The Benz-G 4X 54% (hioxifilcon D) soft contact lens for daily wear is indicated for the correction of visual acuity in aphakic or not-aphakic persons with nondiseased eyes that are myopic or hyperopic. The spherical lens may be worn by persons who exhibit astigmatism of 0.75 Diopters or less that does not interfere with visual acuity. The toric lens may be worn by persons who exhibit astigmatism of up to 10.00 Diopters. Eye care practitioners may prescribe the lens for frequent/planned replacement wear, with cleaning disinfection and scheduled replacement. When prescribed for frequent/planned replacement wear, the lens may be disinfected using a chemical disinfection system.

Device Description

Benz-G 4X 54% (hioxifilcon D) lathed soft contact lenses are hemispherical shells and are available as spherical or toric lens designs. The Benz-G 4X 54% (hioxifilcon D) lathed soft contact lens is fabricated from hioxifilcon D, which is a non-ionic, copolymer of 2-hydroxyethyl methacrylate (2-HEMA) and 2,3-Dihydroxypropyl Methacrylate (Glycerol Methacrylate, GMA) and cross-linked with ethylene glycol dimethacrylate (EGDMA). It consists of 46% hioxifileon D and 54% water by weight when immersed in normal buffered saline solution buffered. The lens is available with a blue visibility handling tint, phthalocyanato (2) - (copper). 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 and appear somewhat warped. However, it will return to its proper configuration when completely rehydrated in the proper storage solution.

AI/ML Overview

The provided text describes a 510(k) premarket notification for a soft contact lens, the Benz-G 4X (hioxifilcon D) Lathed Sphere and Toric Lenses. The submission asserts substantial equivalence to a predicate device, Extreme H2O® 54% (hioxifilcon D) molded soft contact lens (K051430).

Based on the document, here's an analysis of the acceptance criteria and supporting studies:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly present "acceptance criteria" in a typical quantitative clinical trial sense (e.g., a specific sensitivity or specificity threshold). Instead, the substantial equivalence is based on a comparison of material properties, intended use, and non-clinical performance to a predicate device. The performance characteristics are compared as follows:

Characteristic	Acceptance Criteria (Predicate: Extreme H2O® 54% Molded Lens)	Reported Device Performance (Benz-G 4X Lathed Lens)
Intended Use	Same as new device	Same as predicate device
Lens Material	Hioxifilcon D	Hioxifilcon D
Material Classification	FDA Group 2 (> 50% H₂O, non-ionic polymer)	FDA Group 2 (> 50% H₂O, non-ionic polymer)
Production Method	Cast-Molded	Lathe-Cut
Water content	54% +/- 2	54% +/- 2
Refractive Index (hydrated)	1.414	1.408
Light Transmission	Greater than 95% T	Greater than 95% T
Tint	Blue Phthalocyanato (2) - (copper)	Blue Phthalocyanato (2) - (copper)
Oxygen Permeability (Fatt Dk)	21	18
Cytotoxicity (Agar Diffusion)	Considered non-cytotoxic	Considered non-cytotoxic
Systemic Reaction (Systemic Injection)	Did not induce significantly greater biological reaction than controls	Did not induce significantly greater biological reaction than controls
Ocular Irritation (Primary Ocular Irritation)	Non-irritant	Non-irritant

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

The document states, "It was determined that clinical studies were not necessary to establish the safety and effectiveness of the Benz-G 4X (hioxifilcon D) lathed lens." Therefore, there is no "test set" in the context of a clinical trial with human subjects. The data provenance is from non-clinical testing (e.g., Agar Diffusion Test, Systemic Injection Test, Primary Ocular Irritation Test) performed in accordance with 21 CFR, Part 58. The specific number of samples for these tests is not provided, nor is the country of origin, though it's implied to be from the manufacturer's testing.

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

Not applicable. As clinical studies were not deemed necessary, there was no "ground truth" derived from human experts in a clinical setting. The non-clinical tests rely on standardized methodologies and interpretation by qualified laboratory personnel, rather than expert consensus on medical images or diagnoses.

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

Not applicable. There was no "test set" requiring adjudication by multiple readers or experts. The non-clinical tests have objective endpoints.

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. This device is a soft contact lens, not an AI-powered diagnostic or assistive tool for human readers. Therefore, an MRMC study comparing human reader performance with and without AI assistance is irrelevant.

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

Not applicable. This device is a physical medical device (contact lens), not an algorithm or AI system.

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

For the non-clinical tests, the "ground truth" is derived from the objective results of the standardized biological and chemical tests. For example, in the Agar Diffusion Test, the absence of a zone of inhibition would be considered "non-cytotoxic," which is an objective observation rather than an interpretive "ground truth" from an expert. Similarly, for the systemic injection test, the "ground truth" comes from comparing biological reactions to control articles, and for ocular irritation, the "ground truth" is the observation of non-irritancy based on established criteria.

8. The sample size for the training set

Not applicable. This is not an AI/ML device that requires a "training set." The manufacture of the contact lens relies on established materials and processes, not a machine learning model.

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

Not applicable. As there is no training set for an AI/ML model, there is no ground truth established for it.

Summary

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BENZ RESEARCH & DEVELOPMENT

510(k) Premarket Notification

AUG -6 2007

510(k) SUMMARY OF SAFETY AND EFFECTIVENESS

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.

Kob2854 The assigned 510(k) number is:

Applicant Information:

Date Prepared:	8/03/2007
Name:	Benz Research & Development6447 Parkland DriveSarasota, FL 34243
Contact Person:	Arthur WardRegulatory ConsultantBenz Research & Development
Phone number:	941-758-8256
Fax number:	941-758-1191
Device Information:
Device Classification:	Class II
Classification number:	LPL
Classification Name:	Lens, Soft Contact, Daily Wear
Trade Name:	Benz-G 4X (hioxifilcon D) Lathed Sphere andToric Lenses

Purpose of the 510(k) Submission:

Benz Research & Development is requesting clearance from the FDA to manufacture and market Benz-G 4X (hioxifilcon D) Lathed Lenses.

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Predicate Devices:

The Benz-G 4X 54% (hioxifilcon D) lathed soft contact lens is substantially equivalent to the Extreme H2O® 54% (hioxifilcon D) molded soft contact lens already cleared under 510(k) K051430.

In addition, Benz-G 4X (hioxifilcon D) lathed lens is manufactured at Benz Research & Development according to the same manufacturing processes as the following previously cleared hydrophilic contact lenses:

Benz-G 5X (hioxifilcon A)	K952620	(MAF-700)
Benz-G 3X (hioxifilcon B)	K964528	(MAF-816)

Device Description:

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 and appear somewhat warped. However, it will return to its proper configuration when completely rehydrated in the proper storage solution.

Intended Use (Indications):

Eve care practitioners may prescribe the lens for frequent/planned replacement wear, with cleaning disinfection and scheduled replacement. When prescribed for

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frequent/planned replacement wear, the lens may be disinfected using a chemical disinfection system.

Comparison to Predicate Device:

Side by side comparison testing was conducted on the molded lenses Extreme H2O® 54% (hioxifilcon D) cleared under 510(k) K051430 and lathed lenses manufactured by Benz Research & Development from hioxifilcon D material.

	Predicate Device	New Device
	Extreme H₂O® 54% Molded Lens	Benz-G 4X Lathed Lens
Intended Use:	Intended for daily wear for thecorrection of visual acuity in aphakicand non aphakic persons with non-diseased eyes that are myopic orhyperopic. The spherical lens may beworn by persons who exhibitastigmatism of 0.75 Diopters or lessthat does not interfere with visualacuity. The toric lens may be wornby persons who exhibit astigmatismof up to 10.00 Diopters.Lenses are intended for frequent and/ or planned replacement wear asprescribed by the eye carepractitioner.	Intended for daily wear for thecorrection of visual acuity in aphakicand non aphakic persons with non-diseased eyes that are myopic orhyperopic. The spherical lens may beworn by persons who exhibitastigmatism of 0.75 Diopters or lessthat does not interfere with visualacuity. The toric lens may be wornby persons who exhibit astigmatismof up to 10.00 Diopters.Lenses are intended for frequent and/ or planned replacement wear asprescribed by the eye carepractitioner.
Lens Material:	Hioxifilcon D	Hioxifilcon D
Material Classification:	FDA Group 2(> 50% H₂O, non-ionic polymer)	FDA Group 2(> 50% H₂O, non-ionic polymer)
Production Method:	Cast-Molded	Lathe-Cut
Water content:	54% +/- 2	54% +/- 2
Refractive Index:	1.414 hydrated	1.408 hydrated
Light Transmission:	Greater than 95% T	Greater than 95% T
Tint	Blue Phthalocyanato (2) - (copper)	Blue Phthalocyanato (2) - (copper)
Oxygen Permeability(ANSI Z80:2004 upgradedpolarographic method) in FattDk units	21	18

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Non-clinical Testing:

The following toxicological testing was performed in accordance with the regulations set forth in 21 CFR, Part 58

a) Agar Diffusion Test ISO The test article is considered non-cytotoxic
b) Systemic Injection Test ISO The test article did not induce a significantly greater biological reaction than their control articles.
c) Primary Ocular Irritation ISO The test article is considered to be a non-irritant

Clinical Data:

It was determined that clinical studies were not necessary to establish the safety and effectiveness of the Benz-G 4X (hioxifilcon D) lathed lens. The Benz-G 4X (hioxifilcon D) lathed lens is formulated from the same components as the previously cleared Extreme H2O® 54% (hioxifilcon D) molded contact lens. The physical / chemical / toxicological results of the Benz-G 4X (hioxifilcon D) lathed lens also show that it is substantially equivalent to the Extreme H2O® 54% (hioxifilcon D) molded contact lens.

Conclusion:

The information provided in this premarket submission establishes that the Benz-G 4X (hioxifilcon D) lathed lens is substantially equivalent in terms of intended use, materials, toxicological and physiochemical properties to the predicate device, Extreme H2O® 54% (hioxifilcon D) molded contact lens. In addition, The Benz-G 4X (hioxifilcon D) lathed lens is manufactured at Benz Research & Development according to the same manufacturing processes as the following previously cleared hydrophilic contact lenses: Benz-G 5X (hioxifilcon A) K952620 Benz-G 3X (hioxifilcon B) K964528 (MAF-816)

The Benz-G 4X (hioxifilcon D) material is formulated from the same components as the previously cleared Benz-G 5X (hioxifilcon A) and Benz-G 3X (hioxifilcon B), but with a different ratio of components that bracket the new material between these two cleared materials.

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Benz-G 4X (hioxifilcon D) lathed lens therefore meets the requirements of substantial equivalence and is as safe and effective as the predicate device.

・

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Image /page/5/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features the department's name in a circular arrangement around a stylized symbol. The symbol consists of three abstract human profiles facing to the right, with flowing lines suggesting movement or progress.

AUG -6 2007

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Benz Research & Development c/o Arthur J. Ward, Ph.D. AJW Technologies Consultants, Inc. 962 Allegro Lanc Apollo Beach, FL 33572

Re: K062854

Trade/Device Name: Benz-G 4X (hioxifilcon D) Lathed Sphere and Toric Lenses Regulation Number: 21 CFR 886.5925 Regulation Name: Lens, Soft Contact, Daily Wear Regulatory Class: Class II Product Code: LPL Dated: July 25, 2007 Received: July 30, 2007

Dear Dr. 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. Isting 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 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. Egelhus, 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 STATEMENT

Device Name: Benz G 4X (Hioxifilcon D) soft contact lens

INDICATIONS FOR USE:

The Benz G 4X (Hioxifilcon D) soft contact lens for daily wear is indicated for the correction of visual acuity in aphakic or not-aphakic persons with non-diseased eyes that are myopic or hyperopic. The spherical lens may be worn by persons who exhibit astigmatism of 0.75 Diopters or less that does not interfere with visual acuity. The toric lens may be worn by persons who exhibit astigmatism of up to 10.00 Diopters.

Eye care practitioners may prescribe the lens for frequent/planned replacement wear, with cleaning disinfection and scheduled replacement. When prescribe for frequent/planned replacement wear, the lens may be disinfected using a chemical disinfection system.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

(Division Sign-Off)	Ming-chuen Shl
Division of Ophthalmic Ear,
Nose and Throat Devises
510(k) Number	K062854

Prescription Use (Per 21 CRF 801.109)	X	or	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.