I-55 Single Vision (methafilcon A) Soft (Hydrophilic) Contact Lens for Daily Wear is indicated for daily wear for the correction of refractive ametropia (myopia and hyperopia) in aphakic or not aphakic persons with non-diseased eyes that may exhibit refractive and/or corneal astigmatism up to 2.00 Diopters that does not interfere with visual acuity.

I-55 Toric (methafilcon A) Soft (Hydrophilic) Contact Lens for Daily Wear is indicated for daily wear for the correction of refractive ametropia (myopia, hyperopia and astigmatism) in aphakic and not aphakic persons with non-diseased eyes that may exhibit refractive and/or comeal astigmatism up to 5.00 Diopters.

Multifocal (methafilcon A) Soft (Hydrophilic) Contact Lens for Daily I-55 Wear is indicated for daily wear for the correction of refractive ametropia (myopia and hyperopia) and presbyopia in aphakic or not aphakic persons with non-diseased eves that may exhibit refractive and/or corneal astigmatism up to 2.00 Diopters that does not interfere with visual acuity.

The lenses may be disinfected using chemical (not heat) or hydrogen peroxide, disinfecting systems. Eyecare practitioners may prescribe the lenses for daily wear and/or frequent replacement.

Device Description

I-55 Single Vision, I-55 Toric and I-55 Multifocal (methafilcon A) Soft (Hydrophilic) Daily Wear Contact Lenses are hemispherical flexible shells that cover the cornea and a portion of the adjacent sclera. The I-55 Single Vision Contact Lens is available in a single vision lens design, the I-55 Toric Contact Lens is available in a back surface design, and the I-55 Multifocal Contact Lens is available in a concentric lens design. The lens material (methafilcon A) is a hydrophilic co-polymer of 2-hydroxyethyl methacrylate (HEMA) and methacrylic acid, cross-linked with ethyleneglycol dimethacrylate (EGDMA), using AIBN as the initiator. The lens contain 55% water by weight. I-55, I-55 Toric and I-55 Multifocal initiation The Tenb Contain of hilic) Contact Lenses for Daily Wear are visibility tinted using Pigment Blue 15, ([Phthalocyaninato(2-)] copper) which is approved for coloring contact lenses under 21 CFR § 74.3045.

AI/ML Overview

The provided text describes soft contact lenses and a comparison to a predicate device. It does not contain information about acceptance criteria or a study that proves the device meets specific performance criteria through a data-driven approach, which would be typical for an AI/ML medical device.

Here's an analysis based on the provided text, specifically noting what is missing regarding your request:

1. Table of Acceptance Criteria and Reported Device Performance:

The document provides a comparison table between the new device (I-55 Single Vision, I-55 Toric, and I-55 Multifocal) and a predicate device (Definition AC). This comparison acts as the primary "performance" metric, aiming to show substantial equivalence rather than meeting specific statistical acceptance criteria for a new, AI-driven functionality.

Characteristic	Acceptance Criteria (Predicate Device Value)	Reported Device Performance (I-55 Lenses)
Material	methafilcon A	methafilcon A
Material Classification	Hydrophilic Lens Group 1	Hydrophilic Lens Group 1
Indication for Use	myopia, hyperopia, astigmatism, presbyopia	myopia, hyperopia, astigmatism, presbyopia
Water Content	55%	55%
Visible Light Transmittance	98%	99%
Dk (35° C)	$18.86 \times 10^{-11}$	$19.01 \times 10^{-11}$
Powers	+20.00 to -20.00 Diopters	+20.00 to -20.00 Diopters
Color	blue visibility	blue visibility
Refractive Index	1.416	1.415
Specific Gravity	1.030	1.039
Method of Manufacture	Molded	Molded

Missing from the document relevant to "acceptance criteria" for an AI/ML device:

Specific quantitative performance metrics like sensitivity, specificity, accuracy, AUC, etc., and their corresponding pre-defined acceptance thresholds.
A statistical study demonstrating that the device meets these thresholds. The document instead relies on demonstrating "substantial equivalence" to a predicate device for its physical and chemical properties and indications for use.

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

Sample Size for Test Set: Not applicable/Not mentioned. The document describes pre-clinical tests (Systemic Injection, Primary Ocular Irritation, Cytotoxicity, and Physico-chemical testing) and shelf-life testing. These are not what would typically be considered "test sets" for evaluating AI/ML performance on clinical data.
Data Provenance: Not applicable/Not mentioned for any clinical data evaluation. The pre-clinical tests were likely conducted in a lab setting.

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

Not applicable. The "ground truth" in this context relates to the established safety of the lens material and its physicochemical properties, which are determined by standard laboratory tests and material science, not by expert review of clinical cases.

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

Not applicable. As no clinical test set requiring expert adjudication is described, no adjudication method is relevant.

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:

No MRMC study was done. This device is a contact lens, not an AI/ML diagnostic or assistive tool for human readers.

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

Not applicable. This is not an algorithm.

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

The "ground truth" for the safety and equivalence claim is based on:
- Results of standard pre-clinical tests (Systemic Injection, Primary Ocular Irritation, Cytotoxicity).
- Conformance to standards for residue levels.
- Physicochemical testing results.
- Shelf-life stability data.
  These are objective measurements and established scientific protocols rather than expert consensus on clinical cases or pathology.

8. The sample size for the training set:

Not applicable. There is no AI/ML algorithm being trained, so no training set exists.

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

Not applicable.

In summary:

This 510(k) summary is for a physical medical device (contact lenses) and demonstrates substantial equivalence to a predicate device based on material properties, manufacturing method, and safety testing (toxicology, irritation). It does not involve any AI/ML components or clinical performance studies with acceptance criteria, ground truth establishment by experts, or reader studies as would be expected for an AI/ML device.

Summary

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K080794

510(k) Summary

Submitter Information:

PolyVue Distribution, Inc. 759 Appian Way Pinole, California 94564

Contact Person:	Garold L. Edwards
Telephone:Fax:	(408) 221-3860(831) 335-0166
Date Prepared:	March 3, 2008
Device Name:
Common Name:	Soft (Hydrophilic) Contact Lens
Trade/Proprietary Names:	I-55 Single Vision (methafilcon A) Soft(Hydrophilic) Contact Lens for Daily WearI-55 Toric (methafilcon A) Soft (Hydrophilic)Contact Lens for Daily WearI-55 Multifocal (methafilcon A) Soft (Hydrophilic)Contact Lens for Daily Wear

Soft (Hydrophilic) Contact Lens Classification Name:

Class II (21 CFR 886.5925) Device Classification:

Predicate Devices:

The molded Definition AC (methafilcon A) Soft (Hydrophilic) Contact Lens was selected as the predicate device.

Description of Devices:

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initiator. The lens contain 55% water by weight. I-55, I-55 Toric and I-55 Multifocal initiation The Tenb Contain of hilic) Contact Lenses for Daily Wear are visibility tinted using Pigment Blue 15, ([Phthalocyaninato(2-)] copper) which is approved for coloring contact lenses under 21 CFR § 74.3045.

Comparison to Predicate Devices

Lens type	I-55 Single Vision,I-55 Toric and I-55Multifocal(methafilcon A) Soft(Hydrophilic) ContactLenses for Daily Wear	Definition AC(methafilcon A) Soft(Hydrophilic) ContactLenses for Daily Wear
Predicatedevice 510(k)		K051095
Material	methafilcon A	methafilcon A
Materialclassification	Hydrophilic Lens Group 1	Hydrophilic Lens Group 1
Indication foruse	myopia, hyperopia,astigmatism andpresbyopia	myopia, hyperopia,astigmatism andpresbyopia
Water content	55%	55%
Visible lighttransmittance	99%	98%
Dk (35° C)	$19.01 \times 10^{-11}$	$18.86 \times 10^{-11}$
Powers	+20.00 to -20.00Diopters	+20.00 to -20.00Diopters
Color	blue visibility	blue visibility
RefractiveIndex	1.415	1.416
Specific gravity	1.039	1.030
Method ofmanufacture	Molded	Molded

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Image /page/2/Picture/0 description: The image shows a handwritten string of alphanumeric characters. The string appears to be "K080794". The characters are written in black ink on a white background. The handwriting is somewhat stylized, with some characters slightly overlapping or connected.

Indications for Use:

The I-55 Single Vision (methafilcon A) Soft (Hydrophilic) Contact Lens is indicated for daily wear for the correction of refractive ametropia (myopia and hyperopia) in aphakic or not-aphakic persons with non-diseased eyes that may exhibit refractive and/or corneal astigmatism up to 2.00 diopters that does not interfere with visual acuity.

The I-55 Toric (methafilcon A) Soft (Hydrophilic) Contact Lens is indicated for daily wear for the correction of refractive ametropia (myopia, hyperopia and astigmatism) in aphakic and/or not aphakic persons with non-diseased eyes that may exhibit refractive and/or corneal astigmatism up to 5.00 Diopters.

The I-55 Multifocal (methafilcon A) Soft (Hydrophilic) Contact Lens is indicated for daily wear for the correction of refractive ametropia (myopia and hyperopia) and presbyopia in aphakic or not-aphakic persons with non-diseased eyes that may exhibit refractive and/or corneal astigmatism up to 2.00 diopters that does not interfere with visual acuity.

The lenses may be disinfected using chemical (not heat) or hydrogen peroxide disinfecting systems. Eyecare practitioners may prescribe the lenses for daily wear and/or frequent replacement.

Description of Safety and Substantial Equivalence:

A series of pre-clinical tests were performed to demonstrate the safety and effectiveness of I-55 Single Vision, I-55 Toric, and I-55 Multifocal (methafilcon A) Soft (Hydrophilic) Contact Lenses for Daily Wear, and to establish substantial equivalence to the predicate devices.

Results of Systemic Injection, Primary Ocular Irritation and Cytotoxicity Tests show the lenses to be non-toxic and non-irritating. I-55 lenses were extracted and evaluated for conformance to standards. Results showed no evidence of unacceptable levels of residues in the extracts. Physicochemical testing of I-55 lenses demonstrated equivalence to the predicate devices.

Conclusion:

Information submitted in the 510(k) establishes that I-55 Single Vision, I-55 Toric and I-55 Multifocal (methafilcon A) contact lenses have comparable physjcochemical properties to the predicate devices and do not raise questions of safety and effectiveness. Shelf life testing has shown the lenses remain sterile and that lens properties do not change before the expiration date. Therefore, the devices are substantially equivalent to the predicate devices.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized depiction of an eagle or bird-like figure, with its wings forming a flowing, abstract shape. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES-USA" is arranged in a circular pattern around the bird symbol.

Public Health Service

Poly Vue Distribution, Inc. c/o Garold L. Edwards, OD. FAAO 7077 McAdams Lane Felton, CA 95018

DEC 1 7 2008

Re: K080794

Trade/Device Name: I-55 Single Vision (methafilcon A) Soft (hydrophilic) Contact Lens for

Daily Wear

I-55 Toric (methafilcon A) Soft (hydrophilic) Contact Lens for Daily Wear I-55 Multifocal (methafilcon A) Soft (hydrophilic) Contact Lens for

Daily Wear

Regulation Number: 21 CFR 886.5925 Regulation Name: Soft (hydrophilic) contact lens Regulatory Class: Class II Product Code: LPL Dated: November 18, 2008 Received: November 21, 2008

Dear Dr. Edwards:

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 (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

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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 vours.

M. B. Egorlums, 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

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Indications for Use

510(k) Number: K080794

Device Names:

I-55 Single Vision (methafilcon A) Soft (Hydrophilic) Contact Lens for Daily Wear I-55 Toric (methafilcon A) Soft (Hydrophilic) Contact Lens for Daily Wear I-55 Multifocal (methafilcon A) Soft (Hydrophilic) Contact Lens for Daily Wear

Indications for Use:

The lenses may be disinfected using chemical (not heat) or hydrogen peroxide, disinfecting systems. Eyecare practitioners may prescribe the lenses for daily wear and/or frequent replacement.

Prescription Use (Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use (21 CFR 807 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

ing-chun Shih

(Division Sign-Off) Division of Ophthalmic and Ear. Nose and Throat Devices

510(k) Number

014

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.