BENZ-G 3X Spherical (hioxifilcon B) soft (hydrophilic) contact lenses made from BENZ-G 3X (hioxifilcon B) optical blanks in clear or a blue visibility tint are indicated in daily wear for the correction of visual acuity in aphakic and/or non-aphakic persons with with non-diseased eyes. The Spherical lenses are available from +20.00 to - 20.00 Diopters for persons who have up to 1.50 Diopters of astigmatism where the astagmatism does not interfare with visual acuity.

BENZ-G 3X Toric (hioxifilcon B) soft (hydrophilic) contact lenses made from BENZ-G 3X (hioxifilcon B) optical blanks in clear or blue visibility tint are indicated in daily wear for the correction of visual acuity in aphakic and/or non-aphakic The toric lenses are persons with with non-diseased eyes. available from +20.00 to -20.00 Diopters and up to 4.50 Diopters of astigmatic correction.

The material. BENZ-G 3X (hioxifilcon B), is a non-ionic polymer that may be disinfected using either the heat (thermall or the chemical (not heat) disinfection system.

Device Description

BENZ-G 3X (hioxifilcon B) Spherical or Toric is lathed into a soft (hydrophilic) contact lens which is a hemispherical shell. The non-ionic The Toric has a Toric Base Curve. material, hioxifilcon B is a copolymer of 2-hydroxyethyl methrylate (2-HEMA) and 2,3-Dihydroxypropyl methacrylate (Glycerol Methacrylate, GMA). The copolymer consists of 52% BENZ-G 3X (hioxifilcon B) and 48% water by weight when immersed in normal saline solution buttered with sodium bicarbonate.

AI/ML Overview

This document describes a 510(k) premarket notification for a contact lens, not an AI/ML powered medical device. Therefore, the questions related to AI/ML specific aspects like AI assistance, standalone algorithm performance, training/test set details, ground truth establishment methods, expert adjudication, and MRMC studies are not applicable.

The provided text focuses on the safety and effectiveness of the BENZ-G 3X (hioxifilcon B) contact lenses. However, it does not contain a table of acceptance criteria or the specific device performance values against those criteria that would typically be found in a clinical study report for an AI/ML device. It primarily details preclinical studies and general information about the device and its material.

Here's a breakdown of the applicable information:

1. Table of Acceptance Criteria and Reported Device Performance:

Not Applicable. The submission does not contain a defined table of acceptance criteria for performance metrics in the context of an AI/ML device, nor does it present device performance against such criteria. The document discusses "normal limits" for toxicology, microbiology, and biocompatibility, but these are not quantified acceptance criteria for an AI/ML model's output.

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

Not Applicable. This is not an AI/ML study, so there is no "test set" in that context. The preclinical studies mentioned (toxicology, microbiology, biocompatibility, preservative uptake, lens stability) would have involved samples of the device or materials, but specific sample sizes for these tests are not provided in this summary. Data provenance is implied to be from internal BENZ Research and Development studies or contracted labs (Toxikon, ATCON, Metro Optics of Austin), but no country of origin is explicitly stated beyond "US" companies. The studies are prospective in the sense that they were conducted for this submission.

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

Not Applicable. As there is no AI/ML test set, there is no ground truth established by experts in this context. The "truth" for preclinical tests would be defined by standard laboratory protocols and benchmarks (e.g., absence of toxicity, successful sterilization).

4. Adjudication method for the test set:

Not Applicable. No AI/ML test set or expert adjudication is described.

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 is not an AI/ML device.

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

Not Applicable. This is not an AI/ML device.

7. The type of ground truth used:

Not Applicable. For the preclinical studies (toxicology, microbiology, biocompatibility, etc.), the "ground truth" would be objective laboratory measurements and adherence to established scientific and regulatory standards (e.g., "within normal limits" for toxicology, successful sterilization validation). There's no interpretive "ground truth" like pathology or expert consensus.

8. The sample size for the training set:

Not Applicable. This is not an AI/ML device; there is no training set.

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

Not Applicable. This is not an AI/ML device.

In summary, the provided document is a 510(k) summary for a physical contact lens and does not contain the type of information requested for an AI/ML medical device submission.

Summary

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SUPPLEMENT to K964528 BENZ-G 3X (hioxifileon B) JAN. 15. 1997

6.0 SUMMARY of SAFETY AND EFFECTIVENESS

MAR
10 1997

General Information: I .
A. Generic (USAN) Name: hioxifilcon B

B. Device Trade Name: BENZ-G 3X (hioxiTilcon B) Spherical and Toric Soft (Hydrophilic) Contact Lenses for Daily Wear in Clear and with a Blue Visibility Tint

ﻦ Sponsor's Name and BENZ Research and Development, Inc. Address: 6447 Parkland Drive Sarasota, FL 24243 (941) 758-8256

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x964528 D. 510(k) Number:

II. Indications

The material. BENZ-G 3X (hioxifilcon B), is a non-ionic polymer that may be disinfected using either the heat (thermall or the chemical (not heat) disinfection system.

III. Device Description

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510(k) NOTTFICATION for BENZ-G 3X (hioxifilcon B) Jan. 15, 1997

6.0 SUMMARY OF SAFETY AND EFFECTIVENESS

The lens BEN7-G 3X (hioxifilcon B) is made from BEN7-G 3X (hioxifilcon B) optical buttons. When the lens is hydrated and placed on the cornea it acts as a refracting medium to focus light ravs on the retina.

RENZ-G 3X (hioxifilcon B) optical buttons with visibility tint were subjected to extraction studies and showed no identifiable evidence of tint pigment leeching.

TV. Alternative Practices or Procedures

Alternative practices or procedures are in the use of available prescription products Soft and RGP Contact Lenses and spectacles for the same indication.

V. Technical Summaries

A_ Pre Clinical

1. Toxicology
  Toxikon ran all pre-clinical studies necessary for review for Class TT daily wear soft (hydrophilic) Results were within normal limits. contact lenses.

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1. Microbiology
  Relevant studies have been run and are included with This includes autoclave this 510(k) notification. validation.
1. Tiens.compatibility studies run by BENZ Research and Development included with this Notification in Section 6.3 "Tens Compatibility Studies"
  Conclusion: Within Normal Timits
1. Lens Stability The Shelf life studies have been started by Metro Optics of Austin, Tnc. and will be complete later in the year. The procedure is based on sample supplied by FDA in Guidance Document for 510)k) for Daily Wear Contact Tenses, May 1994. Study will be completed in late January 1997 to assure sterility to the one year duration. No product will be distributed until tests are complete and the FDA has approved manufacture and distribution.
5 -Preservative Uptake Tests were run by ATCON and are included in this Notification in Sect 6.5 They fall within normal limits.

This application includes application for Heat and Chemical (Not Heat) disinfection as the polymer as the polymer is Non-ionic. In house tests showing that heat

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6.0 SUMMARY OF SAFETY AND EFFECTIVENESS

has no injurious effect on the lenses made of this polvmer. BENZ-G 3X studies are on file at BENZ R&D and are included with this supplement.

BENZ RESEARCH AND DEVELOPMENT, TNC. will own the polymer BENZ-G 3X (hioxifilcon B) optical blanks in clear and with blue visibility tint and make the polymer available to any contact lens laboratory that will apply to the FDA through 510(k) Notification and he approved to manufacture and distribute soft (hydrophilic) contact lenses made from BENZ-G 3X.

This summary of safety and effectiveness enclosed covers the hioxifilcon B lathe-cut lens made by RENZ. Research and Development. Tnc.

A favorable recommendation from the FDA for the BENZ-G 3X (hioxifilcon B) Spherical and Toric Contact Lenses made from HENZ-G 3X (hioxifileon B) in clear or with blue visibility Tint for daily wear use is anticipated. We feel that a review of notification will show that this polymer is close enough to the approved BENZ-G 55 (5X) (hioxifilcon A) (48% water as opposed to 58% water). The BENZ-G 55 (5X) was both safe and effective for its intended purpose of a daily wear contact lens.

Should additional information be desired, please contact Wally Stirling. South East Regulatory Associates, The. 770-475-1668 .

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.