The Ampleye Scleral RGP Lens (roflufocon D, roflufocon E, hexafocon A, paflufocon D) for daily wear is indicated for use for the management of irregular astigmatism, corneal degeneration or dystrophy caused by keratoconus, keratoglobus, pellucid marginal degeneration (PMD), post corneal trauma/scaring, post keratoplasty, post K-Pro, post RK, post LASIK, Salzmann's nodular degeneration. Cogan's dystrophy, granular corneal dystrophy, lattice corneal dystrophy or Reis-Bucklers dystrophy.

The Ampleye Scleral RGP Lens (roflufocon D, roflufocon E, hexafocon A, paflufocon D) is also indicated for therapeutic management of ocular surface disease from dry eye including ocular pemphigoid, Stevens-Johnson syndrome, symblepharon formation, graft vs host disease, persistent epithelial defect, exposure keratitis, neurotrophic keratopathy( herpes zoster, familial dysautonomia), Sjogern's syndrome, filamentary keratitis, limbal stem cell deficiency, atopy, ectodermal dysplasia. When prescribed for therapeutic use for irregular astigmatism or ocular surface diseases, the Ampleye Scleral RGP Lens may also provide correction of refractive error including myopia, presbyopia and regular astigmatism.

Eye care 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 Ampleye Scleral RGP Lens (roflufocon D, roflufocon E, hexafocon A, paflufocon D) for daily wear is a large diameter rigid gas permeable contact lens design that vaults over the cornea and rests on the conjunctiva overlying the sclera. The Ampleye Scleral RGP Lens is lathe cut from one of the following hydrophobic, FDA Group #3 fluoro-silicone acrylate materials: roflufocon D, roflufocon E, hexafocon A, or paflufocon D.

AI/ML Overview

The provided document is a 510(k) summary for a contact lens device, the Ampleye Scleral RGP Lens. This type of submission focuses on demonstrating substantial equivalence to a predicate device rather than undergoing a full clinical study with acceptance criteria in the way a novel therapeutic or diagnostic device would.

Therefore, the information typically requested in your prompt regarding acceptance criteria and detailed study results for device performance (e.g., accuracy, sensitivity, specificity, statistical significance with effect size) is not present for this contact lens device in this particular document.

Here's how to interpret the document in the context of your request:

1. Table of Acceptance Criteria and Reported Device Performance:

No specific acceptance criteria for a "device performance" study (e.g., accuracy metrics) are provided.
Instead, the "performance" demonstrated is the ability to manufacture lenses to established finished product specifications within ANSI Z80.20-2016 tolerance and bioburden levels within acceptance criteria. These are manufacturing and safety standards, not clinical performance metrics in the sense of predictive or diagnostic accuracy.

Acceptance Criteria (Manufacturing/Safety)	Reported Device Performance (Ampleye Scleral RGP Lens)
Lenses manufactured within ANSI Z80.20-2016 tolerances for various parameters (Base Curve, Center Thickness, Diameter, Spherical Power, Cylindrical Power, Cylindrical Axis, Multifocal Power).	All lenses were manufactured to established finished product specifications within the ANSI Z80.20-2016 tolerance.
Bioburden: < 100 CFU per lens	Colony Forming Units (CFU) per lens was within the established acceptance criteria of less than 100 CFU per lens.

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

Test Set for Manufacturing Verification: The document states "Bench Testing-manufacturing verification testing was conducted to demonstrate the ability of Art Optical Contact Lens, Inc. to manufacture lenses, on a repeatable basis, from supplied lens blanks to a variety of prescribed parameters." It does not specify the sample size for this bench testing.
Test Set for Bioburden Testing: "Bioburden testing conducted on rigid gas permeable lenses manufactured at Art Optical Contact Lens, Inc." The sample size for bioburden testing is not specified.
Data Provenance: The testing was "conducted at Art Optical Contact Lens, Inc.", implying the data is generated internally by the manufacturer. It is "retrospective" in the sense that it's performed on manufactured lenses to meet a standard, but not a prospective clinical trial.

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

Not applicable. This document describes manufacturing and safety testing, not a study where expert-established ground truth is used for performance evaluation (e.g., for an AI algorithm).

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

Not applicable. This is not a study requiring expert adjudication of results.

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:

No MRMC study was done. This is a contact lens device, not an AI-assisted diagnostic tool.

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

Not applicable. This device does not involve an AI algorithm.

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

For Manufacturing Verification: The "ground truth" or reference standard would be the ANSI Z80.20-2016 tolerance specifications.
For Bioburden Testing: The "ground truth" or reference standard would be the established acceptance criteria of < 100 CFU per lens, likely derived from microbiological standards.

8. The sample size for the training set:

Not applicable. There is no "training set" as this is not an AI/machine learning device.

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

Not applicable. There is no "training set" for ground truth establishment.

Summary of the document's approach to "proving" substantial equivalence:

The document primarily relies on:

Reference to previously cleared 510(k)s (K033594, K162005, and K052983) for the safety and effectiveness of the contact lens materials (roflufocon D, E, hexafocon A, paflufocon D). This means the materials themselves have already undergone review and met safety/effectiveness standards.
Bench testing to confirm manufacturing capabilities to specific ANSI standards.
Bioburden testing to ensure manufacturing hygiene and product safety.
Comparison to predicate devices (BostonSight PD Prosthetic Device, K161461, and Custom Stable RGP Scleral Contact Lens, K170335) across various characteristics like materials, production method, classification, intended use, and physical properties to demonstrate that the new device does "not raise different questions of safety and effectiveness."

This approach is typical for contact lens 510(k) submissions, where the focus is on established material safety and equivalence of design/manufacturing to existing cleared devices, rather than a direct clinical performance study for accuracy or similar metrics.

Summary

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DEPARTMENT OF HEALTH & HUMAN SERVICES

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Public Health Service

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

September 20, 2017

Art Optical Contact Lens, Inc. % Bret Andre Principal Consultant EyeReg Consulting, Inc. 6119 Canter Ln West Linn, OR 97068

Re: K172314

Trade/Device Name: Ampleye Scleral RGP Lens (roflufocon D. roflufocon E. hexafocon A, paflufocon D) Regulation Number: 21 CFR 886.5916 Regulation Name: Rigid Gas Permeable Contact Lens Regulatory Class: Class II Product Code: HQD Dated: July 28, 2017 Received: August 1, 2017

Dear Bret 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. Iisting 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.

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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 (DICE) 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 (DICE) 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,

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

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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.

The assigned 510(k) number is:	K172314
--------------------------------	---------

Applicant information:

Date Prepared:

July 28th, 2017

3175 3 Mile Rd NW Grand Rapids, MI 49534

Mike Johnson, FCLSA

Name: Address

Contact Person:

Phone number:

(616) 559-5167

Director

Consultant/Correspondent:

Bret Andre EyeReg Consulting, Inc.

Art Optical Contact Lens, Inc.

Phone number (503) 372-5226 Fax number (503) 419-4475

Device Information:

Regulatory Class:	Class II
Regulation Number:	21 CFR 886.5916
Product Code:	HQD
Regulation Name:	Rigid Gas Permeable Contact Lens
Common Name:	Lens, Contact (Other Material) - Daily
Trade/Device Name:	Ampleye Scleral RGP Lens (roflufocon Droflufocon E, hexafocon A, paflufocon D)

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Predicate Devices:

The Ampleye Scleral RGP Lens (roflufocon D, roflufocon E, hexafocon A, paflufocon D) is substantially equivalent to the following predicate device(s)

"BostonSight PD Prosthetic Device" ● Manufactured by Boston Foundation for Sight 510(k) number; K161461
"Custom Stable" Rigid Gas Permeable Scleral Contact Lens" ● Manufactured by Valley Contax, Inc. 510(k) number; K170335

Device Description:

	ROFLUFOCON D	ROFLUFOCON E	HEXAFOCON A	PAFLUFOCON D
Refractive Index	1.4333	1.4332	1.415	1.442
Light Transmission (clear)	>97%	>97%	-	>98%
Light Transmission (tinted)	>90%	>90%	>89%	>93%
Water Content	<1%	<1%	<1%	<1%
Dynamic Contact Angle(Receding)	3°	6°	23°	70°
Specific Gravity	1.166	1.155	1.27	1.10
Shore D Hardness	75	77	80	79
Oxygen Permeability(Dk)ISO/FATT Method	$100 x 10^{-11} (cm^2/sec) (ml O_2/ml x mm Hg @ 35°C)$	$125 x 10^{-11} (cm^2/sec) (ml O_2/ml x mm Hg @ 35°C)$	$111 x 10^{-11} (cm^2/sec) (ml O_2/ml x mm Hg @ 35°C)$	$101 x 10^{-11} (cm^2/sec) (ml O_2/ml x mm Hg @ 35°C)$
Contain one or more of thefollowing color additivesconforming to:21 CFR Part 73 & 74, Subpart D	D & C Green No. 6, FD &C Red No. 17,CI Solvent Yellow 18	D & C Green No. 6, FD& C Red No. 17,CI Solvent Yellow 18	D&C Green No. 6;D&C Yellow No.18; D&C Violet No.2;	D&C Green No. 6:D&C Yellow No. 10:D&C, Perox YellowNo. 9
UV Light Blocking(UVB - 280nm – 315nm; UVA316nm - 380nm)	>98% UVB>95% UVA	>98% UVB>95% UVA	>95% UVB>97% UVA	>95% UVB>97% UVA

The physical properties of the Ampleye Scleral RGP Lens (roflufocon D, roflufocon E, hexafocon A, paflufocon D) are as follows:

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Parameter	Range	Tolerance
Base Curve	5.57mm to 9.64mm	± 0.10 mm
Center Thickness	0.20mm to 0.50mm	± 0.02 mm
Diameter	15.00mm to 17.00mm	± 0.10mm
Spherical Power	-30.00 D to +30.00 D(in 0.25D steps)	± 0.12 (0 to = 5D)<br ± 0.18 (5 to = 10.0D)<br ± 0.25 (10 to = 15D)<br ± 0.37 (15 to = 20D)<br ± 0.50 (over 20D)
Cylindrical Power	Up to -5.00 D(in 0.25 D steps)	± 0.25 (0 to = 2D)<br ± 0.37 (2 to = 4D)<br ± 0.50 (over 4D)
Cylindrical Axis	1º to 180º (in 1º steps)	± 5°
Multifocal Power	+1.00 D to 3.50 D(in 0.25 D steps)	± 0.25D

The available parameters for the Ampleye Scleral RGP Lens (roflufocon D, roflufocon E, hexafocon A, paflufocon D) are as follows:

The Ampleye Scleral RGP Lens (roflufocon D, roflufocon E, hexafocon A, paflufocon D) may be shipped "dry" or "wet". The primary container for shipping the Ampleye Scleral RGP Lens is the Sauflon Flat Coloured Lens Case by Sauflon Pharmaceuticals Ltd. When shipped "wet", the Ampleye Scleral RGP Lenses are packaged and shipped in Boston Simplus Multi-Action Solution by Bausch & Lomb, Inc.

Indication for Use:

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Description of Testing:

~ Non-Clinical Studies ~

Non-clinical testing to demonstrate the safety and effectiveness of contact lenses manufactured from roflufocon D, roflufocon E, hexafocon A, and paflufocon D has been addressed by reference to 510(k) K033594, K162005, and K052983.

Additionally, the following testing was performed on finished Ampleye Scleral RGP Lenses (roflufocon D, roflufocon E, hexafocon A, paflufocon D):

Bench Testing-manufacturing verification testing was conducted to demonstrate the ability of Art Optical Contact Lens, Inc. to manufacture lenses, on a repeatable basis, from supplied lens blanks to a variety of prescribed parameters. All lenses were manufactured to established finished product specifications within the ANSI Z80.20-2016 tolerance.

Bioburden Testing-bioburden testing conducted on rigid gas permeable lenses manufactured at Art Optical Contact Lens, Inc. demonstrated that the colony forming units (CFU) per lens was within the established acceptance criteria of less than 100 CFU per lens.

~ Clinical Studies ~
Clinical testing to demonstrate the safety and effectiveness of contact lenses manufactured from roflufocon D, roflufocon E, hexafocon A, paflufocon D has been previously addressed.
~ Conclusions Drawn from Testing ~
Testing presented in this submission for the Ampleye Scleral RGP Lens (roflufocon D, roflufocon E, hexafocon A, paflufocon D) demonstrate no significant differences from the predicate devices-supporting the substantial equivalence claim.

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Substantial Equivalence:

The Ampleye Scleral RGP Lens (roflufocon D, roflufocon E, hexafocon A, paflufocon D) is substantially equivalent to the predicate device(s), and does not raise different questions of safety and effectiveness.

The Ampleye Scleral RGP Lens (roflufocon D, roflufocon E, hexafocon A, paflufocon D) is substantially equivalent to the BostonSight PD Prosthetic Device (predicate device) in the following key areas:

Components/Materials/Formulation (roflufocon and hexafocon contact lens materials) ●
Storage solution for wet shipping ●
FDA classification and group number (Class 2, Group #3 Fluoro Silicone Acrylate) ●
Lathe cut manufacturing process ●
Scleral (large diameter) design
Actions and intended use ●
Therapeutic indications for use ●

The Ampleye Scleral RGP Lens (roflufocon D, roflufocon E, hexafocon A, paflufocon D) is substantially equivalent to the Custom Stable Rigid Gas Permeable Scleral Contact Lens (predicate device) in the following key areas:

Components/Materials/Formulation (roflufocon contact lens materials) ●
FDA classification and group number (Class 2, Group #3 Fluoro Silicone Acrylate) ●
Lathe cut manufacturing process ●
Scleral (large diameter) design
Actions and intended use ●
Therapeutic indications for use ●

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	Ampleye Scleral RGP Lens	Custom Stable™ Rigid GasPermeable Scleral Contact LensK170335	BostonSight PD ProstheticDeviceK161461
	Subject Device	Predicate Device	Predicate Device
Indication for Use	Indicated for use for the management ofirregular astigmatism, cornealdegeneration or dystrophy caused bykeratoconus, keratoglobus, pellucidmarginal degeneration (PMD), postcorneal trauma/scaring, postkeratoplasty, post K-Pro, post RK, postPRK, post LASIK, Salzmann's nodulardegeneration, Cogan's dystrophy,granular corneal dystrophy, latticecorneal dystrophy or Reis-Bucklersdystrophy. Also indicated for therapeuticmanagement of ocular surface diseasefrom dry eye including ocularpemphigoid, Stevens-Johnson syndrome,symblepharon formation, graft vs hostdisease, persistent epithelial defect,exposure keratitis, neurotrophickeratopathy( herpes simplex, herpeszoster, familial dysautonomia), Sjogern'ssyndrome, filamentary keratitis, limbalstem cell deficiency, atopy, ectodermaldysplasia.When prescribed for therapeutic use forirregular astigmatism or ocular surfacediseases, the Ampleye Scleral RGP Lensmay also provide correction of refractiveerror including myopia, hyperopia,presbyopia and regular astigmatism.	Indicated for use for the management ofmultiple ocular conditions, such as,degenerations that lead to an irregularcorneal shape, dystrophies, post-surgery(e.g. corneal transplant, LASIK, radialkeratotomy), and corneal scarring. The lensmay also be prescribed for the managementof ocular surface diseases (e.g. dry eyesyndrome, Keratoconjunctivitis Sicca (Graftvs Host Disease, Sjogren's syndrome,Filamentary Keratitis), limbal stem celldeficiency, epidermal ocular disorders,neurotrophic keratitis, and cornealexposure/lagophthalmos).When prescribed for therapeutic use, theCustom Stable RGP Scleral Lenses is alsoindicated for correction of refractive error inpersons with myopia, hyperopia orpresbyopia.	Indicated for therapeutic use in eyeswith ocular surface disease from dryeye (e.g. ocular Graft-versus-Hostdisease, Sjögren's syndrome, dryeye syndrome), limbal stem celldeficiency (e.g.Stevens-Johnsonsyndrome, chemical and thermalburns, radiation), disorders of theskin (e.g. atopy, ectodermaldysplasia), neurotrophic keratitis(e.g. Herpes simplex, Herpes zoster,Familial Dysautonomia), andcorneal exposure (e.g. anatomic,paralytic) that might benefit fromthe presence of an expanded tearreservoir and protection against anadverse environment. Whenprescribed for therapeutic use fordistorted cornea or ocular surfacedisease, the BostonSight PDProsthetic Device may incidentallyprovide correction of refractiveerror.
Device andClassification	Class IILenses, Rigid Gas Permeable,Daily WearHQD	Class IILenses, Rigid Gas Permeable,Daily WearHQD	Class IILenses, Rigid GasPermeable, Daily WearHQD
Production Method	Lathe-cut	Lathe-cut	Lathe-cut
USAN	Roflufocon DRoflufocon EHexafocon APaflufocon D	Roflufocon DRoflufocon E	Roflufocon DRoflufocon EOprifocon AHexafocon B
FDA Group #	Group # 3 Fluoro SiliconeAcrylate	Group # 3 Fluoro SiliconeAcrylate	Group # 3 Fluoro SiliconeAcrylate
Water Content	<1%	<1%	<1%
UV Absorber/Blockeravailable	YES	YES	YES

The following table depicts the characteristics of the Ampleye Scleral RGP Lens (rofflufocon D, roflufocon E, hexafocon A, paflufocon D), as well as the predicate device(s).

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.