VISTAKON (GENFILCON A) CONTACT LENS, CLEAR AND WITH VISIBILIITY TINT by VISTAKON, JOHNSON & JOHNSON VISION PRODUCTS, INC.

The VISTAKON Contact Lens (spherical) is indicated for daily wear for the correction of refractive ametropia (myopia, hyperopia and presbyopia) in aphakic or non-aphakic persons with non-diseased eyes who may have 1.00 D of astigmatism or less.
The VISTAKON MULTIFOCAL Contact Lens is indicated for daily wear for the correction of distance and near vision in presbyopic aphakic or non-aphakic persons with non-diseased eyes who may have 0.75 D of astigmatism or less.
The VISTAKON TORIC Contact Lens is indicated for daily wear for the correction of visual acuity in aphakic or non-aphakic persons with non-diseased eyes that are hyperopic or myopic and may have 10.00 D of astigmatism or less.
Eye care practitioners may prescribe the lens for single-use disposable wear or for frequent/planned replacement wear, with cleaning disinfection and scheduled replacement (see WEARING SCHEDULE). When prescribed for frequent/planned replacement, the lens may be disinfected using a chemical disinfection system only.

Device Description

The VISTAKON (genfilcon A) Soft (hydrophilic) Contact Lens is available as a spherical lens, a spherical multifocal lens and an astigmatic (toric) lens. The lens material (genfilcon A) is a copolymer of 2-hydroxyethyl methacrylate and methacrylic acid cross-linked with tetraethylene glycol dimethacrylate and ethylene glycol dimethacrylate. The VISTAKON Contact Lens with visibility tint is tinted blue using Reactive Blue Dye #4 to make the lens more visible for handling. The VISTAKON Contact Lens is a hemispherical shell.

AI/ML Overview

This document describes the Vistakon (genfilcon A) Contact Lens. The provided text, however, focuses on showing substantial equivalence to a predicate device and does not define explicit acceptance criteria or provide a detailed study report with performance metrics against those criteria. Instead, it outlines the non-clinical and clinical studies conducted to demonstrate safety and effectiveness.

Here's an analysis of the provided information based on the request, with the understanding that specific numerical "acceptance criteria" against which a device's performance is measured are not explicitly stated in this 510(k) summary:

1. Table of Acceptance Criteria and Reported Device Performance

As mentioned, explicit, quantitative "acceptance criteria" are not provided in the typical sense (e.g., "sensitivity must be >X%"). Instead, the studies aim to demonstrate that the device is safe and effective for its intended use and substantially clinically equivalent to the predicate device. The performance is implicitly assessed by showing that it does not pose new or greater risks, and offers comparable benefits to the predicate.

Criteria/Category	Acceptance Criteria (Implicit)	Reported Device Performance
Material Properties (Chemistry)	Properties consistent with FDA Group I lenses; compatible with approved lens care products; acceptable shelf-life stability; no significant difference in leachable materials compared to predicate.	Material property data reflected properties of Group I lenses. Lens care product manufacturers previously showed compatibility with Group I lenses. Shelf-life stability based on approved protocols (initial claim after 6 months real-time data). No significant differences in leachable materials found between subject and predicate device.
Toxicology	Extracts not considered ocular irritants; extracts not considered systemically toxic; lens not cytotoxic.	Ocular Irritation study indicated extracts would not be considered ocular irritants. USP Systemic Toxicity study indicated extracts would not be considered systemically toxic. Cytotoxicity study indicated the lens is not cytotoxic.
Microbiology/Sterilization	Sterilization process validated to deliver a minimum SAL of 10^-6; compatible with approved disinfection efficacy of lens care products; sterility maintained throughout shelf-life.	Moist heat sterilization validated to deliver a minimum SAL of 10^-6. Lens care product manufacturers established disinfection efficacy in lens groups. Shelf-life stability data supports lens sterility.
Clinical Safety & Effectiveness (Daily Wear)	Safe and effective for intended use; substantially clinically equivalent to the predicate device (Optima FW). No new or increased adverse reactions, symptoms, problems, or complaints; comparable slit lamp evaluations, visual acuity, lens wear time, and fit assessment; comparable discontinuation rates.	The VISTAKON (genfilcon A) trial contact lens was found to be safe and effective for its intended use and at least substantially clinically equivalent to the predicate device. Parameters measured included adverse reactions, symptoms, problems and complaints, slit lamp evaluations, visual acuity, lens wear time, fit assessment, and discontinuations. (Specific comparative metrics not provided in this summary, but the conclusion states equivalence).
Overall Legal Standing (510(k) Purpose)	Safety and effectiveness supported; substantially equivalent to the predicate device.	"The data presented in this Premarket Notification support the safety and effectiveness of the subject device... The subject device has been shown to be substantially equivalent to the predicate device."

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

Sample Size: "at least 50 patients with a 2:1 ratio of subject device to predicate device".
- This means 33 patients for the subject device (VISTAKON) and 17 patients for the predicate device (Optima FW), totaling 50 patients.
Data Provenance: Not explicitly stated regarding country of origin. The study was a "clinical trial for daily wear contact lens materials with a new USAN name according to the Premarket Notification (510(k)) Guidance Document for Daily Wear Contact Lenses (May 1994)," which implies it was conducted to meet US regulatory requirements. It was a prospective clinical trial.

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

The document does not describe the establishment of a "ground truth" in the way it would for an AI-powered diagnostic device (e.g., expert consensus on image labels). Instead, patient outcomes and clinical assessments were the primary endpoints.
The clinical trial involved "eye care practitioners" who evaluated parameters such as slit lamp evaluations, visual acuity, and fit assessment. Their specific qualifications (e.g., "ophthalmologist with X years of experience") are not detailed in this summary.

4. Adjudication Method for the Test Set

The document does not mention an adjudication method (such as 2+1 or 3+1 consensus) for the clinical trial data. Clinical trials typically rely on standardized protocols and trained clinical investigators to collect and assess data, not necessarily an "adjudication" panel for ground truth in the AI sense.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size

No, an MRMC comparative effectiveness study, as typically described for AI systems, was not performed. This product is a contact lens, not an AI diagnostic system. The clinical study compares the subject device directly to a predicate device in human patients, assessing endpoints related to safety and performance. There is no concept of "human readers improving with AI vs without AI assistance" in this context.

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

This is not applicable as the submission is for a physical medical device (contact lens), not an algorithm or AI system.

7. The Type of Ground Truth Used

The "ground truth"
- For non-clinical studies: Laboratory measurements, chemical analyses, toxicology tests, and microbiological validation following established scientific protocols and GLP regulations.
- For clinical studies: Patient-reported outcomes (symptoms, complaints), objective clinical measurements (slit lamp evaluations, visual acuity), and assessments by qualified eye care practitioners (fit assessment, adverse reactions). The overall "ground truth" for the clinical trial was the observed safety and effectiveness in patients compared to the predicate device.

8. The Sample Size for the Training Set

This is not applicable, as this is a contact lens submission and does not involve AI or machine learning models that require a "training set."

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

This is not applicable, as there is no training set for an AI model.

Summary

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Summary of 510(k) Submission K 964b12

Summary	The 510(k) submission summary consists of these sections Name and address of submitter Identification of device Predicate device Description of device Intended use Characteristics Non clinical studies Clinical studies Conclusions drawn from studies Flow Chart for 510(k) Daily Wear Contact Lens Materials
Name andaddress ofsubmitter	Vistakon, Johnson & Johnson Vision Products, Inc.4500 Salisbury Road, Suite 300Jacksonville, Florida 32216Contact: Susan L. WaltonPhone: 904/443-1439Date Prepared: November 14, 1996
Identification ofDevice	Trade name: VISTAKON (genfilcon A) Contact Lens, clear and with visibility tint. Common or usual name: Soft (hydrophilic) Contact Lens (daily wear) FDA Classification: Class II
PredicateDevice	Optima FW (polymacon) Visibility Tinted Contact Lens
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Description ofDevice	The VISTAKON (genfilcon A) Soft (hydrophilic) Contact Lens is available asa spherical lens, a spherical multifocal lens and an astigmatic (toric) lens. Thelens material (genfilcon A) is a copolymer of 2-hydroxyethyl methacrylate andmethacrylic acid cross-linked with tetraethylene glycol dimethacrylate andethylene glycol dimethacrylate. The VISTAKON Contact Lens with visibilitytint is tinted blue using Reactive Blue Dye #4 to make the lens more visible forhandling. The VISTAKON Contact Lens is a hemispherical shell.
Intended Use	The VISTAKON Contact Lens (spherical) is indicated for daily wear for thecorrection of refractive ametropia (myopia, hyperopia and presbyopia)in aphakic or non-aphakic persons with non-diseased eyes who mayhave 1.00 D of astigmatism or less.The VISTAKON MULTIFOCAL Contact Lens is indicated for daily wear forthe correction of distance and near vision in presbyopic aphakic ornon-aphakic persons with non-diseased eyes who may have 0.75 D ofastigmatism or less.The VISTAKON TORIC Contact Lens is indicated for daily wear for thecorrection of visual acuity in aphakic or non-aphakic persons with non-diseased eyes that are hyperopic or myopic and may have 10.00 D ofastigmatism or less.
	Eye care practitioners may prescribe the lens for single-use disposable wear orfor frequent/planned replacement wear, with cleaning disinfection andscheduled replacement (see WEARING SCHEDULE). When prescribed forfrequent/planned replacement, the lens may be disinfected using a chemicaldisinfection system only.
Characteristics	The VISTAKON (genfilcon A) Contact Lens is classified into FDA Group Ifor contact lens materials. The predicate device was chosen from FDA GroupI. The VISTAKON (genfilcon A) Contact Lens is compared to the predicatedevice in the following table.Continued on next page

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	VISTAKON (genfilcon A)Contact Lens with visibilitytint		Optima FW Visibility TintedContact Lens
	Measured	Label	Measured	Label
Water Content, %	47.5	48	41.2	38.6
Refractive Index @ 20°C	1.43	1.43	1.44	1.43
Dk, non-edge corrected	14.1	13.0	7.5	8.5*
Color (if tinted)	light blue	light blue	light blue	light blue
Base Curve, mm	8.6	8.6	8.4	8.7
Diameter, mm	14.0	14.0	14.0	14.0
Power, D	-0.99	-1.00	-0.98	-1.00

Dk units = x 10''' (cm²/sec) (ml O½ml x mm Hg) *edge correction method not identified in Bausch & Lomb labeling

Non clinicalStudies	Included as non clinical studies are chemistry, toxicology, lenses and package, microbiology
Chemistry	Material property data were generated on the subject device and the predicate device. The data for both devices reflect properties of Group I lenses. The lens care product manufacturers have previously shown compatibility of Group I lenses with their products.
	The shelf-life stability for VISTAKON (genfilcon A) Contact Lenses is based upon approved stability protocols from N18-033. The initial shelf-life of the lens will be declared based on the data generated under one of these protocols. Shelf-life will not be claimed until a minimum of six months of real time data have been collected and found to be acceptable.
	Studies were conducted to determine the leachable materials from the subject and predicate devices. The results indicate that, at the levels of detection reported, there are no significant differences between the subject device and the predicate device.
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In accordance with the May 1994 Guidance Document for Daily Wear contact Toxicology, lenses, toxicology studies have been conducted on the VISTAKON (genfilcon genfilcon A lens A) soft (hydrophilic) contact lenses, clear and with visibility tint. material 1. The Ocular Irritation study indicates the extracts would not be considered ocular irritants under the conditions of the study. The USP Systemic Toxicity study indicates the extracts would not be 2. considered systemically toxic under the conditions of the study. 3. The Cytotoxicity study indicates that the lens is not cytotoxic under the conditions of the study. No additional toxicology studies have been conducted on the plastic primary Toxicology, package packaging materials, as the materials are the same as those previously tested materials and reported under N18-033. The lens sterilization process, moist heat sterilization, has been validated to Microbiology deliver a minimum SAL of 10d. The lens care product manufacturers have established a reasonable assurance of disinfection efficacy of their care products with the lens groups for which they are approved. The lens will be presented in the same primary package currently used for other products approved under N18-033. There are shelf-life stability data which support lens sterility throughout the shelf-life claimed for the product. The safety of the lens material in the spherical design has been confirmed Clinical studies through a clinical trial for daily wear contact lens materials with a new USAN name according to the Premarket Notification (510(k)) Guidance Document for Daily Wear Contact Lenses (May 1994). The study evaluated at least 50 patients with a 2:1 ratio of subject device to predicate device for three (3) months. Parameters measured included adverse reactions, symptoms, problems and complaints, slit lamp evaluations, visual acuity, lens wear time. fit assessment and discontinuations. The VISTAKON (genfilcon A) trial contact lens was found to be safe and effective for its intended use and at least substantially clinically equivalent to the predicate device.

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Conclusions drawn from studies

1. Validity of Scientific Data

Toxicology studies were conducted by a contract laboratory under Good Laboratory Practice Regulations. Microbiology, chemistry, shelf-life stability, and leachables studies were conducted by in-house laboratories and followed scientific protocols. The data were determined to be scientifically valid under 21 CFR 860.7.

2. Safety and Effectiveness

The data presented in this Premarket Notification support the safety and effectiveness of the subject device when used in accordance with the labeled directions for use and for the requested indication. The subject device has been shown to be substantially equivalent to the predicate device.

3. Risk and Benefits

The risks of the subject device are the same as those normally attributed to the wearing of soft (hydrophilic) contact lenses on a daily wear basis. The benefits to the patient are the same as those for other soft (hydrophilic) contact lenses.

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.