The IntelliWave1, Sphere (Acofilcon B) Soft Contact Lenses for daily wear are indicated for the correction of ametropia (myopia and hyperopia) in aphakic and non-aphakic persons with nondiseased eyes. 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 IntelliWave1, Toric (Acofilcon B) Soft Contact Lenses for daily wear are indicated for the correction of ametropia (myopia and hyperopia) in aphakic and non-aphakic persons with nondiseased eyes and/or possesses refractive astigmatism not exceeding 5.00 diopters.

The IntelliWave1, Multifocal (Acofilcon B) Soft Contact Lenses for daily wear are indicated for the correction of ametropia (myopia and hyperopia) in aphakic and non-aphakic persons with nondiseased eyes and/or possesses refractive astigmatism of .75 diopters or less where the astigmatism does not interfere with visual acuity and are presbyopic requiring add power of up to +4.00 diopters.

The IntelliWave1, Multifocal Toric (Acofilcon B) Soft Contact Lenses for daily wear are indicated for the correction of ametropia (myopia and hyperopia) in aphakic and non-aphakic persons with nondiseased eyes and/or possesses refractive astigmatism not exceeding 5.00 diopters and are presbyopic requiring add power of up to +4.00 diopters.

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.

The IntelliWave2, Sphere (Hioxifilcon B) Soft Contact Lenses for daily, wear are indicated for the correction of ametropia (myopia and hyperopia) in aphakic and non-aphakic persons with nondiseased eyes. 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 IntelliWave2, Toric (Hioxifilcon B) Soft Contact Lenses for daily wear are indicated for the correction of ametropia (myopia and hyperopia) in aphakic and non-aphakic persons with nondiseased eyes and/or possesses refractive astigmatism not exceeding 5.00 diopters.

The IntelliWave2, Multifocal (Hioxifilcon B) Soft Contact Lenses for daily wear are indicated for the correction of ametropia (myopia and hyperopia) in aphakic and non-aphakic persons with nondiseased eyes and/or possesses refractive astigmatism of .75 diopters or less where the astigmatism does not interfere with visual acuity and are presbyopic requiring add power of up to +4.00 diopters.

The IntelliWave2, Multifocal Toric (Ilioxifilcon B) Soft Contact Lenses for daily wear are indicated for the correction of ametropia (myopia and hyperopia) in aphakic and non-aphakic persons with nondiseased eyes and/or possesses refractive astigmatism not exceeding 5.00 diopters and are presbyopic requiring add power of up to +4.00 diopters.

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 lons may be cleaned and disinfected using a chemical (not heat) lens care system.

Device Description

The IntelliWave1, Soft Daily Wear Contact Lenses are fabricated from (Acofilcon B), which in the dry (unhydrated) state may be machined and polished. The hydrophilic nature of this matcrial allows the lens to become soft and pliable when immersed in an aqueous solution. The non-ionic lens material, (acofilcon B) is a terpolymer based on high purity Giycerol Methacrylate 2,3-Dihydroxypropyl Methacrylate (GMA), with N-vinyl-2-pyrrolidone (NVP), methy] methacrylate (MMA), and 2-hydroxyethyl methacrylate (2-HEMA) and cross-linked with Diallyl Maleate (DAM). It consists of 51% acofilcon B and 49% water by weight when immersed in normal saline solution buffered with sodium tetraborate. The lens material is available in clear and with a blue visibility-handling tint, Color additive 'Reactive Blue 4' 21 CFR part 73.2121.

The IntelliWave2, Soft Daily Wear Contact Lenses are fabricated from (Hioxifilcon B), 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, hioxifilcon B is a copolymer of 2-hydroxyethyl methacrylate (2-HEMA) and 2,3-Dihydroxypropyl Methacrylate (Glycerol Methacrylate, GMA) and cross-linked with ethylene glycol dimethacrylate (EGDMA). It consists of 51% hioxifilcon B and 49% water by weight when immersed in normal saline solution buffered with sodium tetraborate. The lens material is available clear and with a blue visibility handling tint, phthalocyanato (2) - (copper).

AI/ML Overview

The provided text is a 510(k) Summary for contact lenses and does not describe a study that uses acceptance criteria and reports device performance in the way typically seen for AI/ML devices or diagnostic tools. Instead, this document focuses on demonstrating substantial equivalence to existing predicate devices.

Therefore, many of the requested points related to a study, ground truth, expert review, and AI performance metrics are not applicable here.

Here's an analysis based on the provided document:

Acceptance Criteria and Reported Device Performance

The concept of "acceptance criteria" and "reported device performance" in this 510(k) summary is centered on demonstrating that the new devices (IntelliWave1 and IntelliWave2 contact lenses) are substantially equivalent to their predicate devices. The acceptance criteria for substantial equivalence are met when the new devices have the "same as predicate device" characteristics across several key attributes.

Table of Acceptance Criteria and Reported Device Performance:

Characteristic	Acceptance Criteria (Implied: "Same as Predicate")	IntelliWave1 Reported Performance	IntelliWave2 Reported Performance	Predicate (Contaflex GM3 49%)	Predicate (BENZ-G3X)
Intended Use	Same as predicate device	Same	Same	Specified for daily wear, correction of visual acuity in aphakic and non-aphakic persons	Specified for daily wear, correction of visual acuity in aphakic and non-aphakic persons
Functionality	Same as predicate device	Same	Same	Acts as a refractive medium	Acts as a refractive medium
Indications	Same as predicate device	Daily wear, Soft (hydrophilic)	Daily wear, Soft (hydrophilic)	Daily wear, Soft (hydrophilic)	Daily wear, Soft (hydrophilic)
Production Method	Same as predicate device	Lathe-cut	Lathe-cut	Lathe-cut	Lathe-cut
FDA Group #	Same as predicate device	Group # 1 < 50% Water, Nonionic Polymers	Group # 1 < 50% Water, Nonionic Polymers	Group # 1 < 50% Water, Nonionic Polymers	Group # 1 < 50% Water, Nonionic Polymers
USAN Name	Acofilcon B (for IntelliWave1) / Hioxifilcon B (for IntelliWave2)	Acofilcon B	Hioxifilcon B	Acofilcon B	Hioxifilcon B
Water Content	48.0% (for predicate)	49%	49%	48.0%	48.0%
Oxygen Permeability	15.89 X 10-11 (for Contaflex) / 16.40 X 10-11 (for BENZ-G3X)	15.89 X 10-11	16.40 X 10-11	15.89 X 10-11	16.40 X 10-11
Specific Gravity	1.142 (for Contaflex) / 1.137 (for BENZ-G3X)	1.142	1.137	1.142	1.137

Note on Water Content: The document states the IntelliWave lenses have 49% water content, while the predicate devices are listed with 48.0%. However, the "same as predicate device" is checked for the water content category, and slight numerical differences within an acceptable range for that category (Group #1 < 50% Water) are typically deemed acceptable for substantial equivalence. The key is that they fall within the same classification group.

Study Details (or lack thereof for AI/ML)

Sample size used for the test set and the data provenance: This document does not describe a "test set" in the context of an AI/ML study. The basis for safety and effectiveness is presented as being substantially equivalent to legally marketed predicate devices, relying on their established safety profile (pre-clinical toxicology, clinical study data from the predicate devices, manufacturing/chemistry data). No specific sample size for a new clinical study for the IntelliWave lenses is detailed here as the primary means of demonstrating performance. The provenance of the predicate device data is not specified in this summary. It would be historical data for those predicate devices.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. This is not an AI/ML diagnostic device requiring expert-established ground truth. The "ground truth" for contact lenses is established through their physical and chemical properties, and their performance in clinical trials (which would have been conducted for the predicate devices).
Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable.
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 diagnostic device.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is not an algorithm.
The type of ground truth used (expert consensus, pathology, outcomes data, etc): The "ground truth" for contact lenses lies in their material properties (water content, oxygen permeability, specific gravity, refractive index, etc.), biocompatibility, and clinical performance (visual acuity correction, comfort, absence of adverse events). This is derived from standard materials science, manufacturing quality control, and historical clinical data for the specific type of device and materials.
The sample size for the training set: Not applicable. This is not an AI/ML device.
How the ground truth for the training set was established: Not applicable.

Summary

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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:	K073621
Applicant information:
Date Prepared:	December 21, 2007
Name:Address	Art Optical Contact Lens, Inc.3175 3 Mile Road NWWalker, Michigan 49534
Contact Person:Phone number:	Mike Johnson, FCLSADirector of Consultation Services(616) 559-5167
Consultant:Phone number	Med-Vice Consulting, Inc.Martin Dalsing(970) 243-5490
Device Information:
Device Classification:	Class II
Classification Number:	LPL
Classification Name:	Lenses, Soft Contact, Daily Wear
Trade Name:	IntelliWave1, Soft Daily Wear Contact Lens (Acofilcon B)IntelliWave2, Soft Daily Wear Contact Lens (Hioxifilcon B)

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Equivalent Devices:

The IntelliWave1, Soft Daily Wear Contact Lenses (Acofficon B) and IntelliWave2, Soft Daily Wear Contact Lenses (Hioxifilcon B) are substantially equivalent to the following predicate devices in terms of contact tens. material, intended use and design.

Predicate devices include:

Contaflex GM3 49% manufactured by Contamac Ltd: K024045

BENZ-G 3X manufactured by Benz Research and Development, K964528

IntelliWave1 Device Description:

The non-ionic lens material, (acofilcon B) is a terpolymer based on high purity Giycerol Methacrylate 2,3-Dihydroxypropyl Methacrylate (GMA), with N-vinyl-2-pyrrolidone (NVP), methy] methacrylate (MMA), and 2-hydroxyethyl methacrylate (2-HEMA) and cross-linked with Diallyl Maleate (DAM). It consists of 51% acofilcon B and 49% water by weight when immersed in normal saline solution buffered with sodium tetraborate. The lens material is available in clear and with a blue visibility-handling tint, Color additive 'Reactive Blue 4' 21 CFR part 73.2121.

The Physical properties of the lens are:

Refractive Index	1.52 (dry) 1.42 (hydrated)
Light Transmission	greater than 94%
Surface Character	hydrophilic
Water Content	49 %
Specific Gravity	1.142 (hydrated)
Oxygen Permeability	15.89 X 10-11 (cm2/sec) (ml O 2/ml x hPa @ 35°C), (revised Fatt method)

IntelliWave1 Indications for Use

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The IntelliWave1, Toric (Acofilcon B) Soft Contact Lenses for daily wear are indicated for the correction of ametropia (myopia and hyperopia) in aphakic and non-aphakic persons with nondiseased cyes and/or possesses refractive astigmatism not exceeding 5.00 diopters.

The IntelliWave1, Multifocal (Acofilcon B) Soft Contact Lenses for daily wear are indicated for the correction of ametropia (myopia and hyperopia) in aphakic and non-aphakic persons with nondiseased eyes and/or possesses refractive astigmatism of .75 diopters or less where the astigmatism docs not interfyre with visual acuity and are presbyopic requiring add power of up to +4.00 diopters.

IntelliWave2 Device Description:

The non-ionic lens material, hioxifilcon B is a copolymer of 2-hydroxyethyl methacrylate (2-HEMA) and 2,3-Dihydroxypropyl Methacrylate (Glycerol Methacrylate, GMA) and cross-linked with ethylene glycol dimethacrylate (EGDMA). It consists of 51% hioxifilcon B and 49% water by weight when immersed in normal saline solution buffered with sodium tetraborate. The lens material is available clear and with a blue visibility handling tint, phthalocyanato (2) - (copper).

The Physical properties of the lens are:

Refractive Index	1.51 (dry) 1.42 (hydrated)
Light Transmission	greater than 94%
Surface Character	hydrophilic
Water Content	49 %
Specific Gravity	1.137 (hydrated)
Oxygen Permeability	$16.40 X 10^{-11}$ (cm2/sec) (ml O2/ml x hPa @ 35oC), (revised Fatt method)

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

IntelliWave2 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 lons may be cleaned and disinfected using a chemical (not heat) lens care system.

Substantial Equivalence:

The device will be manufactured according to specified process controls and a quality assurance program. The established safety profile (pre-clinical toxicology, clinical study data, manufacturing/chemistry data) of the device is equivalent to the Contaflex GM3 49% and the BENZ-G 3X. Being similar with respect to indications for use, materials, physical construction and safety & effectiveness to the predicate devices, this meets the requirements per section 510(k) of the act regarding substantial equivalence and does not raise different questions of safety and effectiveness than the predicate devices identified above.

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The following matrix illustrates the production method, lens function and material characteristics of the IntelliWavel, Soft Daily Wear Contact Lens (Acofilcon B) and IntelliWave2, Soft Daily Wear Contact Lens (Hioxifilcon B), as well as the predicate devices.

	IntelliWavenew device	CONTAFLEX GM3 49%(acofilcon B)predicate device	BENZ-G3X(hioxifilcon B)predicate device
Intended Use	same aspredicate device	Indicated for daily wear for thecorrection of visual acuity inaphakic and not aphakicpersons with non-diseased eyeswith myopia or hyperopia.	Indicated for daily wear for thecorrection of visual acuity inaphakic and not aphakicpersons with non-diseased eyeswith myopia or hyperopia.
Functionality	same aspredicate device	After machining from theoptical blank, the contact lensesact as a refractive medium thatfocus light rays from near anddistant objects on the retina.	After machining from theoptical blank, the contact lensesact as a refractive medium thatfocus light rays from near anddistant objects on the retina.
Indications	same aspredicate device	Daily wear, Soft (hydrophilic)contact lens	Daily wear, Soft (hydrophilic)contact lens
ProductionMethod	same aspredicate device	Lathe-cut	Lathe-cut
FDA Group #	same aspredicate device	Group # 1 < 50% Water,Nonionic Polymers	Group # 1 < 50% Water,Nonionic Polymers
USAN name	same aspredicate device	Acofilcon B	Hioxifilcon B
Water Content	same aspredicate device	48.0%	48.0%
OxygenPermeability	same aspredicate device	15.89 X 10-11 (cm2/sec)(ml O2/ml x mm Hg @ 35degrees C),(revised Fatt method).	16.40 X 10-11 (cm2/sec)(ml O2/ml x mm Hg @ 35degrees C),(revised Fatt method).
SpecificGravity	same aspredicate device	1.142	1.137

Substantial Equivalence Matrix

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/5/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized caduceus, which is a symbol often associated with healthcare, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - U.S.S" arranged in a circular fashion around the symbol. The caduceus is depicted with a series of curved lines that form a stylized representation of a staff with entwined snakes.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JUL - 8 2008

Art Optical Contact Lens, Inc. c/o Mr. Martin Dalsing Medvice Consulting, Inc 806 Kimball Ave. Grand Junction, CO 81501

Re: K073621

Trade/Device Name: IntelliWave1 Soft Daily Wear Contact Lens (acofilcon B), clear and blue visibility tint IntelliWave2 Soft Daily Wear Contact Lens (hioxifilcon B), clear and blue visibility tint Regulation Number: 21 CFR 886.5925 Regulation Name: Soft (hydrophilic) Contact Lens Regulatory Class: Class II Product Code: LPL Dated: June 25, 2008 Received: June 26, 2008

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.

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

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 Center for Devices and Radiological Health's (CDRH's) Office of Compliance at (240) 276-0115. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at 240-276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at 240-276-3464. 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. Eglinton, mD

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

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

INDICATIONS FOR USE STATEMENT

IntelliWave1, Soft Daily Wear Contact Lens (Acofilcon B) clear and blue visibility tint. Device Name:

INDICATIONS FOR USE:

The IntelliWave1, Sphere (Acofilcon B) Soft Contact Lenses for daily wear are indicated for the correction of The Intellited was a le recomber D) our Still State and non-aphakic persons with nondiseased eyes. The lens may be allietiopia (nryopia) in apatismatism of .75 diopters or less where the astigmatism does not interfere with visual acuity.

The Intelli Wavel, Toric (Acofilcon B) Soft Contact Lenses for daily wear are indicated for the correction of I I le intentively Torto (Acomeon II) beir only aphakic persons with nondiseased eyes and/or possesses refractive astigmatism not exceeding 5.00 diopters.

The IntelliWave1, Multifocal (Acofilcon B) Soft Contact Lenses for daily wear are indicated for the correction I fie intent waver, mannoom (namakic and non-aphakic persons with nondiseased eyes and/or of anteropia (info@pla and ir/perspire) in 'ippers or less where the astigmatism does not interfere with visual acuity and are presbyopic requiring add power of up to +4.00 diopters.

The IntelliWave1, Multifocal Toric (Acofilcon B) Soft Contact Lenses for daily wear are indicated for the I III Intelli Waret, Minitious Tone (1100mooa) in aphakic and non-aphakic persons with nondiseased eyes contection of allietionalism not exceeding 5.00 diopters and are presbyopic requiring add power of up to +4.00 diopters.

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

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use (Per 21 CFR 801.109)

Myn Smith Over-The-Counter Use

Division Sign-Off)
Division of Ophthalmic Ear,
(Optional Format 1-2-90)
Nose and Throat Devises

{8}------------------------------------------------

INDICATIONS FOR USE STATEMENT

Device Name: IntelliWave2, Soft Daily Wear Contact Lens (Hioxifilcon B) clear and blue visibility tint.

INDICATIONS FOR USE:

The IntelliWave2, Sphere (Hioxifilcon B) Soft Contact Lenses for daily wear are indicated for the correction of I ho finen may opia and hyperopia) in aphakic and non-aphakic persons with nondiseased eyes. The lens may be wom by persons who exhibit refractive astigmatism of .75 diopters or less where the astigmatism does not interfere with visual acuity.

The Intelli Wave2, Toric (Hioxifilcon B) Soft Contact Lenses for daily wear are indicated for the correction of The Intentives) Porto (Intentia) in aphakic and non-aphakic persons with nondiseased eyes and/or possesses refractive astigmatism not exceeding 5.00 diopters.

The IntelliWave2, Multifocal Toric (Hioxifilcon B) Soft Contact Lenses for daily wear are indicated for the I III hitem of ametropia (myopia and hyperopia) in aphakic and non-aphakic persons with nondiseased eyes concesses refractive astigmatism not exceeding 5.00 diopters and are presbyopic requiring add power of up to +4.00 diopters.

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use (Per 21 CFR 801.109)

Myra Luther

Over-The-Counter Use

(Division Sign-Off)
Division (Optional Format 1-2-96)
Ophthalmic Ear,
Nose and Throat Devises

510(k) Number

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.