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510(k) Data Aggregation
(245 days)
ACUVUE® OASYS MAX 1-DAY Contact Lenses (senofilcon A) are indicated for daily disposable wear for the correction of vision in people with non-diseased eyes who are nearsighted (hyperopic) and may have 1.00D or less of astigmatism that does not interfere with visual acuity.
ACUVUE® OASYS MAX 1-DAY Contact Lenses for ASTIGMATISM (senofilcon A) are indicated for daily disposable wear for the correction of vision in people with non-diseased eyes who may be nearsighted (myopic) or farsighted (hyperopic) and have 10.00D or less of astigmatism.
ACUVUE® OASYS MAX 1-DAY MULTIFOCAL Contact Lenses (senofilcon A) are indicated for daily disposable wear for the correction of vision in people with non-diseased eyes who are presbyopic and may be nearsighted (myopic) or farsighted (hyperopic) and may have 0.75D or less of astigmatism that does not interfere with visual acuity.
ACUVUE® OASYS MAX 1-DAY MULTIFOCAL Contact Lenses for ASTIGMATISM (senofilcon A) are indicated for daily disposable wear for the correction of vision in people with non-diseased eyes who are presbyopic and may be nearsighted (myopic) or farsighted (hyperopic) and have 10.00D or less of astigmatism.
The lenses are to be prescribed for daily disposable wear. Therefore, no cleaning or disinfection is required. Lenses should be discarded upon removal.
The subject device is a soft (hydrophilic) contact lens available in a spherical, toric, multifocal and/or multifocal toric design. The composition of the lens is 62% senofilcon A and 38% water by weight when hydrated and stored in the buffered saline solution with methyl ether cellulose. The lens is supplied sterile (steam) in a foil sealed plastic package. The lenses are hemispherical or hemitoric shells. To date a 2-year shelf-life has been established.
The subject device is made of a silicone hydrogel material containing an internal wetting agent. The lens is tinted using Reactive Blue 247. A benzotriazole UV absorbing monomer is used to block UV radiation in combination with a novel fused tricyclic chromophore that also blocks UV radiation and reduces transmittance in the range from 380 nm to 450 mm.
The provided document is a 510(k) Premarket Notification for ACUVUE® OASYS MAX 1-DAY Contact Lenses (senofilcon A). It focuses on demonstrating substantial equivalence to predicate and reference devices, primarily through technological characteristics and non-clinical performance data, rather than new clinical performance data for the subject device.
Therefore, the document does not contain the following information typically associated with a study proving a device meets acceptance criteria:
- A table of acceptance criteria and reported device performance based on a new clinical study.
- Sample sizes used for a new clinical test set.
- Number of experts used to establish ground truth or qualifications of those experts.
- Adjudication methods for a new clinical test set.
- Multi-reader multi-case (MRMC) comparative effectiveness study results.
- Standalone (algorithm only) performance data.
- Type of ground truth used (as no new clinical ground truth development is described).
- Sample size for a training set (as this is not an AI/ML device with a training phase).
- How ground truth for a training set was established.
Instead, the document states:
"Demonstration of the physical, chemical and sphere/toric optical design equivalency of the subject device to the predicate device and multifocal design equivalency to the reference device supports the safety and effectiveness of the subject device. Therefore, in accordance with FDA Premarket Notification (510(k)) Guidance Document for Daily Wear Contact Lenses, May 12, 1994, clinical performance data to demonstrate substantial equivalence are not required."
This indicates that the acceptance criteria for this device's approval were primarily based on its technological similarity and non-clinical performance data being equivalent to already approved devices, rather than a new clinical trial proving performance against defined clinical acceptance criteria.
However, the document does list non-clinical performance data (in-vitro and in-vivo tests) that were performed to assess properties, safety, and effectiveness. While not a "clinical study" in the sense of patient outcomes for acceptance criteria, these tests serve a similar purpose for demonstrating safety and performance.
Here's an attempt to extract relevant information based on the provided text, interpreting "acceptance criteria" as meeting the standards set by the predicate/reference devices and safety tests, since a traditional clinical study with defined performance metrics isn't presented:
Acceptance Criteria and Device Performance (Based on Non-Clinical Data and Substantial Equivalence)
The approval of the ACUVUE® OASYS MAX 1-DAY Contact Lenses (senofilcon A) was primarily based on demonstrating substantial equivalence to predicate and reference devices through:
- Comparison of technological characteristics.
- Non-clinical performance data (in-vitro and in-vivo tests) to assess properties and safety.
The acceptance criteria are implicitly met by demonstrating that the subject device's properties and safety profile are comparable to or within acceptable ranges of previously cleared devices and established safety standards.
1. Table of Acceptance Criteria (Implied by Predicate/Reference Equivalence and Non-Clinical Tests)
| Characteristic/Property | Acceptance Criteria (Implied by Predicate/Reference & Standards) | Reported Device Performance (Subject Device) |
|---|---|---|
| Material | senofilcon A | senofilcon A |
| ISO Classification Group | Group 5C (Silicone hydrogel: low water subgroup) | Group 5C (Silicone hydrogel: low water subgroup) |
| UV Blocker | Yes | Yes |
| Water Content | 38% | 38% |
| Refractive Index | 1.42 | 1.42 |
| Oxygen Permeability (Dk) | 103 x 10⁻¹¹ (cm²/sec)(mL O₂/mL * mm Hg) | 103 x 10⁻¹¹ (cm²/sec)(mL O₂/mL * mm Hg) |
| Specific Gravity | 0.98-1.12 | 0.98-1.12 |
| Light Transmittance: Visible (380-780 nm) | ≥ 78% | ≥ 78% (varies with power) |
| Light Transmittance: (451-780 nm) | ≥ 90% | ≥ 90% |
| Light Transmittance: (380-450 nm) | < 45% | < 45% |
| Light Transmittance: UVA (315-380 nm) | < 10.0% | < 10.0% |
| Light Transmittance: UVB (280-315 nm) | < 1.0% | < 1.0% |
| Biocompatibility | Non-toxic, non-irritating (per ISO 10993 standards) | Non-toxic, non-irritating |
| Indicated Use & Wear Schedule | Equivalent to predicate/reference for daily disposable wear | Equivalent to predicate/reference for daily disposable wear |
2. Sample Sizes and Data Provenance (for Non-Clinical Tests)
- Sample Sizes: Not explicitly stated for each specific non-clinical test (e.g., number of lenses tested for oxygen permeability, number of animals in biocompatibility studies). The document mentions "a series of in-vitro and in-vivo tests."
- Data Provenance: The tests were conducted following the 1994 FDA Guidance Document for Daily Wear Contact Lenses. Biocompatibility tests were conducted in accordance with GLP regulation (21 CFR Part 58). Other testing was conducted according to valid scientific protocols. The location of these tests (e.g., country of origin) is not specified. The data is retrospective in the sense that it was collected prior to this submission but not from a new clinical patient study.
3. Number of Experts and Qualifications for Ground Truth
- This information is not applicable as the submission relies on non-clinical tests and substantial equivalence to previously approved devices, not a new clinical study requiring human expert consensus for ground truth on patient data.
4. Adjudication Method for the Test Set
- Not applicable, as there was no clinical test set requiring human adjudication for ground truth.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
- Not applicable. This is not an AI/ML device that assists human readers, nor is it a device that measures improved diagnostic accuracy over human readers. Its approval is based on safety, physical properties, and equivalence to existing contact lenses.
6. Standalone Performance
- Not applicable in the context of AI/ML or diagnostic devices. The "standalone performance" of the device refers to its inherent physical, chemical, and optical characteristics and biocompatibility, as detailed in the non-clinical performance data.
7. Type of Ground Truth Used
- For the purpose of substantial equivalence and safety, the "ground truth" is derived from:
- Established industry standards and material properties: Such as ISO standards (e.g., ISO 18369-1:2017) for material classification and physicochemical test methods (e.g., Fatt method for Dk).
- Regulatory safety guidelines: FDA Guidance Document for Daily Wear Contact Lenses (1994) and GLP regulations (21 CFR Part 58).
- Prior approval for predicate/reference devices: The performance and safety profiles of the VISTAKON (senofilcon A) Soft Contact Lens (K042275) and ACUVUE® (etafilcon A) Soft Contact Lens for Presbyopia (K141670) serve as the "ground truth" for equivalence.
8. Sample Size for the Training Set
- Not applicable. This device is not an AI/ML algorithm that requires a "training set."
9. How the Ground Truth for the Training Set was Established
- Not applicable, as there is no AI/ML training set.
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(46 days)
The ACUVUE® (senofilcon A) Soft Contact Lens MULTIFOCAL is indicated for daily wear for the optical correction of refractive ametropia (myopia and hyperopia) and/or presbyopia in phakic persons with non-diseased eyes who may need up to 4.00 of ADD power and have 0.75D or less of astigmatism.
The ACUVUE® (senofilcon A) Soft Contact Lens MULTIFOCAL TORIC is indicated for daily wear for the optical correction of refractive ametropia (myperopia, and/or astigmatism) and presbyopia in phakic or aphakic persons with non-diseased eyes who may need up to 4.00D of ADD power and may have 10.00D or less of astigmatism.
Eye Care Professionals may prescribe the lenses either for daily disposable wear or frequent/planned replacement wear with cleaning, disinfection and scheduled replacement. When prescribed for daily disposable wear, no cleaning or disinfection is required. Lenses should be discarded upon removal. When prescribed for frequent/planned replacement wear, the lenses may be disinfected using a chemical disinfection system only and should be discarded after the recommended wearing period as prescribed by the Eye Care Professional.
When the lenses are worn in a frequent/planned replacement modality, they are intended to be worn for up to 2 weeks (14 days).
The subject device is a soft (hydrophilic) contact lens available in a multifocal and/or multifocal toric design. The composition of the lens is 62% senofilcon A and 38% water by weight when hydrated and stored in the buffered saline solution with methyl ether cellulose. The lens is supplied sterile (steam) in a foil sealed plastic package. The lenses are hemispherical or hemitoric shells.
The subject device is made of a silicone hydrogel material containing an internal wetting agent. The lens 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 transmittance characteristics for these lenses are less than 1.0% in the UVB range of 280 nm to 315 nm and less than 10.0% in the UVA range of 315 nm to 380 nm for the entire power range.
This document is a 510(k) summary for the ACUVUE® (senofilcon A) Soft Contact Lens MULTIFOCAL and ACUVUE® (senofilcon A) Soft Contact Lens MULTIFOCAL TORIC. It discusses the substantial equivalence of the new device to previously cleared predicate and reference devices.
Here's an analysis of the provided text in the context of the requested information:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly state "acceptance criteria" in the traditional sense of a pass/fail threshold for a study endpoint. Instead, it presents physicochemical properties and parameters of the subject device, which are implicitly the performance characteristics that need to be within an acceptable range to demonstrate equivalence to the predicate and reference devices.
In this case, the "device performance" is the reported property/parameter values.
| Property / Parameter | Reported Device Performance (ACUVUE® (senofilcon A) Soft Contact Lens Multifocal) |
|---|---|
| Water Content | 38% |
| Refractive Index | 1.42 |
| Oxygen Permeability (Fatt method, edge corrected) | 103 x 10-11 (cm²/sec)(mL O2/mL * mm Hg) |
| Oxygen Permeability (Fatt method, non-edge corrected) | 122 x 10-11 (cm²/sec)(mL O2/mL * mm Hg) |
| Light Transmittance: Visible | 89% to 99% |
| Light Transmittance: UVA (315 nm to 380 nm) | < 10.0% |
| Light Transmittance: UVB (280 nm to 315 nm) | < 1.0% |
| DCA Advancing Contact Angle (degree) | 38 – 74 |
| Diameter | 12.0 mm to 15.0 mm |
| Center Thickness, varies with power | 0.060 – 1.000 mm (-3.00D: 0.070 mm, +3.00D: 0.147 mm) |
| Base Curve | 7.85 mm to 10.00 mm |
| Sphere Powers | -20.00D to +20.00D |
| ADD Powers | Up to +4.00D |
| Axis | 2.5° to 180° |
| Cylinder | -0.25D to -10.00D |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
The document explicitly states: "clinical performance data to demonstrate substantial equivalence are not required."
Therefore, there is no "test set" in the context of clinical performance data described in this document. The non-clinical performance data involved "finished product testing for verification of the modified design," but no specific sample sizes or data provenance are provided for these tests.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
Not applicable, as no clinical performance data requiring expert ground truth for a test set was conducted or reported in this document.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable, as no clinical performance data requiring adjudication was conducted or reported in this document.
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-powered diagnostic device. No MRMC study was conducted.
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 AI-powered algorithm. No standalone algorithm performance was assessed.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
Not applicable, as no clinical performance data requiring ground truth was conducted or reported in this document. The "ground truth" for the non-clinical tests would be the established specifications and measurement standards for the material and design properties.
8. The sample size for the training set
Not applicable, as no AI/machine learning model was developed for this device. Therefore, there is no "training set."
9. How the ground truth for the training set was established
Not applicable, as there is no training set for an AI/ML model for this device.
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