The Marietta Contact Lens (polymacon), Tinted Contact Lens for daily wear is indicated for the correction of visual acuity in aphakic and not aphakic persons with non-diseased eyes with myopia or hyperopia, and to enhance and/or alter the apparent eye color. The lens may be worn by persons who exhibit refractive astigmatism of 0.75 diopters or less where the astigmatism does not interfere with visua acuity.

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

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

Device Description

The Marietta Contact Lens (polymacon), Tinted Daily Wear Contact Lens is available as a single vision spherical lens. The hydrophilic nature of this material allows the lens to become soft and pliable when immersed in an aqueous solution.

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.

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.

As part of the manufacturing process, the lenses containing the color additives are thoroughly washed to remove unbound color additives. The manufacturing process alters and/or changes the specifications to the clear version of a contact lens by affixing a listed color reactive additive on that portion of the anterior (front) surface of the lens that corresponds to the iris. The color additive effect is formed by reacting one or more of the color additives listed in this paragraph with (poly hydroxyethyl methacrylate). The reactive color additives that may be used either alone or in combination are: reactive black 5, reactive blue 19, reactive blue 4, reactive blue 163, reactive red 11, reactive red 180, reactive yellow 15, reactive yellow 86, or reactive orange 78. The color additives used are not removed by lens handling and cleaning/disinfecting procedures. Except for affecting the amount of light transmittance through the lens, the coloring process does not alter the original characteristics of the pre-tinted lens.

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

This document is a 510(k) summary for a contact lens (Marietta Contact Lens (polymacon), Tinted Daily Wear Contact Lens). The 510(k) pathway is for demonstrating substantial equivalence to a legally marketed predicate device, rather than proving a new device meets acceptance criteria through a clinical study with specific performance metrics like those for AI/ML devices. Therefore, the provided text does not contain explicit acceptance criteria and a study demonstrating performance against those criteria in the way you might expect for an AI/ML device.

However, I can extract the relevant information from the document to infer the acceptance criteria and how the device demonstrated "performance" for its regulatory pathway.

Here's an attempt to answer your request based on the provided document, adapting the terminology to fit the context of a 510(k) for a contact lens:

Description of Acceptance Criteria and Study for the Marietta Contact Lens (polymacon), Tinted Daily Wear Contact Lens

This submission is a 510(k) for a modified contact lens, demonstrating substantial equivalence to pre-existing predicate devices. As such, the "acceptance criteria" are primarily established by the characteristics and safety profile of the predicate devices, and the "study" is a comparison and verification that the modified device maintains these characteristics.

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria are essentially the characteristics of the predicate devices. The "reported device performance" is a demonstration that the modified device meets or is comparable to these characteristics.

Acceptance Criteria (from Predicate)	Reported Device Performance (Modified Device)
Intended Use: Daily wear for visual acuity correction in aphakic/non-aphakic persons with non-diseased eyes, myopia/hyperopia.	Met – same intended use.
Functionality: Acts as a refractive medium to focus light on retina.	Met – same functionality.
Indications: Daily wear, Soft (hydrophilic) contact lens.	Met – same indications.
Production Method: Lathe-Cut.	Met – same production method.
FDA Group #: Group # 1 < 50% Water, non-ionic Polymer.	Met – same FDA Group #.
USAN Name: polymacon.	Met – same USAN name.
Water Uptake (%): 38.0%.	Met – 38.0%.
Sterility of Device: SAL = $10^{-6}$.	Met – SAL = $10^{-6}$ (Note: one predicate was "Non-sterile product," but the modified device matches the other predicate for sterility).
Material Composition: Polymacon, 2-HEMA, EGDMA, initiator, 38% water content.	Met – same core composition (polymacon, 2-HEMA, EGDMA, initiator, 38% water).
Physical Properties (Refractive Index): Not explicitly stated for predicate but 1.43 (hydrated) for modified device.	1.43 (hydrated) (demonstrates consistent physical properties).
Specific Safety/Biocompatibility: No adverse effects from coloring agents.	Lenses thoroughly washed to remove unbound color additives; coloring process does not alter original characteristics beyond light transmittance. Verified by use of listed color additives.
Cleaning/Disinfection Compatibility: Chemical (not heat) lens care system.	Compatible with chemical (not heat) lens care system.
Light Transmission (tinted): Expected for colored lens.	Greater than 90% (new specification for tinted version).
Oxygen Permeability: Expected for polymacon lens.	8.4 X 10-11 (cm2/sec) (ml O2/ml x mm Hg @ 35°C), (revised Fat method).

2. Sample Size Used for the Test Set and the Data Provenance

Since this is a 510(k) for a contact lens, the "test set" does not refer to a dataset for an algorithm. Instead, it refers to the physical lenses and potentially human subjects used in biocompatibility, physical property, and clinical performance testing (though detailed clinical study results are not provided in this summary). The document does not specify a sample size for any in vivo testing. The data provenance would be from Marietta Vision's internal testing and comparison to their own predicate devices. It is implicit that any human subject testing would be prospective, though details are not provided.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts

This concept is not applicable here. "Ground truth" in the context of AI/ML evaluation (e.g., expert consensus on medical images) is not relevant for this medical device submission. The "truth" for physical and chemical properties of a contact lens is established through validated laboratory testing methods. Clinical performance and safety are typically assessed by optometrists/ophthalmologists, but no specific "ground truth" expert panel is mentioned as would be for an AI diagnostic device.

4. Adjudication Method for the Test Set

This concept is not applicable. There's no interpretive test set requiring adjudication in the way an AI diagnostic device would.

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-powered diagnostic tool. There are no "human readers" or "AI assistance" involved in its direct function.

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

This is not applicable as the device is a physical contact lens, not an algorithm.

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

The "ground truth" for this device's characteristics is based on established physical, chemical, and biological testing methods for contact lenses, and comparison to the known properties and safety profiles of previously cleared predicate devices (their own Addvantage 38 (Polymacon), K942302 and Marietta Contact Lens, color enhanced, K002647). For safety and clinical performance, the ground truth would be based on clinical observations and established ophthalmic standards.

8. The Sample Size for the Training Set

This is not applicable as the device is a contact lens, not an AI model requiring a training set.

9. How the Ground Truth for the Training Set was Established

This is not applicable as the device is a contact lens, not an AI model.

Summary of the "Study" from the Document:

The "study" or justification for equivalence in this 510(k) is primarily a technological characteristics comparison (as presented in the table on page 3) between the modified device and its predicate devices. This comparison demonstrates that:

The Intended Use, Functionality, Indications, Production Method, FDA Group #, USAN Name, and Water Uptake (%) are identical to the predicate devices.
The Sterility Assurance Level (SAL) is $10^{-6}$, which aligns with one predicate and indicates a sterile product, satisfying safety requirements.
The material composition (polymacon, 2-HEMA, EGDMA, initiator, 38% water) is the same.
The modification strictly involves the incorporation of specific, listed reactive color additives to the anterior surface, which are stated to be thoroughly washed and not to alter the original characteristics of the lens except for light transmittance.
New physical properties for the tinted version (Light Transmission >90%, Oxygen Permeability 8.4 X 10-11) are provided, implicitly demonstrating that these are within acceptable ranges for a safe and effective contact lens of this type.

The core argument for acceptance is substantial equivalence to existing, legally marketed predicate devices, meaning the modified device is as safe and effective as the predicates and does not raise new questions of safety or effectiveness.

Summary

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SPECIAL 510(k) SUMMARY

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:
--------------------------------	--

K052606

Applicant information:

Date Prepared:

September 19, 2005

Marietta Vision 397 N. Sessions Street Marietta, GA 30060

Name:
Address:

Contact Person: Phone number:

John Patterson 770 792 0208

FDA US Agent/ Medvice Consulting, Inc. Official Correspondent: 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:	Marietta Contact Lens (polymacon), Tinted Daily WearContact Lens

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Unmodified Predicate Devices:

The Marietta Contact Lens (polymacon), Tinted Daily Wear Contact Lens is substantially equivalent to Marietta Vision's own unmodified predicate devices:

1. Addvantage 38 (Polymacon), K942302, Marietta Vision,
1. Marietta Contact Lens, color enhanced, K002647, Marietta Vision.

Description of Modified Device:

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 (tinted)	greater than 90%
Water Content	38% ± 2%
Oxygen Permeability	8.4 X 10-11 (cm2/sec) (ml O2/ml x mm Hg @ 35°C), (revised Fatmethod).

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Intended Use:

The Marietta Contact Lens (polymacon), Tinted Daily Wear Contact Lens 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 to enhance and/or alter the apparent eye color. The lens may be worn by persons who exhibit refractive astigmatism of 0.75 diopters or less where the astigmatism does not interfere with visual acuity.

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

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.

Technological Characteristics Comparison:

The technological characteristics of the Marietta Contact Lens (polymacon), Tinted Daily Wear Contact Lens as compared to the technological characteristics of the unmodified predicate devices are illustrated in the following table.

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Technological Characteristic / Device	Marietta Contact Lens(polymacon), TintedDaily Wear ContactLensModified Device	Addvantage 38(polymacon),Unmodified DeviceK942302	Marietta Contact LensColor Enhanced,Unmodified DeviceK002647
Intended Use	Indicated for daily wearfor the correction ofvisual acuity in aphakicand not aphakic personswith non-diseased eyeswith myopia orhyperopia.	Indicated for daily wearfor the correction ofvisual acuity in aphakicand not aphakic personswith non-diseased eyeswith myopia orhyperopia.	Indicated for daily wearfor the correction ofvisual acuity in aphakicand not aphakic personswith non-diseased eyeswith myopia orhyperopia.
Functionality	The contact lenses act asa refractive medium thatfocus light rays fromnear and distant objectson the retina.	The contact lenses act asa refractive medium thatfocus light rays fromnear and distant objectson the retina.	The contact lenses act asa refractive medium thatfocus light rays fromnear and distant objectson the retina.
Indications	Daily wear, Soft(hydrophilic) contactlens	Daily wear, Soft(hydrophilic) contactlens	Daily wear, Soft(hydrophilic) contactlens
ProductionMethod	Lathe-Cut	Lathe-cut	Lathe-cut
FDA Group #	Group # 1 < 50% Water.non-ionic Polymer	Group # 1 < 50% Waternon-ionic Polymer	Group # 1 < 50% Waternon-ionic Polymer
USAN name	polymacon	polymacon	polymacon *
WaterUptake(%)	38.0%	38.0%	38.0% *
Sterility ofDevice	SAL = $10^{-6}$	SAL = $10^{-6}$	Non-sterile product

Unmodified device is approved for all soft hydrophilic lenses (not applicable for silicone hydrogels)

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Image /page/4/Picture/1 description: The image is a seal for the Department of Health & Human Services USA. The seal is circular and contains the text "DEPARTMENT OF HEALTH & HUMAN SERVICES · USA" around the perimeter. In the center of the seal is a stylized image of an eagle.

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

DEC 15 2005

Marietta Vision C/O Mr. Martin Dalsing Medvice Consulting, Inc. 2214 Sanford Dr. Suite #B7 Grand Junction, CO 81505

Re: K052606

Trade/Device Name: Marietta (polymacon) Tinted Daily Wear Contact Lens Regulation Number: 21 CFR 886.5925 Regulation Name: Soft (hydrophilic) contact lens Regulatory Class: Class II Product Code: LPL Dated: November 11, 2005 Received: November 17, 2005

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. Drue, 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.

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Page 2 - Mr. Martin Dalsing

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,

David M. Whipple

Acting 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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Marietta Vision Special 510(k): Device Modification, Premarket Notification

INDICATIONS FOR USE STATEMENT

Device Name:

Marietta Contact Lens (polymacon), Tinted Contact Lens.

INDICATIONS FOR USE:

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

(PLEASE DO OT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDEL

Concurrence of CDRH, Office of Device Evaluation (ODE)

Kaur Wanta
(Division Sign-Off)
Division of Ophthalmic Ear,
Nose and Throat Devises

Prescription Use
(Per 21 CFR 801.109)
510(k) Number K052606
Over-The-Counter Use

(Optional Format 1-2-96)

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.