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510(k) Data Aggregation
(115 days)
The Legacy (ocufilcon D) Performance-Tinted SPHERICAL contact lenses for daily wear are indicated for the correction of refractive ametropia (myopia and hyperopia) in aphakic or not-aphakic persons with non-diseased that may exhibit astigmatism up to 2.0 diopters that does not interfere with visual acuity.
The Legacy (ocufilcon D) Performance-Tinted TORIC Soft Contact Lenses for daily wear are indicated for the correction of refractive error in aphakic and not-aphakic persons with myopia or hyperopia and/or possesses refractive astigmatism not exceeding 5.00 diopters.
The Legacy ( ocufilcon D) Performance-Tinted MUL TIFOCAL Soft Contact Lenses for daily wear are indicated for the correction of refractive ametropia (myopia and hyperopia) and presbyopia in aphakic persons with nondiseased eyes that may exhibit astigmatism up to 2.0 diopters that does not interfere with visual acuity.
Daily wear replacement schedules may vary from patient and should be decided by eye care practitioners in consultation with their patients.
Eye care practitioners may prescribe any of the above lenses for 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 disinfecting system.
Eye care practitioners may prescribe any of the above lenses for single use daily disposable wear. When prescribed for daily disposable wear the lens is to be discarded after each removal.
The Legacy (ocufilcon D) Performance-Tinted Soft (Hydrophilic) Daily Wear Contact Lenses are hemispherical shells with molded spherical base curves and molded front surfaces. The hydrophilic characteristics allow aqueous solutions to enter the lens. The lenses are fabricated from ocufilcon D, which is a hydrophilic co-polymer of 2-Hydroxyethyl methacrylate (2-HEMA) and methacrylic acid (MAA), cross-linked with ethylene glycol dimethacrylate (EGDMA), plus an initiator. The co-polymer consists of 45% ocufiocon D and 55% water by weight when immersed in saline solution. The (ocufiocon D) name has been adopted by the United States Adopted Names Council (USAN).
The Legacy (ocufilcon D) Performance-Tinted Soft (Hydrophilic) Daily Wear Contact Lenses are subsequently tinted to achieve different colors using permanently listed color additives that conform to 21 CFR Part 73.3121. The lenses are processed to incorporate the 'listed' color additives and contain only the amount of the additive needed to accomplish the intended coloring effect. The lenses contain one or a combination of one or more of the following 'listed' color additives: Reactive Black 5, Reactive yellow 15, Reactive orange 78, Reactive red 180.
The Legacy (ocufilcon D) Performance-Tinted Contact Lenses are designed to aid visual performance in athletic settings. Legacy (ocufilcon D) Performance Tinted Contact Lenses enhance contrast in a wide range of outdoor light conditions. This enables the wearer to see a ball or selected objects with greater clarity than with the naked eye.
The Legacy (ocufilcon D) Performance-Tinted Soft (Hydrophilic) Daily Wear Contact Lenses incorporate a UV absorbing monomer. The lenses block >95% in the UVB range (280mm - 315nm), and >50% in the UVA range (316nm - 380nm).
The Legacy (ocufilcon D) Performance-Tinted Soft (Hydrophilic) Daily Wear Contact Lenses are manufactured in the sphere, toric, and multifocal design configurations.
The Legacy (Ocufilcon D) Performance-Tinted Soft (Hydrophilic) Daily Wear Contact Lenses underwent a series of non-clinical tests to demonstrate their safety and effectiveness. Clinical testing was not required as the performance of ocufilcon D materials has been previously established.
1. Table of Acceptance Criteria and Reported Device Performance:
The following table summarizes the performance data for the Legacy (ocufilcon D) Performance-Tinted Soft (Hydrophilic) Daily Wear Contact Lenses, compared against established standards or general expectations for contact lenses.
| Parameter | Acceptance Criteria (or Standard) | Reported Device Performance |
|---|---|---|
| Toxicology | ||
| In-Vitro Cytotoxicity | Non-toxic (in accordance with ISO 10993-5) | Non-toxic |
| Systemic Toxicity | Non-toxic (meets ISO 10993-11 requirements for systemic injection) | Non-toxic |
| Acute Ocular Irritation | No ocular irritation (in accordance with ISO 10993-10) | No ocular irritation |
| Compatibility | ||
| Solution Compatibility | Compatible with chemical disinfection systems currently marketed for soft (hydrophilic) contact lenses | Compatible with chemical disinfection systems |
| Shelf Life | Stable, sterile, and package integrity maintained over labeled expiration date | Stability, sterility, and package integrity maintained over labeled expiration date |
| Physicochemical & Mechanical Properties | Consistent with predicate device and established standards (e.g., ANSI Z80.20) | Consistent with predicate device and established standards |
| Chord Diameter | ±0.20 mm | Meets tolerance (range: 11.00 mm to 15.00 mm) |
| Center Thickness | When ≤ 0.10 mm → ±0.010 mm + 10%; When > 0.10 mm → ±0.015 mm + 5% | Meets tolerance (range: 0.05 mm to 0.15 mm) |
| Base Curve | ±0.20 mm | Meets tolerance (range: 7.00 mm to 10.0 mm) |
| Back Vertex Power (F'v) | When 0.00 < F'v ≤ 10.00 D → ±0.25 D; When 10.00 < F'v ≤ 20.00 D → ±0.50 D | Meets tolerance (range: +20.00D to -20.00D) |
| Cylinder Power (F'c) | When 0.00 < F'c ≤ 2.00 D → ±0.25 D; When 2.00 < F'c ≤ 4.00 D → ±0.37 D | Meets tolerance (range: -0.25D to -4.00D) |
| Cylinder Axis | When 0.00 < F'c ≤ 1.50 D → ± 8°; When F'c > 1.50 D → ± 5° | Meets tolerance (range: 10° to 180°) |
| Multifocal Add Power | ±0.37 D | Meets tolerance (range: +0.25D to +4.00D) |
| Surface Appearance | Lenses should be clear with no surface defect | Clear with no surface defect |
| Oxygen Permeability (x 10⁻¹¹ (cm²/sec)(mlO2)/(ml x mmHg)) | ±20% of 19.6 | 19.6 |
| Light Transmission - Tinted (@ 380-780nm) | > 38% | > 38% (reported with ±5% tolerance) |
| Ultraviolet Radiation Transmittance (TUVB: 280-315 nm; TUVA: 316-380 nm) | < 5 % TUVB; < 50 % TUVA (Specifically: < 0.05Tv TUVB; < 0.50Tv TUVA) | < 5 % TUVB; < 50 % TUVA |
| Water Content | ±2% of 55% | 55% |
| Refractive Index (hydrated) | ±0.005 of 1.410 | 1.410 |
2. Sample size used for the test set and the data provenance:
The document does not explicitly state a specific sample size for each non-clinical test. However, it indicates that "A series of preclinical testing was performed." The provenance for the non-clinical toxicology tests is that they were conducted "in accordance with the GLP regulation." The data is thus scientifically valid under 21 CFR 860.7. No specific country of origin is mentioned for the test data, beyond the general adherence to international standards (ISO). The nature of the testing is non-clinical (laboratory-based), rather than retrospective or prospective patient data.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
Not applicable. This device is a contact lens and its performance criteria are based on objective physical, chemical, and biological compatibility measurements, not on expert interpretations of medical images or conditions. The "ground truth" is established by adherence to recognized international standards (e.g., ISO, ANSI) and regulatory guidelines.
4. Adjudication method for the test set:
Not applicable. The tests performed are objective, quantitative measurements (e.g., cytotoxicity, oxygen permeability, refractive index) rather than human-interpreted assessments requiring 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:
Not applicable. This is a contact lens, not an AI-assisted diagnostic or imaging device. Therefore, MRMC studies and AI assistance are not relevant.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
Not applicable. As noted above, this is a physical medical device, not a software algorithm.
7. The type of ground truth used:
The "ground truth" for the non-clinical tests was established by objective standards and regulatory guidelines. This includes:
- International Standards: ISO 10993-5 (In-Vitro Cytotoxicity), ISO 10993-11 (Systemic Toxicity), ISO 10993-10 (Acute Ocular Irritation), and ANSI Z80.20 (Ophthalmics – Contact Lenses – Standard Terminology, Tolerances, Measurements And Physicochemical Properties).
- Regulatory Compliance: Adherence to GLP (Good Laboratory Practice) regulations and 21 CFR 73.3121 for color additives.
- Predicate Device Comparison: The physicochemical and mechanical properties were also compared for "consistent material properties" with the primary predicate device (ILICON (ocufilcon D) Soft (Hydrophilic) Daily Wear Contact Lenses, K182247).
8. The sample size for the training set:
Not applicable. This is a physical medical device, not a machine learning model requiring a training set.
9. How the ground truth for the training set was established:
Not applicable. As this device does not use machine learning, no training set or its associated ground truth was established.
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(53 days)
The ILICON (ocufilcon D) SPHERICAL contact lenses for daily wear are indicated for the correction of refractive ametropia (myopia and hyperopia) in aphakic or not-aphakic persons with non-diseased that may exhibit astigmatism up to 2.0 diopters that does not interfere with visual acuity. The lens is available clear or tinted and may be used to enhance or alter the apparent color of the eve.
The ILICON (ocufilcon D) TORIC Soft Contact Lenses for daily wear are indicated for the correction of refractive error in aphakic and not-aphakic persons with non-diseased eyes with myopia or hyperopia and/or possesses refractive astigmatism not exceeding 5.00 diopters. The lens is available clear or tinted and may be used to enhance or alter the apparent color of the eye.
The ILICON (ocufilcon D) MULTIFOCAL Soft Contact Lenses for daily wear are indicated for the correction of refractive ametropia (myopia and hyperopia) and presbyopia in aphakic persons with non-diseased eyes that may exhibit astigmatism up to 2.0 diopters that does not interfere with visual acuity. The lens is available clear or tinted and may be used to enhance or alter the apparent color of the eye.
The ILICON (ocufilcon D) MULTIFOCAL TORIC Soft Contact Lenses for daily wear are indicated for the correction of refractive ametropia (myopia and hyperopia) and presbyopia in aphakic persons with non-diseased eves that may exhibit astigmatism up to 5.0 diopters that does not interfere with visual acuity. The lens is available clear or tinted and may be used to enhance or alter the apparent color of the eye.
Daily wear replacement schedules may vary from patient and should be decided by eye care practitioners in consultation with their patients.
Eye care practitioners may prescribe any of the above lenses for 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 disinfecting system.
Eye care practitioners may prescribe any of the above lenses for single use daily disposable wear. When prescribed for daily disposable wear the lens is to be discarded after each removal.
The ILICON (ocufilcon D) Soft (Hydrophilic) Daily Wear Contact Lenses (Tinted, Color) are hemispherical shells with molded spherical base curves and molded front surfaces. The hydrophilic characteristics allow aqueous solutions to enter the lenses are fabricated from ocufilcon D, which is a hydrophilic co-polymer of 2-Hydroxyethyl methacrylate (2-HEMA) and methacrylic acid (MAA), cross-linked with ethylene glycol dimethacrylate (EGDMA), plus an initiator. The copolymer consists of 45% ocufiocon D and 55% water by weight when immersed in saline solution. The (ocufiocon D) name has been adopted by the United States Adopted Names Council (USAN).
The ILICON (ocufilcon D) Soft (Hydrophilic) Daily Wear Contact Lenses (Tinted, Color) are available tinted for visibility, and tinted to enhance or alter the apparent color of the eye. The lenses are processed to incorporate the 'listed' color additives and contain only the amount of the additive needed to accomplish the intended coloring effect. The lenses contain one or a combination of one or more of the following 'listed' color additives: Rutile TiO2, Iron Oxide, (Pathalocyaninto(2-))Copper, Carbazole Violet, Phthalocyanine Green.
When producing the color lenses, the manufacturing process changes the specifications to the clear contact lens by pad-printing the color pigment(s)-entrapping the colorants in the interpenetrating network of the contact lens material in a location that corresponds to the iris. The color pigments used are not removed by lens handling and cleaning/disinfecting procedures. Except for affecting the amount of light transmittance through the lens, the coloring process does not alter the original characteristics of the pre-tinted lens. The tinting pattern has a clear pupil diameter of 6.0 mm.
The ILICON (ocufilcon D) Soft (Hydrophilic) Daily Wear Contact Lenses (Tinted, Color) incorporate a UV absorbing monomer. The lenses block >95% in the UVB range (280nm - 315nm), and >50% in the UVA range (316nm - 380nm).
The ILICON (ocufilcon D) Soft (Hydrophilic) Daily Wear Contact Lenses (Tinted, Color) are manufactured in the sphere, toric, and multifocal design configurations.
The provided document is a 510(k) Summary for the ILICON (ocufilcon D) Soft (Hydrophilic) Daily Wear Contact Lenses (Tinted, Color). This document describes the device, its intended use, and a comparison to predicate devices to establish substantial equivalence. It does not describe a clinical study of the type you are asking about, which typically involve AI/ML performance metrics, expert adjudication, or MRMC studies.
Instead, this submission focuses on demonstrating the safety and effectiveness of the contact lenses through non-clinical testing (toxicology, shelf-life, physicochemical, and mechanical properties). Clinical testing was not deemed necessary as the clinical performance of soft contact lenses made from ocufilcon D material has been previously established.
Therefore, I cannot fulfill all parts of your request as the provided text does not contain the specific information about acceptance criteria for an AI/ML device, a study proving device meets acceptance criteria as typically understood in AI/ML performance studies, sample sizes for test sets in an AI/ML context, data provenance, expert qualifications, adjudication methods, MRMC studies, standalone performance with AI, or ground truth establishment for such a study.
However, I can extract the relevant information regarding the device's technical specifications and the non-clinical tests performed:
1. A table of acceptance criteria and the reported device performance
The document provides a table of "Parameter" and "Tolerance*" which can be considered acceptance criteria, and the "Range" or specific value as the reported performance, indicating the device meets these specifications.
| Parameter | Acceptance Criteria (Tolerance*) | Reported Device Performance (Range/Value) |
|---|---|---|
| Chord Diameter | ±0.20 mm | 11.00 mm to 15.00 mm |
| Center Thickness | When ≤ 0.10 mm → ±0.010 mm + 10%; When > 0.10 mm → ±0.015 mm + 5% | 0.05 mm to 0.15 mm |
| Base Curve | ±0.20 mm | 7.00 mm to 10.0 mm |
| Back Vertex Power (F'v) | When 0.00 < F'v ≤ 10.00 D → ±0.25 D; When 10.00 < F'v ≤ 20.00 D → ±0.50 D | +20.00D to -20.00D (in 0.25D steps) |
| Cylinder Power (F'c) | When 0.00 < F'c ≤ 2.00 D → ±0.25 D; When 2.00 < F'c ≤ 4.00 D → ±0.37 D | -0.25D to -4.00D (in 0.25D steps) |
| Cylinder Axis | When 0.00 < F'c ≤ 1.50 D → ± 8°; When F'c > 1.50 D → ± 5° | 10° to 180° (in 10° steps) |
| Multifocal Add Power | ±0.37 D | +0.25D to +4.00D (0.50D steps) |
| Surface Appearance | Lenses should be clear with no surface defect | - |
| Oxygen Permeability (x 10-11(cm²/sec)(mlO2)/(ml x mmHg)) | ±20% | 19.6 |
| Light Transmission - Tinted (@ 380-780nm) | ±5% | 95% |
| Ultraviolet Radiation Transmittance | TUVB (280 to 315 nm) < 0.05TV; TUVA (316 to 380 nm) < 0.50TV | < 5 % TUVB; < 50 %TUVA |
| Water Content | ±2% | 55% |
| Refractive Index | +0.005 | 1.410 (hydrated) |
Non-clinical Performance Data:
- Toxicology: Non-toxic (In-Vitro Cytotoxicity, Systemic Toxicity, Acute Ocular Irritation).
- Shelf Life: Stability, sterility, and package integrity demonstrated over the labeled expiration date.
- Physicochemical & Mechanical Properties: Consistent material properties (refractive index, water content, Dk, % transmission (visible & UV), tensile strength, modulus, % elongation to break, specific gravity and polymerization residuals) with predicate devices.
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
The document does not specify sample sizes for non-clinical tests (e.g., number of lenses tested for physicochemical properties, number of animals for toxicology). Data provenance is not detailed in terms of country of origin of the data for these non-clinical tests, nor is it categorized as retrospective or prospective in the context of clinical studies. However, the toxicity tests were conducted in accordance with GLP (Good Laboratory Practice) regulations.
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. This device is a medical device (contact lens), not an AI/ML diagnostic tool, and its evaluation did not involve human expert interpretation or ground truth establishment in that manner.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable, as no such clinical test set requiring adjudication 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, as this is not an AI-assisted device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable, as this is not an AI/ML algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
The "ground truth" equivalent for this device is the established physical, chemical, and biological properties and safety profiles for contact lenses made from ocufilcon D material, demonstrated through conformance to established standards (e.g., ISO, ANSI Z80.20) and non-clinical testing results.
8. The sample size for the training set
Not applicable, as this device does not involve a "training set" in the context of AI/ML.
9. How the ground truth for the training set was established
Not applicable.
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