The OPTIMUM GP (roflufocon A, B, C, D & E) Daily Wear Contact Lens may be prescribed in otherwise non-diseased eyes that require a rigid gas permeable lens for the management of irregular corneal conditions such as; keratoconus, pellucid marginal degeneration or following penetrating keratoplasty or refractive (e.g. LASIK) surgery. 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 (roflufocon A, B, C, D & E) Daily Wear Contact Lens is a rigid gas permeable methacrylate copolymer of Methvi methacrylate. 1.1.3.3.3 - Hexafluoroisopropyl Methacrylate. Methacryloxypropyl Tris(trimethylsiloxy) silane, 1,3-bis(methacryloxypropyl)-1,1,3-tetrakis(trimethyl siloxy)disiloxane, 2-Hydroxyethyl Methacrylate, and Methacrviic acid cross-linked with Ethylene Glycol Dimethacrylate. The OPTIMUM GP (roflufocon A, B, C, D & E) Daily Wear Contact Lens are available have as lathe cut contact lenses in clear and tinted versions. 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. 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 - 315mm and 95% in the UVA range of 316 - 380nm.

AI/ML Overview

The provided text does not contain information about acceptance criteria for a device's performance, nor does it describe a study proving a device meets such criteria in terms of algorithm-driven performance metrics (like sensitivity, specificity, or reader improvement).

Instead, the document is a 510(k) summary for a contact lens (OPTIMUM GP Daily Wear Contact Lens) seeking additional indications for use. The core of the submission is to demonstrate substantial equivalence to existing predicate devices, implying that the new indications for use do not raise new questions of safety or effectiveness.

Here's a breakdown of the specific points requested, based on the provided text:

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

The document does not present "acceptance criteria" in the typical sense of quantitative performance metrics for an AI/algorithm driven device. Instead, it focuses on the lens's physical properties and its "substantial equivalence" to predicate devices for its intended use. The closest elements to 'performance' are the physical properties.

Characteristic	Acceptance Criteria (Implied by Predicate)	Reported Device Performance (OPTIMUM GP)
Indication for Use	Management of irregular corneal conditions such as keratoconus, pellucid marginal degeneration or following penetrating keratoplasty or refractive (e.g. LASIK) surgery in otherwise non-diseased eyes.	The OPTIMUM GP Daily Wear Contact Lens may be prescribed in otherwise non-diseased eyes that require a rigid gas permeable lens for the management of irregular corneal conditions such as; keratoconus, pellucid marginal degeneration or following penetrating keratoplasty or refractive (e.g. LASIK) surgery.
Device Classification	Class II, Daily wear, Rigid Gas Permeable RGP Contact Lens, HQD	Class II, Daily wear, Rigid Gas Permeable RGP Contact Lens, HQD
Production Method	Lathe-cut	Lathe-cut
FDA Group #	Group # 3 Fluoro Silicone Acrylate	Group # 3 Fluoro Silicone Acrylate
Water Content	<1%	<1%
UV Absorber/Blocker available	YES	YES
Physical Properties	(Compared to predicate devices like Boston ES®, Boston EO®, Boston XO® and Dyna Intra-Limbal Lens, which exhibit similar material properties suitable for their indicated use)	(roflufocon A) Refractive Index: 1.4527, Light Transmission (clear): >97%, Light Transmission (tinted): >90%, Wetting Angle: 12°, Specific Gravity: 1.189, Oxygen Permeability (Dk): 26 x 10-11 (roflufocon B) Refractive Index: 1.4454, Light Transmission (clear): >97%, Light Transmission (tinted): >90%, Wetting Angle: 13°, Specific Gravity: 1.181, Oxygen Permeability (Dk): 46 x 10-11 (roflufocon C) Refractive Index: 1.4406, Light Transmission (clear): >97%, Light Transmission (tinted): >90%, Wetting Angle: 6°, Specific Gravity: 1.178, Oxygen Permeability (Dk): 65 x 10-11 (roflufocon D) Refractive Index: 1.4333, Light Transmission (clear): >97%, Light Transmission (tinted): >90%, Wetting Angle: 3°, Specific Gravity: 1.166, Oxygen Permeability (Dk): 100 x 10-11 (roflufocon E) Refractive Index: 1.4332, Light Transmission (clear): >97%, Light Transmission (tinted): >90%, Wetting Angle: 6°, Specific Gravity: 1.155, Oxygen Permeability (Dk): 125 x 10-11

2. Sample size used for the test set and the data provenance:

Not applicable. This is a contact lens seeking additional indications, not an AI/algorithm device that would typically have "test sets" of data for performance evaluation in that manner. The submission relies on material properties and clinical experience with similar devices.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

Not applicable. This document does not describe the establishment of ground truth by experts in the context of a "test set" for an algorithm.

4. Adjudication method for the test set:

Not applicable. No "test set" or adjudication method is described for an algorithm performance study.

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-assisted device.

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

Not applicable. This is not an algorithm.

7. The type of ground truth used:

Not applicable in the context of an algorithm's performance validation. The "ground truth" for the device's safety and effectiveness for the additional indications is implicitly established by the long-standing safe and effective use of the identified predicate devices with the same indications, and the physical/chemical similarity of the OPTIMUM GP lens to those predicates.

8. The sample size for the training set:

Not applicable. This is not an AI/algorithm device that uses a "training set."

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

Not applicable.

Summary of the Study that Proves Acceptance Criteria are Met (based on the provided text):

The "study" or justification for meeting acceptance criteria for this device is entirely based on demonstrating substantial equivalence to legally marketed predicate devices. The document highlights:

Identical Indications for Use: The requested indications for use for the OPTIMUM GP lens are the same as those for the predicate devices (Boston ES®, Boston EO®, Boston XO® RGP contact lenses and Dyna Intra-Limbal Lens).
Similar Device Characteristics: The OPTIMUM GP lens shares critical characteristics with its predicates, including classification (Class II, HQD), production method (lathe-cut), FDA Group # (Fluoro Silicone Acrylate), water content (<1%), and availability of UV absorber/blocker.
Material Properties: The physical properties (Refractive Index, Light Transmission, Wetting Angle, Specific Gravity, Oxygen Permeability) of the various roflufocon types (A, B, C, D, E) are provided, suggesting that these properties are within acceptable ranges for rigid gas permeable lenses used for the stated indications, akin to the predicates.
Prior Approval: The Safety and Efficacy and description of the OPTIMUM GP (roflufocon A, B, C, D & E) Daily Wear Contact Lens was previously demonstrated in 510(k) K0033594, indicating it was already approved for daily wear. This current submission is for additional indications.

Therefore, the "proof" that the device meets "acceptance criteria" for its new indications is derived from its fundamental similarity to predicate devices that are already legally marketed for those same indications, along with its previously established safety and efficacy for daily wear. No separate performance study on a "test set" in the context of algorithm evaluation is present.

Summary

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K070628

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:

Applicant information:

Date Prepared:	February 15, 2007
Name:	CONTAMAC Ltd.
Address	Bearwalden Business Park
Saffron Walden
Essex England CB11 4JX
Contact Person:	Robert McGregor
Phone number:	44-1799 542 000
US Agent:	Medvice Consulting, Inc.
Martin Dalsing
Phone number	(970) 243-5490
Fax number	(970) 243-5501
Device Information:
Device Classification:	Class II
Classification Number:	HQD
Classification Name:	Lenses, Rigid Gas Permeable, Daily Wear
Trade Name:	OPTIMUM GP (roflufocon A, B, C, D & E) Daily WearContact Lens.
Purpose of 510(k):	Additional Indications for Use.

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Equivalent Devices:

The OPTIMUM GP (roflufocon A, B, C, D & E) Daily Wear Contact Lens is substantially equivalent to the following predicate devices.

PREDICATE DEVICES

Predicate device manufacturer:

Device name:

1.) Polymer Technology
1400 North Goodman Street Rochester. NY 14603

and the Boston XO® (hexafocon A) Rigid Gas Permeable Contact Lenses 510(k) #K053124

Boston ES® (enflufocon A), Boston EO (enflufocon B),

2.) Lens Dynamics 14998 W. 6th Avenue, Suite 830 Golden, CO 80401
Dyna Intra-Limbal Lens 510(k) #K020006

Device Description:

The Safety and Efficacy and description of the OPTIMUM GP (roflufocon A, B, C, D & E) Daily Wear Contact Lens was demonstrated in 510(k) K0033594.

The OPTIMUM GP (roflufocon A, B, C, D & E) Daily Wear Contact Lens are available have as lathe cut contact lenses in clear and tinted versions. 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.

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 - 315mm and 95% in the UVA range of 316 - 380nm.

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	(roflufocon A)	(roflufocon B)	(roflufocon C)	(roflufocon d)	(roflufocon e)
Refractive Index	1.4527	1.4454	1.4406	1.4333	1.4332
Light Transmission(clear)	>97%	>97%	>97%	>97%	>97%
Light Transmission(tinted)	>90%	>90%	>90%	>90%	>90%
Wetting Angle(Dynamic contactreceding angle)	12°	13°	6°	3°	6°
Specific Gravity	1.189	1.181	1.178	1.166	1.155
OxygenPermeability (Dk)ISO/FATT Method	$26 x 10^{-11}$(cm²/sec) (ml O₂/ml xmm Hg @ 35°C)	$46 x 10^{-11}$(cm²/sec) (ml O₂/ml xmm Hg @ 35°C)	$65 x 10^{-11}$(cm²/sec) (ml O₂/ml xmm Hg @ 35°C)	$100 x 10^{-11}$(cm²/sec) (ml O₂/ml xmm Hg @ 35°C)	$125 x 10^{-11}$(cm²/sec) (ml O₂/ml xmm Hg @ 35°C)
Visitint lensescontain one or moreof the followingcolor additives andconform to:21 CFR Part 73 &74, Subpart DMedical Devices	D & C Green No.6, FD & C RedNo. 17 CI SolventYellow 18	D & C Green No.6, FD & C RedNo. 17 CI SolventYellow 18	D & C Green No.6, FD & C RedNo. 17 CI SolventYellow 18	D & C GreenNo. 6, FD & CRed No. 17 CISolvent Yellow18	D & C Green No.6, FD & C RedNo. 17 CI SolventYellow 18

The physical properties of the OPTIMUM GP (roflufocon A, B, C, D & E) Daily Wear Contact Lens are:

Indication for Use:

Substantial Equivalence:

The OPTIMUM GP (roflufocon A, B, C, D & E) Daily Wear Contact Lens is substantially equivalent and does not raise different questions of safety and effectiveness than the predicate device identified previously.

The following comparison table depicts characteristics of the OPTIMUM GP material, as well as the predicate devices.

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	CharacteristicsComparison	OPTIMUM GP	BOSTON ES, EO&XO	Dyna Intra-LimbalLens
		New Device	Predicate Device	Predicate Device
1.)	Indication for Use	The OPTIMUM GP(roflufocon A, B, C, D & E)Daily Wear Contact Lensmay be prescribedin otherwise non-diseasedeyes that requirea rigid gas permeable lens forthe managementof irregular corneal conditionssuch as:keratoconus, pellucidmarginal degenerationor following penetratingkeratoplasty or followingrefractive (e.g. LASIK)surgery.	The Boston ES®(enflufocon A) , BostonEO® (enflufocon B) andBoston XO® (hexafoconA) RGP contact lenses maybe prescribed in otherwisenon-diseased eyes thatrequire a rigd contact lensfor management ofirregular corneal conditionssuch as keratoconus,pellucid marginaldegeneration, or followingpenetrating keratoplasty orrefractive (e.g. LASIK)surgery.	TheDyna Intra-Limbal(enflufocon or hexafoconA) Lens lens may beprescribed in otherwise nondiseased eyes that require arigid contact lens for themanagement of irregularcorneal conditions such askeratoconus, pellucidmarginal degeneration orfollowing penetratingkeratoplasty.
2.)	Device andClassification	Class IIDaily wear, Rigid GasPermeable RGPContact LensHQD	Class IIDaily wear, Rigid GasPermeable RGP ContactLensHQD	Class IIDaily wear, Rigid GasPermeable RGP ContactLensHQD
3.)	ProductionMethod	Lathe-cut	Lathe-cut	Lathe-cut
4.)	FDA Group #	Group # 3 FluoroSilicone Acrylate	Group # 3 FluoroSilicone Acrylate	Group # 3 FluoroSilicone Acrylate
5.)	Water Content	<1%	<1%	<1%
6.)	UVAbsorber/Blockeravailable	YES	YES	YES

Substantial Equivalence Table

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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 consists of a stylized eagle with three lines forming its body and wing. The eagle faces right. Encircling the eagle is the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" in a circular arrangement.

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MAY - 1 2007

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: K070628

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: HQD Dated: February 15 2007 Received: March 7, 2007

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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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. Eychler SiWD

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

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INDICATIONS FOR USE STATEMENT

K070628

Device Name:

OPTIMUM GP (roflufocon A, B, C, D & E) Daily Wear Contact Lens

INDICATIONS FOR USE:

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.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use X
(Per 21 CFR 801.109)
or
Over-The-Counter Use __

(Optional Format 1-2-96)

Marc Robles
(Division Sign-Off)
Division of Ophthalmic Ear,
Nose and Throat Devises
510(k) Number K070628

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.