The See Clear Spherical Soft Contact Lenses (polymacon) for Daily Wear are indicated for the correction of visual acuity in aphakic and not aphakic person 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.

Eye care 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.

Device Description

The See Clear Spherical Soft Contact Lens (polymacon) for Daily Wear (clear. visibility-tinted, and decorative) are hemispherical shells with molded spherical base curves and lathe-cut front surfaces and are designed to fit over the corneal surface of the eye. These lenses are designed with varying base curves that conform to the shape of the radius of the cornea and center over the apex of the cornea to provide correction of refractive ametropia (myopia, hyperopia, and astigmatism) in aphakic and not-aphakic persons with non-diseased eves.

The non-ionic lens material, polymacon, is a hydrophilic copolymer of 2hydroxyethyl methacrylate (2-HEMA) cross-linked with ethylene glycol dimethacrylate (EGDMA), plus an initiator. It consists of consists of 62% polymacon and 38% water by weight when immersed in normal buffered saline solution. The lenses are available clear, or with a visibility-handling tint, or with a decorative tint intended to enhance or alter the apparent color of the eye for dayto-day cosmetic or occasional theatrical purposes. These decorative designs may be distributed under a unique or "private label" trade name such as See Clear, See Clear Color, and Fierce Contact Lenses. Lenses are tinted only with FDAapproved ("listed") listed color additives for which FDA has previously reviewed the toxicology / biocompatibility profiles. Tinted lenses contain only the amount of color additive needed to accomplish the intended decorative effect.

In the dry (unhydrated) state the lens is machined and polished. In the hydrated state, the lens conforms to the curvature of the eye covering the cornea and extending slightly beyond the limbus forming a transparent or colored optical surface. When placed on the cornea, the See Clear Spherical Soft Contact Lens (polymacon) for Daily Wear acts as a refracting medium to focus light rays on the retina.

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.

AI/ML Overview

The provided text describes a 510(k) submission for the "See Clear Spherical Soft Contact Lens (polymacon) for Daily Wear." This submission aims to demonstrate substantial equivalence to a predicate device, the "MiGwang Comfort 38 (polymacon) Spherical Soft Contact Lens for Daily Wear."

Based on the provided information, there is NO study described that details acceptance criteria and device performance in the way typically expected for a medical device that improves human performance (e.g., AI assistance, diagnostic tools).

Instead, this document focuses on demonstrating substantial equivalence to a predicate device for a contact lens. The "acceptance criteria" are implied by the comparison to the existing, legally marketed predicate device, rather than specific performance metrics against a defined standard. The "study" here refers to the collection of non-clinical performance data to show that the new device has similar characteristics to the predicate.

Here's an analysis based on the request, interpreting "acceptance criteria" and "study" within the context of a 510(k) for a contact lens:

1. Table of acceptance criteria and the reported device performance

For a 510(k) submission aiming for substantial equivalence, the "acceptance criteria" are generally that the new device's technical characteristics and intended use are sufficiently similar to the predicate device and do not raise new questions of safety or effectiveness. The "performance" is therefore a comparison against the predicate.

Comparison Element	Acceptance Criteria (Predicate Device Performance)	Reported Device Performance (Subject Lens)
Intended Use	Daily wear correction of visual acuity in aphakic or not aphakic person 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.	Daily wear correction of refractive ametropia (myopia, hyperopia, and astigmatism) in aphakic and not-aphakic persons with non-diseased eyes. The lenses are available clear, or with a visibility-handling tint, or with a decorative tint intended to enhance or alter the apparent color of the eye for day-to-day cosmetic or occasional decorative purposes.
Material/USAN	polymacon	polymacon
Production Method	Molded Base Curve Surfaces with Lathe-Cut Front Curve Surfaces	Molded Base Curve Surfaces with Lathe-Cut Front Curve Surfaces
Water Content	38% +/- 2%	38% +/- 2%
Index of Refraction	1.43	1.43 (hydrated)
Light Transmittance (clear)	>90%	>90% T
Light Transmittance (tinted)	Not explicitly stated for predicate in comparison table, but general "tinted" category exists.	>80% T
Oxygen Permeability	9.77 X 10^-11 (cm^2/sec) (ml O2/ml x mm Hg @ 35°C), (revised Fatt method)	11.92 X 10^-11 (cm^2/sec) (ml O2/ml x mm Hg @ 35°C), (revised Fatt method)
Specific Gravity	1.165	1.184 (hydrated)
Tensile Strength @ Break (MPa)	0.559	0.55
Modulus of Elasticity (MPa)	0.728	0.78
Elongation @ Break (%)	127.36	99.9
Breaking Force (Nmm)	0.66	0.66

Note regarding "Acceptance Criteria": For a 510(k), acceptance criteria are not typically expressed as strict pass/fail thresholds for quantitative performance values in the same way a direct efficacy or diagnostic performance study might. Instead, the submission argues that the new device's parameters are similar enough to the predicate device, or differences do not raise new questions of safety or effectiveness. For example, the oxygen permeability of the subject lens is higher than the predicate, which would generally be seen as a positive or at least not a negative safety concern. The elongation at break is lower, but the tensile strength and breaking force are similar. The submission asserts overall "substantial equivalence."

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

The document lists "Non-Clinical Performance Data" which includes:

Chemical composition of finished lenses
Purity of initial monomers
Shelf Life
Leachability of Residual Monomers
Leachability of Color Additives
Biocompatibility testing
Sterilization Validation
Color and light transmittance
Refractive index
Water content
Oxygen permeability
Specific gravity
Mechanical Testing

Sample Size: The document does not specify the sample sizes used for any of these non-clinical tests.
Data Provenance: The document does not specify the country of origin of the data or whether it was retrospective or prospective. It only states that testing "has been performed."

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 type of information is not relevant or included in the provided 510(k) summary for a contact lens. The "ground truth" for non-clinical performance data is derived from standard laboratory testing methods (e.g., revised Fatt method for oxygen permeability). There is no "test set" and "ground truth" established by human experts in the context of diagnostic interpretation as implied by the question.

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

Not applicable. There is no human adjudication process described for the non-clinical performance data of a contact lens.

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 a diagnostic or AI-assisted device for human readers. No MRMC study was 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.

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

For the non-clinical performance data, the "ground truth" is established by direct physical, chemical, and biological measurements and tests performed according to recognized standards and methods (e.g., revised Fatt method for oxygen permeability, standard mechanical testing). It is not expert consensus, pathology, or outcomes data in the context of diagnostic accuracy.

8. The sample size for the training set

Not applicable. This device is a physical product (contact lens), not an AI algorithm requiring a training set.

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

Not applicable. No training set is involved.

Summary

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Image /page/0/Picture/0 description: The image shows the words "THE SEE CLEAR company" in a stylized format. The words "THE", "S", "e", and "e" are in white letters on a black background. The words "C", "L", "E", "A", and "R" are in black letters on a white background.

See Clear Spherical Soft Contact Lens (polymacon) for Daily Wear (clear, visibility-tinted, and decorative)

I. Submitter Information

510(k) Owner:	The See Clear Company, Inc.4995 Buford HWY Ste 102Norcross, GA 30071, USA
Contact Person:	Ms. DaYoung Kim719-761-7603 (office)866-504-8066 (fax)
Consultant &SubmissionCorrespondent:	Kevin Randall, Principal ConsultanComplianceAcuity, Inc.16576 W. 53rd WayGolden, CO 80403(303) 828-0844 (direct)(303) 828-0835 (fax)Email: info@complianceacuity.com
Date SummaryPrepared:	October 25, 2011

II. Name of Device

Trade Name: See Clear Spherical Soft Contact Lens (polymacon) for Daily * Wear (clear, visibility-tinted, decorative). Clear and decorative designs may be distributed under unique or "private label" trade names such as See Clear, See Clear Color, and Fierce Contact Lenses.
- Common Name: Daily Wear Soft Contact Lens
- Classification Name: Lenses, Soft Contact, Daily Wear
મ USAN (generic name): Polymacon

III. Predicate Devices

In conformance with Section 510(k) of the Food, Drug and Cosmetic Act, The See Clear Company hereby submits this notification of our intent to manufacture and place into interstate commerce the See Clear Spherical Soft Contact Lens (polymacon) for Daily Wear. The predicate device to which substantial equivalence is being claimed is identified in the matrix below:

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Image /page/1/Figure/1 description: The image shows the words "THE See CLEAR company". The words "THE", "S", "e", and "e" are in white letters on a black background. The words "C", "L", "E", "A", and "R" are in black letters on a white background.

See Clear Spherical Soft Contact Lens (polymacon) for Daily Wear (clear, visibility-tinted, and decorative)

Subject Device	Predicate Device(s)
See Clear Spherical Soft Contact Lens(polymacon) for Daily Wear (clear,visibility-tinted, and decorative)	MiGwang Comfort 38 (polymacon)Spherical Soft Contact Lens for DailyWear (clear, tinted, and cosmetic)(K051477)

A comparison of similarities and differences between the See Clear Spherical Soft Contact Lens (polymacon) for Daily Wear, and the legally marketed predicate lens has been tabulated in the Substantial Equivalence Comparison Matrix exhibited below:

Comparison Element	Subject Lens:	Predicate:
Identification	See Clear Spherical SoftContact Lens (polymacon)for Daily Wear(clear, visibility-tinted,decorative)	MiGwang Comfort 38(polymacon) Spherical SoftContact Lens for DailyWear (clear, tinted, andcosmetic)
Manufacturer	The See Clear Company	MiGwang Contact Lens Co.Ltd.
510(k) Number	K111345	K051477
Intended Use	Daily wear correction ofrefractive ametropia (myopia,hyperopia, and astigmatism) inaphakic and not-aphakicpersons with non-diseasedeyes. The lenses are availableclear, or with a visibility-handling tint, or with adecorative tint intended toenhance or alter the apparentcolor of the eye for day-to-daycosmetic or occasionaldecorative purposes.	Daily wear correction ofvisual acuity in aphakic or notaphakic person with non-diseased eyes with myopia orhyperopia. The lens may beworn by persons who exhibitrefractive astigmatism of .50diopters or less where theastigmatism does not interferewith visual acuity. The lens isavailable clear or tinted andmay be used to enhance oralter the apparent color of theeye.
Production Method	Molded Base CurveSurfaces with Lathe-CutFront Curve Surfaces	Molded Base CurveSurfaces with Lathe-CutFront Curve Surfaces
Hydrophilic Material / USAN	polymacon	polymacon
Water Content	$38 % +/- 2%$	$38 % +/- 2%$
Index of Refraction	$1.43$	$1.43$

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K111345

Image /page/2/Picture/1 description: The image shows the words "THE SEE CLEAR company" in a stylized format. The words "THE" and "SEE" are in white letters on a black background, while the word "CLEAR" is in black letters on a white background. The word "company" is in black letters on a white background and is smaller than the other words.

See Clear Spherical Soft Contact Lens (polymacon) for Daily Wear (clear, visibility-tinted, and decorative)

Comparison Element	Subject Lens:	Predicate:
Light Transmittance	>90%	>90%
Oxygen Permeability	$11.92 X 10^{-11} (cm^2/sec) (ml O_2/ml x mm Hg @ 35°C),$(revised Fatt method)	$9.77 X 10^{-11} (cm^2/sec) (ml O_2/ml x mm Hg @ 35°C),$(revised Fatt method)
Specific Gravity	1.184	1.165
Tensile Strength @ Break(MPa)	0.55	0.559
Modulus of Elasticity(MPa)	0.78	0.728
Elongation @ Break (%)	99.9	127.36
Breaking Force (Nmm)	0.66	0.66

The See Clear Spherical Soft Contact Lens (polymacon) for Daily Wear is substantially equivalent to the predicate device in terms of the following key areas:

Same Indications for Use .
Same Contraindications .
Same Design concepts .
Same "Listed" Color Additives .
. Same Production Method used in the fabrication of the lens
Same Lens Function t
Same Warnings .
Same Precautions .
Same polymer (polymacon) .
Similar Parameters being offered .

It is the conviction of The See Clear Company that the information and data submitted in this 510(k) substantiate our ability to manufacture a contact lens with a safety and effectiveness profile that is substantially equivalent to the predicate device, and does not raise different questions of safety and effectiveness. When placed on the human eye the See Clear Spherical Soft Contact Lens (polymacon) for Daily Wear performs the same function as the legally marketed predicate device identified herein.

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Image /page/3/Picture/0 description: The image shows a logo for "The See Clear company". The words "The", "See", and "Clear" are arranged in a grid-like fashion, with each letter occupying a square. The word "company" is written in a smaller font size to the right of the grid.

See Clear Spherical Soft Contact Lens (polymacon) for Daily Wear (clear, visibility-tinted, and decorative)

IV. Device Description & Technological Characteristics

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 these polymacon lenses are:

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Image /page/4/Picture/0 description: The image shows a logo for "The See Clear company". The words "The", "See", and "Clear" are arranged in a 3x3 grid, with each word occupying a cell. The word "company" is written to the right of the grid.

111345

510(k) SUMMARY OF SAFETY AND EFFECTIVENESS K11345

See Clear Spherical Soft Contact Lens (polymacon) for Daily Wear (clear, visibility-tinted, and decorative)

Refractive Index	1.43 (hydrated)
Light Transmission (clear)	greater than 90% T
Light Transmission (tinted)	greater than 80% T
Water Content	38% +/- 2%
Specific Gravity	1.184 (hydrated)
Oxygen Permeability	11.92 X 10-11 (cm2/sec) (ml O2/ml x mm Hg @ 35 °C), (revised Fatt method).

V. Intended Use

VI. Non-Clinical Performance Data

To support the substantial equivalence claim made herein, a combination of nonclinical analysis and testing has been performed as detailed in this Premarket Notification. This includes:

• Chemical composition of finished lenses	• Color and light transmittance
• Purity of initial monomers	• Refractive index
• Shelf Life	• Water content
• Leachability of Residual Monomers	• Oxygen permeability
• Leachability of Color Additives	• Specific gravity
• Biocompatibility testing	• Mechanical Testing
• Sterilization Validation

END OF 510(k) SUMMARY

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Image /page/5/Picture/1 description: The image shows the seal of the Department of Health & Human Services (HHS). The seal features a stylized eagle with three lines forming its body and wings. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the eagle.

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

NOV - 2 2011

The See Clear Company c/o Mr. Kevin Randall Official Correspondent Compliance Acuity 16576 W. 531d Way Golden, CO 80403

Re: K111345

Trade/Device Name: See Clear Spherical Soft Contact Lens (polymacon) for Daily Wear (clear, visibility-tinted, and decorative) Regulation Number: 21 CFR 886.5925 Regulation Name: Soft (hydrophilic) Contact Lens Regulatory Class: Class II Product Code: LPL Dated: September 30, 2011 Received: October 4, 2011

Dear Mr. Randall:

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.

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Page 2 - Mr. Kevin Randall

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-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 go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21CFR 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 Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.

Sincerely yours.

Sincerely yours,

Kesia Alexander

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

Enclosure

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K111345

Indications for Use

510(k) Number (if known): K111345

Device Name:

See Clear Spherical Soft Contact Lens (polymacon) for Daily Wear (clear, visibility-tinted, and decorative)

Indications For Use:

The See Clear Spherical Soft Contact Lenses (polymacon) for Daily Wear are indicated for the correction of visual acuity in aphakic and not aphakic person with nondiseased 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.

Prescription Use × (Part 21 CFR 801 Subpart D) AND/OR

Over-The-Counter Use (Part 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 (ODE)

Marc Rollog

Division of Ophthalmic, Neurological and Ear, Nose and Throat Devices

510(k) Number K111345

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.