The AQUASOFT ALL-DAY (hioxifilcon A) 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 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.

The AQUASOFT ALL-DAY T (hioxifilcon A) 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 may have astigmatism of 7.00D of astigmatism or less. 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.

Device Description

The AQUASOFT ALL-DAY & ALL-DAY T (hioxifilcon A) Soft (hydrophilic) Contact Lens is available as a single vision spherical lens, and as a back surface astigmatic (toric) lens. The hydrophilic nature of this material allows the lens to become soft and pliable when immersed in an aqueous solution.

The non-ionic lens material, (hioxifilcon A) is a random copolymer of 2-hydroxythyl methacrylate and 2,3 -dihydroxypropyl methacrylate, cross linked with ethylene glycol dimethacrylate. It consists of 43% hioxifilcon A and 57% water by weight when immersed in sodium carbonate buffered saline solution. The lens is available clear or with a blue visibility-handling tint, color additive 'Reactive Blue 19', 21 CFR part 73.2121. The United States Adopted Names Council (USAN) has adopted the (hioxifilcon A) name.

In the hydrated state, the lens conforms to the curvature of the eye covering the cornea and extending slightly beyond the limbus forming a colorless, transparent optical 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 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 57% water by weight.

AI/ML Overview

This 510(k) summary describes a new contact lens device, the AQUASOFT ALL-DAY & ALL-DAY T (hioxifilcon A) Daily Wear Contact Lens, and compares it to predicate devices to establish substantial equivalence. The document primarily focuses on demonstrating that the new device shares similar technological characteristics and intended use with existing legally marketed devices.

However, it does not contain information related to a study proving the device meets specific acceptance criteria in the way described by the user's detailed request. The 510(k) summary is for a medical device (contact lens), and its demonstration of safety and effectiveness typically relies on comparing its physical and chemical properties and intended use to predicate devices, rather than a clinical study with performance metrics in the context of AI/diagnostic devices.

Therefore, many of the requested fields cannot be filled from the provided text.

Based on the provided text, here is what can be extracted and what cannot:

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

The document provides a comparison of technological characteristics between the new device and predicate devices. These characteristics serve as the basis for establishing substantial equivalence, indicating that the new device performs similarly to the predicates. While not explicitly "acceptance criteria" in a traditional diagnostic study sense, these are the properties that must be substantially equivalent.

Characteristic	Acceptance Criteria (Implied by Predicates)	Reported Device Performance (AQUASOFT ALL-DAY & ALL-DAY T)
Intended Use	Correction of visual acuity in aphakic and not aphakic persons with non-diseased eyes with myopia or hyperopia for daily wear.	Indicated for daily wear for the correction of visual acuity in aphakic and not aphakic persons with non-diseased eyes with myopia or hyperopia.
Functionality	Contact lenses act as a refractive medium that focus light rays from near and distant objects on the retina.	The contact lenses act as a refractive medium that focus light rays from near and distant objects on the retina.
Indications	Daily wear, Soft (hydrophilic) contact lens	Daily wear, Soft (hydrophilic) contact lens
Production Method	Cast-molded or Lathe-Cut (predicates include both)	Cast-molded
FDA Group #	Group # 2 (>50% Water, non-ionic Polymer) or Group # 4 (>50% Water, ionic Polymer)	Group # 2 (>50% Water, non-ionic Polymer)
USAN name	hioxifilcon A or etafilcon A	hioxifilcon A
Water Uptake (%)	~58.0% - 61.2% (range of predicates)	57.0%
Oxygen Permeability (Dk)	~19.9 - 20.5 x 10^-11 (range of predicates)	20.0 x 10^-11 (cm2/sec) (ml O2/ml x mm Hg @ 35°C), (Fatt method, ISO 9913-1).
Specific Gravity	~1.017 - 1.118 (for the two predicates with data)	1.129

Regarding the study that proves the device meets the acceptance criteria:

The document describes a 510(k) submission, which relies on demonstrating substantial equivalence to legally marketed predicate devices. This is not a study in the sense of a clinical trial designed to measure performance against a specific set of acceptance criteria for diagnostic output or treatment efficacy. Instead, it's a submission of data (physical properties, chemical composition, intended use, manufacturing method) that shows the new device is as safe and effective as a predicate device.

Specifically, the "study" mentioned is the comparison of the new device's technological characteristics to those of three predicate devices. This comparison (Table #1) is the core evidence presented.

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

Not applicable/Not provided. This type of information is typically not included in a 510(k) submission for a contact lens, as it's not a diagnostic device with a "test set" of patient data for performance evaluation in the requested manner. The "data" here refers to the device's physical and chemical properties.

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

Not applicable/Not provided. This concept of "ground truth" and expert adjudication is relevant for diagnostic devices or AI algorithms evaluating medical images/data, not for the physical properties of a contact lens.

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

Not applicable/Not provided.

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/Not provided. The device is a contact lens, not an AI-powered diagnostic tool.

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

Not applicable/Not provided. The device is a contact lens, not an algorithm.

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

Not applicable/Not provided. The "ground truth" for a contact lens's performance is its physical and chemical properties and its ability to correct vision, which is evaluated through refractive measurements and observation during eye care professional fittings, not through pathology or outcomes data in the context of a diagnostic test.

8. The sample size for the training set:

Not applicable/Not provided. There is no "training set" in the context of a contact lens 510(k) submission.

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

Not applicable/Not provided.

Summary

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MAY 1 5 2006

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: K052290 Applicant information: Initial Date Prepared: August 15, 2005 : Name: ClearLab PTE, Ltd. Address 139, Joo Seng Raod #06-01 Singapore 368362 Contact Person: Mike Read Phone number: Country code 65+ 67491090 Fax number: Country code 65+ 62848534 Parent Company: 1800 CONTACTS, Inc. 66 E. Wadsworth Park Drive 3rd. Floor Draper, UT 84020 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:

AQUASOFT ALL-DAY & ALL-DAY T (hioxifilcon A) Daily Wear Contact Lens.

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Equivalent Predicate Devices:

The AQUASOFT ALL-DAY & ALL-DAY T (hioxifilcon A) Soft Contact Lenses are substantially equivalent to the following predicate devices:

1. Extreme H2O (hioxifilcon A), K992692, Manufactured by Hydrogel Vision Corp.
1. Benz-G 5X (hioxifilcon A), K983773, Manufactured by Benz Research & Development
1. MIERU (etafilcon A), K030167, manufactured by ClearLab International PTE LTD.

Device Description:

The hydrophilic characteristics allow aqueous solutions to enter the lens and in its fully hydrated state the lens is approximately 57% water by weight. The physical properties of the lens are:

Refractive Index	1.4058 (wet)
Light Transmission	greater than 95%
Water Content	57 %
Specific Gravity	1.1287 (hydrated)
Oxygen Permeability	20.0 x 10-11 (cm2/sec) (ml O2/ml x mm Hg @ 35°C), (Fatt method, ISO 9913-1).

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Intended Use:

The AOUASOFT ALL-DAY (hioxifilcon A) 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 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.

The AQUASOFT ALL-DAY T (hioxifileon A) 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 may have astigmatism of 7.00D of astigmatism or less. The lens may be cleaned and disinfected using a chemical (not heat) lens care system.

Technological Characteristics:

The technological characteristics of the AQUASOFT ALL-DAY & ALL-DAY T contact lens as compared to the technological characteristics of the predicate devices are illustrated on the following page.

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Pre-Clinicalequivalency /Device	AQUASOFTALL-DAY& ALL-DAY T(hioxifilcon A)New Device	Extrreme H2O(hioxifilcon A)predicater device	Benz-G 5X(hioxifilcon A)predicater device	MIERU(etafilcon A)predicate device
Intended Use	Indicated for dailywear for the correctionof visual acuity inaphakic and notaphakic persons withnon-diseased eyes withmyopia or hyperopia.	Indicated for dailywear for the correctionof visual acuity inaphakic and notaphakic persons withnon-diseased eyes withmyopia or hyperopia.	Indicated for dailywear for the correctionof visual acuity inaphakic and notaphakic persons withnon-diseased eyes withmyopia or hyperopia.	Indicated for dailywear for the correctionof visual acuity inaphakic and notaphakic persons withnon-diseased eyes withmyopia or hyperopia.
Functionality	The contact lenses actas a refractive mediumthat focus light raysfrom near and distantobjects on the retina.	The contact lenses actas a refractive mediumthat focus light raysfrom near and distantobjects on the retina.	The contact lenses actas a refractive mediumthat focus light raysfrom near and distantobjects on the retina.	The contact lenses actas a refractive mediumthat focus light raysfrom near and distantobjects on the retina.
Indications	Daily wear, Soft(hydrophilic) contactlens	Daily wear, Soft(hydrophilic) contactlens	Daily wear, Soft(hydrophilic) contactlens	Daily wear, Soft(hydrophilic) contactlens
ProductionMethod	Cast-molded	Cast-molded	Lathe-Cut	Cast-molded
FDA Group #	Group # 2 >50%Water, non-ionicPolymer	Group # 2 >50%Water, non-ionicPolymer	Group # 2 >50%Water, non-ionicPolymer	Group # 4 >50%Water, ionic Polymer
USAN name	hioxifilcon A	hioxifilcon A	hioxifilcon A	etafilcon A
WaterUptake(%)	57.0%	61.2%	58.0%	58.0%
OxygenPermeability(Dk)	20.0 x 10-11 (cm2/sec)(ml O2/ml x mm Hg @35 degrees C), (Fattmethod, ISO 9913-1).	20.5 x 10-11 (cm2/sec)(ml O2/ml x mm Hg @35 degrees C), (revisedFatt method).	20.2 x 10-11 (cm2/sec)(ml O2/ml x mm Hg @35 degrees C), (revisedFatt method).	19.9 x 10-11 (cm2/sec)(ml O2/ml x mm Hg @35 degrees C), (revisedFatt method).
SpecificGravity	1.129	1.118	not measured	1.017

Table #1, Aquasoft All-Day as compared to predicate devices

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Image /page/4/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three stripes extending from its head, representing the department's commitment to health, human services, and well-being. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the eagle symbol.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MAY 1 5 2006

ClearLab PTE., LTD c/o Mr. Martin Dalsing Medvice Consulting, Inc. 2214 Sanford Drive, Suite # B7 Grand Junction, CO 81505

Re: K052290

Trade/Device Name: Aquasoft All-Day & All-Day To (hioxifilcon A) Daily Wear Contact Lens Regulation Number: 21 CFR 886.5925 Regulation Name: Soft (hydrophilic) Contact Lens Regulatory Class: Class II Product Code: LPL Dated: May 2, 2006 Received: May 5, 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.

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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 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:

K052290

Device Name:

AQUASOFT ALL-DAY & ALL-DAY T (hioxifilcon A) Daily Wear Contact Lens.

INDICATIONS FOR USE:

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

Prescription Use
X
(Part 21 CFR 801 Subpart D)

AND/OR

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

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Mysa Smith

n of Onlithalmic Ear Nose and Throat Devis

510(k) Number

Page 1 of

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.