The Special Eyes 59 (hioxifilcon A) Sphere and Toric soft contact lenses for daily wear, are indicated for the correction of visual acuity in aphakic and non aphakic persons with nondiseased eyes with myopia or hypercopia, and/or posses refractive astigmatism not exceeding 10 diopters. They are available for either conventional wear or planned replacement modalities.

The Special Eyes 49 (hioxifilcon B) Sphere and Toric soft contact lenses for daily wear, are indicated for the correction of visual acuity in aphakic and non aphakic persons with nondiseased eyes with myopia or hypercopia, and/or posses refractive astigmatism not exceeding 10 diopters. They are available for either conventional wear or planned replacement modalities.

Device Description

SpecialEyes 59 and 49 soft contact lenses are hemispherical shells available in spherical or toric lens designs and in. hioxifilcon A and hioxifilcon B materials.The lenses are fabricated by lathe cutting hioxifilcon A and hioxifilcon B materials both non-ionic copolymers of 2hydroxeyethylmethacrylate (2-HEMA) and Glycerol Methacrylate (GMA). The water content by weight is 49% for hioxifilcon B and 59% for hioxifilcon A. when immersed in normal saline. 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 optical surface.

AI/ML Overview

The provided text describes the 510(k) summary for the SpecialEyes 59 and SpecialEyes 49 Sphere and Toric soft contact lenses. It focuses on demonstrating substantial equivalence to predicate devices rather than proving a device meets specific performance criteria through a study. Therefore, most of the requested information regarding acceptance criteria and performance studies cannot be directly extracted or inferred from this document.

Here's what can be gathered:

1. A table of acceptance criteria and the reported device performance

The document does not explicitly state acceptance criteria in terms of performance metrics (e.g., visual acuity improvement percentage, lens fit success rate) and subsequent reported device performance against those criteria. Instead, it relies on demonstrating adherence to manufacturing specifications and substantial equivalence to existing predicate devices.

Acceptance Criteria (Inferred from Preclinical Testing)	Reported Device Performance
Product conformance to dimensional specifications	All product conformed to specification requirements.
Adherence to specific manufacturing materials	Hioxifilcon A and Hioxifilcon B materials (non-ionic copolymers of 2-HEMA and Glycerol Methacrylate (GMA)).
Water content by weight	49% for hioxifilcon B and 59% for hioxifilcon A (when immersed in normal saline).

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 mentions "Dimensional and verification testing has been completed" and "All product conformed to specification requirements." However, it does not specify the sample size used for this testing, nor does it provide details on the data provenance (country of origin, retrospective/prospective). This testing appears to be internal manufacturing quality control rather than a clinical trial.

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 information is not applicable or available in this submission. The "ground truth" here is adherence to manufacturing specifications, not a clinical assessment requiring expert consensus.

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

This information is not applicable or available in this submission. Adjudication methods are typically used in clinical studies involving interpretation, which is not the primary focus of this submission.

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

An MRMC comparative effectiveness study was not done. This submission is for contact lenses, which are not typically evaluated using MRMC studies, especially not in the context of AI assistance.

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

This information is not applicable. The device is a soft contact lens, not an algorithm.

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

The "ground truth" for this submission is based on manufacturing specifications and physical properties of the contact lenses (e.g., dimensions, material composition, water content). The document also extensively references substantial equivalence to predicate devices, implying that the performance and safety profiles of those previously cleared devices serve as an established baseline.

8. The sample size for the training set

This information is not applicable. The device is a physical product (contact lens), not an AI algorithm that requires a training set.

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

This information is not applicable. See point 8.

Summary of the Study:

The submission for SpecialEyes 59 and SpecialEyes 49 soft contact lenses is a 510(k) premarket notification. The "study" described is primarily preclinical testing focusing on dimensional and verification aspects to ensure the manufactured devices conform to specified requirements. The core argument for device acceptance is substantial equivalence to several predicate devices already cleared by the FDA (K983773, K964528, K042242, K981252, K953199, K964902).

The claim of substantial equivalence is based on the proposed device having an equivalent intended use, manufacturing materials, operating principles, and physical, operational, and biological specifications as compared to the predicate devices. Toxicological, microbiological, lens compatibility, preservation uptake, and shelf life studies were completed on the predicate device (K964528) and directly leveraged for this submission, indicating that new comprehensive studies for these aspects were not performed on the SpecialEyes lenses themselves, given their identical nature to the predicate.

Summary

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K060821

510(K) SUMMARY (as required by 807.92(c))

Submitter of 510(k):	SpecialEyes, LLC.P.O. Box 21417Bradenton, FL 34204Phone: 886-404-1060 Fax:886-404-1030
Contact Person:	Steve Brauner
Date of Summary:	May 4, 2006
Trade/Proprietary Name:	Special Eyes 59 and Special Eyes 49Sphere and Toric Soft Contact Lenses
Classification Name:	Lenses, soft contact, daily wear
Product Code:	LPL

Intended Use:

Device Description:

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Preclinical Testing:

Dimensional and verification testing has been completed and included in Section 10 of this submission. As evidenced in the results all product conformed to specification requirements. All other preclinical testing such as toxicology, microbiology, lens compatibility, preservation uptake tests and shelf life studies were completed on the predicate device, which is identical to the device proposed in this 510(k), see K964528.

Substantial Equivallence to Predicate Device:

SpecialEyes claims the proposed device to be substantially equivalent to the devices previously cleared by FDA as listed below. SpecialEyes claims this equivalence be cause the proposed device has an equivalent intended use, manufacturing materials, operating principles, and physical, operational and biological specification as compared to the predicate devices.

The similarities and differences between the proposed and predicate devices have been identified and explained in the Comparison Matrix which has been included in Section 9 of this submission.

K983773 - BENZ G-5X (HIOXIFILCON A) SOFT DAILY WEAR CONTACT LENS K964528 - BENZ-G 3X (HIOXIFILCON B) SPHERICAL AND TORIC SOFT DAILY WEAR CONTACT LENS K042242 - ALDEN HP SHPERE AND TORIC / OXYLENS K981252 - ALDEN HP SHPERE AND TORIC / OXYLENS K953199 - METRO OPTICS SATUREYES SPHEREICAL AND TORIC K964902 - METRO OPTICS SATUREYES SPHEREICAL AND TORIC

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized depiction of an eagle or bird with three curved lines representing its wings or feathers. The bird is positioned to the right of the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA", which is arranged in a circular fashion around the bird.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MAY 18 2006

SpecialEyes, LLC c/o Mr. Arthur J. Ward AJW Technololgy Consultant, Inc. 962 Allegro Lane Apollo Beach, FL 33572

Re: K060821

Trade/Device Name: SpecialEyes59 and SpecialEyes 49 Sphere and Toric soft contact lenes Regulation Number: 21 CFR 886.5925 Regulation Name: Soft (hydrophilic) Contact Lenses Regulatory Class: II Product Code: LPL Dated: May 4, 2006 Received: May 8, 2006

Dear Mr. Ward:

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.

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Page 2 -- Mr. Arthur J. Ward

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/cdrl/industry/support/index.html.

Sincerely yours,

M.B. Egelston - M.D.

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 (if known): K060821

Device Name: SpecialEyes 59 and SpecialEyes 49 Sphere and Toric soft contact lenses

Indications for Use:

The Special Eyes 59 (hioxifilcon A) Sphere and Toric soft contact lenses for daily wear, are indicated for the correction of visual acuity in aphakic and non aphakic persons with nondiseased eves with myopia or hypercopia, and/or posses refractive astigmatism not exceeding 10 diopters. They are available for either conventional wear or planned replacement modalities.

Prescription Use X
(Part 21 CFR 801 Subpart D)

AND

(PLEASE DO NOT WRITE BELOW THIS

AND/OR

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

(PLEASEDO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

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

510(k) Number

Page 1 of 1

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.