ACUVUE (ETAFILCON A) CONTACT LENS CLEAR & W/VISIBILITY TINT W/UV BLOCKER by VISTAKON, JOHNSON & JOHNSON VISION PRODUCTS, INC.

The ACUVUE 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 ACUVUE MULTIFOCAL Contact Lens is indicated for daily wear for the correction of distance and near vision in presbyopic, aphakic or nonaphakic persons with non-diseased eyes who may have 0.75 D of astigmatism or less.

The ACUVUE Toric Contact Lens is indicated for daily wear for the correction of visual acuity in aphakic or non-aphakic persons with nondiseased eyes that are hyperopic or myopic and may have 10.00 D of astigmatism or less.

Eye care practitioners may prescribe the lens for either single-use disposable wear or 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 only.

Device Description

The ACUVUE (etafilcon A) Soft (hydrophilic) Contact Lens is available as a spherical lens, spherical multifocal lens and an astigmatic (toric) lens. The lens material (etafilcon A) is a copolymer of 2-hydroxyethyl methacrylate and methacrylic acid cross-linked with 1,1,1-trimethylol propane trimethacrylate and ethylene glycol dimethacrylate. The ACUVUE Contact Lens with visibility tint is tinted blue using Reactive Blue Dye #4 to make the lens more visible for handling. A benzotriazole UV absorbing monomer is used to block UV radiation. The average transmittance characteristics are less than 5 % in the UVB range of 280 to 315 nm and less than 30 % in the UVA range of 316 to 380 nm.

AI/ML Overview

The provided text describes a 510(k) submission for ACUVUE (etafilcon A) Contact Lenses, focusing on the substantial equivalence to a predicate device rather than a new medical device requiring extensive acceptance criteria and a standalone study for performance. Here's an analysis based on the provided information:

This submission is for a contact lens, which is a medical device, but the context indicates it's an update to an existing product (ACUVUE with UV blocker) seeking substantial equivalence to a predicate device. Therefore, the "acceptance criteria" and "study" are geared towards demonstrating this equivalence rather than establishing completely new performance benchmarks for a novel AI or diagnostic device.

Here's an attempt to extract and format the information as requested, acknowledging the limitations of applying these categories to a contact lens 510(k) submission:

Acceptance Criteria and Device Performance for ACUVUE (etafilcon A) Contact Lens (with UV blocker)

The primary "acceptance criteria" for this 510(k) submission are based on demonstrating substantial equivalence to the predicate device, ACUVUE (etafilcon A) Contact Lens clear and with visibility tint. Performance is largely assessed through a comparative analysis of physical and chemical characteristics.

1. Table of Acceptance Criteria and Reported Device Performance

Characteristic	Acceptance Criterion (Predicate Device Label Claim)	Reported Device Performance (Subject Device Measured Avg)	Comparison/Outcome
% Water Content	58%	60%	Close to claim, slightly higher
Refractive Index @ 20° C	1.40 ± 0.01	1.40	Meets claim
Dk (Fatt method, non-edge corrected)	28 + 5.6 x 10⁻¹¹ cm²/sec (ml O₂/ml*mmHg)	26 x 10⁻¹¹ cm²/sec (ml O₂/ml*mmHg)	Within the range of the predicate, slightly lower than mean but within acceptable variance (implied by 5.6 variability)
Color	light blue	light blue	Matches predicate
% T @ 593 nm	85% minimum	Conforms	Meets minimum
% T @ 280 - 315 nm	avg < 5%	2.0%	Meets criterion (significantly less than 5%)
% T @ 316 - 380 nm	avg < 30%	15.3%	Meets criterion (significantly less than 30%)
Base Curve Radius, mm	8.8 mm	8.87 mm	Very close to claim
Diameter, mm	14.0 mm	14.05 mm	Very close to claim
Power, Diopters	-1.00 D	-0.97 D	Very close to claim

Note: The "acceptance criteria" here are the established specifications or performance of the predicate device, or general industry standards for contact lenses. The subject device demonstrates performance within these established ranges or meets the specific new UV blocking claims.

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

Sample Size: Not explicitly stated for each characteristic measurement. The values "% Water Content", "Refractive Index", "Dk", "Base Curve Radius", "Diameter", and "Power" are reported as "Measured (avg)", suggesting measurements were taken on a sample of devices.
Data Provenance: Not explicitly stated (e.g., country of origin). The studies appear to be internal or contracted by Vistakon, Johnson and Johnson Vision Products, Inc. The toxicology studies were conducted by a contract laboratory under Good Laboratory Practice Regulations.
Retrospective or Prospective: The physical and chemical characterization data would be considered prospective in the sense that new samples of the subject device were manufactured and tested for these properties.

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

N/A. For this type of device (contact lens) and submission (510(k) for substantial equivalence), "experts" are not typically used to establish a "ground truth" for the test set in the way they would be for an AI diagnostic device (e.g., radiologists for image interpretation). The "ground truth" is based on objective physical, chemical, and biological measurements and established safety standards.

4. Adjudication method for the test set

N/A. Adjudication methods (like 2+1, 3+1) are common in studies involving subjective interpretation (e.g., image analysis by multiple readers). Here, the testing involves objective measurements of material properties, toxicology, and sterility, which do not require interpretive adjudication.

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

N/A. This is not an AI-assisted device. The submission pertains to contact lenses, not diagnostic or interpretive software.

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

N/A. This is not an algorithm or software device. Performance is inherent to the physical product.

7. The type of ground truth used

For the various aspects of the device, the "ground truth" is established by:

Physical and Chemical Measurements: Objective measurements using validated laboratory methods (e.g., for water content, refractive index, Dk, transmittance, dimensions, power).
Toxicology Studies: In vivo and in vitro laboratory assays (e.g., ocular irritation, systemic toxicity, cytotoxicity, oral gavage toxicity, Ames test) with outcomes interpreted against pre-defined safety thresholds and regulatory standards.
Microbiology Studies: Validation of sterilization processes to achieve a specified Sterility Assurance Level (SAL) and compatibility with approved lens care products.
Material Property Data: Comparison of chemical compositions and properties to established standards and the predicate device.
Leachable Studies: Laboratory analysis to detect leachable monomers or additives against detection limits.

8. The sample size for the training set

N/A. This is not a machine learning or AI device that requires a "training set." The product's properties are determined by its manufacturing process and material composition, not by learning from a dataset.

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

N/A. As there is no training set, this question is not applicable.

Summary of Non-Clinical Studies Mentioned (Acting as the "Study" for Acceptance Criteria Demonstration):

The document primarily relies on non-clinical studies to demonstrate safety and substantial equivalence:

Toxicology Studies:
- Ocular Irritation (on molded etafilcon A contact lenses)
- USP Systemic Toxicity (on molded etafilcon A contact lenses)
- Cytotoxicity (on molded etafilcon A contact lenses)
- 4-week Oral Gavage Toxicity Study in Rats (on neat UV absorbing additive)
- Ames Salmonella/Microsome Reverse Mutation Assay (on neat UV absorbing additive)
- Conducted by a contract laboratory under Good Laboratory Practice Regulations.
Microbiology Studies:
- Validation of moist heat sterilization process (minimum SAL of 10⁻⁶).
- Shelf-life stability data to support sterility claims.
Chemistry Studies:
- Material property data comparison between current and modified materials (showing no significant differences except for UV transmittance).
- Compatibility with Group IV lens care products (relying on prior demonstrations).
- Leachable materials studies from finished lenses (indicating no leachable monomers or additives at detection levels).
Shelf-life Studies:
- Protocols approved under N18-033, with initial shelf-life declared based on data, and a minimum of six months of real-time data collected.

Conclusion Drawn from Studies:
The studies support the safety and effectiveness of the device and its substantial equivalence to the predicate device, especially regarding the addition of a UV blocker. Clinical studies were explicitly not required for this Premarket notification because the USAN name and process are the same as the predicate device.

Summary

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Summary of 510(k) Submission

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1. Name andaddress ofsubmitter	Vistakon, Johnson and Johnson Vision Products, Inc.4500 Salisbury Road, Suite 300Jacksonville, Florida 32216Contact: Denise E. McEachernPhone: 904-443-1762Date Prepared: July 17, 1996
2. Identificationof Device	a. Trade name: ACUVUE (etafilcon A) Contact Lens clear and visibility tintwith UV blockerb. Common or Usual Name: Soft (hydrophilic Contact Lens (daily wear)c: Classification II
3. PredicateDevice	ACUVUE (etafilcon A) Contact Lens clear and with visibility tint
4. Descriptionof Device	The ACUVUE (etafilcon A) Soft (hydrophilic) Contact Lens is available as aspherical lens, spherical multifocal lens and an astigmatic (toric) lens. The lensmaterial (etafilcon A) is a copolymer of 2-hydroxyethyl methacrylate andmethacrylic acid cross-linked with 1,1,1-trimethylol propane trimethacrylateand ethylene glycol dimethacrylate. The ACUVUE Contact Lens with visibilitytint is tinted blue using Reactive Blue Dye #4 to make the lens more visible forhandling. A benzotriazole UV absorbing monomer is used to block UVradiation. The average transmittance characteristics are less than 5 % in theUVB range of 280 to 315 nm and less than 30 % in the UVA range of 316 to380 nm.

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S. Intended Use The ACUVUE Contact Lens (spherical) is indicated for daily wear for the correction of refractive ametropia (myopia, hyperopia and presbyopia) in (indications) aphakic or non-aphakic persons with non-diseased eyes who may have 1.00 D of astigmatism or less.

The ACUVUE MULTIFOCAL Contact Lens is indicated for daily wear for the correction of distance and near vision in presbyopic, aphakic or nonaphakic persons with non-diseased eyes who may have 0.75 D of astigmatism or less.

A characteristics comparison to the predicate device is presented below. 6. 2 Characteristics

Characteristic	Predicate DeviceMeasured (avg)	Subject DeviceMeasured (avg)	Subject andPredicate DeviceLabel Claim
% Water Content	59%	60%	58%
Refractive Index @ 20° C	1.40	1.40	$1.40 \pm 0.01$
Dk (Fatt method, non-edgecorrected)	$30 \times 10^{-11}$ (cm²/sec)(ml O₂/mlmmHg)	$26 \times 10^{-11}$ (cm²/sec)(ml O₂/mlmmHg)	$28 + 5.6 \times 10^{-11}$ cm²/sec)(ml O₂/mlmmHg)
Color	light blue	light blue	light blue
% T @ 593 nm	Conforms	Conforms	85 % minimum
% T @ 280 - 315 nm	N/A	2.0	avg < 5%
% T @ 316 - 380 nm	N/A	15.3	avg < 30%
Base Curve Radius, mm	8.84 mm	8.87 mm	8.8 mm
Diameter, mm	14.02 mm	14.05 mm	14.0 mm
Power, Diopters	-0.95 D	-0.97 D	-1.00 D

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The following information summarizes the nonclinical data. The references to 6.b. Nonclinical studies with lens care apply only to the frequent replacement wear schedule of studies the device.

In accordance with the May 1994 Guidance Document for Daily Wear contact 6. b. 1. Toxicology lenses, toxicology studies have been conducted on the molded etafilcon A soft (hydrophilic) contact lenses with visibility and UV absorber. The Ocular Irritation and USP Systemic Toxicity studies indicate the extracts would not be considered ocular irritants, nor systemically toxic under the conditions of the study. 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 packaging materials, as the materials are the same as those previously tested and reported under N18-033.

Two additional toxicology studies have been conducted on the neat UV absorbing additive. These studies were: (1) 4 week Oral Gavage Toxicity Study in Rats with a 2 week Recovery and (2) The Ames Salmonella/Microsome Reverse Mutation Assay - Preincubation Method. The results of the studies were: Based on the data presented in the 4 Week Oral Gavage Toxicity Study, the no observable adverse effect level for the test article in rats appears to be 50 mg/kg; the results of Ames Salmonella/Microsome Reverse Mutation Assays - Preincubation Method indicate that under the conditions of the study, the test article did not induce positive increases in the numbers of histidine revertants per plate of any of the tester strains either in the presence or absence of Aroclor-induced rat liver microsomes.

6.b.2. Microbiology

The lens sterilization process, moist heat sterilization, has been validated to deliver a minimum SAL of 10°. The lens falls into FDA Group IV. 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 is shelf-life stability data supporting that the lens remains sterile through the shelf-life claimed for the product.

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6.b.3.Chemistry	Material property data were generated on the current and modified materials.There are no significant differences in the properties of the current or modifiedmaterials except where expected, % T in the UV range. The lens care productmanufacturers have previously shown compatibility of group IV lenses withtheir products.
6.b.4. Shelf-life	Shelf-life stability protocols have been approved under N18-033. The initialshelf-life of the lens will be declared based on the data generated under anapproved protocol. Shelf-life will not be claimed until a minimum of sixmonths of real time data have been collected and found to be acceptable.
6.b.5.Leachables	Studies were conducted to determine the leachable materials from the finishedlens. The results indicate that, at the levels of detection reported, there are noleachable monomers or additives.
6.c. Summary ofClinical Studies	Clinical studies were not required for this Premarket notification as the USANname and process are the same as the predicate device.
6.d. ConclusionsDrawn fromStudies	1. Validity of Scientific DataToxicology studies were conducted by a contract laboratory underGood Laboratory Practice Regulations. The laboratory has beenaudited by Vistakon and found to be in compliance. Microbiology,chemistry, shelf-life stability, and leachables studies were conducted byin-house laboratories and followed scientific protocols. The data weredetermined to be scientifically valid under 21 CFR 860.7.
	2. Safety and EffectivenessThe data presented in this Premarket Notification support the safetyand effectiveness of the subject device when used in accordance withthe labeled directions for use and for the requested indication. Thesubject device has been shown to be substantially equivalent to thepredicate device.
	3. Risk and BenefitsThe risks of the subject device are the same as those normallyattributed to the wearing of soft (hydrophilic) contact lenses on andaily wear basis. The benefits to the patient are the same as those forother 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.