The COLORSOFT. Color Enhanced Tinted Soft Contact Lens is indicated for daily wear to enhance and/or alter the apparent eve color. The COLORSOFT visitint provides for ease of patient handling and does not effect 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 is to be disinfected according to the original lens manufacturer's recommendation.

Device Description

COLORSOFT. Color Enhanced Tinted Soft Contact Lens are color enhanced soft contact lenses that have been previously prescribed for a specific patient. They have been supplied to Colorsoft Laboratories to be modified by a tinting process using 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 reactive additive on that portion of the anterior (front) surface of the lens that corresponds to the iris. The COLORSOFT. Color Enhanced Tinted Soft Contact Lens are available in a light, medium or dark shade of the following enhance colors; Colorsoft Blue, Deep Blue, Aspen Green, Aquamarine, Yellow, Violet, Red, Chocolate, and Amber. COLORSOFT, Color Enhanced Tinted Soft Contact Lens are also available in a standard blue 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 blue 21, reactive blue 21, 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 and 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.

The following are tint patterns available to the practitioner:

Clear Pupil diameter (2,00mm to 8,00mm), standard is 4,5mm.
Annular (iris) diameter (8.00mm to 13.5mm), standard is 11.5mm diameter.
-Black pupil diameter (2.0mm to 12.5mm), standard is 4.0mm diameter.

AI/ML Overview

The provided text is a 510(k) summary for the COLORSOFT Color Enhanced Tinted Soft Contact lens. It focuses on demonstrating substantial equivalence to a predicate device rather than providing a detailed study proving the device meets specific acceptance criteria in the manner one might expect for a novel medical device with entirely new performance claims.

Here's an analysis based on the provided text:

Acceptance Criteria and Reported Device Performance

The acceptance criteria are not explicitly stated in a quantitative table with performance metrics that the COLORSOFT device met. Instead, the submission relies on demonstrating substantial equivalence to an existing predicate device, the DURASOFT 2 COLORS tinted soft contact lens. The "performance" is implicitly assumed to be equivalent to the predicate device, as the COLORSOFT lenses are essentially existing soft contact lenses enhanced with color using FDA-listed additives.

The table presented (Table #1 - Substantial Equivalence) highlights the similarities and differences between the COLORSOFT device and the predicate in terms of intended use, indications, actions, FDA "listed" colored additives, color additive characteristics, and colors offered. It doesn't present a set of quantitative performance metrics for "acceptance criteria" against which the COLORSOFT device was specifically tested and reported for safety and effectiveness in an independent study within this document. The argument is that because the core lens properties remain unchanged (except for light transmittance due to tinting), and the color additives are previously FDA-listed and well-established, the device is inherently safe and effective in the same manner as the predicate.

Information Not Found in the Provided Text:

The nature of this 510(k) submission, which focuses on substantial equivalence rather than a de novo approval with new performance claims, means that much of the requested information regarding detailed study design (sample sizes, expert qualifications, adjudication, MRMC studies, standalone performance, training data) is not present in the provided document.

Here's why and what's missing:

No explicit "acceptance criteria" table with reported performance: The submission's "acceptance criteria" are effectively the characteristics of the predicate device.
No specific study proving the device meets acceptance criteria: The provided document does not describe a new, independent study designed to prove the COLORSOFT device meets new performance criteria beyond what is already accepted for tinted contact lenses using FDA-approved color additives. The substantial equivalence argument is the "study."

Summary of Requested Information Based on Provided Text:

Table of Acceptance Criteria and Reported Device Performance:

Feature/Characteristic	Colorsoft Laboratories ("COLORSOFT")	Predicate Device (Durasoft 2 Colors)	Acceptance Criteria (Implicit)
Intended Use	Daily wear, Soft (hydrophilic) contact lens	Daily wear, Soft (hydrophilic) contact lens	Equivalent to predicate
Indication	Enhance/alter apparent eye color; ease of handling; no effect on iris color; disinfected per original manufacturer's instructions.	Enhance/alter apparent eye color, including ocular masking.	Equivalent to predicate
Actions	Refracting medium to focus light rays on retina.	Refracting medium to focus light rays on retina.	Equivalent to predicate
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 and reactive red 180.	Iron oxides, chromium oxide greens, titanium dioxide, [phthalo-cyaninato (2-)] copper carbazole violet and phthalocyanine green.	Use FDA-listed color additives in minimum reasonable amounts.
Uses and restrictions (Additives)	Amounts not to exceed minimum reasonably required for intended coloring effect.	Amounts not to exceed minimum reasonably required for intended coloring effect.	Equivalent to predicate
Color Additive Characteristics	Not removed by lens handling/cleaning. Optical and performance characteristics not altered by coloring process (except light transmittance).	Not removed by lens handling/cleaning. Optical and performance characteristics not altered by coloring process.	Equivalent to predicate
Colors Offered	Colorsoft Blue, Deep blue, Aspen Green, Jade, Aquamarine, Yellow, Violet, Red, Chocolate, and Amber.	Sky blue, Jade green, Aquamarine and Violet blue.	Not directly comparable, but both offer various colors. Acceptable that specific colors differ as long as process/additives are safe.

Note: The "acceptance criteria" are implicitly met by demonstrating that the COLORSOFT device is substantially equivalent to the predicate device across these characteristics.

Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
- Not explicitly stated. The document does not describe a clinical "test set" in the context of a new performance study. The substantial equivalence argument relies on the established safety and efficacy of the predicate device and the FDA-listed color additives.
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/Not stated. This type of information is typically relevant for studies involving human interpretation (e.g., image analysis, diagnostic accuracy). This submission doesn't detail such a study.
Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not applicable/Not stated. See point 3.
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 colored contact lens, not an AI or diagnostic imaging device that would involve human "readers" or AI assistance.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not applicable. This device is a physical medical device, not a software algorithm.
The type of ground truth used (expert consensus, pathology, outcomes data, etc):
- Implicitly, regulatory compliance and prior FDA approvals. The "ground truth" for the safety and effectiveness claims relies on:
  - The fact that the base contact lens (pre-tinted) was already approved and prescribed.
  - The color additives used are "FDA 'listed'" as safe for contact lenses.
  - The manufacturing process ensures thorough washing to remove unbound additives.
  - The process does not alter original lens characteristics (except light transmittance).
  - The predicate device has established safety and efficacy.
The sample size for the training set:
- Not applicable/Not stated. There is no "training set" in the context of machine learning or a de novo clinical trial described in this document.
How the ground truth for the training set was established:
- Not applicable/Not stated. See point 8.

Conclusion:

The provided document is a 510(k) summary demonstrating substantial equivalence for the COLORSOFT colored contact lenses. It does not contain information about a new clinical study with specific acceptance criteria, test sets, expert ground truth establishment, or AI-related metrics as would be found for novel diagnostic or AI-powered devices. The "study" here is the comparative analysis against an already approved predicate device and reliance on the FDA-listed status of the color additives.

Summary

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JUN 3 ............................................................................................................................................................................

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:	K990815
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Applicant information:

Date Prepared:	March 12, 1999
Name:	Colorsoft Laboratories Corporation
Address	623 Glacier DriveGrand Junction, CO 81503
Contact Person:	Ms. Deanna Werber
	President
Phone Number:	(970) 248-9445
USA Consultant:	Martin Dalsing,Med-Vice Consulting, Inc.Consultant for Colorsoft Laboratories Corporation623 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:	COLORSOFT, Color Enhanced Tinted Soft Contact

lens for Daily Wear

Lenses, Soft Contact, Daily Wear Classification Name:

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Substantially Equivalent Devices:

The "COLORSOFT" tinted soft contact lens is substantially equivalent to the DURASOFT 2 COLORS tinted soft contact lens, the predicate device.

INDICATIONS FOR USE:

Device Descriptive Characteristics:

The following are tint patterns available to the practitioner:

Clear Pupil diameter (2,00mm to 8,00mm), standard is 4,5mm. ।
Annular (iris) diameter (8.00mm to 13.5mm), standard is 11.5mm diameter. -
-Black pupil diameter (2.0mm to 12.5mm), standard is 4.0mm diameter.

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The following table summarizes Colorsoft Laboratories claim of substantial equivalency in terms of safety and efficacy to the predicate devices previously mentioned

1.)	INTENDED USE	Daily wear, Soft (hydrophilic) contactlens	Daily wear, Soft (hydrophilic) contactlens
2.)	INDICATION	The Colorsoft Choices Soft ContactLenses for daily wear are indicated forenhancing and/or altering the apparenteye color. The Colorsoft Choices visitintprovides for ease of patient handling anddoes not effect iris color. The lens is tobe disinfected following the originalmanufacturer's instructions.	The Durasoft 2 Colors for daily wear areindicated for enhancing and/or alteringthe apparent eye color, including ocularmasking.
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, reactiveblue 19, reactive 21, reactive blue 163,reactive yellow 15, reactive yellow 86,reactive orange 78, reactive red 11 andreactive red 180.	The colored pigments consist of ironoxides, chromium oxide greens, titaniumdioxide, [phthalo-cyaninato (2-)] coppercarbazole violet and phthalocyaninegreen.
a.	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 not removedby lens handling andcleaning/disinfecting procedures. Theoptical and performance characteristicsare not altered by the lens coloringprocess.	The color additives used are not removedby lens handling andcleaning/disinfecting procedures. Theoptical and performance characteristicsare not altered by the lens coloringprocess.
6.)	Colors Offered	Colorsoft Blue, Deep blue, Aspen Green,Jade, Aquamarine, Yellow, Violet, Red,Chocolate, and Amber	Sky blue, Jade green, Aquamarine andViolet blue

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 and Human Services. The logo features a stylized eagle with three stripes representing the department's commitment to health, human services, and well-being. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle. The logo is black and white.

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JUN 3 1939

Mr. Martin Dalsing Med-Vice Consulting, Inc. Consultant for Adventure in Colors, Inc. 623 Glacier Drive Grand Junction, CO 81503

Re: K990815 Trade Name: COLORSOFT, Color Enhanced Tinted Soft Contact lens for Daily Wear Regulatory Class: II Product Code: 86 LPL Dated: March 12, 1999 Received: March 11, 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:

COLORSOFT, Color Enhanced Tinted Soft Contact lens for Daily Wear

INDICATIONS FOR USE:

The COLORSOFT, Color Enhanced Tinted Soft Contact Lens is indicated for daily wear to enhance and/or alter the apparent eye color. The COLORSOFT visibility-handling tint provides for ease of patient handling and does not effect iris color.

(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.

X Prescription Use (Per 21 CFR 801 109)

Division Sion-Off Division of Ophthalmic Devices

Over-The-Counter Use

510(k) Number K990815
(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.