The CANTOR & SILVER 5X PROSTHETIC Tinted Soft Contact Lens are indicated for daily wear to enhance or alter the apparent eye color, including ocular masking, either in sighted eyes that require a prosthetic contact lens for cosmetic management of conditions such as corneal, iris or lens abnormalities. The lens may also be prescribed for the correction of refractive ametropia (myopia, hyperopia and astigmatism) in aphakic and not aphakic persons or for occlusive therapy for conditions such as diplopia, amblyopia or extreme photophobia. The lens are disinfected using a hydrogen peroxide lens care system only and are available in a frequent replacement program.

Device Description

The CANTOR & SILVER 5X PROSTHETIC Tinted Soft Contact Lens are tinted with FDA "listed" color additives. The color additives are used in amounts not to exceed the minimum reasonably required to accomplish the intended coloring effect. As part of the manufacturing process, the lens containing the color additives are thoroughly washed to remove unbound reactive color additives. The manufacturing process alters and/or changes the specifications to the clear version of a contact lens by affixing a listed reactive color additive on that portion of the anterior (front) surface of the lens that corresponds to the iris. The CANTOR & SILVER 5X PROSTHETIC Tinted Soft Contact Lens are tinted to the eyecare professional instructions.

The prosthetic color additive effect is formed by reacting one or more of the reactive color additives listed in this paragraph with (poly hydroxyethyl methacrylate). The reactive color additives that may be used either alone or in combination are: reactive blue 21, reactive blue 19, reactive blue 19, reactive blue 4. reactive blue 163, reactive red 11, reactive red 180, reactive yellow 15, reactive yellow 86, or reactive orange 78. The color additives used are not removed by lens handling or approved cleaning/disinfecting procedures. The prosthetic lens tinting process does not alter the optical and/or performance characteristics of the finished tinted soft contact lens.

Tint Patterns Available:

Clear lens with Black Pupil. Pupil sizes available in 2.0 mm to 12.5 mm.
Black Occluder Lens. A Central Black area that occludes light. Available to full lens diameter in 0.5 mm increments.
Black Annular with clear pupil. Black Annular diameter range 7.5 mm to full lens diameter in 0.5 mm increments. Clear Pupil diameter range 2.0 mm to 7.5 mm in 0.5 mm increments.
Tinted lens with Black Pupil. Uses the CANTOR & SILVER 5X PROSTHETIC Tinted Soft Contact Lens with black pupil. Pupil sizes available in 2.0 mm to 12.5 mm diameter.

AI/ML Overview

Here's an analysis of the provided text regarding the acceptance criteria and study for the Cantor & Silver 5X Prosthetic Tinted Soft Contact Lens:

Acceptance Criteria and Device Performance:

The provided document, a 510(k) summary, primarily focuses on demonstrating substantial equivalence to predicate devices rather than establishing novel acceptance criteria for specific performance metrics. Therefore, explicit "acceptance criteria" and "reported device performance" in the traditional sense of a clinical trial with quantitative endpoints are not present. Instead, substantial equivalence is claimed based on comparable intended use, indications, and material/manufacturing characteristics.

The table below summarizes the characteristics presented for substantial equivalence. The "Acceptance Criteria" column reflects the implicit criteria for being considered substantially equivalent (i.e., being similar to the predicate device), and the "Reported Device Performance" column reflects the characteristics of the subject device.

Acceptance Criteria (Implied: Similar to Predicate)	Reported Device Performance (Cantor & Silver 5X Prosthetic)
Intended Use: Cosmetic Management of conditions such as corneal, iris, or lens abnormalities. (Matching predicate device)	Intended Use: Cosmetic Management of conditions such as corneal, iris, or lens abnormalities.
Indication: Comprehensive indications for daily wear, cosmetic management, refractive correction, and occlusive therapy. (Matching predicate device, except for disinfection system)	Indication: Daily wear for enhancing/altering eye color, ocular masking, corneal/iris/lens abnormalities, refractive ametropia correction (myopia, hyperopia, astigmatism) in aphakic and non-aphakic persons, occlusive therapy (diplopia, amblyopia, extreme photophobia). Disinfected using hydrogen peroxide only. Frequent replacement program.
FDA "listed" colored additives: Use of specified reactive colored additives. (Matching predicate device, but specific additives differ)	FDA "listed" colored additives: Reactive black 5, reactive blue 4, reactive blue 19, reactive 21, reactive blue 163, reactive yellow 15, reactive yellow 86, reactive orange 78, reactive red 11, reactive red 180.
Uses and restrictions: Color additives not to exceed minimum required for prosthetic effect. (Matching predicate device)	Uses and restrictions: Color additives not to exceed minimum reasonably required to accomplish the intended prosthetic effect.
Color Additive Characteristics: Not removed by handling/cleaning; optical/performance characteristics not altered by coloring. (Matching predicate device)	Color Additive Characteristics: Not removed by lens handling and approved cleaning/disinfecting procedures. Optical and performance characteristics are not altered by the lens coloring process.

Study Details:

The provided document does not contain information about a specific clinical study with quantitative performance metrics to "prove the device meets acceptance criteria" in the way one might expect for a new device claiming superiority or unique performance. Instead, the submission is based on substantial equivalence to existing legally marketed devices.

Therefore, many of the requested study-specific details are not applicable or explicitly stated in this 510(k) summary.

Sample size used for the test set and the data provenance: Not applicable. No specific "test set" or clinical study with patient data detailed in this 510(k) summary. The comparison is against characteristics of predicate devices.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. No "ground truth" derived from expert consensus on a test set is mentioned.
Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not applicable. No adjudication process for study data is mentioned.
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 device is a contact lens, not an AI diagnostic tool, so an MRMC study is irrelevant.
If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: Not applicable. This is not an algorithm or AI device.
The type of ground truth used (expert consensus, pathology, outcomes data, etc): Not applicable in the context of a clinical performance study. The "ground truth" for the substantial equivalence claim would be the established characteristics and regulatory approval of the predicate devices.
The sample size for the training set: Not applicable. No "training set" is mentioned as this is not an AI/machine learning device.
How the ground truth for the training set was established: Not applicable.

Summary

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510 (k) 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.

The assigned 510(k) number is:	K992500
Applicant information:
Date Prepared:	July 23, 1999
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
USA Consultant:	Martin Dalsing,Med-Vice Consulting, Inc.Consultant for Cantor & Silver, Inc.623 Glacier DriveGrand Junction, CO 81503(970) 243-5490Fax #: (970) 243-5501E-mail: mdalsing@gj.net

Device Information:

Device Classification:	Class II
Classification Number:	LPL
Trade Name:	Cantor and Silver 5X Prosthetic Tinted(hioxifilcon A) Soft Daily Wear Contact Lens
Classification Name:	Lens, Soft Contact, Daily Wear

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Substantially Equivalent Devices:

The "CANTOR & SILVER 5X PROSTHETIC" Tinted Soft Contact Lens is substantially equivalent to the "Alden Classic Prosthetic Tinted Soft Contact Lens" and the Cantor & Silver "CANTOR & SILVER 5X Tinted", the predicate devices.

Device Descriptive Characteristics:

Tint Patterns Available:

1. Clear lens with Black Pupil. Pupil sizes available in 2.0 mm to 12.5 mm.
1. Black Occluder Lens. A Central Black area that occludes light. Available to full lens diameter in 0.5 mm increments.
1. Black Annular with clear pupil. Black Annular diameter range 7.5 mm to full lens diameter in 0.5 mm increments. Clear Pupil diameter range 2.0 mm to 7.5 mm in 0.5 mm increments.
1. Tinted lens with Black Pupil. Uses the CANTOR & SILVER 5X PROSTHETIC Tinted Soft Contact Lens with black pupil. Pupil sizes available in 2.0 mm to 12.5 mm diameter.

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INDICATIONS FOR USE:

The following table summarizes Cantor & Silver Limited claim of substantial equivalency in terms of safety and efficacy to the predicate devices previously mentioned.

Characteristic	CANTOR & SILVER 5XPROSTHETIC(Cantor & Silver)	ALDEN CLASSIC PROSTHETIC(Predicate Device)
1.)	INTENDEDUSE	Cosmetic Management of conditions such ascorneal, iris, or lens abnormalities	Cosmetic Management of conditions such ascorneal, iris, or lens abnormalities.
2.)	INDICATION	The CANTOR & SILVER 5XPROSTHETIC Tinted Soft Contact Lens areindicated for daily wear to enhance or alterthe apparent eye color, including ocularmasking, either in sighted or non-sightedeyes that require a prosthetic contact lensfor cosmetic management of conditions suchas corneal, iris or lens abnormalities. Thelens may also be prescribed for thecorrection of refractive ametropia (myopia,hyperopia and astigmatism) in aphakic andnot aphakic persons or for occlusive therapyfor conditions such as diplopia, amblyopiaor extreme photophobia. The lens aredisinfected using a hydrogen peroxide lenscare system only and are available in afrequent replacement program.	The ALDEN CLASSIC PROSTHETIC(polymacon) Tinted, Soft Contact Lens isindicated for daily wear to enhance or alterthe apparent eye color, including ocularmasking, either in sighted or non-sightedeyes that require a prosthetic contact lensesfor cosmetic management of conditions suchas corneal, iris or lens abnormalities. Thelens may also be prescribed for thecorrection of refractive ametropia (myopia,hyperopia and astigmatism) in aphakic andnot aphakic persons or for occlusive therapyfor conditions such as diplopia, amblyopiaor extreme photophobia. The lens may bedisinfected with either a chemical or a heatdisinfection system.
3.)	FDA "listed"colored additives	The reactive colored additives consist ofreactive black 5, reactive blue 4, reactiveblue 19, reactive 21, reactive blue 163,reactive yellow 15, reactive yellow 86,reactive orange 78, reactive red 11 andreactive red 180.	Vat Green 1, Vat Brown 1,Vat Blue 6,
4.)	Uses andrestrictions	The color additives listed above may be usedto color contact lenses in amounts not toexceed the minimum reasonably required toaccomplish the intended prosthetic effect.	The color additives listed above may be usedto color contact lenses in amounts not toexceed the minimum reasonably required toaccomplish the intended prosthetic effect.
5.)	Color AdditiveCharacteristics	The color additives used are not removed bylens handling and approvedcleaning/disinfecting procedures. Theoptical and performance characteristics arenot altered by the lens coloring process.	The color additives used are not removed bylens handling and approvedcleaning/disinfecting procedures. Theoptical and performance characteristics arenot altered by the lens coloring process.

Table #1 - Substantial Equivalence

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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 consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract image of an eagle or bird-like figure with stylized wings.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

AUG 1 8 1999

Cantor Silver Limited c/o Mr. Martin Dalsing MED-VICE CONSULTING, INC. 623 Glacier Drive Grand Junction, CO 81503

Re: K992500

Trade Name: CANTOR & SILVER 5X Prosthetic Tinted (hioxifilcon A) Soft Daily Wear Contact Lens

Regulatory Class: II Product Code: 86 LPL Dated: July 23, 1999 Received: July 26, 1999

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

Device Name:

CANTOR & SILVER 5X PROSTHETIC Tinted Soft Contact lens

INDICATIONS FOR USE:

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Daniel W. C. Brown, Ph.D.
(Division Sign Off)

Division Sign-Off) Division of Ophthalmic Devices K992500 510(k) Number .

Prescription Use X (Per 21 CFR 801.109)

Over-The-Counter Use __

(Optional Format 1-2-96)

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.