The Aquaflex 2 Contact Lens is indicated for daily wear for the correction of refractive ametropia (myopia and hyperopia) and astigmatism up to 1.50 diopters or less in aphakic and/or not-aphakic persons with non-diseased eyes. The lens may be disinfected using either a heat or chemical disinfection system.

Device Description

The Aquaflex 2 (tefilcon) Soft (hydrophilic) Contact Lens is available as a spherical lens. The lens material, tefilcon, is a hydrophilic polymer of 2-hydroxyethyl methacrylate crosslinked with ethylene glycol dimethacrylate. The Aquaflex 2 Contact Lens is a hemispherical shell.

AI/ML Overview

Here's an analysis of the provided text regarding the acceptance criteria and study for the Aquaflex 2 (tefilcon) Soft (hydrophilic) Contact Lens, structured to address your specific points:

Note: The provided document is a 510(k) summary for a contact lens, which primarily focuses on demonstrating substantial equivalence to a predicate device rather than presenting a novel device's performance against specific acceptance criteria in a detailed clinical study report. Therefore, some of your requested information, particularly around detailed study methodology (sample sizes, expert qualifications, adjudication, MRMC, training sets), is not present in this type of regulatory submission. The information provided heavily relies on the equivalence to a previously cleared device.

Acceptance Criteria and Device Performance Study for Aquaflex 2 (tefilcon) Soft (hydrophilic) Contact Lens

1. Table of Acceptance Criteria and Reported Device Performance

As this is a 510(k) submission based on substantial equivalence, explicit "acceptance criteria" for novel performance metrics are not typically presented in this format. Instead, the document asserts equivalence to a predicate device across several key characteristics. The performance of the Aquaflex 2 is described by its physical/optical properties, which are implicitly accepted if they are comparable to the predicate and meet established safety and effectiveness profiles for contact lenses.

Characteristic	Acceptance Criteria (Implied by Substantial Equivalence to Predicate)	Reported Device Performance (Aquaflex 2)
Physical/Optical Properties	Comparable to predicate device (BayVue polymacon lens) and within established safe ranges for daily wear contact lenses.	Specific Gravity: 1.18
		Refractive Index (wet): 1.43
		Light Transmittance: 98%
		Water Content: 37.5%
		Oxygen Permeability: 8.9 x 10^-11 (cm/sec)(ml O2/ml x mm Hg) @ 21°C (Fatt Method)
Intended Use	Matching the intended use of the predicate device for daily wear, correction of refractive ametropia (myopia, hyperopia), and astigmatism <= 1.50 diopters.	Indicated for daily wear for correction of refractive ametropia (myopia and hyperopia) and astigmatism up to 1.50 diopters or less in aphakic and/or not-aphakic persons with non-diseased eyes.
Manufacturing/Quality	Established process controls and quality management system similar to existing marketed devices.	Manufactured according to specified process controls and a quality management system.
Safety Profile	Equivalent to LL-Bifocal (tefilcon) Contact Lens (K971647) regarding pre-clinical toxicology and manufacturing/chemistry data.	Established safety profile (pre-clinical toxicology and manufacturing/chemistry data) is equivalent to the LL-Bifocal (tefilcon) Contact Lens, 510(k) K971647.

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

The document does not explicitly state a sample size for a test set or provide details about prospective/retrospective studies or country of origin for clinical data. This is because a 510(k) submission for substantial equivalence primarily relies on benchmarking against a predicate device and established safety profiles of similar materials, rather than a de novo clinical trial with a "test set" in the context of diagnostic AI. The "study" here is demonstrating the equivalence of the new device's material and design to already approved devices.

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

This information is not applicable/not provided in this 510(k) summary. The evaluation relies on comparing the device's characteristics against known and accepted properties of predicate devices and materials, not on establishing a "ground truth" via expert consensus for a new diagnostic claim.

4. Adjudication Method for the Test Set

This information is not applicable/not provided for the same reasons as (3).

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done, What was the Effect Size of How Much Human Readers Improve with AI vs. Without AI Assistance

This information is not applicable. This is a contact lens, not an AI-powered diagnostic device, and therefore no MRMC study or AI assistance is involved.

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

This information is not applicable, as it is a physical medical device (contact lens), not an algorithm.

7. The Type of Ground Truth Used

The "ground truth" used in this submission is the established safety, efficacy, and material properties of the predicate device (BayVue polymacon) and a previously cleared lens of the same material (LL-Bifocal tefilcon, K971647). The submission aims to show that the Aquaflex 2 device is substantially equivalent to these established benchmarks.

8. The Sample Size for the Training Set

This information is not applicable/not provided. There is no "training set" in the context of an AI algorithm for this device. The development and testing of a contact lens involve material science, engineering, and clinical trials (if required for novel claims, but not for this 510(k) based on equivalence).

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

This information is not applicable/not provided for the same reasons as (8).

Summary of the Study Proving Acceptance Criteria:

The study proving the device meets acceptance criteria (defined as demonstrating substantial equivalence to a predicate device) is the 510(k) premarket notification process itself. This process does not involve a traditional clinical study with a defined test set, ground truth experts, or AI performance metrics.

Instead, the submission for the Aquaflex 2 (tefilcon) Soft (hydrophilic) Contact Lens demonstrates its acceptance by:

Identifying a Predicate Device: The BayVue (polymacon) Soft (hydrophilic) Contact Lens.
Demonstrating Material Equivalence: The Aquaflex 2 uses tefilcon, a hydrophilic polymer whose safety profile is explicitly stated as equivalent to the LL-Bifocal (tefilcon) Contact Lens (K971647).
Comparing Physical and Optical Properties: Listing key properties (specific gravity, refractive index, light transmittance, water content, oxygen permeability) to show they fall within accepted ranges for contact lenses and are comparable to safe and effective lenses on the market.
Matching Intended Use: Showing the indications for use are identical to the predicate device.
Asserting Similar Manufacturing and Quality Systems: Stating that manufacturing, packaging, and sterilization procedures are similar to currently marketed devices and that a quality management system is in place.

The FDA's review of this comparison, culminating in the "substantially equivalent" determination in the provided letter (K050743), serves as the "proof" that the device meets the implicit acceptance criteria for market clearance under the 510(k) pathway.

Summary

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APR 1 3 2005

510(k) Summary

K 050743

Applicant Information

Date prepared:	March 21, 2005
Name:	Unilens Corp., USA
Address:	10431 72nd Street, NorthLargo, FL 33777
Contact person:	Josepha Bruno, Director Quality Assurance
Phone number:	(727) 544-2531 x306
Fax number:	(727) 545-1883

Device Information

Device classification:	Class II
Classification number:	LPL
Classification name:	Lenses, Soft Contact, Daily Wear
Trade name:	Aquaflex 2 (tefilcon) Soft (hydrophilic) Contact Lens

Equivalent device

The Aquaflex 2 (tefilcon) Soft (hydrophilic) Contact Lens for Daily Wear is substantially equivalent to the predicate device identified below in terms of intended use and design.

Predicate device: BayVue (polymacon) Soft (hydrophilic) Contact Lens

Device description

The Aquaflex 2 Contact Lens is a hemispherical shell of the following dimensions:

Chord diameters	12.5 to 17.0mm
Center thickness	varies with power; Standard design 0.10 mm to 0.56 mmand Superthin design 0.05 mm to 0.39 mm
Base curves	7.0 to 10.5mm
Powers	-20.00 to +20.00D
Optical zone diameters	5.0 to 10.0mm

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The physical/optical properties of the lens are:

specific gravity	1.18
refractive index (wet)	1.43
light transmittance	98%
water content	37.5%
oxygen permeability	8.9 x 10-11 (cm/sec)(ml O2/ml x mm Hg), measured at 21°C (Fatt Method)

Intended use

Substantial equivalence

The new device will be manufactured according to specified process controls and a quality management system currently in place. The device will undergo manufacturing, packaging and sterilization procedures similar to devices currently manufactured, marketed and distributed by Unilens Corp., USA. The established safety profile (pre-clinical toxicology and manufacturing/chemistry data) of the device is equivalent to the LL-Bifocal (tefilcon) Contact Lens, 510(k) K971647. Being similar with respect to indications for use, materials, physical construction and safety and effectiveness to the predicate device, this meets the requirements per section 510(k) of the act regarding substantial equivalence and does not raise different questions of safety and effectiveness than the predicate device identified above.

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Image /page/2/Picture/12 description: The image shows the seal of the U.S. Department of Health and Human Services. The seal features a stylized eagle with three stripes representing the three branches of government. The eagle is encircled by the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" in a circular arrangement.

APR 1 3 2005

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Unilens Corp., USA c/o Josepha Bruno Director, Quality Assurance 10431 72nd Street North Largo, FL 33777

Re: K050743

Trade/Device Name: Aquaflex 2 (tefilcon) Soft (hydrophilic) Contact Lens Regulation Number: 21 CFR 886.5925 Regulation Name: Soft (hydrophilic) Contact Lens Regulatory Class: Class II Product Code: LPL Dated: March 21, 2005 Received: March 21, 2005

Dear Ms. Bruno:

We have reviewed your Section 510(k) premarket notification of intent to market the device we nave reviewed your becamed the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate for use stated in the encreations of the enactment date of the Medical Device Amendments, or to conninered pror to May 20, 1978) in accordance with the provisions of the Federal Food, Drug, de vices that have been require approval of a premarket approval application (PMA). and Cosmetic Act (110c) that do noves, subject to the general controls provisions of the Act. The I ou may, dicrerere, mains of the Act include requirements for annual registration, listing of general controls provision 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 If your device is onashined (600 a00 rols. Existing major regulations affecting your device can may be subject to back acceral Regulations, Title 21, Parts 800 to 898. In addition, FDA may be found in the Oous or ements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean I lease be advised that I Drivedants of your device complies with other requirements of the Act that I DA has made a acternmentations administered by other Federal agencies. You must of ally I colch statutes and regaranents, including, but not limited to: registration and listing (21 Comply with an the Act 31equirements, as a manufacturing practice requirements as set CFN in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic forth in the quarty by sions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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Page 2 - Josepha Bruno

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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Indications for Use

510(k) Number (if known): k050743___________________________________________________________________________________________________________________________________________

Device Name: Aquaflex 2 (tefilcon) Soft (Hydrophilic) Contact Lens

Indications for Use:

The Aquaflex 2 Contact Lens is indicated for daily wear for the correction of refractive I he Aquariex 2 Conact Lons is no astigmatism up to 1.50 diopters or less in aphakic and/or anteropia (inyopia and ifyperopla) and antigation way be disinfected using either a heat or chemical disinfection system.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use(Part 21 CFR 801 Subpart D)	X
	AND/OR	Over-The-Counter-Use(Part 21 CFR 807 Subpart C)

(Division Sign-Off)

Division of Ophthalmic Ear,

Nose and Throat Devises

510(k) Number	K050743
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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.