The MiGwang Comfort 38 (polymacon) Spherical 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. The lens may be worn by persons who exhibit refractive astigmatism of .50 diopters or less where the astigmatism does not interfere with visual acuity. The lens is available clear or tinted and may be used to enhance or alter the apparent color of the eye.

The MiGwang Comfort 38 (polymacon) Toric 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 5.00 diopters. The lens is available clear or tinted and may be used to enhance or alter the apparent color of the eye.

Eyecare practitioners may prescribe any of the above lenses for frequent/planned replacement wear, with cleaning disinfection and scheduled replacement. When prescribed for frequent/planned replacement wear, the lens may be disinfected using a chemical disinfecting system.

Device Description

The MiGwang Comfort 38 (polymacon) Soft Contact Lenses are hemispherical shells with molded spherical base curves and lathe-cut front surfaces. The MiGwang Comfort 38 soft contact lens is fabricated from a nonionic polymer,

The nonionic lens material, (polymacon) is a hydrophilic polymer of 2- Hydroxyethyl methacrylate (2-HEMA) and cross-linked with ethylene glycol dimethacrylate (EGDMA), plus an initiator. The copolymer consists of 62% polymacon and 38% water by weight when immersed in normal buffered saline solution. The lenses are available clear or tinted. Lenses are tinted with one or a combination of one or more of the following 'listed' color additives: C.I. Reactive black 5, C.I. Vat orange 5, Iron oxides, C.I. Pigment green 7, C.I. Vat brown 1, C.I. Vat yellow 3, C.I. Vat blue 6, C.I. vat orange 1, C.I. Vat green 1, C.I. Pigment blue 36, C.I. Pigment violet 23, D&C Green No.6, phthalocyanato (2) copper, D&C Yellow No. 10. D&C Red No. 17 and Titanium dioxide. Lenses that contain a unique tinting pattern are subsequently processed to incorporate the 'listed' color additives, and contain only the amount of color additive needed to accomplish the intended coloring effect.

In the hydrated state, the lens conforms to the curvature of the cornea and extending slightly beyond the limbus forming a transparent or colored optical surface. The (polymacon) 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.

The hydrophilic characteristics allow aqueous solutions to enter the lens and in its fully hydrated state the lens is approximately 38% water by weight. The physical properties of the lens are:

Refractive Index: 1.43 (hydrated)
Light Transmission (clear): greater than 90%
Light Transmission (tinted): greater than 90%
Water Content: 38% ± 2%
Oxygen Permeability: 9.77 X 10-11 (cm2/sec) (ml O2/ml x mm Hg @ 35°C), (revised Fatt method).

AI/ML Overview

The provided text describes a 510(k) submission for a soft contact lens and focuses on demonstrating substantial equivalence to already marketed predicate devices. It does not contain information about a study that measures device performance against specific acceptance criteria using a test set, expert ground truth, or statistical analysis.

Therefore, I cannot provide the requested information in the format described, as the document does not include a performance study with detailed acceptance criteria and outcome metrics for the new device.

However, I can extract the information that is present regarding the device's properties and its comparison to predicate devices, which served as the basis for its substantial equivalence claim.

Acceptance Criteria and Device Performance (Based on Substantial Equivalence)

The acceptance criteria are not explicitly stated as performance targets, but rather as substantial equivalence to predicate devices based on material, properties, and intended use. The "reported device performance" is essentially its physical characteristics and safety profile, which are declared equivalent to the predicates.

1. Table of Acceptance Criteria and Reported Device Performance

Criterion / Property	MiGwang Comfort 38 (Proposed Device)	Predicate Device (Advantage 38)	Predicate Device (Contaflex 38)	Acceptance (Substantial Equivalence)
Manufacturer	MiGwang Contact Lens Company	Preferred Optics	Contamac Ltd.	N/A (Manufacturer identity)
Intended Use	Daily Wear, Soft (hydrophilic) Contact Lens	Daily Wear, Soft (hydrophilic) Contact Lens	Daily Wear, Soft (hydrophilic) Contact Lens	Equivalent
Indications for Use	Correction of visual acuity in aphakic/not aphakic persons with non-diseased eyes with myopia or hyperopia, and/or refractive astigmatism not exceeding 5.00 diopters. Spherical lenses: astigmatism <= 0.50 diopters.	Correction of refractive ametropia (myopia, hyperopia, astigmatism <= 2.50 diopters) in aphakic/not aphakic persons with non-diseased eyes.	Correction of refractive ametropia (myopia, hyperopia, presbyopia, astigmatism) in aphakic/not aphakic persons with non-diseased eyes.	Equivalent (similar range of conditions)
Manufacturing Method	Lathe-cut (Semi-Molded)	Lathe-Cut	Lathe-Cut	Equivalent
Material Name (USAN)	polymacon	polymacon	polymacon	Equivalent
Water Content (%)	38% ± 2% (Doc stated 37% in equivalence table, 38% in properties)	38%	37%	Equivalent (within acceptable range for polymacon)
Refractive Index	1.43 (hydrated)	Not specified for predicates	Not specified for predicates	N/A (Comparable to polymacon)
Light Transmission (clear)	> 90%	Not specified for predicates	Not specified for predicates	N/A (Industry standard for clear)
Light Transmission (tinted)	> 90%	Not specified for predicates	Not specified for predicates	N/A (Industry standard for tinted)
Oxygen Permeability	9.77 X 10-11 (cm2/sec) (ml O2/ml x mm Hg @ 35°C) (revised Fatt method)	Not specified for predicates	Not specified for predicates	N/A (Characteristic of polymacon)
Toxicity (safety)	Non-Toxic	Non-Toxic	Non-Toxic	Equivalent

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

Not applicable. The document does not describe a clinical performance study with a test set. The submission relies on demonstrating substantial equivalence to already approved devices rather than presenting new clinical study data for device performance. The "data provenance" mentioned in the document refers to the established safety profile (preclinical toxicology and manufacturing/chemistry data) of the polymacon material, deemed equivalent to that of the predicate devices.

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

Not applicable. No such test set or expert ground truth establishment is described in this document.

4. Adjudication method for the test set

Not applicable. No such test set or adjudication method is described in this 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

Not applicable. This device is a contact lens, not an AI-powered diagnostic tool, so an MRMC study comparing human readers with and without AI assistance is irrelevant and was not performed.

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, so a standalone performance study in this context is irrelevant and was not performed.

7. The type of ground truth used

The "ground truth" in this context is the established safety and effectiveness of the polymacon material, as demonstrated by its long-standing use in the "Advantage 38" and "ContaFlex 38" predicate devices. This implicitly refers to:

Historical clinical data/usage: The predicate devices have been safely and effectively used in the market.
Material properties data: Scientific and manufacturing data supporting the safety and performance characteristics of the polymacon polymer.

8. The sample size for the training set

Not applicable. No training set for an algorithm is discussed. The "training" for this device would be the extensive prior use and testing of the polymacon material in similar contact lenses.

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

Not applicable. Similar to point 8, no training set in the AI sense is relevant. The "ground truth" for the material (polymacon) was established through years of research, manufacturing, and clinical use of contact lenses made from this polymer, leading to its FDA approval in predicate devices. This includes:

Preclinical toxicology studies: To ensure the material is non-toxic to ocular tissues.
Physical and chemical characterization: To determine properties like water content, oxygen permeability, refractive index, and light transmission.
Clinical experience: The history of safe and effective use of contact lenses made from polymacon in the market.

Summary

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

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.

051477

Applicant information:

The assigned 510(k) number is:

Date Prepared:	January 30, 2006
Name:	MiGwang Contact Lens Co. Ltd.
Address	116-2, Hyupsuk-riNamchunmyun, Kyoungsan,Kyoungbuk, Korea
Contact Person:	Mr. Ssang Gi, Kim
Phone number:	82-53-811-2262
USA Consultant:	Med-Vice Consulting. Inc.Martin Dalsing
Phone number	(970) 243-5490
Fax number	(970) 243-5501

Device Information:

Device Classification:	Class II
Classification Number:	LPL
Classification Name:	Lenses, Soft Contact. Daily Wear

Trade Name: MiGwang Comfort 38 (polymacon) Spherical and Toric Soft Contact Lens for Daily Wear (clear & tinted)

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

Purpose of 510(k) Submission:

The MiGwang Contact Lens Company proposes to manufacture, market and sell into United States interstate commerce, a soft contact lens of the (polymacon) soft contact lens material and made available in a spherical and toric product configuration. Data supporting substantial equivalency to predicate devices, and safety and efficacy of the (polymacon) polymer is contained in this submission.

Equivalent Devices:

MiGwang Comfort 38 (polymacon) Spherical and Toric Soft Contact Lens for Daily Wear is substantially equivalent to the following predicate devices:

Predicate devices:

. "Advantage 38" (polymacon) manufactured by Preferred Optics.
· "ContaFlex 38" (polymacon) manufactured by Contamac Ltd.

Device Description:

The nonionic lens material, (polymacon) is a hydrophilic polymer of 2- Hydroxyethyl methacrylate (2-HEMA) and cross-linked with ethylene glycol dimethacrylate (EGDMA), plus an initiator. The copolymer consists of 62% polymacon and 38% water by weight when immersed in normal buffered saline solution. The lenses are available clear or tinted. Lenses are tinted with one or a combination of one or more of the following 'listed' color additives: C.I. Reactive black 5, C.I. Vat orange 5, Iron oxides, C.I. Pigment green 7, C.I. Vat brown 1, C.I. Vat yellow 3, C.I. Vat blue 6, C.I. vat orange 1, C.I. Vat green 1, C.I. Pigment blue 36, C.I. Pigment violet 23, D&C Green No.6, phthalocyanato (2) copper, D&C Yellow No. 10. D&C Red No. 17 and Titanium dioxide. Lenses that contain a unique tinting ppttern are subsequently processed to incorporate the *listed' color additives, and contain only the amount of color additive needed to accomplish the intended coloring effect.

In the hydrated state, the lens conforms to the curvature of the cornea and extending slightly beyond the limbus forming a transparent or colored optical surface. The (polvmacon) 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.

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

The hydrophilic characteristics allow aqueous solutions to enter the lens and in its fully hydrated state the lens is approximately 38% water by weight. The physical properties of the lens are:

Refractive Index	1.43 (hydrated)
Light Transmission (clear)	greater than 90%
Light Transmission (tinted)	greater than 90%
Water Content	38% ± 2%
Oxygen Permeability	9.77 X 10-11 (cm2/sec) (ml O2/ml x mm Hg @ 35°C), (revised Fattmethod).

Intended Use:

Eyecare practitioners may prescribe the above lenses for frequent/planned replacement wear, with cleaning disinfection and scheduled replacement. When prescribed for frequent/planned replacement wear, the lens may be disinfected using a chemical disinfecting system.

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

Substantial Equivalence:

The MiGwang Comfort 38 Soft Contact Lens will be manufactured according to specificd process controls and a cGMP quality assurance program currently in place. The established safety profile (preclinical toxicology and manufacturing/chemistry data) of the MiGwang Comfort 38 contact lens material is equivalent to the predicate devices identified previously. Being similar with respect to indications for use, materials, physical construction and safety & effectivencss to the predicate devices, this meets the requirements per section 510(k) of the act regarding substantial equivalence and does not morne diferent questions of safety and effectiveness than the predicate device identified above.

The following matrix illustrates the equivalencies of the MiGwang Comfort 38 Spherical and toric Soft Contact Lens, as well as the substantial equivalent predicate devices.

Substantial Equivalency	MiGwangComfort 38	Advantage 38	Contaflex 38
Manufacture	MiGwang ContactLens Company	Preferred Optics	Contamac Ltd.
INDICATION	Soft Contact Lenses for dailywear are indicated for thecorrection of visual acuity inaphakic and not aphakicpersons with non-diseased eyeswith myopia or hyperopiaand/or possesses refractiveastigmatism not exceeding5.00 diopters, and/or arepresbyopic NOTE: refractiveastigmatism and presbyopiaN A for spherical lenses.	Soft Contact lenses for dailywear are indicated for thecorrection of refractiveametropia (myopia, hyperopiaand astigmatism) in aphakicand not aphakic persons withnon-diseased eyes that mayexhibit refractive and/orcorneal astigmatism up to 2 50diopters NOTE: refractiveastigmatism N/A for sphericallenses.	Soft Contact lenses for dailywear are indicated for thecorrection of refractiveametropia (myopia andhyperopia), presbyopia andastisgmatism in aphakic andnot aphakic persons with non-diseased eyes NOTE:refractive astigmatism N/A forspherical lenses.
INTENDED USE	Daily Wear. Soft(hydrophilic) ContactLens	Daily Wear, Soft(hydrophilic) ContactLens	Daily Wear. Soft(hydrophilic) ContactLens
Manufacturing Method	Lathe-cut(Semi-Molded)	Lath-Cut	Lath-Cut
USAN name Materialname	polymacon	polymacon	polymacon
Water Content (%)	37%	38%	37%
Toxicity(safety)	Non-Toxic	Non-Toxic	Non-Toxic

Substantial Equivalence Matrix

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

DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/4/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo consists of a circle with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract symbol that resembles an eagle or bird with three stylized lines forming the body and wings. The logo is black and white.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MAR 1 0 2006

MiGwang Contact Lens Co., Ltd. c/o Mr. Martin Dalsing Medvice Consulting Inc. 2214 Sanford Drive, B7 Grand Junction, CO 81505

Re: K051477

Trade/Device Name: MiGwang Comfort 38 (polymacon) Spherical and Toric Soft Contact Lens for Daily Wear (clear and tinted)

Regulation Number: 21 CFR 886.5925 Regulation Name: Soft (hydrophilic) contact lens Regulatory Class: Class II Product Code: LPL Dated: January 30, 2006 Received: February 1, 2006

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.

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

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 (301) 827-8910. 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 (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

MB Eychus - MD

Malvina B. Eydelman, M.D Acting Division Director Division of Ophthalmic and Ear, Nose and Throat Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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

INDICATIONS FOR USE STATEMENT

MiGwang Comfort 38 (polymacon) Spherical and Toric Soft Contact Lens for Device Name: Daily Wear (clear & tinted)

INDICATIONS FOR USE:

The MiGwang Comfort 38 (polymacon) Spherical 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 mypia or hyperopia. The lens may be worn by persons who exhibit refractive astigmatism of .50 dioptirs of least where the astigmatism docs not interfere with visual acuity. The lens is available clear or tissens and may be used to enhance or alter the apparent color of the eye.

The MiGwang Comfort 38 (polymacon) Toric 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 mysia or hyperopia and/or possesses refractive astigmatism not exceeding 5.00 diopters. The lens is available clear or tinted and may be used to enhance or alter the apparent color of the cye.

Eyecare practitioners may prescribe any of the above lenses for frequent/planned replacement wear, with cleaning disinfection and scheduled replacement. When prescribed for frequent/playneed remary wear, the lens may be disinfected using a chemical disinfecting system.

Prescription Use
(Per 21 CFR Subpart D)

AND/OR

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

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

Concurrence of CDRH, Office of Device Evaluation (ODF)

Myra Smith

ion of Ophthalmic Ear, Nose and Throat Devises

510(k) Number K051477

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.