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510(k) Data Aggregation
(30 days)
ACUVUE (ETAFILCON A) CONTACT LENS, CLEAR AND WITH VISIBILITY TINT WITH UV BLOCKER, FOR DAILY WEAR
The VISTAKON (etafilcon A) Soft (hydrophilic) Contact Lens (spherical), Clear and Visibility Tinted with UV Blocker, for Daily Disposable Wear is indicated for daily wear for the correction of refractive ametropia (myopia and hyperopia) in aphakic or not-aphakic persons with not diseased eyes who may have 1.00D or less of astigmatism.
The VISTAKON (etafilcon A) Soft (hydrophilic) Bifocal Contact Lens, Clear and Visibility Tinted with UV Blocker, for Daily Disposable Wear is indicated for daily wear for the correction of distance and near vision in presbyopic, aphakic or not-aphakic persons with non-diseased eyes who may have 0.75 D of astigmatism or less.
The VISTAKON (etafilcon A) Soft (hydrophilic) Toric Contact Lens, Clear and Visibility Tinted with UV Blocker, for Daily Disposable Wear is indicated for daily wear for the correction of visual acuity in aphakic or not-aphakic persons with non-diseased eyes who are hyperopic or myopic and may have 10.00 D of astigmatism or less.
The VISTAKON (etafilcon A) Soft (hydrophilic) Toric Bifocal Contact Lens, Clear and Visibility Tinted with UV Blocker, for Daily Disposable Wear is indicated for daily wear for the correction of distance and near vision in presbyopic aphakic or not aphakic persons with non-diseased who may have 10.00 D of astigmatism or less.
VISTAKON (etafilcon A) Soft (hydrophilic) Contact Lens, Clear and Visibility Tinted with UV Blocker, for Daily Disposable Wear help protect against transmission of harmful UV radiation to the cornea and into the eye.
The VISTAKON (etafilcon A) Soft (hydrophilic) Contact Lens, Clear and Visibility Tinted with UV Blocker, for Daily Disposable Wear is to be prescribed for Daily Disposable Wear and is to be discarded after each removal.
The VISTAKON® (etafilcon A) Soft (hydrophilic) Contact Lens, Clear and Visibility Tinted with UV Blocker for Daily Disposable Wear 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 trimethacrylate. The VISTAKON® 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. The lens is a hemispherical shell.
Here's the breakdown of the acceptance criteria and study information based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
| Property | Acceptance Criteria (Predicate Label Claim) | Reported Device Performance (Subject Device Label Claim) |
|---|---|---|
| Water Content, % | 58 | 58 |
| Refractive Index @ 20° C | 1.40 | 1.40 |
| Dk-Fatt method, non-edge corrected (cm²/sec)(ml O₂/mlmmHg) | 28.0 x 10⁻¹¹ | 28.0 x 10⁻¹¹ |
| Specific Gravity, (calc.) | 0.98 - 1.12 | 0.98 - 1.12 |
| Light Transmission | Minimum 85% | Minimum 85% |
| Base Curve Radius, mm | 7.85 mm to 10.0 mm | 7.85 mm to 10.0 mm |
| Diameter, mm | 12.0 mm to 15.0 mm | 12.0 mm to 15.0 mm |
| Power, Diopters | Varies with power: 0.06 mm to 1.00 mm | Varies with power: -20.0 D to + 20.0 D |
| Center Thickness, mm | -20.0 D to + 20.0 D | 0.06 mm to 1.00 mm |
Note on Power and Center Thickness: The table in the document has the Power and Center Thickness rows swapped in the "Subject Device Label Claim" column compared to the "Predicate Device Label Claim" column. I have listed them as they appear in the document for the subject device.
2. Sample Size Used for the Test Set and Data Provenance
The document explicitly states: "The technological characteristics, formulation, manufacturing, and sterilization processes are the same as the predicate device, therefore no clinical data is required." This implies that there was no separate "test set" in the context of a clinical study for the subject device. The equivalence was established based on non-clinical testing and comparison to the predicate device's established performance.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
Not applicable. No clinical test set requiring expert ground truth was performed for the subject device.
4. Adjudication Method for the Test Set
Not applicable. No clinical test set was performed.
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 contact lens, not an AI-assisted diagnostic tool.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was Done
Not applicable. This device is a contact lens, not an algorithm.
7. The Type of Ground Truth Used
The "ground truth" for the subject device's performance was established through:
- Non-clinical testing: This includes Toxicology Testing (Cytotoxicity, Ocular Irritation, Systemic Toxicity), Leachables, Physical/Chemical Testing, and Stability Testing.
- Comparison to a legally marketed predicate device: The predicate device, 1-DAY ACUVUE® Brand (etafilcon A) Contact Lens cleared via K013973, served as the established "ground truth" for acceptable performance and safety. The subject device demonstrated substantial equivalence based on identical technological characteristics and non-clinical test results.
8. The Sample Size for the Training Set
Not applicable. The document describes a medical device (contact lens), not a machine learning or AI model that requires a training set.
9. How the Ground Truth for the Training Set Was Established
Not applicable. No training set was used.
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(75 days)
ACUVUE (ETAFILCON A) CONTACT LENS CLEAR & W/VISIBILITY TINT W/UV BLOCKER
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.
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.
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 |
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