The Intelliwave4, sphere (safrofilcon A) Silicone Hydrogel Soft Contact Lenses for daily wear are indicated for the correction of visual acuity in aphakic persons with non-diseased eyes with myopia or hyperopia. The lens may be worn by persons who exhibit refractive astigmatism of .75 diopters or less where the astigmatism does not interfere with visual acuity.

The Intelliwave4, toric (safrofilcon A) Silicone Hydrogel Soft Contact Lenses for daily wear are indicated for the correction of visual acuity in aphakic and not aphakic persons with myopia or hyperopia and/or possesses refractive astigmatism not exceeding 12 diopters.

The Intelliwave4, multifocal (safrofilcon A) Silicone Hydrogel Soft Contact Lenses for daily wear are indicated for the correction of visual acuity in aphakic and not aphakic persons with myopia or hyperopia and/or possesses refractive astigmatism not exceeding 12 diopters and are presbyopic requiring add power of up to +4.00 diopters.

The IntelliWave4, multifocal toric (safrofilcon A) Silicone Hydrogel Soft Contact Lenses for daily wear are indicated for the correction of ametropia (myopia and hyperopia) in aphakic persons with non-diseased eyes and/or possesses refractive astigmatism not exceeding 4 diopters and are presbyopic requiring add power of up to +4.00 diopters.

The IntelliWave4, irregular cornea (safrofilcon A) Silicone Hydrogel Soft Contact Lenses for daily wear are indicated for the correction of ametropia (myopia and hyperopia) in aphakic and non-aphakic persons and may be prescribed in otherwise non-diseased eyes that require a Soft Contact Lens for the management of irregular corneal conditions such as keratoconus and post graft fitting.

IntelliWave4 UV lenses help protect against transmission of harmful UV radiation to the eye.

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 or hydrogen peroxide disinfection systems.

Device Description

The Intelliwave4 Silicone Hydrogel Soft Contact Lenses are fabricated from safrofilcon A, which in the dry (unhydrated) state may be machined and polished. The hydrophilic nature of this material allows the lens to become soft and pliable when immersed in an aqueous solution.

The non-ionic lens material (safrofilcon A) is a daily wear silicone hydrogel contact lens that is not surface treated and characterized by a high water content. The lens material is composed of silicone monomers cross linked with other monomers and optionally incorporates Reactive Blue 246 (21 CFR 73.3106) as an integrated handling tint. The lenses are made by lathe-cut for custom RX. It consists of 35% safrofilcon A and 65% water by weight when immersed in a buffered saline solution. The (safrofilcon A) name has been adopted by the United States Adopted Names Council (USAN).

In the hydrated state, the lens conforms to the curvature of the eye covering the cornea and extending slightly beyond the limbus forming a colorless, transparent optical surface. The (safrofilcon A) soft hydrophilic contact lens has a spherical back surface. The hydrophilic properties of the lens require that it be maintained in a fully hydrated state in a solution compatible with the eye. If the lens dries out, it will become hard and appear somewhat warped however, it will return to its proper configuration when completely rehydrated in the proper storage solution.

In the Intelliwave4 Contact Lens with UV Blocker and center thickness of 0.18mm, a Benzophenone UV absorbing monomer is used to block UV radiation. The UV Blocker is 2-(4-Benzoyl-3-hydroxyphenoxy)ethyl acrylate. The UV blocking for Intelliwave4 lenses averages > 99% in the UVB range of 280nm - 315nm and >77% in the UVA range of 316 - 380mm.

The hydrophilic characteristics allow aqueous solutions to enter the lens and in its fully hydrated state the lens is approximately 65% water by weight. The lenses will be manufactured in spherical, aspherical, toric, and multifocal configurations with the following features and properties.

AI/ML Overview

The provided text describes the Intelliwave4 contact lens and its substantial equivalence to a predicate device, IntelliWave3. It is a 510(k) summary, which focuses on demonstrating that a new device is as safe and effective as a legally marketed predicate device. This type of regulatory submission does not typically involve detailed acceptance criteria tables or studies designed to "prove" a device meets acceptance criteria in the way a novel device might. Instead, it relies on demonstrating equivalence through comparison of design, materials, and clinical performance.

However, based on the information provided, I can extract the closest parallels to your requested categories:

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

The document doesn't explicitly state "acceptance criteria" in a quantitative, pass/fail manner for specific performance metrics in a table. Instead, it compares the new device (Intelliwave4) to a predicate device (IntelliWave3) to demonstrate substantial equivalence. The "performance" is described in terms of safety and efficacy being "similar overall performance" to the predicate.

Here's a table reflecting the comparative properties and a summary of performance as reported:

Acceptance Criteria (Implied by Substantial Equivalence Goal)	Reported Device Performance (Intelliwave4)
Similar Safety & Effectiveness	"Clinical evaluation demonstrated similar overall performance to the concurrent predicate control in the clinically relevant areas of vision, health, and comfort and fit when worn for daily wear." "The risks of the subject device are the same as those normally attributed to the wearing of Silicone Hydrogel, Daily Wear Soft Contact Lens. The benefits to the patient are the same as those for other Silicone Hydrogel contact lenses."
Physical and Material Properties Consistency	"Lens physical and material properties are consistent with currently marketed lenses." (Specific properties are listed, but no explicit "acceptance criteria" for these, rather they are presented as characteristics.) Refractive Index (wet): 1.3841 Visible Light Transmission: >98% Surface Character: hydrophilic Water Content: 65 % Specific Gravity: 1.102 (hydrated) Oxygen Permeability: 46.46 x 10-11 (cm²/sec) (ml O2/ml x hPa @ 35°C). (revised Fatt method). UV Blocker: > 99% in UVB (280nm - 315nm), >77% in UVA (316 - 380mm)
Sterility & Shelf-Life	"Lenses supplied in glass vials are sterile for the indicated shelf-life"
Packaging Material & Extracts Safety	"The packaging material and extracts are not toxic and not irritating"

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

Test set sample size: 60 patients
Data provenance: Not explicitly stated regarding country of origin, but the study was a "bilateral, open-label, parallel group, and randomized daily wear study" which indicates a prospective design. Given the FDA submission, it implicitly refers to data relevant for US regulatory purposes, likely with US or internationally recognized standards.

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)

This information is not provided in the document. The clinical study details are very brief. It mentions "Clinical evaluation demonstrated similar overall performance," but it does not specify the number or qualifications of clinicians involved in assessing "vision, health, and comfort and fit."

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

This information is not provided in the document.

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

This is not applicable. The device is a contact lens, not an AI-assisted diagnostic tool. The clinical study compares the new contact lens to a predicate contact lens.

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

This is not applicable. The device is a contact lens.

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

The "ground truth" for the clinical study was the clinical evaluation of 60 patients over three months, assessing "vision, health, and comfort and fit." This falls under outcomes data or clinical assessments by potentially multiple clinicians, although the specific number and qualifications are not detailed.

8. The sample size for the training set

This is not applicable in the context of this device. A training set is typically for machine learning algorithms. The Intelliwave4 contact lens is a physical medical device. The "training" for its development would involve material science, engineering, and manufacturing, not a data-based training set.

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

This is not applicable for the reasons stated in point 8.

Summary

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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features the department's name in a circular arrangement around a symbol. The symbol consists of a stylized caduceus, which is a staff with two snakes entwined around it, often associated with medicine and healthcare. The logo is simple and recognizable, representing the department's role in promoting health and well-being.

Public Health Service

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

January 12, 2015

Art Optical Contact Lens, Inc. % Mr. Bret Andre Official Correspondent EveReg Consulting, Inc. 474 NE 61st Place Hillsboro, Oregon 97124

Re: K142641

Trade/Device Name: Intelliwave4 Regulation Number: 21 CFR 886.5925 Regulation Name: Soft (Hydrophilic) Contact Lens Regulatory Class: Class II Product Code: LPL Dated: December 4, 2014 Received: December 8, 2014

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.

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 device

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related 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,

Kesia Y. Alexander -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

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Indications for Use

510(k) Number (if known) K142641

Device Name

Intelliwave4, Silicone Hydrogel Daily Wear Soft Contact Lens (safrofilcon A)

Indications for Use (Describe)

IntelliWave4 UV lenses help protect against transmission of harmful UV radiation to the eye.

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)

CONTINUE ON A SEPARATE PAGE IF NEEDED.

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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:	K142641
--------------------------------	---------

Applicant information:

Date Prepared:	October 20th, 2014
Name:	Art Optical Contact Lens, Inc.
Address	3175 3 Mile Road NWWalker, Michigan 49534
Contact Person:	Mike Johnson, FCLSADirector of Consultative Services
Phone number:	(616) 559-5167
Consultant:	Bret AndreEyeReg Consulting, Inc.474 NE 61st PLHillsboro, OR 97124
Phone number	(503) 372-5226

Device Information:

Device Classification:	Class II
Product Code:	LPL

Soft (hydrophilic) Contact Lens (21 CFR 886.5925)

Intelliwave4, Silicone Hydrogel Daily Wear Soft

Contact Lens (safrofilcon A)

Classification Name:

Trade Name:

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Equivalent Devices:

The Intelliwave4, Silicone Hydrogel Daily Wear Soft Contact Lenses (safrofilcon A) are substantially equivalent to the following predicate devices:

Predicate devices:

"IntelliWave3 (efrofilcon A)" by Art Optical Contact Lens, Inc. 510(k) number; K100221

Device Description:

UV Absorber:

The Physical properties of the lens are:

Refractive Index (wet)	1.3841
Visible Light Transmission	>98%
Surface Character	hydrophilic
Water Content	65 %
Specific Gravity	1.102 (hydrated)
Oxygen Permeability	46.46 x 10-11 (cm²/sec) (ml O2/ml x hPa @ 35°C). (revised Fatt method).

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• Chord Diameter	12.0 mm to 16.00
------------------	------------------

Center Thickness
Base Curve ●
Power Range ●
Cylinder Power (Toric) ●
Add Power (Multifocal) ●

mm 0.01 mm to 0.50 mm 8.0 mm to 9.5 mm -20.00D to +20.00D in 0.25 steps -0.25D to -10.00D

+0.50D to +3.00D
The lens is supplied sterile in vials containing a buffered saline solution. Vial labeling is printed with appropriate lot numbering, expiration dating and lens parameter identification. Expiration dating has been established based on studies of product stability, package integrity, and validation of the sterilization process.

Intended Use:

The Intelliwave4, sphere (safrofilcon A) Silicone Hydrogel Soft Contact Lenses for daily wear are indicated for the correction of visual acuity in aphakic persons with nondiseased eyes with myopia or hyperopia. The lens may be worn by persons who exhibit refractive astigmatism of .75 diopters or less where the astigmatism does not interfere with visual acuity.

The Intelliwave4, toric (safrofilcon A) Silicone Hydrogel Soft Contact Lenses for daily wear are indicated for the correction of visual acuity in aphakic and not aphakic persons with non-diseased eyes with myopia or hyperopia and/or possesses refractive astigmatism not exceeding 12 diopters.

The Intelliwave4, multifocal (safrofilcon A) Silicone Hydrogel Soft Contact Lenses for daily wear are indicated for the correction of visual acuity in aphakic and not aphakic persons with non-diseased eyes with myopia or hyperopia and/or possesses refractive astigmatism not exceeding 12 diopters and are presbyopic requiring add power of up to +4.00 diopters.

The IntelliWave4, multifocal toric (safrofilcon A) Silicone Hydrogel Soft Contact Lenses for daily wear are indicated for the correction of ametropia (myopia and hyperopia) in aphakic and non-aphakic persons with non-diseased eyes and/or possesses refractive astigmatism not exceeding 4 diopters and are presbyopic requiring add power of up to +4.00 diopters.

IntelliWave4 UV lenses help protect against transmission of harmful UV radiation to the cornea and into the eye.

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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 or hydrogen peroxide disinfection systems.

Testing:

Non-clinical Testing A series of in vitro and in vivo preclinical toxicology and biocompatibility tests were performed to assess the safety and effectiveness of the IntelliWave4 (safrofilcon A) Silicone Hydrogel Soft Contact Lenses packaged in glass vials. All non-clinical toxicology tests were conducted in accordance with the GLP regulation. All other testing was conducted according to valid scientific protocols.
Test results of the non-clinical testing on the IntelliWave4 (safrofilcon A) Silicone Hydrogel Soft Contact Lenses demonstrate that:
Lenses supplied in glass vials are sterile for the indicated shelf-life, ●
. The packaging material and extracts are not toxic and not irritating, and
. Lens physical and material properties are consistent with currently marketed lenses.
A bilateral, open-label, parallel group, and randomized daily wear study Clinical Testing was performed to evaluate the safety and efficacy of the IntelliWave4 (safrofilcon A) Silicone Hydrogel Soft Contact Lens. The study evaluated 60 patients over a three (3) months period. Clinical evaluation demonstrated similar overall performance to the concurrent predicate control in the clinically relevant areas of vision, health, and comfort and fit when worn for daily wear.

Conclusions Drawn from Studies

Validity of Scientific Data

Several laboratories under Good Laboratory Practice regulations conducted toxicology studies, Microbiology, chemistry, shelf-life stability studies and followed scientific protocols. The data were determined to be scientifically valid under 21 CFR 860.7

Substantial Equivalence

Information presented in this Premarket Notification establishes that the IntelliWave4, (safrofilcon A) Silicone Hydrogel Daily Wear Soft Contact Lens is as safe and effective as the predicate device when used in accordance with the labeled directions for use and for the requested indication.

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Risks and Benefits

The risks of the subject device are the same as those normally attributed to the wearing of Silicone Hydrogel, Daily Wear Soft Contact Lens. The benefits to the patient are the same as those for other Silicone Hydrogel contact lenses.

Substantial Equivalence:

The following matrix illustrates the production method, lens function and material characteristics of the Intelliwave4, (safrofilcon A) Silicone Hydrogel Daily Wear Soft Contact Lens, as well as the predicate devices.

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Substantial Equivalence Matrix

	Art Optical IntelliWave4,Silicone Hydrogel(safrofilcon A)New Device	Art Optical IntelliWave³,Silicone Hydrogel(efrofilcon A)Predicate Device510(k) K100221
Intended Use	Indicated for daily wear for the correction ofvisual acuity in aphakic and not apjakic personswith non-diseased eyes with myopia orhyperopia. The lens may also be prescribed formanagement of irregular corneal conditionssuch as keratoconus and post graft fitting.	Indicated for daily wear for the correction ofvisual acuity in aphakic and not apjakic personswith non-diseased eyes with myopia orhyperopia. The lens may also be prescribed formanagement of irregular corneal conditionssuch as keratoconus and post graft fitting.
Functionality	Same as predicate device	The contact lenses act as a refractivemedium that focus light rays fromnear and distant objects on the retina
Indications	Daily wear. Silicone Hydrogel Soft(hydrophilic) contact lens	Daily wear. Silicone Hydrogel Soft(hydrophilic) contact lens
Production Method	Lathe-Cut, custom manufactured	Lathe-Cut, custom manufactured
USAN name	safrofilcon A	efrofilcon A
Water Content (%)	65%	74%
Oxygen Permeability	46.46 x 10-11 (cm2/sec) (ml O2/ml x hPa@ 35oC), (revised Fatt method)	60 x 10-11 (cm2/sec) (ml O2/ml x hPa @350C), (revised Fatt method)
Specific Gravity	1.102	1.139

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.