The ADVENTURE TINTS, Color Enhanced Tinted Soft Contact Lens is indicated for daily wear to enhance and/or alter the apparent eye color. The ADVENTURE TINTS 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 may be disinfected using a chemical disinfection system only.

Device Description

ADVENTURE TINTS, 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 Adventure in Colors 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 ADVENTURE TINTS, Color Enhanced Tinted Soft Contact Lens are available in a light, medium or dark shade of the following enhance colors; Blue, Deep Blue, Green, Aqua, Yellow, Lavender, Brown, Ultra Violet (Hot Pink), and Amber. ADVENTURE TINTS. 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 black 5. reactive blue 19, reactive blue 19, reactive blue 4, reactive blue 163, reactive red 11, 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. l
Black pupil diameter (2.0mm to 12.5mm), standard is 4.0mm diameter. -
Occluder diameter (2.00mm to 12.5mm). a

AI/ML Overview

Here's an analysis of the provided text regarding the acceptance criteria and study information for the ADVENTURE TINTS, Color Enhanced Tinted Soft Contact lens:

1. Table of Acceptance Criteria and Reported Device Performance

The provided text does not explicitly state specific quantitative acceptance criteria or detailed study results for device performance beyond a comparison to a predicate device. The information focuses on establishing substantial equivalence based on intended use, indications, actions, color additives, characteristics, and colors offered.

The closest we can come to "reported device performance" are the characteristics presented in the Substantial Equivalence table (Table #1), which essentially state the device meets the same characteristics as the predicate.

Characteristic	Acceptance Criteria (Implied by Predicate)	Reported Device Performance (ADVENTURE TINTS)
INTENDED USE	Daily wear, Soft (hydrophilic) contact lens	Daily wear, Soft (hydrophilic) contact lens
INDICATION	Enhance and/or alter apparent eye color, including ocular masking.	Enhance and/or alter apparent eye color. Visitint provides for ease of patient handling and does not affect iris color. Pre-tinted lens optical parameters remain the same except for decreased light transmittance. Disinfect using chemical disinfection system only.
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.
FDA "listed" colored additives	Use of FDA-listed colored pigments (iron oxides, chromium oxide greens, titanium dioxide, [phthalo-cyaninato (2-)] copper, carbazole violet and phthalocyanine green). Amounts not to exceed the minimum reasonably required.	Use of FDA-listed reactive 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). Amounts not to exceed the minimum reasonably required.
Color Additive Characteristics	Color additives used are not removed by lens handling and cleaning/disinfecting procedures. Optical and performance characteristics are not altered by the lens coloring process.	Color additives used are not removed by lens handling and cleaning/disinfecting procedures. Optical and performance characteristics are not altered by the lens coloring process (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).
Colors Offered	Sky blue, Jade green, Aquamarine and Violet blue	Blue, Green, Aqua, Yellow, Lavender, Brown, Ultra Violet (hot pink) and Amber. Also available in a standard blue visibility-handling tint.

Crucially, the document explicitly states: "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." This statement indicates that no specific optical performance metrics beyond light transmittance were assessed or reported as changed. The primary focus is on the safety of the tinting process and the color additives.

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

The provided text does not mention any specific test set, its sample size, or data provenance (e.g., country of origin, retrospective/prospective). The submission focuses on substantial equivalence to a predicate device based on descriptive characteristics and regulatory compliance of materials and processes.

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

This information is not provided in the document. No "ground truth" establishment by experts for a test set is described, as there is no mention of a clinical or performance study with human subjects or a defined test set that required expert evaluation.

4. Adjudication Method for the Test Set

As there is no mention of a test set or expert evaluation, there is no information about an adjudication method.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and The Effect Size of How Much Human Readers Improve with AI vs. Without AI Assistance

This device is a tinted contact lens, not an AI-powered diagnostic or assistive tool. Therefore, no MRMC comparative effectiveness study was done, and the concept of "human readers improving with AI" does not apply to this product.

6. If a Standalone (Algorithm Only Without Human-in-the Loop Performance) Was Done

This device is a physical medical device (contact lens), not an algorithm or software. Therefore, no standalone "algorithm-only" performance study was done.

7. The Type of Ground Truth Used (Expert Consensus, Pathology, Outcomes Data, etc.)

The document does not describe a study involving "ground truth" as typically understood in the context of diagnostic device validation. The "ground truth" for this submission revolves around:

Regulatory compliance: The listed color additives are FDA-approved for contact lenses.
Material safety: The manufacturing process ensures unbound reactive color additives are removed.
Equivalence to predicate: The assumption is that if the new device shares the same fundamental characteristics and uses approved materials/processes as a legally marketed predicate, it is safe and effective for its stated use.

8. The Sample Size for the Training Set

The concept of a "training set" is relevant to machine learning or AI models. Since this is a physical medical device, there is no training set in that context.

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

As there is no training set, there is no information on how its "ground truth" was established.

Summary of Study Information:

The provided 510(k) summary is for a tinted contact lens where substantial equivalence is primarily established through a comparison of product characteristics, materials, and intended use to a legally marketed predicate device. It does not contain information about clinical trials, performance studies with human subjects, or any form of algorithmic testing. The "study" described is essentially a detailed comparison to a predicate device and a demonstration of compliance with relevant material safety and manufacturing regulations.

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:	K984098
Applicant information:
Date Prepared:	November 12, 1998
Name:Address	Adventure in Color's1511 Washington AvenueGolden, CO 80401
Contact Person:Phone Number:	Mrs. Elizabeth Harper(303) 271-9644
USA Consultant:	Martin Dalsing,Med-Vice Consulting, Inc.Consultant for Adventure in Colors, 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:	ADVENTURE TINTS, Color Enhanced Tinted Soft Contactlens

Classification Name: Lenses, Soft Contact, Daily Wear

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Substantially Equivalent Devices:

The "ADVENTURE TINTS" tinted soft contact lens is substantially equivalent to 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. l
Black pupil diameter (2.0mm to 12.5mm), standard is 4.0mm diameter. -
Occluder diameter (2.00mm to 12.5mm). a

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The following table summarizes Adventure in Colors claim of substantial equivalency in terms of safety and efficacy to the predicate device previously mentioned.

	Characteristic	ADVENTURE TINTS(Adventure in Colors)	Predicate Device
1.)	INTENDED USE	Daily wear, Soft (hydrophilic) contactlens	Daily wear, Soft (hydrophilic) contactlens
2.)	INDICATION	The ADVENTURE TINTS, ColorEnhanced Tinted Soft Contact Lens isindicated for daily wear to enhanceand/or alter the apparent eye color. TheADVENTURE TINTS visitint providesfor ease of patient handling and does noteffect 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.	The Durasoft 2 Colors for daily wearare indicated for enhancing and/oraltering the apparent eye color,including ocular masking.
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 colored pigments consist of ironoxides, chromium oxide greens, titaniumdioxide, [phthalo-cyaninato (2-)]copper, carbazole violet andphthalocyanine green.
a.	Usesandrestrictions	The color additives listed above may beused to color contact lenses in amountsnot to exceed the minimum reasonablyrequired to accomplish the intendedcoloring effect.	The color additives listed above may beused to color contact lenses in amountsnot to exceed the minimum reasonablyrequired to accomplish 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	Blue, Green, Aqua, Yellow, Lavender,Brown, Ultra Violet (hot pink) andAmber	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 & Human Services. The logo consists of a circular border 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 facing to the right, with three curved lines above them, resembling a bird in flight.

Public Health Service

MAY 1 0 1999

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

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

Re: K984098 Trade Name: ADVENTURE TINTS, Color Enhanced Tinted Soft Contact lens for Daily Wear Regulatory Class: II Product Code: 86 LPL Dated: March 30, 1999 Received: April 2, 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 Roerl 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: ADVENTURE TINTS, Color Enhanced 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. Brown
(Division Sign-Off)
Division of Ophthalmic Devices
Prescription Use (Per 21 CFR 801.109)	x
510(k) Number	K984098
	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.