequency 55 UV lenses are indicated for daily wear for the correction of refractive ametropia (myopia and hyperopia) in aphakic and not-aphakic persons with non-diseased eyes. The lenses may be worn by persons who exhibit astigmatism of 2.00 diopters or less that does not interfere with visual acuity.

Frequency 55 UV Toric lenses are indicated for daily wear for the correction of refractive ametropia (myopia, hyperopia, and astigmatism) in aphakic and not-aphakic persons with non-diseased eyes. The lenses may be worn by persons who have astigmatism of 12.00 diopters or less.

FREQUENCY 55 LENSES WITH UV ABSORBING MONOMER HELPS PROTECT AGAINST TRANSMISSION OF HARMFUL UV RADIATION TO THE CORNEA AND THE EYE.

Note: Only chemical (not heat) and hydrogen peroxide disinfection systems may be used with Frequency 55 UV lenses.

Frequent/Planned Replacement Wear

Disposable Wear

When prescribed for Disposable Wear, the wearing time prescribed by the eye care practitioner is for daily wear (single use). Patients should be instructed to discard the lenses at each removal.

6. Substantial Equivalence:

Comparison to Predicate Device

	Frequency 55 UVUV416 (methafilcon A) Soft (hydrophilic)Contact Lens forDaily Wear	Sauflon 55 UVUV416 (methafilcon A) Soft (hydrophilic)Contact Lens for DWK013649	Frequency 55 withUVAM (methafilcon A)Soft (hydrophilic)Contact Lens for DWK982997
Lens Material	methafilcon A	Methafilcon AEquivalent	methafilcon AEquivalent
Material Classification	Group 4 >50% ionicpolymer	Equivalent	Equivalent
Indication	Myopia, hyperopiaand astigmatism	Myopia andHyperopia	Myopia, hyperopiaand astigmatism
Water Content	55%	55%	55%
Light Transmittance (%)At 590nm	94.61	94.61	93.58
UVA region (316-380nm)	36.00	36.00	4.09
UVB region (280-315nm)	9.41	9.41	6.00
Dk (35° C)	$15.8 x 10^{-11}$	$15.8 x 10^{-11}$	$14.0 x 10^{-11}$
Powers	+20.00 to -20.00 D	+20.00 to -20.00 D	+20.00 to -20.00 D
Tint	Clear or Aquamarine	Aquamarine	Clear or Aquamarine
Manufacturing Method	Fully Molded	Fully Molded	Fully Molded
Lens Design	SphericalAsphericBack Surface Toric	Sphere	SphericalAsphericBack Surface Toric
Packaging	Blister Pack	Blister Pack	Blister Pack

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7. Toxicology

The following toxicological tests were performed on Frequency 55 UV lenses:

Cytotoxicity Study Using the ISO Agarose Overlay Method a)
Under the conditions of this study, the test article showed no evidence of causing oell Iysis of Onder the conditions of this Stary, the test antists of the negative and positive controls performed as anticipated.
b) ISO Ocular Irritation Study in the Rabbit
Under the conditions of this study, the test article extracts would not be considered irritants to the ocular tissue of the rabbit.
ISO Acute Systemic Toxicity Study in the Mouse ে
Under the conditions of this study, there was no mortality or evidence of systemic toxicity from the extracts. Each test article extract met the test requirements.

8. Additional Non-Clinical Testing

a) Leachability Study
Leaching studies were undertaken to demonstrate colorfastness of assessing the acceptability of tinting the Frequency 55 UV lens with CI Reactive Blue and Reactive Yellow 86. This study demonstrates how, after two weeks of extraction at 37°c in saline, undetectable levels of dye (below 1ppm) were observed in the extraction solutions.
b) Determination of Extractables using High Pressure Liquid Chromatography
Under the conditions of this study, the test extracts did no contain residual monomers within the detection limits of the analysis.

9. Conclusions

The Frequency 55 UV (methafilcon A) Soft (hydrophilic) Contact Lens will be manufactured according to specified process controls and an ISO 9001/EN46001 and CGMP quality assurance program currently in place. The established safety profile (preclinical, toxicological, chemical/optical) of the Frequency 55 UV is equivalent to Sauflon 55 UV and Frequency 55 with UVAM.

Being similar with respect to indications for use, materials and comparable physiochemical properties to the predicate devices, this meets the requirements per section 510(k) of the act regarding substantial equivalence and does not raise questions of safety and effectiveness than the predicate devices.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

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 circular design with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the top half of the circle. Inside the circle is a stylized graphic of three human profiles facing to the right, stacked on top of each other.

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

APR 2 6 2002

CooperVision, Inc. c/o Ms. Bonnie Tsymbal Manager, Regulatory Affairs 711 North Road Scottsville, NY 14546

Re: K020392

. K020592
Trade/Device Name: Frequency 55 UV (methafilcon A) Soft (hydrophilic) Regulation Number: 886.5925 Regulation Name: Soft (hydrophilic) Contact Lens Regulatory Class: Class II Product Code: LPL Dated: February 5, 2002 Received: February 6, 2002

Dear Ms. Tsymbal:

We have reviewed your Section 510(k) premarket notification of intent to market the device we nave reviewed your becamed the device is substantially equivalent (for the indications felerenced above and nave develommed and marketed predicate devices marketed in interstate for use stated in the encrosure) to regars and the Medical Device Amendments, or to comments provision to May 20, 1976, the excordance with the provisions of the Federal Food, Drug, devices that have occh recuire approval of a premarket approval application (PMA).
and Cosmetic Act (Act) that do not require approval of a premarket approval application (PM allu Cosmette Act (11ct) that to hevice, subject to the general controls provisions of the Act. The You may, ulciclore, market the act include requirements for annual registration, listing of general controls provisions of ractice, 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 If your device is classified (600 a00 rols. Existing major regulations affecting your device can may oc subject to such additions, Title 21, Parts 800 to 898. In addition, FDA may oublish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean I lease of advisou that I Dr over device complies with other requirements of the Act that I Dr Hab Intactions and regulations administered by other Federal agencies. You must or any I cutili statutes and regirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set CI K Pat 007); mooning (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

{5}------------------------------------------------

Page 2- Ms. Bonnie Tsymbal

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 and additionally 21 CFR Part 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" (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

{6}------------------------------------------------

CooperVision

Indication for Use Statement

711 North Roz Scottsville, New York 1454 (716) 385-68 x (716) 889-569

510(k) Number: K020392

Device Name:

Frequency 55 UV Frequency 55 UV Aspheric Frequency 55 UV Toric

Indication for Use:

1. Frequency 55 UV and Frequency 55 UV Aspheric lenses are indicated for daily wear for the correction of refractive ametropia (myopia and hyperopia) in aphakic and not-aphakic persons with non-diseased eyes. The lenses may be worn by persons who exhibit astigmatism of 2.00 diopters or less that does not interfere with visual acuity.
1. Frequency 55 UV Toric lenses are indicated for daily wear for the correction of refractive ametropia (myopia, hyperopia, and astigmatism) in aphakic and not-aphakic persons with nondiseased eyes. The lenses may be worn by persons who have astigmatism of 12.00 diopters or less.

FREQUENCY 55 LENSES WITH UV ABSORBING MONOMER HELPS PROTECT AGAINST TRANSMISSION OF HARMFUL UV RADIATION TO THE CORNEA AND THE EYE.

Note: Only chemical (not heat) and hydrogen peroxide disinfection systems may be used with Frequency 55 UV lenses.

Frequent/Planned Replacement Wear

Disposable Wear

When prescribed for Disposable Wear, the wearing time prescribed by the eye care practitioner is for daily wear (single use). Patients should be instructed to discard the lenses at each removal.

PLEASE DO NO WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED

Concurrence of CDRH, Office of Device Evaluation (ODE)

Daniel W.L. Brown, Ph.D.

Nose and Throat Devises

310(k) Number_K020392

Prescription Use
(Per 21 CFR 801.109) x

Over-The-Counter

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.

Acceptance Criteria and Device Performance (for Substantial Equivalence)

Study Information (as applicable for a 510(k) for contact lenses)

510(k) SUMMARY OF SAFETY AND EFFECTIVENESS

3. Predicate Device:

4. Device Description:

. Cylindrical Powers:

Transmittance Curves

5. Indications for Use:

FREQUENCY 55 LENSES WITH UV ABSORBING MONOMER HELPS PROTECT AGAINST TRANSMISSION OF HARMFUL UV RADIATION TO THE CORNEA AND THE EYE.

Frequent/Planned Replacement Wear

Disposable Wear

6. Substantial Equivalence:

Comparison to Predicate Device

7. Toxicology

8. Additional Non-Clinical Testing

9. Conclusions

DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

APR 2 6 2002

Page 2- Ms. Bonnie Tsymbal

Indication for Use Statement

Indication for Use:

Frequent/Planned Replacement Wear

Disposable Wear

PLEASE DO NO WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED

§ 886.5925 Soft (hydrophilic) contact lens.