The OPTIMUM GP OK contact lenses are indicated for daily wear in an orthokeratology fitting program for the temporary reduction of myopia of up to 5.00 diopters in non-diseased eyes. To maintain the orthokeratology effect of myopia reduction, lens wear must be continued on a prescribed wearing schedule.

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

Device Description

The OPTIMUM GP OK Daily Wear Contact Lens (roflufocon D & E) may be prescribed in a daily wear orthokeratology fitting program for the temporary reduction of myopia of up to 5.00 diopters in non-diseased eyes.

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

The OPTIMUM GP OK Daily Wear Contact Lens (roflufocon D & E) may be packaged and shipped "dry" or "wet" in a polypropylene contact lens case. The primary container for shipping the OPTIMUM GP OK lenses is the PolyVial /PolyPack Contact Lens Case. When shipped "wet", the OPTIMUM GP OK lenses may be packaged and shipped in the Optimum Cleaning, Disinfecting and Storage (CDS) GP solution. The active ingredients in Optimum GP Cleaning Disinfecting and Storage solution are Lauryl salt of imidazoline, octylphenoxypolyethoxyethanol, and preserved with benzyl alcohol 0.3% and disodium edetate 0.5%.

The OPTIMUM GP OK Daily Wear Contact Lens (roflufocon D & E) 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.

In the OPTIMUM GP OK Daily Wear Contact Lens (roflufocon D & E) with UV Blocker, a Benzophenone UV blocking monomer 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 280nm – 315nm and 95% in the UVA range of 316 – 380nm.

AI/ML Overview

The provided text is a 510(k) summary for the OPTIMUM GP OK (Orthokeratology) Daily Wear Contact Lens. It does not describe a study that uses acceptance criteria in the manner typically associated with AI/ML device performance evaluations. The document focuses on demonstrating substantial equivalence to predicate devices for regulatory clearance, rather than presenting a detailed clinical or technical study with specific performance metrics and acceptance thresholds for a novel device function.

Therefore, many of the requested fields cannot be directly extracted or are not applicable from this type of regulatory document.

However, I can extract information related to product specifications and a comparison to predicate devices, which serve a similar purpose in demonstrating that the new device is "as good as" existing, cleared devices.

Here's an attempt to answer the questions based on the provided text, while noting where information is not available:

1. Table of Acceptance Criteria and Reported Device Performance

This document does not present "acceptance criteria" in the context of a statistical study with performance metrics (e.g., sensitivity, specificity, accuracy) for a new algorithm or diagnostic test. Instead, it demonstrates substantial equivalence by comparing the physical and chemical properties and indications for use of the proposed device to legally marketed predicate devices. The "performance" here is that its characteristics are similar enough to existing devices to not raise new questions of safety and effectiveness.

Here's a table comparing key characteristics of the subject device with its predicates, as presented in the document:

Characteristic	OPTIMUM GP OK (Subject Device)	Predicate: OPTIMUM GP (K033594) (roflufocon D & E)	Predicate: CONTEX OK (K973697) (siflufocon A)	Predicate: BOSTON XO2 (K071266) (hexafocon B)
Indication for Use	Daily wear in orthokeratology for temporary reduction of myopia up to 5.00 diopters	Management of irregular corneal conditions (not orthokeratology)	Daily wear in orthokeratology for temporary reduction of myopia up to 3.00 diopters	Daily wear in orthokeratology for temporary reduction of myopia up to 5.00 diopters
Device Classification	Class II rigid gas permeable contact lens	Class II rigid gas permeable contact lens	Class II rigid gas permeable contact lens	Class II rigid gas permeable contact lens
Product Code	MUW	HQD	MUW	MUW
Production Method	Lathe-cut	Lathe-cut	Lathe-cut	Lathe-cut
USAN (Material)	roflufocon D, & E	roflufocon A, B, C, D, & E	siflufocon A	hexafocon B
FDA Group #	Group # 3 Fluoro Silicone Acrylate	Group # 3 Fluoro Silicone Acrylate	Group # 3 Fluoro Silicone Acrylate	Group # 3 Fluoro Silicone Acrylate
Oxygen Permeability (Dk)	D: 100, E: 125	D: 100, E: 125	81	141
Water Content	<1%	<1%	<1%	<1%
UV Absorber/Blocker available	YES	YES	NO	YES
Myopia reduction (Orthokeratology claim)	Up to 5.00 Diopters	N/A (different indication)	Up to 3.00 Diopters	Up to 5.00 Diopters

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 refers to demonstrating "safety" through K033594, which itself encompasses "Clinical Performance" for the material (roflufocon D & E). However, this document does not describe a new clinical study. It leverages prior clearance of the material and the intended use.
Therefore, there is no explicit "test set" sample size or data provenance mentioned for a new study within this 510(k) submission.

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 a test set.

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

Not applicable. There is no test set or adjudication method 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 device is a contact lens, not an AI/ML diagnostic or assistive device that would involve human readers or AI assistance.

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

Not applicable. This device is a contact lens, not an algorithm.

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

Not applicable. The clearance is based on substantial equivalence to predicate devices, not on a new study requiring a defined ground truth. Previous clearances (K033594 for material safety, K973697 and K071266 for orthokeratology indication and design) would have involved their own safety and effectiveness data, likely including outcomes data from clinical trials for contact lenses (e.g., visual acuity, corneal health, adverse events) to support their original clearance.

8. The sample size for the training set

Not applicable. This is not an AI/ML device with a training set.

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

Not applicable.

Summary

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

Image /page/0/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is circular, with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the top half of the circle. In the center of the circle is an abstract symbol that resembles a stylized caduceus, with three human profiles facing to the right.

Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

July 13, 2016

Contamac Ltd. % Mr. Bret Andre Principal Consultant EyeReg Consulting, Inc. 6119 Canter Ln. West Linn, OR 97068 Re: K160859 Trade/Device Name: OPTIMUM GP OK (Orthokeratology) Daily Wear Contact Lens (roflufocon D & E) Regulation Number: 21 CFR 886.5916 Regulation Name: Daily Wear Rigid Gas Permeable (hydrophobic) Contact Lens (Orthokeratology) Regulatory Class: Class II Product Code: MUW Dated: May 25, 2016 Received: June 1, 2016

Dear Mr. Andre:

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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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.

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

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); medical device reporting (reporting of medical devicerelated adverse events) (21 CFR 803); 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.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours.

Denise E. Hampton -S

for 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

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

DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

Indications for Use

510(k) Number (if known)

K160859

Device Name

OPTIMUM GP OK (Orthokeratology) Daily Wear Contact Lens (roflufocon D & E)

Indications for Use (Describe)

Type of Use (Select one or both, as applicable)

Prescription Use (Part 21 CFR 801 Subpart D)

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

PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.

FOR FDA USE ONLY

Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)

This section applies only to requirements of the Paperwork Reduction Act of 1995.

DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.

The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov

"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."

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

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:	K160859
Applicant information:
Date Prepared:	March 23 rd , 2016
Name:	Contamac Ltd.
Address	Carlton HouseShire HillSaffron WaldenEssex CB11 3AU
Contact Person:	Robert McGregor
	Managing Director
Phone number:	44-1799 542 000
Consultant:	EyeReg Consulting, Inc.
	Bret Andre6119 Canter LnWest Linn, OR 97068
Phone number	(503) 372-5226
Fax number	(503) 419-4475
Device Information:
Device Classification:	Class II
Product Code:	MUW
Classification Name:	Daily Wear Rigid Gas Permeable (hydrophobic) ContactLens (Orthokeratology) (21 CFR 886.5916)
Trade Name:	OPTIMUM GP OK (Orthokeratology)Daily Wear Contact Lens (roflufocon D & E)

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

Purpose of Submission:

~ New Indication ~

Predicate Devices:

The OPTIMUM GP OK for daily wear is substantially equivalent to the following predicate device(s)

Predicate device:

Predicate devicemanufacturer	Device name	510(k) number
Contamac Ltd.	OPTIMUM GP (Oxygen Permeable) Daily WearContact Lenses (roflufocon A, B, C, D, & E)	K033594
Contex, Inc.	CONTEX OK (orthokeratology) contact lens	K973697
Polymer Technology	Boston X02 (hexafocon B) Daily Wear ContactLens	K071266

Device Description:

In the OPTIMUM GP OK Daily Wear Contact Lens (roflufocon D & E) with UV Blocker, a Benzophenone UV blocking monomer 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 280nm – 315nm and 95% in the UVA range of 316 – 380nm. The physical properties of the OPTIMUM GP OK Contact Lens are as follows:

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

	(roflufocon d)	(roflufocon e)
Refractive Index	1.4333	1.4332
Light Transmission (clear)	>97%	>97%
Light Transmission (tinted)	>90%	>90%
Wetting Angle (Dynamic contactreceding angle)	3°	6°
Specific Gravity	1.166	1.155
Oxygen Permeability(Dk)ISO/FATT Method	$100 \times 10^{-11} \frac{cm^2}{sec} (ml O_2/ml x mm \newline Hg @ 35°C)$	$125 \times 10^{-11} \frac{cm^2}{sec} (ml O_2/ml x mm \newline Hg @ 35°C)$
Visitint lenses contain one or more ofthe following color additivesconforming to:21 CFR Part 73 & 74, Subpart D	D & C Green No. 6, FD & C RedNo. 17,CI Solvent Yellow 18	D & C Green No. 6, FD & C RedNo. 17,CI Solvent Yellow 18

The lens parameters of the OPTIMUM GP OK Contact Lens are as follows:

米 Chord Diameter:
ન્ન્સ Center Thickness:
米 Base Curve (BC):
米 Secondary Curves:
米 Peripheral Curves:
米 Spherical Powers:

6.5 to 11.5 mm 0.10 to 0.70 mm 6.5 to 11.0 mm 0.10 to 2.0 mm (flatter or steeper than BC) 0.10 to 2.0 mm (flatter or steeper than BC) -10.00 to +3.00 D

Indication 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.

Description of Safety:

The safety profile for finished lenses manufactured from the (roflufocon D & E) rigid gas permeable (RGP) materials is demonstrated in K033594-which addresses the following areas:

· Biocompatibility
· Shelf Life (Wet Shipping)
· Solution Compatibility
· Clinical Performance

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

Substantial Equivalence:

Comparison to Predicate Device(s):

The OPTIMUM GP OK Daily Wear Contact Lens (roflufocon D & E) is substantially equivalent to the OPTIMUM GP (Oxygen Permeable) Daily Wear Contact Lenses (roflufocon A, B, C, D, & E)cleared under K033594-in terms of the following:

· contact lens material (roflufocon D. & E)—including physicochemical and mechanical properties of finished lenses
· lathe cut manufacturing process
manufacturing facility
· final packaging and wet shipping procedures

The OPTIMUM GP OK Daily Wear Contact Lens (roflufocon D & E) is substantially equivalent to the Boston X02 (hexafocon B) Daily Wear Contact Lens and CONTEX OK-cleared under K071266 and K973697, respectively-in terms of the following:

· indications for use (daily wear orthokeratology)
orthokeratology lens design

The OPTIMUM GP OK Daily Wear Contact Lens (roflufocon D & E) are substantially equivalent to the predicate device as depicted in the following table, and do not raise different questions of safety and effectiveness than the predicate device identified previously.

{7}------------------------------------------------

The following table depicts the pre-clinical characteristics of the OPTIMUM GP OK Daily Wear Contact Lens (roflufocon D & E), as well as the predicate device.

	OPTIMUM GP OK(Orthokeratology)	OPTIMUM GP	CONTEX OK	BOSTON XO2
	Subject Device	Predicate Device	Predicate Device	Predicate Device
Indication for Use	Indicated for daily wear in anorthokeratology fittingprogram for the temporaryreduction of myopia of up to5.00 diopters in non-diseasedeyes. To maintain theorthokeratology effect ofmyopia reduction, lens wearmust be continued on aprescribed wearing schedule.	May be prescribed inotherwise non-diseased eyesthat require a rigid gaspermeable lens for themanagement of irregularcorneal conditions such as;keratoconus, pellucidmarginal degeneration offollowing penetratingkeratoplasty or followingrefractive (e.g. LASIK)surgery.	Indicated for dailywear in anorthokeratologyfitting program forthe temporaryreduction of myopiaof up to 3.00 dioptersin non-diseased eyes.To maintain theorthokeratologyeffect of myopiareduction, lens wearmust be continued ona prescribed wearingschedule.	Indicated for daily wearin an orthokeratologyfitting program for thetemporary reduction ofmyopia of up to 5.00diopters in non-diseasedeyes. To maintain theorthokeratology effect ofmyopia reduction, lenswear must be continuedon a prescribed wearingschedule.
Device andClassification	Class IIDaily Wear Rigid GasPermeable (hydrophobic)Contact Lens (21 CFR886.5916)	Class IIDaily Wear Rigid GasPermeable (hydrophobic)Contact Lens (21 CFR886.5916)	Class IIDaily Wear RigidGas Permeable(hydrophobic)Contact Lens (21CFR 886.5916)	Class IIDaily Wear Rigid GasPermeable(hydrophobic) ContactLens (21 CFR886.5916)
Product Code	MUW	HQD	MUW	MUW
Production Method	Lathe-cut	Lathe-cut	Lathe-cut	Lathe-cut
USAN	roflufocon D, & E	roflufocon A, B, C, D, &E	siflufocon A	hexafocon B
FDA Group #	Group # 3 Fluoro SiliconeAcrylate	Group # 3 Fluoro SiliconeAcrylate	Group # 3 FluoroSilicone Acrylate	Group # 3 FluoroSilicone Acrylate
Oxygen Permeabilityx 10-11 (cm2/sec)(ml O2/ml x mm Hg @ 35°C)	Roflufocon D: 100Roflufocon E: 125	Roflufocon D: 100Roflufocon E: 125	81	141
Water Content	<1%	<1%	<1%	<1%
UV Absorber/Blockeravailable	YES	YES	NO	YES

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.