The ADVENTURE TINTS PROSTHETIC Tinted Soft Contact lens is 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 occlusive therapy for conditions such as diplopia, amblyopia or extreme photophobia. The lens may be disinfected using a chemical disinfection system only.

Device Description

The ADVENTURE TINTS PROSTHETIC Tinted Soft Contact Lenses 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 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 reactive color additive on that portion of the anterior (front) surface of the lens that corresponds to the iris. The ADVENTURE TINTS PROSTHETIC contact lenses 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 black 5, 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 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 increments.
Tinted Jens with Black Pupil. Uses the Adventure Tints tinted contact lens with black pupil. Pupil sizes available in 2.0 mm to 12.5 mm diameter.

AI/ML Overview

The provided text is a 510(k) summary for the "ADVENTURE TINTS PROSTHETIC Tinted Soft Contact Lens", which is seeking substantial equivalence to existing predicate devices. The document does not contain information about specific acceptance criteria or a study proving that the device meets such criteria in the way typically found for novel diagnostic algorithms or medical devices with quantifiable performance metrics (e.g., sensitivity, specificity, accuracy).

Instead, the submission demonstrates substantial equivalence based on a comparison of intended use, indications, and material characteristics with predicate devices. This type of device (tinted soft contact lens for prosthetic use) is not typically subject to performance studies involving sensitivity, specificity, or human-in-the-loop improvements because its primary function is cosmetic and occlusive, not diagnostic or therapeutic in a way that requires statistically demonstrated clinical effectiveness for novel claims.

Therefore, many of the requested fields cannot be directly extracted from the provided text.

Here's an attempt to answer based on the available information, noting where data is absent:

Acceptance Criteria and Device Performance

The concept of "acceptance criteria" for this device, as presented in the 510(k) summary, revolves around demonstrating substantial equivalence to predicate devices, particularly regarding safety and intended use. The performance metrics are descriptive rather than quantitative, focusing on the preservation of optical properties and the safety of the tinting process.

(No specific table of quantitative acceptance criteria and reported device performance from a study is provided in the document.)

The document effectively argues that the device's characteristics are substantially equivalent to the predicate devices, implying that their performance and safety profiles are also similar.

Detailed Study Information (Based on Available Text)

A table of acceptance criteria and the reported device performance:
- Acceptance Criteria (Implicit from Substantial Equivalence Comparison):
  - Intended Use: Cosmetic management of conditions such as corneal, iris, or lens abnormalities.
  - Indication for Use: Daily wear to enhance or alter eye color, including ocular masking, for cosmetic management of conditions like corneal/iris/lens abnormalities, or for occlusive therapy (diplopia, amblyopia, extreme photophobia). Disinfectable by chemical disinfection system only.
  - FDA "listed" colored additives: Use of specific 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).
  - Uses and restrictions for color additives: Amounts not to exceed the minimum reasonably required, similar to predicate.
  - Color Additive Characteristics: Not removed by lens handling/cleaning/disinfecting, optical and performance characteristics are not altered by coloring process.
- Reported Device Performance:
  - Matches the intended use and indications of the predicate devices.
  - Uses FDA "listed" color additives, albeit a different set than one predicate, but still within approved categories for contact lenses.
  - Conforms to restrictions on color additive usage.
  - "The color additives used are not removed by lens handling and approved cleaning/disinfecting procedures. The optical and performance characteristics are not altered by the lens coloring process." (Matches predicate).
Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
- Not Applicable. The submission does not describe a clinical performance study with a "test set" in the traditional sense of a study designed to quantify device performance with patient data. The substantial equivalence argument relies on comparing the device's design and materials to legally marketed predicate devices, and the inherent understanding of the performance of those predicate devices.
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. No ground truth establishment by experts for a specific test set is described.
Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not Applicable. No adjudication method for a test set is described.
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 is not an AI-assisted diagnostic device, and no MRMC study was performed or is relevant to its substantial equivalence demonstration.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not Applicable. This is a physical medical device (contact lens), not an algorithm.
The type of ground truth used (expert consensus, pathology, outcomes data, etc):
- Not Applicable, in the traditional sense. The "ground truth" for this submission is implicitly the established safety and effectiveness of the legally marketed predicate devices, under the assumption that the new device's similar design and materials will yield comparable results.
The sample size for the training set:
- Not Applicable. This is not a machine learning device and therefore does not have a training set.
How the ground truth for the training set was established:
- Not Applicable. This is not a machine learning device.

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:	K992054
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Applicant information:

Date Prepared:	June 18th, 1999
Name:	Adventure in Color's
Address	1511 Washington AvenueGolden, CO 80401
Contact Persons:	Mrs. Elizabeth HarperMr. Stan Harper
Phone Number:	(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 PROSTHETIC

ADVENTURE TINTS PROSTHETIC Tinted Soft Contact Iens

Classification Name: Lenses, Soft Contact, Daily Wear :

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Substantially Equivalent Devices:

The "ADVENTURE TINTS PROSTHETIC" Tinted Soft Contact Lens is substantially equivalent to the "Alden Classic Prosthetic Tinted Soft Contact Lens" and the Adventure in Colors "Adventure Tints Color Enhanced Tinted Soft Contact Lens", the predicate devices.

Device Descriptive Characteristics:

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 black 5, 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 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:

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 increments.
1. Tinted Jens with Black Pupil. Uses the Adventure Tints tinted contact lens with black pupil. Pupil sizes available in 2.0 mm to 12.5 mm diameter.

INDICATIONS FOR USE:

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INDICATIONS FOR USE:

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.

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

	Characteristic	ADVENTURE TINTS(Adventure in Colors)	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 ADVENTURE TINTS PROSTHETICTinted Soft Contact lens is indicated fordaily wear to enhance or alter the apparenteye color, including ocular masking, eitherin sighted or non-sighted eyes that require aprosthetic contact lens for cosmeticmanagement of conditions such as corneal,iris or lens abnormalities. The lens mayalso be prescribed for occlusive therapy forconditions such as diplopia, amblyopia orextreme photophobia. The lens may bedisinfected using a chemical disinfectionsystem only.	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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DEPARTMENT OF HEALTH & HUMAN SERVICES

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 stylized eagle with three stripes representing the department's mission. The eagle is enclosed in a circle with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter.

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JUL - 7 1999

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

Re: K992054 Trade Name: Adventure Tints Prosthethic Tinted Soft Contact Lens Regulatory Class: II Product Code: 86 LPL Dated: June 17, 1999 Received: June 17, 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:

ADVENTURE TINTS 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)

Samuel W.C. Brown PhD

Division Sign-Off) Division of Ophthalmic Devices 510(k) Number_K992054

Over-The-Counter Use

Prescription Use X (Per 21 CFR 801.109)

(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.