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510(k) Data Aggregation
(59 days)
The ACUVUE® (senofilcon C) Soft (hydrophilic) Contact Lens (spherical) is indicated for daily wear for the optical correction of refractive ametropia (myperopia) in phakic or aphakic persons with non-diseased eyes who may have 1.00D or less of astigmatism.
The ACUVUE® (senofilcon C) Soft (hydrophilic) Contact Lens TORIC is indicated for daily wear for the optical correction of refractive ametropia (myperopia) in phakic or aphakic persons with non-diseased eyes who may have 10.00D or less of astigmatism.
The ACUVUE® (senofilcon C) Soft (hydrophilic) Contact Lens MULTIFOCAL is indicated for the optical correction of refractive ametropia (myperopia) and/or presbyopia in phakic or aphakic persons with nondiseased eyes who may need up to 4.00D of ADD power and may have 0.75D of astigmatism or less.
The ACUVUE® (senofilcon C) Soft (hydrophilic) Contact Lens MULTIFOCAL TORIC is indicated for daily wear for the optical correction of refractive ametropia (myopia, hyperopia, 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 of astigmatism or less.
These lenses contain a UV Blocker to help protect against transmission of harmful UV radiation to the cornea and into the eye.
Eye Care Professionals may prescribe the lenses either for daily disposable wear or frequent/planned replacement wear with cleaning, disinfection and scheduled replacement (see REPLACEMENT SCHEDULE). When prescribed for daily disposable wear, lenses should be discarded upon removal. When prescribed for frequent/planned replacement wear, the lenses may be disinfected using a chemical disinfection system only. The contact lens is to be discarded after the recommended wearing period as prescribed by the Eye Care Professional.
The ACUVUE® (senofilcon C) Soft Contact Lens is a soft (hydrophilic) contact lens available in a spherical, toric, multifocal and/or multifocal-toric design. The composition of the lens is 59% senofilcon C and 41% water by weight when hydrated and stored in 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 4-year shelf-life has been established.
The ACUVUE® (senofilcon C) Soft Contact Lens 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 are less than 1% in the UVB range of 280 nm to 315 nm and less than 10% in the UVA range of 316 nm to 380 nm for the entire power range.
This document is a 510(k) premarket notification for ACUVUE® VITA™ (senofilcon C) Brand (Soft) Contact Lenses. It details the safety and efficacy of the device by comparing it to a predicate device.
Here's an analysis of the acceptance criteria and the study proving the device meets them:
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria are implicitly defined by the demonstration of "substantial equivalence" to the predicate device in various safety and performance aspects. The reported device performance is outlined against these implicit criteria through direct comparison with the predicate device.
| Acceptance Criteria (Implicit from Predicate Equivalence) | Reported Device Performance (ACUVUE® (senofilcon C)) |
|---|---|
| Material Properties: | Material Properties: |
| Water Content (Predicate: 48%) | 41% |
| Refractive Index (Predicate: 1.40) | 1.42 |
| Oxygen Permeability (Dk) (Predicate: 128e) | 103d (edge corrected), 122e (non-edge corrected) |
| Specific Gravity (Predicate: 1.04) | 0.98-1.12 |
| UV Blocker presence | Yes (Predicate: No) |
| Indications for Use: | Indications for Use: |
| Spherical Lens: Optical correction of ametropia | Same, with potentially different astigmatism limits (1.00D or less vs. 2.00D or less for predicate) |
| Toric Lens: Optical correction of ametropia (astigmatism) | Same, with different astigmatism limits (10.00D or less vs. 0.25 to -5.00D for predicate) |
| Multifocal Lens: Optical correction of ametropia/presbyopia | Same, with different ADD power and astigmatism limits (up to 4.00D ADD and 0.75D astigmatism or less vs. +0.50 to +3.00D ADD and 2.00D astigmatism or less for predicate) |
| Multifocal-Toric Lens: Optical correction of ametropia/presbyopia/astigmatism | Indicated (Predicate: Not applicable) |
| Daily/Frequent replacement wear | Daily disposable wear or frequent/planned replacement wear |
| Clinical Performance: | Clinical Performance: |
| Overall performance in vision and health comparable to predicate | Demonstrated similar overall performance in clinically relevant areas of vision and health. |
| Safety Profile (e.g., adverse events, slit lamp findings) | Similar to predicate, non-toxic, non-irritating lens material. |
Note: Differences in specific values (e.g., water content, Dk, specific astigmatism limits) are presented and argued not to adversely affect safety and efficacy.
2. Sample Size Used for the Test Set and Data Provenance
- Test Set (Clinical Study):
- Sample Size: 221 subjects total (109 for the test lens, 112 for the control lens).
- Data Provenance: Conducted in the U.S. (United States), described as a prospective, randomized, parallel group design.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
The document does not specify the number of experts or their qualifications for establishing ground truth for the clinical test set beyond implying the involvement of "Eye Care Professionals" who would make clinical determinations (e.g., for visual acuity, slit lamp findings, etc.). It mentions "clinical evaluation" and "clinically relevant areas of vision and health," which implies expert assessment, but no explicit details on the number or their specific qualifications (e.g., years of experience, subspecialty) are provided.
4. Adjudication Method for the Test Set
The document does not explicitly state an adjudication method (e.g., 2+1, 3+1). It describes a "prospective, randomized, parallel group design" clinical study, where data points like slit lamp findings and visual acuity were collected. This suggests standard clinical assessment by the study's optometrists/ophthalmologists, but no specific multi-reader adjudication process is detailed for reaching a "ground truth."
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size
No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not conducted. This study's design was a direct clinical comparison of the new contact lens to a predicate contact lens, focusing on physiological and performance equivalence, not on the improvement of human readers with AI assistance. The device is a contact lens, not an AI diagnostic tool.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
This question is not applicable. The device is a contact lens, not an algorithm or AI system. Therefore, standalone performance (without human-in-the-loop) is not a relevant concept for this product.
7. The Type of Ground Truth Used
For the clinical study, the "ground truth" was established through standard clinical assessments and measurements performed by Eye Care Professionals during the study. This includes:
- Slit lamp findings
- Visual acuity measurements
- Keratometry changes
- Evaluations of problems, symptoms, and complaints
- Adverse reactions
- Reasons for discontinuation
This can be broadly categorized as expert clinical assessment and outcomes data as observed and recorded during the prospective clinical trial.
8. The Sample Size for the Training Set
This question is not applicable. The device is a contact lens and does not involve AI or machine learning that would require a "training set" of data.
9. How the Ground Truth for the Training Set Was Established
This question is not applicable, as there is no training set for this device.
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(396 days)
The VISCO Soft (Hydrophilic) Contact Lenses is indicated for the correction of refractive ametropia (myopia and hyperopia) in phakic or aphakic persons with non-diseased eyes who exhibit refractive astigmatism of 2.00D or less where the astigmatism does not interfere with visual acuity. Eyecare practitioners may prescribe the lens for either single-use disposable wear, or for frequent/planned replacement wear, with cleaning, disinfection, and scheduled replacement. When prescribed for frequent replacement, the lens may be disinfected using a chemical disinfection system only. The VISCO Soft (Hydrophilic) Contact Lenses help protect against transmission of harmful UV radiation to the cornea and into the eye.
The VISCO Soft Contact Lens is a spherical lens with UV blocker. The VISCO Soft Contact Lens is available in hemispherical shell. The lens material is a silicon combination hydrogel. It is a copolymer of 1-vinyl-2-pyrrolidinone (NVP) and Siloxane macromer. The water content is 47%. The VISCO Soft Contact Lens is light blue tinted with "reactive Blue19" for handling visibility purpose. A benzotriazole UV absorbing monomer is used to block UV radiation. The transmittance characteristics are less than 5% (1.1%) in the UVB range of 280-315nm and less than 50% (9.4%) in the UVA range of 316-380nm. The lens is supplied in a sterile state, packaged in a buffered saline solution.
The provided document describes the Visco Soft Contact Lens and its substantial equivalence to a predicate device. However, it does not contain a detailed study report with acceptance criteria for device performance in the context of an AI/ML algorithm. Instead, it focuses on the physicochemical and mechanical properties of the contact lens.
Therefore, many of the requested details regarding AI/ML study design, such as sample size for test/training sets, data provenance, expert ground truth, adjudication methods, and MRMC studies, are not applicable to this document.
Here's an analysis based on the information available:
1. A table of acceptance criteria and the reported device performance
The document does not specify formal "acceptance criteria" in the context of an AI/ML device performance study with specific metrics like sensitivity, specificity, or AUC. Instead, it presents a comparison of the physical and mechanical properties of the Visco Soft Contact Lens to a predicate device. The performance is assessed by showing that these properties are comparable.
| Characteristic | Visco Soft Contact Lens Performance | Predicate Device (BIOFINITY) Performance | Comment |
|---|---|---|---|
| Physicochemical: | |||
| Water Content | 47% | 48% | Similar |
| Oxygen Permeability (Dk) | 150 (Fatt method) | 128 (Fatt method) | Higher Dk for Visco (indicating potentially better oxygen transmission) |
| Refractive Index | 1.410 | 1.40 | Similar |
| Light Transmittance | 94% | >97% | Slightly lower, but still high. The document states it is for handling visibility and UV blocking, which has stricter criteria as below. The UV transmittance values are 1.1% in UVB and 9.4% in UVA, which are below the 5% and 50% benchmarks. |
| Mechanical Strength: | |||
| Tensile strength (Mpa) | $0.55 \pm 0.06$ | $0.50 \pm 0.07$ | Comparable |
| Modulus (Mpa) | $0.59 \pm 0.05$ | $0.8 \pm 0.1$ | Visco has a lower modulus, implying it is softer than the predicate. This feature is a subjective measure, and not a criteria as such. |
| Elongation at break (%) | $106 \pm 5$ | $130 \pm 2$ | Lower elongation at break than the predicate. This feature is a subjective measure, and not a criteria as such. |
| Toughness (J/m³) | $0.26 \pm 0.02$ | Not reported | Compare to Frequency 55: 0.38. Visco is less tough than Frequency 55. This feature is a subjective measure, and not a criteria as such. |
| UV Blocking: | Not explicitly detailed |
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(231 days)
The IntelliWave3, sphere (efrofilcon A) Silicone Hydrogel Soft Contact Lenses for daily wear are indicated for the correction of ametropia (myopia and hyperopia) in aphakic and non-aphakic persons with non-diseased eyes. The lens may be worn by persons who exhibit refractive astigmatism of .75 diopters or less where the astigmatism does not interfere with visual acuity.
The IntelliWave", toric (efrofilcon A) Silicone Hydrogel Soft Contact Lenses for daily wear are indicated I he correction of ametropia (myopia and hyperopia) in aphakic and non-aphakic persons with nondiseased eyes and/or possesses refractive astigmatism not exceeding 12 diopters.
The IntelliWave", multifocal (efrofilcon A) Silicone Hydrogel Soft Contact Lenses for daily wear are indicated for the correction of ametropia (myopia and hyperopia) in aphakic and non-aphakic persons with non-diseased eyes and/or possesses refractive astigmatism not exceeding .75 diopters and are presbyopic requiring add power of up to +4.00 diopters.
The IntelliWave", multifocal toric (efrofilcon A) Silicone Hydrogel Soft Contact Lenses for daily wear are indicated for the correction of ametropia (myopia and hyperopia) in aphakic and non-aphakic persons with non-diseased eyes and/or possesses refractive astigmatism not exceeding 4 diopters and are presbyopic requiring add power of up to +4.00 diopters.
The IntelliWave', irregular cornea (efrofilcon A) Silicone Hydrogel Soft Contact Lenses for daily wear are indicated for the correction of ametropia (myopia and hyperopia) in aphakic and non-aphakic persons and may be prescribed in otherwise non-diseased eyes that require a Soft Contact Lens for the management of irregular corneal conditions such as keratoconus and post graft fitting.
Eyecare practitioners may prescribe the lenses for frequent/planned replacement wear, with cleaning, disinfection and scheduled replacement. When prescribed for frequent/planned replacement wear, the lens may be cleaned and disinfected using a chemical (not heat) lens care system or hydrogen peroxide disinfection systems.
The IntelliWave3 Silicone Hydrogel Soft Contact Lenses are fabricated from efrofilcon A, which in the dry (unhydrated) state may be machined and polished. The hydrophilic nature of this material allows the lens to become soft and pliable when immersed in an aqueous solution.
The non-ionic lens material, (efrofilcon A) is a group 2, daily wear silicone hydrogel contact lens that is not surface treated and characterized by a high water content. The lens material is composed of silicone monomers cross linked with other monomers. The lenses are made by lathe-cut for custom RX. It consists of 26% efrofilcon A and 74% water by weight when immersed in a buffered saline solution. The (efrofilcon A) name has been adopted by the United States Adopted Names Council (USAN).
In the hydrated state, the lens conforms to the curvature of the eye covering the cornea and extending slightly beyond the limbus forming a colorless, transparent optical surface. The (efrofilcon A) soft birghilic contact lens has a spherical back surface. The hydrophilic properties of the lens require that it be maintained in a fully hydrated state in a solution compatible with the eye. If the lens dries out, it will become hard and appear somewhat warped however, it will return to its proper configuration when completely rehydrated in the proper storage solution.
The provided text describes the IntelliWave3 Silicone Hydrogel Daily Wear Soft Contact Lens and its substantial equivalence determination by the FDA. However, it does not include a table of acceptance criteria or a detailed study proving the device meets specific performance criteria in the format requested. The document is a 510(k) summary, which focuses on demonstrating substantial equivalence to predicate devices rather than proving performance against specific acceptance criteria for a new AI/medical device.
Based on the information provided, here's what can be extracted and what is missing:
1. Table of Acceptance Criteria and Reported Device Performance
This information is not explicitly provided in the document in the format of specific, quantifiable acceptance criteria. The document states that "Clinical evaluation demonstrated similar overall performance to the predicate control in the clinically relevant areas of vision, health, and comfort and fit when worn for daily wear." This is a general statement of comparative performance rather than a list of specific acceptance metrics with target values and the device's measured performance against them.
The document does list physical properties of the lens:
| Physical Property | Reported Performance |
|---|---|
| Refractive Index | 1.38 |
| Light Transmission | greater than 97% |
| Surface Character | Hydrophilic |
| Water Content | 74 % |
| Specific Gravity | 1.048 (hydrated) |
| Oxygen Permeability | 59.8 x 10^-11 (cm^2/sec)(ml O2/ml x hPa @ 35°C), (revised Fatt method) |
| Chord Diameter Range | 12.0 mm to 16.00 mm |
| Center Thickness Range | 0.01 mm to 0.50 mm |
| Base Curve Range | 8.0 mm to 9.5 mm |
| Power Range | -20.00D to +20.00D in 0.25 step |
| Cylinder Power (Toric) | -0.25D to -12.00D |
| Cylinder Power (Multifocal Toric) | -0.25D to -4.00D |
| Add Power (Multifocal) | +0.50D to +4.00D |
The "acceptance criteria" for these physical properties are implicitly that they fall within acceptable ranges for contact lenses and are comparable to predicate devices, but explicit criteria are not given. For clinical performance, the criterion seems to be "similar overall performance" to the predicate in key areas.
2. Sample Size Used for the Test Set and Data Provenance
The document states:
- Sample Size: "The study evaluated 63 patients over a three (3) months period."
- Data Provenance: Not explicitly stated (e.g., country of origin). It also does not specify if the data was retrospective or prospective, although the description of a "bilateral, open-label, parallel group, and randomized daily wear study" strongly suggests it was prospective clinical data.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This information is not provided. The "ground truth" for clinical performance likely relies on standardized ophthalmic examinations and patient-reported outcomes, but the adjudication process by experts is not detailed.
4. Adjudication Method (e.g., 2+1, 3+1, none) for the Test Set
This information is not provided.
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
This is not applicable as the device described is a physical medical device (contact lens), not an AI algorithm intended to assist human readers.
6. If a Standalone (i.e. algorithm only without human-in-the loop performance) Was Done
This is not applicable as the device is a physical contact lens, not an AI algorithm. Its performance is inherent in its physical and clinical characteristics when worn by a human.
7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.)
For the non-clinical testing, the "ground truth" was established through standard scientific protocols and toxicology studies according to GLP regulations, indicating laboratory measurements and biological response assessments (e.g., sterility, toxicity, irritation).
For the clinical study, the "ground truth" on performance likely involved:
- Vision: Visual acuity measurements.
- Health: Ophthalmic examinations by eyecare practitioners (e.g., assessing corneal health, ocular surface).
- Comfort and Fit: Patient-reported outcomes and clinical assessment of lens fit by eyecare practitioners.
The comparison was to a "predicate control," meaning direct comparison of these clinical outcomes between the new lens and an existing, legally marketed lens.
8. The Sample Size for the Training Set
This is not applicable as the device is a physical medical device and not an AI algorithm that requires a training set.
9. How the Ground Truth for the Training Set Was Established
This is not applicable for the same reason as above.
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