ColorMax Lenses are colored prescription spectacle lenses that are designed to aid color discrimination performance for those with Deutan and Protan color vision deficiencies. ColorMax Lenses are designed for binocular use. Use of this product may enhance the discrimination of certain colors and may reduce the discrimination of certain colors. This product is not a cure for color vision deficiencies or colorblindness.

AI/ML Overview

Here's an analysis of the provided information regarding the acceptance criteria and study for the ColorMax Lens, structured as requested:

Acceptance Criteria and Study for ColorMax Lens (K984219)

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria	Reported Device Performance
Improvement in color discrimination performance for Deutan and Protan color vision deficiencies.	Clinical performance studies with the Farnsworth Panel D-15 color vision test demonstrated effectiveness by showing that ColorMax Lenses enable red-green color deficient subjects to distinguish between their usual confusion colors.
Potential risks associated with altered color discrimination are comparable to other tinted prescription spectacle lenses (e.g., colored prescription sunglasses).	Implicit: The FDA's substantial equivalence determination implies that the risks were deemed acceptable and comparable to predicate devices. No specific quantitative risk assessment is provided in the summary.

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

Sample Size: Not explicitly stated. The document mentions "red-green color deficient subjects" in the plural, but provides no specific number.
Data Provenance: Not explicitly stated. However, given the context of a US FDA submission, it is highly probable the data was collected in the United States. The study is described as "clinical performance studies," suggesting a prospective nature, although this is not explicitly confirmed.

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

Number of Experts: Not specified.
Qualifications of Experts: Not specified. The study relied on the Farnsworth Panel D-15 color vision test, which has established methods for interpreting results. It's therefore more about the standardized interpretation of a test result rather than expert consensus on individual cases.

4. Adjudication Method for the Test Set

Adjudication Method: Not applicable or not specified. The Farnsworth Panel D-15 test is a standard color vision test with objective scoring based on the arrangement of color caps by the subject. Ground truth is derived directly from the test's protocol, not from expert adjudication of subjective assessments.

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

MRMC Study: No. This device is a physical optical aid, not an AI-powered diagnostic or assistive tool for human readers/analysts. Therefore, an MRMC study comparing human readers with and without AI assistance is not relevant to this device.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

Standalone Performance: Not applicable. The ColorMax Lens is a passive optical device, not an algorithm. Its performance is evaluated through its direct effect on human visual perception when wearing the lenses, hence "human-in-the-loop" is its primary mode of operation.

7. The Type of Ground Truth Used

Type of Ground Truth: The ground truth for effectiveness was established using the Farnsworth Panel D-15 color vision test. This test objectively measures a subject's ability to discriminate between specific colors, providing a quantifiable measure of color vision deficiency and the device's impact on it. The "ground truth" here is the objective performance on a standardized test designed to assess color discrimination.

8. The Sample Size for the Training Set

Sample Size for Training Set: Not applicable. This document describes a medical device submission, not a machine learning model. There is no concept of a "training set" in the context of the ColorMax Lens. The development of the lens itself would have involved optical engineering and material science, likely iterative design and testing, but not a data-driven training set in the AI sense.

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

How Ground Truth for Training Set Was Established: Not applicable, as there is no "training set" for this optical device.

Summary

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K984219

300/8809.

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Summary of Safety and Effectiveness Information	Color Vision Technologies, Inc.
Premarket Notification, Section 510(k)	NOVEMBER 1999

Regulatory Authority: Safe Medical Devices Act of 1990, 21 CFR 807.92

1. Device Name: ColorMax Lens Trade Name:
- Common Lens, Prescription, Color Deficiency Name(s):

Classification Name(s):

Lens, Prescription, Color Deficiency

Establishment Name & Registration Number: 2. Color Vision Technologies, Inc. Name: Number: Pending
Classification(s): 3.

്ര 886.5844 Prescription spectacle lens. (a) Identification. A prescription spectacle lens is a glass or plastic device that is a lens intended to be worn by a patient in a spectacle frame to provide refractive corrections in accordance with a prescription for the patient. The device may be modified to protect the eyes from bright sunlight (i.e., prescription sunglasses). Prescription sunglass lenses may be reflective, tinted, polarizing, or photosensitized. :

(b) Classification. Class 1.
Device Class: 1 Ophthalmic Devices Panel Classification Panel: Product Code(s): 86NAI

4. Indication for Use:

ColorMax Lenses are indicated for use as an optical aid for Deutan and Protan color vision deficiencies.

Section 514 Compliance 5.

Color Vision Technologies, Inc. intends to comply fully with the general controls authorized under Sections 501, 502, 510, 516, 518, 519, and 520 of the Food, Drug, and Cosmetic Act.

6. Special Controls:

No special controls apply to this device.

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7. Device Description:

8. Applicant Name & Address:

Color Vision Technologies, Inc. 19726 Colima Road, Suite 320 Rowland Heights, CA 91748 (714) 730-7900 (714) 730-6800 - fax

9. Company Contact:

Ms. Julie Kim Color Vision Technologies, Inc. 19726 Colima Road, Suite 320 Rowland Heights, CA 91748 (714) 730-7900 (714) 730-6800 - fax

10. Submission Correspondent:

Mr. David W. Schlerf Buckman Company, Inc. 200 Gregory Lane, Suite C-100 Pleasant Hill, CA 94523-3389 (925) 356-2640 (925) 356-2654 - fax

11. Performance Standards:

United States Food and Drug Administration mandated performance standards for this device do not exist. Various voluntary performance standards are utilized. Voluntary standards utilized include U.S.P., ASTM, Standard Operating Procedures, vendor & process certification and qualification procedures, Quality Systems Regulations, ISO materials standards and ISO 9000 series quality regulations.

12. Packaging & Storage:

Packaging:

Packaging of the lens blanks should be inspected on arrival for evidence of shipping damage. Damaged packaging may indicate the presence of damaged product and it should not be used until carefully inspected.

Storage:

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ColorMax Lenses must be handled, stored and used in such a way that they are protected from inadvertent damage, scratching or other surface contamination.

13. Summary Basis for Substantial Equivalence of ColorMax Lenses to Prescription Spectacle Lenses:

ColorMax Lenses are prescription spectacle lenses coated with color filters similar to antireflection coatings and colored prescription sunglass coatings that are already included in the prescription spectacle lens classification. The ColorMax Lenses filters are designed specifically to improve discrimination between colors that are normally confused by people with red-green color vision deficiencies. ColorMax Lenses extend the prescription spectacle lens classification by including optical aid for Protan and Deutan color deficiencies as a new indication for use. Clinical performance studies with the Farnsworth Panel D-15 color vision test have demonstrated the effectiveness of ColorMax Lenses for the new indication by showing that they enable red-green color deficient subjects to distinguish between their usual confusion colors, but reduce their ability to distinguish between some other colors. The potential risks associated with altered color discrimination are comparable for ColorMax Lenses and other tinted prescription spectacle lenses such as colored prescription sunglasses.

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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 caduceus symbol, which is a staff with two snakes entwined around it. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" is arranged in a circular pattern around the caduceus symbol. The logo is black and white.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

NOV I 8 1999

Ms. Julie Kim ColorMax Lenses, Inc. 19726 Colima Road Suite 320 Rowland Heights, CA 91748

Re: K984219 Trade Name: ColorMax Color Vision Enhancement Lenses Regulatory Class: I Product Code: 86 NAI Dated: November 10, 1999 Received: November 10, 1999

Dear Ms. Kim:

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 – Ms. Julie Kim

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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Page 1 of

510(k) Number: K984219

Device Name: ColorMax Lens

Indications For Use: ColorMax Lenses are prescription spectacle lenses Colormax Lenses are preseriperon Sptical aid for that are Indicated also vision deficiences.

PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NECESSARY

Concurrence of CDRH, Office of Device Evaluation (ODE) Division of Ophthalmic Dev 510(k) Numb

Prescription Use X
(Per 21 CFR 801.109)

Over-The-Counter Use (Optional format 1-2-96)

Regulation Number and Section

§ 886.5844 Prescription spectacle lens.

(a)
Identification. A prescription spectacle lens is a glass or plastic device that is a lens intended to be worn by a patient in a spectacle frame to provide refractive corrections in accordance with a prescription for the patient. The device may be modified to protect the eyes from bright sunlight (i.e., prescription sunglasses). Prescription sunglass lenses may be reflective, tinted, polarizing, or photosensitized.(b)
Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in § 886.9.