The SOFTCHROME TINTS, Color Enhanced Tinted Soft Contact Lens is indicated for daily wear to enhance and/or alter the apparent eye color. The SOFTCHROME TINTS visibility tinted lens provides for ease of patient handling and does not affect iris color.

Except for decreased light transmittance due to the tint intensity, the pre-tinted lens optical parameters remain the same as originally prescribed for the user prior to tinting. The lens may be disinfected using a chemical disinfection system only.

Device Description

SOFTCHROME TINTS Transparent Tinted Soft Contact Lens are color enhanced soft contact lenses that have been previously prescribed for a specific patient. The lenses are tinted with utilization of the patented "In-Office Tinting System for Soft Contact Lenses". The tinting system consists of various tinting fixtures, calibrated mixing vessels, pre-mixed color additives, activator solution, neutralizer solution, tinting instructions, tips and recipes. The lens tinting process uses color additives that have been listed as safe for contact lenses in accordance with the FDA's color additive regulations. 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 lenses 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 color additive on that portion of the anterior (front) surface of the lens that corresponds to the iris. The In-Office Tinting System for Soft Contact Lenses offers a variety of colors and intensity levels. The SOFTCHROME TINTS Transparent Tinted Soft Contact Lens is also available in a variety of colors for visibility-handling tint.

The 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 black 5, reactive blue 19, reactive blue 19, reactive blue 4, reactive blue 163. reactive red 11. reactive red 180. reactive vellow 86. or reactive orange 78. The color additives used are not removed by lens handling and approved cleaning/disinfecting procedures. Except for affecting the amount of light transmittance through the lens, the coloring process does not alter the original characteristics of the pre-tinted lens.

AI/ML Overview

This document is a 510(k) summary submission for a medical device, specifically the SOFTCHROME TINTS Transparent Tinted Soft Contact Lens. It provides information for establishing substantial equivalence to a predicate device.

It's important to note that this document does not describe a study to prove the device meets acceptance criteria in the typical sense of a performance study for a diagnostic or therapeutic medical device. Instead, it focuses on demonstrating substantial equivalence to an existing legally marketed device (the predicate device) based on shared characteristics, intended use, and safety/efficacy profile.

Therefore, many of the typical acceptance criteria and study details for AI/ML validation (like sample size for test sets, ground truth methodology, MRMC studies) are not applicable or present in this type of submission. The "acceptance criteria" here are essentially the shared characteristics and claims deemed equivalent to the predicate device.

Here's the information extracted based on your request, with clarifications where the concepts don't directly map to the provided content:

1. Table of Acceptance Criteria and Reported Device Performance

The "acceptance criteria" for this submission are based on demonstrating substantial equivalence to the predicate device. The performance is reported as being similar or identical to the predicate.

Characteristic	Acceptance Criteria (based on Predicate Device: Adventure Tints)	Reported Device Performance (SOFTCHROME TINTS)
1.) INTENDED USE	Daily wear, Soft (hydrophilic) contact lens	Daily wear, Soft (hydrophilic) contact lens
2.) INDICATION	Indicated for daily wear to enhance and/or alter the apparent eye color. Provides ease of patient handling and does not affect iris color. Pre-tinted lens optical parameters remain the same except for decreased light transmittance. Disinfection using a chemical disinfection system only.	Indicated for daily wear to enhance and/or alter the apparent eye color. Provides ease of patient handling and does not affect iris color. Pre-tinted lens optical parameters remain the same except for decreased light transmittance. Disinfection using a chemical disinfection system only.
3.) ACTIONS	In its hydrated state, when placed on the cornea, the lenses act as a refracting medium to focus light rays on the retina.	In its hydrated state, when placed on the cornea, the lenses act as a refracting medium to focus light rays on the retina.
4.) FDA "listed" colored additives	Consist of 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 and reactive red 180.	Consist of 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 and reactive red 180.
4. Uses and restrictions	Color additives may be used to color contact lenses in amounts not to exceed the minimum reasonably required to accomplish the intended coloring effect.	Color additives may be used to color contact lenses in amounts not to exceed the minimum reasonably required to accomplish the intended coloring effect.
5.) Color Additive Characteristics	Not removed by lens handling and cleaning/disinfecting procedures. Optical and performance characteristics are not altered by the lens coloring process.	Not removed by lens handling and cleaning/disinfecting procedures. Optical and performance characteristics are not altered by the lens coloring process.
6.) Colors Offered	Blue, Green, Aqua, Yellow, Lavender, Brown, Ultra Violet (hot pink) and Amber	Aqua, Blue, Sky Blue, Green, Brown, Black, Green, Yellow, Amber and Red (Note: This is the only characteristic where the two devices differ, having different color offerings, but the underlying safety and efficacy of the tinting process and additives are claimed to be equivalent.)

2. Sample size used for the test set and the data provenance

Not applicable in the context of this 510(k) submission. This submission asserts substantial equivalence based on device characteristics, intended use, and materials. It does not describe a clinical performance study using a "test set" of patient data for the device itself. The evidence is drawn from the established safety and efficacy of the predicate device and the materials/process used.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

Not applicable. No such "ground truth" establishment for a medical data test set is described or required for this type of substantial equivalence submission for soft contact lenses.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not applicable. No adjudication method for a test set is described.

5. 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 tinted soft contact lens, not an AI/ML-driven diagnostic or therapeutic device. Therefore, no MRMC study or assessment of human reader improvement with AI assistance was conducted or would be relevant.

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

Not applicable. This device is a physical medical device (contact lens), not an algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

Not applicable. The "ground truth" in this context is the regulatory acceptance and established safety/efficacy of the predicate device and the FDA-listed color additives.

8. The sample size for the training set

Not applicable. There is no "training set" as this is not an AI/ML device.

9. How the ground truth for the training set was established

Not applicable. There is no "training set." The closest concept is that information on the predicate device's safety and effectiveness, and the FDA's listing of the color additives, serves as the basis for the safety and effectiveness claims.

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:

K991995

Applicant information:

Date Prepared:	11 June, 1999
Name:	Softchrome, Inc.
Address	2551 San Ramon Valley Blvd., Suite #105
	San Ramon, CA 94583
Contact Person:	Mrs. Karen L. Johnson
Phone Number:	(925) 743-1285
U.S. Consultant:	Martin Dalsing
	Med-Vice Consulting, Inc.
	Official Correspondent Softchrome, Inc.
	623 Glacier Drive
	Grand Junction, CO 81503
	(970) 243-5490
	Fax #: (970) 243-5501
	E-mail: mdalsing@gj.net

Device Information:

Device Classification:	Class II
Classification Number:	LPL, MZD
Trade Name:	SOFTCHROME TINTSTransparent Tinted Soft Contact Lens
Classification Name:	Lenses, Soft Contact, Daily Wear

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Substantially Equivalent Devices:

The SOFTCHROME TINTS Transparent Tinted Soft Contact Lens is substantially equivalent to the Adventure Tints Color Enhanced Soft Contact Lens, the predicate device.

INDICATIONS FOR USE:

The SOFTCHROME TINTS. Color Enhanced Tinted Soft Contact Lens is indicated for daily wear to enhance and/or alter the apparent eye color. The SOFTCHROME TINTS visibility tinted lens provides for ease of patient handling and does not affect iris color.

Device Descriptive Characteristics:

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The following table summarizes Softchrome Inc. claim of substantial equivalency in terms of safety and efficacy to the predicate devices previously mentioned.

	Characteristic	Softchrome Tints(Softchrome Inc.)	Adventure Tints(Predicate Device)
1.)	INTENDED USE	Daily wear, Soft (hydrophilic) contactlens	Daily wear, Soft (hydrophilic) contactlens
2.)	INDICATION	The SOFTCHROME TINTS,Transparent Tinted Soft Contact Lens isindicated for daily wear to enhanceand/or alter the apparent eye color. TheSOFTCHROME TINTS visitintprovides for ease of patient handling anddoes not affect iris color. Except fordecreased light transmittance due to thetint intensity, the pre-tinted lens opticalparameters remain the same as originallyprescribed for the user prior to tinting.The lens may be disinfected using achemical disinfection system only.	The ADVENTURE TINTS ColorEnhanced Soft Contact Lens is indicatedfor daily wear to enhance and/or alterthe apparent eye color. TheADVENTURE TINTS visitint providesfor ease of patient handling and does notaffect iris color. Except for decreasedlight transmittance due to the tintintensity, the pre-tinted lens opticalparameters remain the same as originallyprescribed for the user prior to tinting.The lens may be disinfected using achemical disinfection system only.
3.)	ACTIONS	In its hydrated state, when placed on thecornea, the lenses act as a refractingmedium to focus light rays on the retina.	In its hydrated state, when placed on thecornea, the lenses act as a refractingmedium to focus light rays on the retina.
4.)	FDA "listed"colored additives	The reactive colored additives consist ofreactive black 5, reactive blue 4,reactive blue 19, reactive 21, reactiveblue 163, reactive yellow 15, reactiveyellow 86, reactive orange 78, reactivered 11 and reactive red 180.	The reactive colored additives consist ofreactive black 5, reactive blue 4,reactive blue 19, reactive 21, reactiveblue 163, reactive yellow 15, reactiveyellow 86, reactive orange 78, reactivered 11 and reactive red 180.
4.	Usesandrestrictions	The color additives listed above may beused to color contact lenses in amountsnot to exceed the minimum reasonablyrequired to accompish the intendedcoloring effect.	The color additives listed above may beused to color contact lenses in amountsnot to exceed the minimum reasonablyrequired to accompish the intendedcoloring effect.
5.)	Color AdditiveCharacteristics	The color additives used are notremoved by lens handling andcleaning/disinfecting procedures. Theoptical and performance characteristicsare not altered by the lens coloringprocess.	The color additives used are notremoved by lens handling andcleaning/disinfecting procedures. Theoptical and performance characteristicsare not altered by the lens coloringprocess.
6.)	Colors Offered	Aqua, Blue, Sky Blue, Green, Brown,Black, Green, Yellow, Amber and Red	Blue, Green, Aqua, Yellow, Lavender,Brown, Ultra Violet (hot pink) andAmber

Table - Substantial Equivalence

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Image /page/3/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized symbol featuring three abstract human profiles or faces, stacked on top of each other, with flowing lines suggesting movement or connection.

Public Health Service

AUG 27 1999

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Softchrome, Inc. c/o Mr. Martin Dalsing Med-Vice Consulting, Inc. 623 Glacier Drive Grand Junction, CO 81503

Re: K991995

Trade Name: SOFTCHROME TINTS, Transparent Tinted Soft Contact lens (tinted with the "In-Office Tinting System for Soft Contact Lenses") Regulatory Class: II

Product Code: 86 MZD Dated: June 11, 1999 Received: June 14, 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:

SOFTCHROME TINTS Transparent 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)

Prescription Use X (Per 21 CFR 801.109) OL

Over-The-Counter Use

(Optional Format 1-2-96)

Hanel W.C. Brown

(Division Sign-Off)

Division of Ophthalmic Devices 510(k) NumberK991995

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SOFTCHROME TINTS, Transparent Tinted Soft Contact Lens for Daily Wear

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Regulation Number and Section

N/A