Prescribed as a colored filter to aid individuals who experience reading discomfort not related to binocular vision problems or uncorrected refractive error.

Prescribed to enhance color discrimination in patients with protan or deutan (red-green) color vision deficiencies.

Device Description

The ChromaGen v3.0 Reading Aid & Color Discrimination Enhancement, Spectacle Lenses are prescription spectacles that have been precision coated with varying hue and saturation filters similar to antireflection coatings and colored prescription sunglass coatings that are already included in the prescription spectacle lens classification. ChromaGen v30 Reading Aid & Color Discrimination Enhancement are available in varying hues and saturation levels duplicate of that available in the ChromaGen v30 Reading Aid & Color Discrimination Enhancement, Soft Contact Lenses. The ChromaGen v30 Reading Aid & Color Discrimination Enhancement, Spectacle Lens has been designed for binocular use, and when used in combination, have been shown to be of use for patients experiencing visual discomfort when reading.

The ChromaGen v3.0 Reading Aid & Color Discrimination Enhancement, Spectacle Lens coating/tinting process does not alter the optical and/or performance characteristics of the finished spectacle lens.

AI/ML Overview

Here's an analysis of the provided text regarding the ChromaGen v3.0 Reading Aid & Color Discrimination Enhancement Spectacle Lenses, focusing on acceptance criteria and supporting studies:

1. Table of Acceptance Criteria and Reported Device Performance

The provided 510(k) summary does not explicitly state numerical acceptance criteria for the ChromaGen v3.0 Spectacle Lenses. Instead, the basis for clearance is substantial equivalence to previously cleared predicate devices (ChromaGen v3.0 Reading Aid Soft Contact Lenses (K012132) and ChromaGen v2.0 Color Discrimination Enhancement Soft Contact Lenses (K994320)).

The reported device performance, in this context, is that the ChromaGen v3.0 Spectacle Lenses achieve "Substantially Equivalent" efficacy to the predicate soft contact lenses.

Acceptance Criteria Category	Specific Acceptance Criteria (Explicitly Stated in Document)	Reported Device Performance (as stated in Document)
Efficacy for Reading Aid	Not explicitly stated as a quantifiable metric for the spectacle lenses. Implied to be equivalent to predicate.	"Substantially Equivalent, Clinical study (reference K994320 & K012132)"
Efficacy for Color Discrimination Enhancement	Not explicitly stated as a quantifiable metric for the spectacle lenses. Implied to be equivalent to predicate.	"Substantially Equivalent, Clinical study (reference K994320 & K012132)"
Prescription Spectacle Lens Classification	Adherence to Class I regulatory requirements.	Classified as Class I.
Manufacturing Process	Spectacle light transmittance identical to predicate contact lenses, and no alteration of optical/performance characteristics.	"coated/tinted to the exact same spectacle light transmittance as the predicate device soft contact lens." "does not alter the optical and/or performance characteristics of the finished spectacle lens."

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

Test Set Sample Size: No new clinical studies were conducted for the ChromaGen v3.0 Spectacle Lenses directly. The submission relies on the efficacy established in the predicate contact lens studies (K994320 & K012132). Therefore, the sample size for a new test set for these spectacle lenses is 0.
Data Provenance: Not specified within this document for the original predicate studies. However, the applicant is based in England. The 510(k) is submitted to the US FDA. We can infer the predicate studies (K994320 & K012132) were likely either performed in the UK or internationally, and were considered acceptable by the FDA for the previous contact lens clearances. This is a retrospective reliance on previously established data.

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

Since no new studies were conducted, there were no new experts specifically used to establish ground truth for a new test set for these spectacle lenses. The ground truth for the predicate contact lens studies is not detailed in this 510(k) summary.

4. Adjudication Method for the Test Set

Not applicable, as no new test set was created or adjudicated for these spectacle lenses.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done

No, an MRMC comparative effectiveness study was not done for the ChromaGen v3.0 Spectacle Lenses. The document explicitly states: "Clinical performance studies are not required for the spectacle version of the ChromaGen v3.0 Reading Aid & Color Discrimination Enhancement product line, as efficacy has been established in K994320 & K012132."
Effect size of human readers improvement with AI vs. without AI assistance: Not applicable as this is not an AI device, and no MRMC study was performed.

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

Not applicable. This device is a physical spectacle lens with colored filters and is not an algorithm or AI.

7. The Type of Ground Truth Used

The ground truth for the efficacy of the predicate contact lenses (which this device relies upon) was established via "Clinical study" as stated repeatedly in the table. The specific type of clinical outcome or assessment used to establish efficacy (e.g., improved reading speed, improved scores on color vision tests, patient-reported outcomes) is not detailed in this 510(k) summary but would have been part of the K994320 and K012132 submissions.

8. The Sample Size for the Training Set

Not applicable. This device does not involve a "training set" in the context of machine learning or AI algorithms. It is a physical medical device.

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

Not applicable. As stated above, this device does not utilize a training set.

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.

KO22373 The assigned 510(k) number is:

Applicant information:

Date Prepared:	June 27, 2002
Name:Address	Cantor & Nissel LimitedMarket PlaceBrackley NorthantsEngland NN13 7DP
Contact Person:	Mr. David CantorManaging Director
USA Consultant:	Martin Dalsing,Medvice Consulting, Inc.Consultant and US Agent for Cantor & Nissel, Ltd.623 Glacier DriveGrand Junction, CO 81503(970) 243-5490Fax #: (970) 243-5501 E-mail: mdalsing@FDApproval.com
Device Information:
Device Classification:	Class I
Regulation Number:	886.5844
Product Code:	NJH, HQG, NAI
Trade Name:	ChromaGen v3.0 Reading Aid & Color DiscriminationEnhancement Spectacle Lenses
Reason for 510(k) submission:	Expanded Device classification to K994320 & K012132
Classification Name:	Prescription Spectacle lens

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Substantially Equivalent Device:

The ChromaGen v3.0 Reading Aid & Color Discrimination Enhancement, Spectacle Lenses are substantially equivalent to the following legally marketed devices:

Cantor & Nissel "ChromaGen v3.0 Reading Aid, Soft Contact Lenses" A tinted contact lens Re: K012132

Cantor & Nissel "ChromaGen v20 Color Discrimination Enhancement, Soft Contact Lenses" A tinted contact lens Re: K994320

Device Descriptive Characteristics:

The ChromaGen v3.0 Reading Aid & Color Discrimination Enhancement, Spectacle Lens coating/tinting process does not alter the optical and/or performance characteristics of the finished spectacle lens.

INDICATIONS FOR USE:

Prescribed for the correction of refractive ametropia and astigmatism) in aphakic and not-aphakic persons.

Prescribed as a colored filter to aid individuals who experience reading discomfort not related to binocular vision problems or uncorrected refractive error.

Prescribed to enhance color discrimination in patients with protan or deutan (red-green) color vision deficiencies.

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Summary Basis for Substantial equivalence

ChromaGen v3.0 Reading Aid & Color Discrimination Enhancement, Spectacle Lenses to ChromaGen v3.0 Reading Aid & Color Discrimination Enhancement Contact Lenses:

ChromaGen v3.0 Reading Aid & Color Discrimination Enhancement, Spectacle Lenses are prescription spectacle lenses coated/tinted to the exact same spectacle light transmittance as the predicate device soft contact lens. Clinical performance studies are not required for the spectacle version of the ChromaGen v3.0 Reading Aid & Color Discrimination Enhancement product line, as efficacy has been established in K994320 & K012132.

	Characteristic	ChromaGen Reading Aid,Spectacle Lenses (subjectdevice)	ChromaGen Reading Aid, SoftContact Lenses (predicatedevice)	ChromaGen ColorDiscrimination Enhancement,Soft Contact Lenses (predicatedevice)
1.)	INDICATIONfor USE	The ChromaGen v1.0 Reading Aid & ColorDiscrimination, Spectacle Lenses areprescription spectacle lenses that areindicated for the correction of refractiveametropia (myopia, hyperopia andastigmatism) in aphakic and not-aphakicpersons. The Chroma Gen V3.0 Reading Aidspectacle lenses may also be prescribed as acolored filter to aid individuals whoexperience reading discomfort not related tobinocular vision problems or uncorrectedrefractive error. The ChromaGen V3.0 ColorDiscrimination Enhancement spectaclelenses may also be prescribed to enhancecolor discrimination in patients with protanor deutan (red-green) color visiondeficiencies.	The ChromaGen v1.0 Reading Aid SoftContact Lenses are indicated for daily wearas an aid for patients who experience visualdiscomfort when reading. The lens may alsobe prescribed for the correction of refractiveametropia (myopia, hyperopia andastigmatism) in aphakic and not-aphakicpersons with non-diseased eyes. Theselenses may also be prescribed as a coloredfilter to aid individuals who experiencereading discomfort not related to binocularvision problems or uncorrected refractiveerror. The lenses are disinfected using ahydrogen peroxide lens care system only andare available in a frequent replacementprogram.	The ChromaGen v2.0 Color DiscriminationEnhancement Soft Contact Lenses areindicated for daily wear to enhance colordiscrimination in patients with protan ordeutan (red-green) color vision deficiencies.The lens may also be prescribed for thecorrection of refractive ametropia (myopia,hyperopia and astigmatism) in aphakic andnot aphakic persons with non-diseased eyes.The lenses are disinfected using anyhydrogen peroxide lens care system or thePuriLens system, and are available in afrequent replacement program.
2.)	Efficacy	Substantially Equivalent, Clinicalstudy (reference K994320 &K012132)	Established, Clinical studyK012132	Established, Clinical studyK994320
3.)	DeviceClassification	Class I	Class II	Class II
4.)	Device type	Spectacle Lens	Soft Contact Lens	Soft Contact Lens

Table of 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 features a stylized eagle with three stripes forming its body and wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged in a circular fashion around the eagle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD - 20850

OCT 07 2002

Cantor & Nissel Limited c/o Mr. Martin Dalsing Medvice Consulting, Inc. 623 Glacier Drive Grand Junction, CO 81503

Re: K022373

Trade Name: ChromaGen v3 . Reading Aid & Color Discrimination Enhancement Spectacle Lenses Classification Regulation Number: 886.5844 Regulation Name: Prescription Spectacle lens Regulatory Class: I Product Code: NJH, HQG, NAI Dated: June 27, 2002 Received: July 22, 2002

Dear Mr. Dalsing:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate 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) that do not require approval of a premarket approval application (PMA). 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 (PMA), 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 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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This letter will allow you to begin marketing your device as described in your Section 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 21 CFR Part 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" (21CFR Part 807.97), Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address littp://www.fda.gov/cdrlv/dsma/dsmamain.html

Sincerely yours.

A. Ralph Rosenthal

A. Ralph Rosenthal, M.D. Director Division of Ophthalmic and Ear, Nose and Throat Devices Office of Device Evaluation Center for Devices and Radiological Health

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INDICATIONS FOR USE STATEMENT

Device Name:

ChromaGen v30 Reading Aid & Color Discrimination Enhancement, Spectacle Lenses

INDICATIONS FOR USE:

Prescribed for the correction of refractive ametropia (myopia, hyperopia and astigmatism) in aphakic and not-aphakic persons.

Prescribed as a colored filter to aid individuals who experience reading discomfort not related to binocular vision problems or uncorrected refractive error.

Prescribed to enhance color discrimination in patients with protan or deutan (red-green) color vision deficiencies.

(PLEASE DO OT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Signature

(Division Sign-Off)
Division of Ophthalmic Ear,
Nose and Throat Devises

510(k) Number	K022373
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Prescription Use		or	Over-The-Counter Use _____
(Per 21 CFR 801.109)

(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.