The Cantor & Nissel Hand Painted Prosthetic (hioxifilcon A) Soft Contact Lens for Daily Wear is indicated for daily wear to enhance or alter the apparent eye color, including ocular masking, either in sighted or non-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 the correction of refractive ametropia (myopia, hyperopia and astigmatism) in aphakic and not aphakic persons or for occlusive therapy for conditions such as diplopia, amblyopia or extreme photophobia. The lens is disinfected using a hydrogen peroxide lens care system only.

Device Description

The Cantor & Nissel Hand Painted Prosthetic (hioxifilcon A) Soft Contact Lens for Daily Wear is a hand painted lens with an iris pattern to mask a disfiguring or unsightly eye condition. The lens may be hand painted in an iris or a non-sighted eye or clear in the center for a sighted eye. Lens opacity is obtained by partially of lenses with FDA "listed" color additives in amounts not to exceed the minimum reasonably required to accomplish the intended iris pattern. The colorants are permanent and are not leached from a lens. The lenses are painted by skilled artists to an eye care practitioners specifications.

AI/ML Overview

This document is a 510(k) summary of safety and effectiveness for a medical device called "Cantor & Nissel Hand Painted Prosthetic (hioxifilcon A) Soft Contact Lens for Daily Wear." It's a premarket notification to the FDA to demonstrate substantial equivalence to legally marketed predicate devices.

Here's the breakdown of the requested information, based on the provided text:

1. A table of acceptance criteria and the reported device performance

The provided 510(k) summary does not contain a table of explicit acceptance criteria or reported device performance in terms of quantitative metrics (e.g., success rates, accuracy, sensitivity, specificity). Instead, it relies on demonstrating substantial equivalence to a predicate device.

The "acceptance criteria" can be inferred from the comparison table, which highlights the similarities in intended use, indications for use, opacity, color additive characteristics, and opaquing agent. The "performance" is implicitly stated as being equivalent to the predicate device, thereby meeting the safety and efficacy standards.

Here's a table summarizing the comparison, which serves as the basis for demonstrating equivalence rather than a set of performance metrics:

Characteristic	CANTOR & NISSEL Hand Painted PROSTHETIC	Predicate Device: Prosthetic (hefilcon A) Soft Contact Lens ~ K992950
Intended Use	Cosmetic Management of conditions such as corneal, iris, or lens abnormalities.	Cosmetic Management of conditions such as corneal, iris, or lens abnormalities.
Indications For Use Statement	Indicated for daily wear to enhance or alter the apparent eye color, including ocular masking, in sighted or non-sighted eyes requiring a prosthetic contact lens for cosmetic management of conditions such as corneal, iris or lens abnormalities. Also prescribed for correction of refractive ametropia (myopia, hyperopia, astigmatism) in aphakic and non-aphakic persons, or for occlusive therapy for conditions such as diplopia, amblyopia, or extreme photophobia. Disinfected using a hydrogen peroxide lens care system only.	Indicated for daily wear to enhance or alter the apparent eye color, including ocular masking, in sighted or non-sighted eyes requiring a prosthetic contact lens for cosmetic management of conditions such as corneal, iris or lens abnormalities. Also prescribed for correction of refractive ametropia (myopia, hyperopia, astigmatism) in aphakic and non-aphakic persons, or for occlusive therapy for conditions such as diplopia, amblyopia, or extreme photophobia. Disinfected with a chemical disinfection system.
Opacity	One or more FDA listed color additives	Partially or totally White
Color Additive Characteristics	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.	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.
Opaquing Agent Used	Use of FDA listed reactive dyes in amounts to accomplish desired hand-painted iris patterns.	Titanium Dioxide

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

The document does not describe a test set or clinical study with a specific sample size. This 510(k) is based on demonstrating substantial equivalence to an existing device, implying that the safety and effectiveness are established through the predicate's history, not new clinical testing for this specific device model. Therefore, there is no mention of data provenance.

3. 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, as no new clinical study or test set requiring ground truth establishment is described.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not applicable, as no new clinical study or test set is described.

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

Not applicable. This is a contact lens, not AI software.

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

Not applicable. This is a contact lens, not AI software.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

Not applicable, as no new clinical study or test set is described. The "ground truth" for the device's acceptable performance is its substantial equivalence to a previously cleared device.

8. The sample size for the training set

Not applicable. This is a physical medical device (contact lens), not a machine learning algorithm.

9. How the ground truth for the training set was established

Not applicable. This is a physical medical device (contact lens), not a machine learning algorithm.

Summary

{0}------------------------------------------------

JUL 3 0 2004

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:	K041700
--------------------------------	---------

Applicant information:

Date Prepared:	June 1, 2004
Name:	Cantor & Nissel Limited
Address	Manor Road, BrackleyNorthamptonshireEngland NN13 7DP
Contact Person:	Mr. David CantorManaging Director/President
Phone Number:	011 44 1280 702002
Fax:	011 44 1280 703003
USA Consultant:	Martin Dalsing,Med-Vice Consulting, Inc.Consultant for Cantor & Nissel, Inc.623 Glacier DriveGrand Junction, CO 81503(970) 243-5490Fax #: (970) 243-5501E-mail: Marty@FDApproval.com

Device Information:

Device Classification:	Class II
Classification Number:	LPL
Trade Name:	Cantor & Nissel Hand Painted Prosthetic (hioxifilcon A)Soft Contact Lens for Daily Wear

Lens, Soft Contact, Daily Wear

Classification Name:

{1}------------------------------------------------

Substantially Equivalent Devices:

The "Cantor & Nissel Hand Painted Prosthetic (hioxifilcon A) Soft Contact Lens for Daily Wear" is substantially equivalent to the "Prosthetic (hefilcon A) Soft Lens ~ K992950".

Device Descriptive Characteristics:

The Cantor & Nissel Hand Painted Prosthetic (hioxifilcon A) Soft Contact Lens for Daily Wear is a I hand painted lens with an iris pattern to mask a disfiguring or unsightly eye condition. The lens may be nand painted inns or a non-sighted eye or clear in the center for a sighted eye. Lens opacity is obtained by partially of enses with FDA "listed" color additives in amounts not to exceed the minimum reasonably required to accomplish the intended iris pattern. The colorants are permanent and are not leached from a lens. The lenses are painted by skilled artists to an eye care practitioners specifications.

INDICATIONS FOR USE:

The lens is disinfected using a hydrogen peroxide lens care system only.

{2}------------------------------------------------

The following table summarizes Cantor & Nissel Limited claim of substantial equivalency in terms of safety and efficacy to the predicate devices previously mentioned.

	Characteristic	CANTOR & NISSELHand Painted PROSTHETIC	Prosthetic (hefilcon A) SoftContact Lens ~ K992950
1.)	INTENDED USE	Cosmetic Management ofconditions such as corneal, iris,or lens abnormalities.	Cosmetic Management of conditionssuch as corneal, iris, or lensabnormalities.
2.)	INDICATIONS FORUSE STATEMENT	The CANTOR & NISSEL HandPainted PROSTHETIC(hioxifilcon A) Soft Contact Lensare indicated for daily wear toenhance or alter the apparent eyecolor, including ocular masking,either in sighted or non-sightedeyes that require a prostheticcontact lens for cosmeticmanagement of conditions suchas corneal, iris or lensabnormalities. The lens may alsobe prescribed for the correction ofrefractive ametropia (myopia,hyperopia and astigmatism) inaphakic and not aphakic personsor for occlusive therapy forconditions such as diplopia,amblyopia or extremephotophobia. The lens isdisinfected using a hydrogenperoxide lens care system only.	The Prosthetic (hefilcon A) SoftContact Lens is indicated for dailywear to enhance or alter the apparenteye color, including ocular masking,either in sighted or non-sighted eyesthat require a prosthetic contactlenses for cosmetic management ofconditions such as corneal, iris orlens abnormalities. The lens mayalso be prescribed for the correctionof refractive ametropia (myopia,hyperopia and astigmatism) inaphakic and not aphakic persons orfor occlusive therapy for conditionssuch as diplopia, amblyopia orextreme photophobia. The lens maybe disinfected with a chemicaldisinfection system.
3.)	OPACITY	One or more FDA listed coloradditives	Partially or totally White
4.)	COLOR ADDITIVECHARACTERISTICS	The color additives used are notremoved by lens handling andapproved cleaning/disinfectingprocedures. The optical andperformance characteristics arenot altered by the lens coloringprocess.	The color additives used are notremoved by lens handling andapproved cleaning/disinfectingprocedures. The optical andperformance characteristics are notaltered by the lens coloring process.
5.)	OPAQUING AGENTUSED	Use of FDA listed reactive dyesin amounts to accomplish desiredhand painted iris patterns.	Titanium Dioxide

{3}------------------------------------------------

Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized depiction of an eagle or bird-like figure with three curved lines representing its wings or feathers. The bird is positioned above the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA", which is arranged in a circular fashion around the bird. The logo is black and white.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JUL 3 0 2004

Cantor & Nissel Ltd. c/o Martin Dalsing Med-Vice Consulting, Inc. 623 Glacier Dr. Grand Junction, CO 81503

Re: K041700

Trade/Device Name: Cantor & Nissel Hand Painted Prosthetic (hioxifilcon A) Soft Contact Lens for Daily Wear Regulation Number: 21 CFR 886.5925 Regulation Name: Soft (hydrophilic) contact lens Regulatory Class: Class II Product Code: LPL Dated: June 1, 2004 Received: June 23, 2004

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.

{4}------------------------------------------------

Page 2 - Martin Dalsing

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), please contact the Office of Compliance at (301) 594-4613. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act 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 http://www.fda.gov/cdrh/dsma/dsmamain.html

Sincerely yours,

Aherl 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

Enclosure

{5}------------------------------------------------

INDICATIONS FOR USE STATEMENT

Cantor & Nissel Hand Painted Prosthetic (hioxifilcon A) Soft Contact Lens Device Name: for Daily Wcar

INDICATIONS FOR USE:

The Cantor & Nissel Hand Painted Prosthetic (hioxifilcon A) Soft Contact Lens for Daily Wear is indicated for daily wear to enhance or alter the apparent eye color, including ocular masking, either in midred or non-sighted eyes that require a prosthetic contact lens for cosmetic management of conditions sighted or non bighted by or lens abnormalities. The lens may also be prescribed for the correction of refractive suon as contrally in or lease in and astigmatism) in aphakic and not aphakic persons or for occlusive ameropa (if your are as diplopia, amblyopia or extreme photophobia. The lens is disinfected using a hydrogen peroxide lens care system only.

(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	K041700
---------------	---------

Prescription Use (Per 21 CFR 801.109)	x
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.