The CANTOR & SILVER 5X (hioxifilcon A) Spherical Soft Contact Lenses for daily wear are indicated for the correction of visual acuity in aphakic persons with non-diseased eyes with myopia or hyperopia. The lens may be worn by persons who exhibit refractive astigmatism of 1.50 diopters or less where the astigmatism does not interfere with visual acuity.

Device Description

The CANTOR & SILVER 5X (hioxifileon A) Soft (Spherical & Toric) Daily Wear Contact lenses are fabricated from hioxifilcon A, which in the dry (unhydrated) state may be machined. The hydrophilic nature of this material allows the lens to become soft and pliable when immersed in an aqueous solution.

In the hydrated state, the lens conforms to the curvature of the eye covering the cornea and extending slightly beyond the limbus forming a colorless, transparent optical surface. The (hioxifileon A) soft hydrophilic contact lens has a spherical back surface. The hydrophilic properties of the lens require that it be maintained in a fully hydrated state in a solution compatible with the eye. If the lens dries out, it will become hard and appear somewhat warped; however, it will return to its proper configuration when completely rehydrated in the proper storage solution.

The hydrophilic characteristics allow aqueous solutions to enter the lens and in its fully hydrated state the lens is approximately 58% water by weight. The physical properties of the lens are:

Refractive Index: 1.515 (dry) 1.404 (hydrated)
Light Transmission (clear): greater than 95% T
Light Transmission (tinted): greater than 95% T
Color Pigment Name: Phthalocyanato (2) - (copper)
Water Content: 58% ± 2%
Specific Gravity: 1.308 (dry) 1.136 (hydrated)
Oxygen Permeability: 20 X 10 to the power of -11 (cm²/sec) (ml O₂/ml x mm Hg @ 35°C), (revised Fatt method)

AI/ML Overview

The provided text describes the CANTOR & SILVER 5X (hioxifilcon A) Soft (Spherical & Toric) Daily Wear Contact Lens. This submission focuses on establishing substantial equivalence to previously marketed predicate devices rather than proving the device meets specific acceptance criteria through a clinical study with detailed performance metrics.

Here's an analysis based on the information provided:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state "acceptance criteria" in the traditional sense of a performance study with numerical targets. Instead, it demonstrates substantial equivalence to predicate devices by comparing manufacturing methods, lens function, and material properties. The "performance" here is an assertion of similarity.

Characteristic	Predicate Device (Acceptance Criteria - Implicit)	CANTOR & SILVER 5X (Reported Performance)
Production Method	Lathe-Cut	Lathe-Cut
Lens Function	Refractive medium focusing light, correcting refractive error (including astigmatism)	Refractive medium focusing light, correcting refractive error (including astigmatism)
Material	Hydrophilic Polymer	Hydrophilic Polymer
Water Content	58%	58%
Polymer Content	42%	42%
Polymer	hioxifilcon A	hioxifilcon A
Dk Value	20	20
Refractive Index (hydrated)	1.404	1.404
Specific Gravity (hydrated)	1.136	1.136
Light Transmission	Greater than 95% T	Greater than 95% T

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

The document describes a comparison against predicate devices to establish substantial equivalence, not a performance study that would typically involve a "test set" of patients or data. Therefore, information about a test set sample size or its provenance (country of origin, retrospective/prospective) is not applicable in this context. The study is a comparison of product specifications and characteristics.

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

Since this is a submission for substantial equivalence based on material properties and manufacturing, there was no "test set" requiring ground truth established by experts. The claims rely on the established properties of the materials and the manufacturing process, which are compared to the predicate devices.

4. Adjudication Method for the Test Set

As there was no test set in the sense of clinical performance data requiring expert review, an adjudication method is not applicable.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study and Effect Size

An MRMC study is relevant for evaluating the performance of AI systems or interventions where human readers are involved in assessing cases. This submission is for a contact lens, which is a medical device, not an AI or imaging diagnostic tool. Therefore, an MRMC comparative effectiveness study was not done, and there is no effect size related to human readers improving with AI assistance.

6. Standalone (Algorithm Only Without Human-in-the-Loop) Performance Study

This concept is applicable to AI and diagnostic algorithms. The CANTOR & SILVER 5X contact lens is a physical medical device. Therefore, a standalone (algorithm only) performance study was not done.

7. Type of Ground Truth Used

The "ground truth" in this context is the established specifications and properties of the predicate devices and the materials used. The substantial equivalence argument rests on matching these characteristics.

8. Sample Size for the Training Set

There is no "training set" as this is not an AI or machine learning device. The product development would involve engineering and material science, not data-driven model training.

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

As there is no training set, this question is not applicable.

Summary

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SUMMARY OF SAFETY AND EFFECTIVENESS

This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR 807.92.

K981179

The assigned 510(k) number is:

Applicant information:

Date Prepared:	May 11th, 1998
Name:	Cantor & Silver Limited
Address	Manor Road, BrackleyNorthamptonshireEngland NN13 6ED
Contact Person:	Mr. David CantorManaging Director/President
Phone Number:	011 44 1280 702002
Fax:	011 44 1280 703003
Official Correspondent:And US Consultant	Med-Vice Consulting, Inc.Mr. Martin DalsingPresident/CCO623 GlacierGrand Junction, CO 81503
Phone Number:	970.243.5490
Fax Number:	970.243.5501

Device Information:

Regulatory Classification:	Class II
Product Code:	86 LPL

CANTOR & SILVER 5X (hioxifilcon A) Soft (Spherical & Toric) Daily Wear Contact Lens (Clear & Blue Visibility Tint, Lathe-cut from Lens Blank)

Classification Name:

Trade Name:

Lenses, Soft Contact, Daily Wear

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Equivalent Devices:

The CANTOR & SILVER 5X (hioxifilcon A) Soft (Spherical & Toric) Daily Wear Contact Lens is substantially equivalent to predicate devices in terms of intended use and design. Predicate devices include "Satureyes" and "Satureyes Toric" manufactured by Metro Optics and the "BENZ-G 5X" manufactured by Benz Research and Development.

Device Description:

The hydrophilic characteristics allow aqueous solutions to enter the lens and in its fully hydrated state the lens is approximately 58% water by weight. The physical properties of the lens are:

Refractive Index	1.515 (dry) 1.404 (hydrated)
Light Transmission (clear)	greater than 95% T
Light Transmission (tinted)	greater than 95% T
Color Pigment Name	Phthalocyanato (2) - (copper)
Water Content	58% ± 2%
Specific Gravity	1.308 (dry) 1.136 (hydrated)
Oxygen Permeability	20 X $10^{-11}$ (cm²/sec) (ml O₂/ml x mm Hg @ 35°C), (revised Fatt method)

Intended Use:

The CANTOR & SILVER 5X (hioxifilcon A) Toric Soft Contact Lenses for daily wear are indicated for the correction of visual acuity in aphakic and not aphakic persons with non-diseased eyes with myopia or hyperopia and/or possesses refractive astigmatism up to 10.00 diopters. All CANTOR & SILVER 5X lenses will be offered as conventional soft contact lenses, as well as planned replacement soft contact lenses.

... 7

The Cantor and Silver 5X (hiosifileon A) Soft (Spherical & Toric) Daily Wear Contact Lear & Blue Visibility Tint, Lath-out from Lans Blank)

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Substantial Equivalence:

The device will be manufactured according to specified process controls and a Quality Management System certified to ISO 9002 and EN46002 by the National Accreditation of Certification Bodies. The System vehicle to 100 900 manufacturing, packaging and sterilization procedures similar to devices currently marketed and distributed by Cantor & Silver Limited in the UK. The established safety profile (preclinical toxicology and manufacturing/chemistry data) of the device is equivalent to the BENZ-G 5X (hioxifilcon A), 510(k) #K952620. Being similar with respect to indications for use, materials, physical construction and safety & effectiveness to the predicate devices, this meets the requirements per section 510(k) of the act regarding substantial equivalence and does not raise different questions of safety and effectiveness than the predicate devices identified above.

The following matrix illustrates that the production method, lens function and material of the CANTOR & SILVER 5X (hioxifilcon A) Soft (Spherical & Toric) Daily Wear Contact Lens (Clear & Blue Visibility Tint, Lathe-cut from Lens Blank), are substantially equivalent to the predicate device(s). In addition, the water content, polymer, Dk value, refractive index, specific gravity, and light transmission are as well substantially equivalent to the predicate device.

	Characteristic	CANTOR & SILVER 5X	PREDICATEDEVICES
1.)	PRODUCTIONMETHOD	Lathe-Cut	SAME
2.)	LENS FUNCTION	Refractive medium that focuses lightrays from near and distant objects onthe retina, while compensating forrefractive error, including(astigmatism)	SAME
3.)	MATERIAL	Hydrophilic Polymer	SAME
a.	Water Content	58%	SAME
b.	Polymer Content	42%	SAME
c.	Polymer	hioxifilcon A	SAME
d.	DK Value	20	SAME
e.	Refractive Index	1.404 (hydrated)	SAME
f.	Specific Gravity	1.136 (hydrated)	SAME
g.	Light Transmission	greater than 95 % T	SAME

SUMMARY OF SAFETY AND EFFECTIVENESS Substantial Equivalence Matrix

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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 is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" around the top half of the circle. Inside the circle is an abstract image of an eagle with three human profiles incorporated into its design.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JUN 2 4 1998

Martin Dalsing Consultant for Cantor & Silver Ltd. Med - Vice Consulting Incorporated 623 Glacier Drive Grand Junction, CO 81503

Re: K981779

Trade Name: CANTOR & SILVER 5X (hioxifilon A) Soft (Spherical & Toric) Daily Wear Contact Lens (Clear & Blue Visibility Tint, Lathe-cut from Lens Blank) Regulatory Class: II Product Code: 86 LPL Dated: May 11,1998 Received: May 20, 1998

Dear Mr. Dalsing:

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. Martin Dalsing

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 FOR USE STATEMENT

CANTOR & SILVER 5X (hioxifilcon A) Soft (Spherical & Toric) Daily Wear Device Name: Contact Lens (Clear & Blue Visibility Tint, Lath-cut from Lens Blank)

INDICATIONS FOR USE:

(PLEASE DO OT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use V (Per 21 CFR 801.109) or

Over-The-Counter Use

(Optional Format 1-2-96)

Signature

$
$

(Division Sign-Off) Division of Ophthalmic Devices

510(k) Number K981779

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.