The FREQUENCY™ 55 UV (methafilcon A) Hydrophilic Contact Lens (clear and tinted) is indicated for daily wear for the correction of refractive ametropia (myopia and hyperopia) and astigmatism in aphakic and not-aphakic persons with non-diseased eyes that may exhibit astigmatism up to 2.00 Dioptres that does not interfere with visual acuity.

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

Device Description

The FREQUENCY 55 UV (methafilcon A) Hydrophilic Contact Lens is available as a spherical lens in both clear and an aqua visibility tint. The lens material (methafilcon A) is a hydrophilic polymer of 2-hydroxyethyl methacrylate (HEMA) which is cross-linked with ethyleneglycol dimethacrylate. When hydrated, the lens consists of 45.0% HEMA and 55.0% water by weight when immersed in normal saline. The lens is visibility tinted aqua with Reactive Blue Dye No. 4 and Reactive Yellow Dye # 86. A benzotriazole 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 10% in the UVA range of 315 to 380 nm. The FREQUENCY 55 UV (methafilcon A) Hydrophilic Contact Lens for Daily Wear is a hemispherical flexible shell which cover the cornea and a portion of the adjacent sclera.

AI/ML Overview

The provided document is a 510(k) Pre-market Notification for a contact lens, the FREQUENCY 55 UV (methafilcon A) Hydrophilic Contact Lens. It details the device's properties and its substantial equivalence to a predicate device. This type of regulatory submission does not typically include information about studies to prove device performance against acceptance criteria in the same way a software or AI/ML device would.

Instead, for contact lenses, "acceptance criteria" are usually based on demonstrating that the new device has equivalent or better physical, optical, and chemical properties, as well as safety (toxicology, leachable compounds), compared to a previously cleared predicate device. The "study" proving this involves direct comparison of these properties through laboratory testing, rather than clinical trials with human readers or AI performance metrics.

Therefore, many of the requested categories (like sample size for test set, number of experts for ground truth, adjudication methods, MRMC studies, standalone performance, training set size) are not applicable to this type of device and submission.

Here's an attempt to answer the questions based on the provided text, recognizing the different nature of this device type:

1. Table of Acceptance Criteria and Reported Device Performance

The "acceptance criteria" for this device are implicitly demonstrating substantial equivalence to the predicate device, FREQUENCY 55 (methafilcon A) Hydrophilic Contact Lens for Daily Wear. This is achieved by showing comparable physical, optical, and chemical properties, and acceptable safety profiles.

Parameter	Acceptance Criteria (Implied: Substantially Equivalent to Predicate)	Reported Device Performance (FREQUENCY 55 UV)	Predicate Device Performance (FREQUENCY 55)
Material	methafilcon A	methafilcon A	methafilcon A
Indication for use	myopia, hyperopia, astigmatism	myopia, hyperopia, and astigmatism	myopia, hyperopia, and astigmatism
Water Content	55%	55%	55%
% Transmittance @ 590nm	Comparable to Predicate (>90% specified in description)	93.58%	95.47%
% Transmittance @ 280-315 nm	Block UV (significantly lower than predicate, <10% specified)	6.00%	82.47%
% Transmittance @ 316-380 nm	Block UV (significantly lower than predicate, <10% specified)	4.09%	95.30%
Dk (35°C) (Edge Corrected)	Comparable to Predicate	$14.00 \times 10^{-11}$	$15.50 \times 10^{-11}$ trending
Powers	-20.00 to +20.00 D	-20.00 to +20.00 D	-20.00 to +20.00 D
Color	Clear and tinted (differs in tint color but functionally similar)	Clear and aqua visibility	Clear and blue visibility
Refractive Index	Comparable to Predicate	1.4027	1.4052
Tensile Strength	Comparable to Predicate	1.26	0.66
Modulus	Comparable to Predicate	0.32	0.48
Elongation at Break	Comparable to Predicate	287	179
Toughness	Comparable to Predicate	1.27	0.38
Manufacturing Method	cast molding	cast molding	cast molding
Toxicological Profile	Non-toxic	Demonstrated non-toxic (cytotoxicity, acute systemic, acute ocular)	(Not specified in table, but predicate would have demonstrated safety)
Residual Monomer/Color Leach.	No leachable color/significant residual monomers	Demonstrated no leachable color/significant residual monomers	(Not specified in table, but predicate would have demonstrated safety)
Sterilization/Packaging	Same as previously cleared devices	Same as K973063 and K971164, sterility released by parametric release.	Same as K973063 and K971164

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

For physical, optical, and chemical properties, the "test set" would consist of manufactured lenses subjected to laboratory measurements. The document does not specify the sample size (number of lenses tested) used for these measurements or the exact provenance (e.g., specific manufacturing batches). The data is generated from laboratory testing of the device itself.

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

N/A. This is a contact lens, not a diagnostic device requiring expert interpretation of medical images or data. Ground truth for properties like water content or transmittance is established by direct measurement using validated laboratory methods and instruments, not by expert consensus on clinical cases.

4. Adjudication Method for the Test Set

N/A. Adjudication methods like "2+1" typically apply to expert review of clinical cases, which is not relevant for the type of testing described for this contact lens.

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

N/A. MRMC studies are used for evaluating diagnostic performance of systems involving human readers, usually in conjunction with AI. This is not applicable to an optical device like a contact lens.

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

N/A. This device does not involve an algorithm or AI. Its performance is measured directly through laboratory characterization of its physical, optical, and chemical properties.

7. The Type of Ground Truth Used

The ground truth for the device's properties is based on direct laboratory measurement using established scientific methods (e.g., for Dk, transmittance, tensile strength, water content). For safety attributes (toxicology, leaching), the ground truth is established through standard biological and chemical testing protocols.

8. The Sample Size for the Training Set

N/A. There is no "training set" in the context of a traditional mechanical/optical medical device like a contact lens. The device's properties are inherent to its design and manufacturing process, not learned from data.

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

N/A. As mentioned above, there is no training set for this type of device.

Summary

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JAN 2 0 1999

510 (k) Summar

SUBMITTER:

Submitted on behalf of:

Company Name:Address:	Aspect Vision Care Ltd.South Point, HambleSouthampton SO31 4RFUnited Kingdom
Phone:	00 1 44 1703 605 200
Fax:	00 1 44 1703 605 299
CONTACT PERSON:	Ivor Atkinson
DATE SUMMARY PREPARED:	August 24, 1998
TRADE NAME:	FREQUENCY 55 UV (methafilcon A) Hydrophilic ContactLens for Daily Wear (clear and tinted)
COMMON NAME:	Contact Lens

SUBSTANTIALLY EQUIVALENT TO:

FREQUENCY 55 UV (methafiloon A) Hydrophilic Contact Lenses for Daily Wear (clear and tinted) are substantially equivalent to FREQUENCY 55 (methafilcon A) Hydrophilic Contact Lenses for Daily Wear (clear and tinted) that received marketing clearance pursuant to K973063, currently marketed in the US. A comparison of properties is found in the chart below.

Preclinical Testing

The results of toxicology testing (cytotoxicity, acute systemic toxicity and acute ocular irritation) have demonstrated that the subject lens in non toxic. Furthermore, the results of residual monomer and colour leachability testing demonstrate that the respective extracts did not contain leachable colour or significant levels of residual monomers.

The physical optical, and chemical properties of the FREQUENCY 55 UV (methafilcon A) Hydrophilic Contact Lens for Daily Wear (clear and tinted) are equivalent to those of the FREQUENCY 55 (methafilcon A) Hydrophilic Contact Lens for Daily Wear (clear and tinted). This lens is in Group 4, lonic, 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 lens will be sterilised and packaged in the same manner as previously cleared in K973063 and K971164. This lens will also be sterility released by parametric release, as cleared in K971164.

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COMPARISON OF PHYSICAL/OPTICAL PROPERTIES:

PARAMETER	FREQUENCY 55 UVTMHydrophilic ContactLens for Daily Wear(clear and tinted with UVBlocker)	FREQUENCY 55 HydrophilicContact Lens for Daily Wear(clear and tinted)
material	methafilcon A	methafilcon A
indication for use	myopia, hyperopia andastigmatism	myopia, hyperopia andastigmatism
water content	55%	55%
% transmittance @ 590nm	93.58%	95.47%
% transmittance @ 280-315 nm	6.00	82.47
% transmittance @ 316-380 nm	4.09	95.30
Dk (35°C) (Edge Corrected)	$14.00 X 10^{-11}$	$15.50 X 10^{-11}$
powers	-20.00 to+20.00 D	-20.00 to+20.00 D
color	clear and aqua visibility	clear and blue visibility
refractive index	1.4027	1.4052
tensile strength	1.26	0.66
Modulus	0.32	0.48
Elongation at Break	287	179
Toughness	1.27	0.38
manufacturing method	cast molding	cast molding

DESCRIPTION of the DEVICE:

14.0mm to 15.0mm Chord Diameter: ●
Center Thickness: 0.03mm to 0.40mm ●
8.40mm to 9.30mm Base Curve: �
Spherical Powers: -20.00 Diopters to +20.00 Diopters .

The physical/optical properties of the lens are:

1.40 Refractive Index: .
% Transmittance @590nm: >90% 0
% Transmittance @ 280-315nm <10% .
% Transmittance @ 316-380nm <10% ●
Specific Gravity (calculated): 1.09 ●
Surface Character: clear ●

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Water Content: .
Oxygen Permeability (Dk) *: .

*[Fatt Method for determination of oxygen permeability, edge corrected]

INDICATIONS FOR USE:

Device Name: Frequency 55 UV (methafilcon A) Hydrophilic Contact Lens for Daily Wear (clear and tinted) .................

్ట్రాల్లో కూడా ప్రాంత్రి ప్రాంత్రమైన సామానికి ప్రాంతాలు The FREQUENCY™ 55 UV (methafilcon A) Hydrophilic Contact Lens (clear and tinted) is indicated for daily wear for the correction of refractive ametropia (myopia and hyperopia) and astigmatism in aphakic and not-aphakic persons with non-diseased eyes that may exhibit astigmatism up to 2.00 Dioptres that does not interfere with visual acuity.

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

PARAMETERS AVAILABLE:

The FREQUENCY™ 55 UV (methafilcon A) Hydrophilic Contact Lens (clear and tinted) →

Powers:	+10.00 to -10.00D
Center Thickness:	0.07mm
Diameter:	14.2mm
Base Curve:	8.6, 8.9mm (minus lenses) and 8.8mm (plus lens)

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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 the department's name arranged in a circular fashion around a symbol. The symbol consists of a stylized caduceus, which is a staff with two snakes entwined around it, and a bowl.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JAN 2 0 1999

Aspect Vision Care Ltd. Mr. Ivor Atkinson Scientific Director South Point, Hamble Southhampton SO 31 4RF, Engand

Re: K982997 Trade Name: FREQUENCY 55 UV (methafilcon A) Hydrophilic Contact Lens for Daily Wear (clear and tinted) Regulatory Class: II Product Code: LPL Dated: November 12, 1998 Received: November 23, 1998

Dear Mr. Atkinson:

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. Ivor Atkinson

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: FREQUENCY 55 UV (methafilcon A) Hydrophilic Contact Lens for Daily Wear (clear and tinted)

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

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED) Concarrence of CDRH, Office of Device Evaluation (ODE)

X Prescription Use

OR Over-the-Counter Use
Daniel W.C. Brown, Ph.D.

(Optional Format 1-2-96)

vision of Ophthalmic Devices 510(k) Number_K982997

153

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.