The OPTIMUM GP (roflufocon A, roflufocon B, roflufocon D, and roflufocon E) Rigid Gas Permeable (RGP) Contact Lens is indicated for daily wear for the correction of visual acuity in aphakic and not aphakic persons with non-diseased eyes with myopia or hyperopia. The lens may be disinfected with a chemical disinfection system only.

Eyecare practitioners may prescribe the lenses for frequent/planned replacement wear, with cleaning, disinfection and scheduled replacement. When prescribed for frequent/planned replacement wear, the lens may be cleaned and disinfected using a chemical (not heat) lens care system.

Device Description

The OPTIMUM GP series of contact lenses are fabricated from the hydrophobic contact lens materials (roflufocon A), (roflufocon B), (roflufocon C), (roflufocon D), & (roflufocon E). When placed on the human cornea, the OPTIMUM GP rigid gas permeable contact lenses act as a refracting medium to focus light rays upon the retina.

OPTIMUM GP Contact Lens for Daily Wear is available with a plasma surface treatment. Lenses are packaged non-sterile and shipped in one of the following GP solutions.

Solution	Manufacturer
Boston Simplus	Bausch & Lomb
Unique Ph	Alcon
Optimum CDS	Lobob Laboratories

The OPTIMUM GP Contact Lens for Daily Wear are available as lathe cut contact lenses with spherical, aspheric, bifocal, multifocal or toric anterior and/or posterior designs in clear and tinted versions.

The OPTIMUM GP Contact Lens for Daily Wear is a rigid gas permeable methacrylate copolymer of Methyl methacrylate, 1,1,1,3,3,3 - Hexafluoroisopropyl Methacrylate, Methacryloxypropyl Tris(trimethylsiloxy) silane, 1,3-bis(methacryloxypropyl)-1,1,3,3-tetrakis(trimethyl siloxy)disiloxane, 2-Hydroxyethyl Methacrylate, and Methacrylic acrylic acid cross-linked with Ethylene Glycol Dimethacrylate.

The OPTIMUM GP Contact Lens for Daily Wear incorporates a visibility tint to make the lens more visible for handling. The tinted lenses contain one or more of the following color additives: D&C Green No.6, C.I. Solvent yellow No. 18, and FD&C Red No. 17.

AI/ML Overview

The provided document describes the modification of an existing contact lens product (OPTIMUM GP) to include a plasma surface treatment, and a UV blocker. The 510(k) summary focuses on demonstrating substantial equivalence to the predicate device.

The document does not contain acceptance criteria for a device's performance based on objective metrics (like sensitivity, specificity, accuracy) for a diagnostic algorithmic device. Instead, it focuses on the technological characteristics and physical properties of a medical device (contact lens) and demonstrates that a modified version maintains substantial equivalence to an existing predicate device.

Therefore, many of the requested points regarding acceptance criteria, study details, and ground truth for an AI/algorithmic device are not applicable or cannot be extracted from this document.

However, I can extract the relevant information concerning the device's characteristics and the comparison made.

Here's an analysis based on the provided text, addressing the points where information is available or indicating when it's not applicable:

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

As mentioned, this document does not present acceptance criteria in terms of clinical performance metrics for an algorithm. Instead, it focuses on the physical and chemical characteristics of the contact lens. The "performance" assessment is around the reduction in contact angle after plasma surface treatment, indicating improved wettability.

Characteristic / Acceptance Criteria (Implied)	Reported Device Performance (Modified Device)
Intended Use	Indicated for daily wear for the correction of visual acuity in aphakic and non-aphakic persons with non-diseased eyes with myopia or hyperopia.
Functionality	Acts as a refractive medium to focus light rays from near and distant objects on the retina.
Production Method	Lathe-cut
FDA Group #	Group # 3 Fluoro Silicone Acrylate
USAN Name	roflufocon
Water Content	<1%
Surface Characteristic	Hydrophobic (prior to treatment)
Wetting Angle (Post Plasma Treatment)	- Optimum Classic: 17% reduction in contact angle - Optimum Comfort: 28% reduction in contact angle - Optimum Extra: 20% reduction in contact angle - Optimum Extreme: 38% reduction in contact angle
UV Blocking	- UVB (280mm-315nm): >98% average blocking - UVA (316-380mm): 95% average blocking

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

Not applicable. This document is for a medical device (contact lens) and is focused on demonstrating substantial equivalence through physical and chemical property comparisons and, for the plasma treatment, a lab-based assessment of wettability (contact angle). No clinical "test set" in the context of an AI algorithm is described. The contact angle measurements would have involved a sample size of lenses, but this specific number is not provided in the summary.

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. This is not a study requiring expert-established ground truth for an algorithmic output.

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

Not applicable.

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 not an AI/algorithmic device.

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

Not applicable. This is not an AI/algorithmic device.

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

For the physical and chemical characteristics, the "ground truth" would be established by standard analytical and material testing methods (e.g., spectrophotometry for UV blocking, goniometry for contact angle, chemical analysis for material composition). For the intended use and functionality, it relies on established clinical understanding of contact lens optics and patient outcomes, which are not detailed in this submission as it's a modification to an already cleared device.

8. The sample size for the training set

Not applicable. This is not an AI/algorithmic device.

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

Not applicable. This is not an AI/algorithmic device.

Summary

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

SPECIAL 510(k) SUMMARY

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:		K062548
Applicant information:
Date Prepared:		August 28th, 2006
Submittals Name:		CONTAMAC Ltd.Bearwalden Business ParkSaffron WaldenEssex United Kingdom CB11 4JX
Contact Person:
Medvice Consulting, Inc.Martin Dalsing, Consultant and U.S. Agent for Contamac Ltd.2214 Sanford Drive, B7Grand Junction, CO 81505(970) 243-5490Fax #: (970) 243-5501E-mail: marty@fdapproval.com
Device Information:
Device Classification:		Class II
	Classification Number:		HQD
	Classification Name:		Daily Wear Rigid Gas Permeable (RGP) Contact Lens
Trade Name:		OPTIMUM GP (Oxygen Permeable) Daily Wear Contact Lenses

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

Device Description:

The OPTIMUM GP series of contact lenses are fabricated from the hydrophobic contact lens materials (roflufocon A), (roflufocon B), (roflufocon C), (roflufocon D), & (roflufocon E). When placed on the (fuman cornea, the OPTIMUM GP rigid gas permeable contact lenses act as a refracting medium to focus light rays upon the retina.

OPTIMUM GP Contact Lens for Daily Wear is available with a plasma surface treatment. Lenses are packaged non-sterile and shipped in one of the following GP solutions.

Solution	Manufacturer
Boston Simplus	Bausch & Lomb
Unique Ph	Alcon
Optimum CDS	Lobob Laboratories

UV Blocker

In the OPTIMUM GP Contact Lens with UV Blocker, a Benzophenone UV blocker is used to block UV radiation. The UV Blocker is 2,2 -Dihydroxy-4,4 dimethoxybenzophenone. The UV blocking for OPTIMUM GP averages > 98% in the UVB range of 280mm - 315nm and 95% in the UVA range of 316 -380mm.

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

Contamac Ltd. Special 510(k): Manufacturing Process Change, Premarket Notification

The following chart depicts the dramatic reduction in the OPTIMUM GP contact lens wetting angle measurements post plasma surface treatment.

Image /page/2/Figure/2 description: The image is a bar graph titled "% Reduction in Contact Angle after Plasma Surface Treatment". The x-axis shows four different categories: Optimum Classic, Optimum Comfort, Optimum Extra, and Optimum Extreme. The y-axis shows the percent reduction, ranging from 0% to 40%. The bar graph shows that Optimum Classic has a 17% reduction, Optimum Comfort has a 28% reduction, Optimum Extra has a 20% reduction, and Optimum Extreme has a 38% reduction.

Unmodified Predicate Devices:

The OPTIMUM GP (Oxygen Permeable) Daily Wear Contact Lenses is substantially equivalent to Contamac Ltd. own unmodified predicate devices:

1. Optimum GP (roflufocon ) K033594, Contamac Ltd.

INDICATIONS FOR USE:

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

Technological Characteristics Comparison:

ﺒﻌﻪ

ु

TechnologicalCharacteristic/Device	Optimum GP(roflufocon) GasPermeable ContactLens.Modified Device	Optimum GP(roflufocon) GasPermeable ContactLens.Un-Modified DeviceK033594
Intended Use	Indicated for daily wearfor the correction ofvisual acuity in aphakicand not aphakic personswith non-diseased eyeswith myopia orhyperopia.	Indicated for daily wearfor the correction ofvisual acuity in aphakicand not aphakic personswith non-diseased eyeswith myopia orhyperopia.
Functionality	After machining fromthe optical blank, thecontact lenses act as arefractive medium thatfocus light rays fromnear and distant objectson the retina.	After machining fromthe optical blank, thecontact lenses act as arefractive medium thatfocus light rays fromnear and distant objectson the retina.
Indication forUse	Daily wear, Rigid GasPermeable RGP ContactLens	Daily wear, Rigid GasPermeable RGP ContactLens
ProductionMethod	Lathe-cut	Lathe-cut
FDA Group #	Group # 3 FluoroSilicone Acrylate	Group # 3 FluoroSilicone Acrylate
USAN name	roflufocon	roflufocon
Water Content	<1%	<1%
Surfacecharacteristic	hydrophobic	hydrophobic

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

DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/4/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle or bird-like symbol with three curved lines forming its body and head. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the bird symbol.

Public Health Service

NOV 1 2006

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Contamac Ltd. c/o Mr. Martin Dalsing Medvice Consulting, Inc. Official Correspondent/Consultant and US Agent for Contamac Ltd. 2214 Sanford Dr. Ste. B7 Grand Junction, CO 81505

Re: K062548

Trade/Device Name: OPTIMUM GP (roflufocon A, roflufocon B, roflufocon C, roflufocon D and roflufocon E) Daily Wear Contact Lens Regulation Number: 21 CFR 886.5916 Regulation Name: Rigid gas permeable contact lenses Regulatory Class: Class II Product Code: HOD Dated: October 19, 2006 Received: October 20, 2006

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 (sec 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.

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

Page 2 - Mr. 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 (240) 276-0115. 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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

M.B. Egdelmin SimD

Malvina B. Eydelman, M.D. Director Division of Ophthalmic and Ear, Nose and Throat Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

{6}------------------------------------------------

INDICATIONS FOR USE STATEMENT

OPTIMUM GP (Oxygen Permeable) Daily Wear Contact Lenses. Device Name:

INDICATIONS FOR USE:

The OPTIMUM GP (roflufocon A, roflufocon B, roflufocon D, and roflufocon D, and roflufocon E) Rigid Gas Permeable (RGP) Contact Lens is indicated for daily wear for the correction of visual acuity in aphakic and not aphakic persons with non-diseased eyes with myopia or hyperopia. The lens may be disinfected with a chemical disinfection system only.

Eyecare practitioners may prescribe the lenses for frequent/planned replacement wear, with cleaning, disioner on and scheduled replacement. When prescribed for frequent/planned replacement wear, the lens may be cleaned and disinfected using a chemical (not heat) lens care system.

Prescription Use X
(Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use (Part 21 CFR 801 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

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

4062548 510(k) Number.

OPTIMUM GP, Daily Wear (Oxygen Permeable) Contact lens

Regulation Number and Section

§ 886.5916 Rigid gas permeable contact lens.

(a)
Identification. A rigid gas permeable contact lens is a device intended to be worn directly against the cornea of the eye to correct vision conditions. The device is made of various materials, such as cellulose acetate butyrate, polyacrylate-silicone, or silicone elastomers, whose main polymer molecules generally do not absorb or attract 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.