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510(k) Data Aggregation
(108 days)
The SPHERICAL/ASPHERE Aurora (ocufilcon D) Soft (Hydrophilic) Daily Wear Contact Lenses are indicated for the correction of refractive ametropia (myopia and hyperopia) in aphakic or not-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 TORIC Aurora (ocufilcon D) Soft (Hydrophilic) Daily Wear Contact Lenses 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 MULTIFOCAL Aurora (ocufilcon D) Soft (Hydrophilic) Daily Wear Contact Lenses are indicated for the correction of refractive ametropia (myopia and hyperopia) and presbyopia in aphakic or not-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.
Daily wear replacement schedules may vary from patient to 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 Aurora (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 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% ocufilcon D and 55% water by weight when immersed in saline solution with polymeric wetting agents. The color additive (Pathalocyaninto(2-))Copper, Iron Oxide and Reactive Yellow 15 are added to the lens material to create a light yellow-green edge-to-edge color to make it easier to see when handling, and additionally, reduce transmittance of short wavelength light in the range of 380nm to 460nm. In addition, lenses contain a benzotriazole monomer to filter UVA and UVB radiation. The (ocufilcon D) name has been adopted by the United States Adopted Names Council (USAN).
The Aurora (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: Reactive Yellow 15, Rutile TiO2, Iron Oxide, (Pathalocyaninto(2-))Copper, Carbazole Violet, Phthalocyanine Green.
When producing the color lenses, the manufacturing process changes the specifications to the light yellow-green 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 Aurora (ocufilcon D) Soft (Hydrophilic) Daily Wear Contact Lenses (Tinted, Color) incorporate a UV absorbing monomer. The lenses filter >95% in the UVB range (280nm - 315nm), and >80% in the UVA range (315nm - 380nm).
The Aurora (ocufilcon D) Soft (Hydrophilic) Daily Wear Contact Lenses (Tinted, Color) are manufactured in the sphere/asphere, toric, and multifocal design configurations.
The provided FDA 510(k) clearance letter and associated summary pertain to a contact lens device, the Aurora (ocufilcon D) Soft (Hydrophilic) Daily Wear Contact Lens (Tinted, Color). It's important to note that this document describes the device as a "Soft (Hydrophilic) Contact Lens," which is a device type, not an AI/ML algorithm. Therefore, many of the typical acceptance criteria and study parameters related to AI/ML device performance (such as sensitivity, specificity, MRMC studies, ground truth establishment for AI/ML, etc.) are not applicable to this type of medical device submission.
The "acceptance criteria" for a contact lens device primarily revolve around its physical, chemical, and biological properties, as well as its safety and functionality for human use, established through non-clinical (laboratory) testing and comparisons to predicate devices. The study proving these criteria are met is typically a combination of non-clinical bench testing and demonstrating substantial equivalence to an already marketed predicate device.
Here's the information based on the provided document, restructured to address your points where applicable:
1. A table of acceptance criteria and the reported device performance
For a contact lens, explicit "acceptance criteria" are often derived from recognized standards (like ANSI Z80.20 mentioned) and the performance of predicate devices. The reported device performance is compared against these and is generally expected to be within acceptable tolerances or equivalent to the predicate.
| Parameter | Acceptance Criteria (Implicitly from Standard/Predicate) | Reported Device Performance (Aurora) |
|---|---|---|
| Chord Diameter | 11.00 mm to 15.00 mm (±0.20 mm tolerance) | 11.00 mm to 15.00 mm (±0.20 mm tolerance) |
| Center Thickness | 0.05 mm to 0.15 mm (Specific tolerances) | 0.05 mm to 0.15 mm (Specific tolerances) |
| Base Curve | 7.00 mm to 10.0 mm (±0.20 mm tolerance) | 7.00 mm to 10.0 mm (±0.20 mm tolerance) |
| Back Vertex Power (F'v) | +20.00D to -20.00D (Specific tolerances) | +20.00D to -20.00D (Specific tolerances) |
| Cylinder Power (F'c) | -0.25D to -4.00D (Specific tolerances) | -0.25D to -4.00D (Specific tolerances) |
| Cylinder Axis | 10° to 180° (Specific tolerances) | 10° to 180° (Specific tolerances) |
| Multifocal Add Power | +0.25D to +4.00D (±0.37 D tolerance) | +0.25D to +4.00D (±0.37 D tolerance) |
| Surface Appearance | Clear with no surface defect | Clear with no surface defect |
| Oxygen Permeability (Dk) | 19.6 (±20% tolerance) | 19.6 (±20% tolerance) |
| Light Transmission (380-780nm) | 95% (±5% tolerance) | 95% (±5% tolerance) |
| Light Transmission (380-460nm) | >75% (>75% tolerance) | >75% (>75% tolerance) |
| UV-B Transmittance | < 5 % | < 5 % |
| UV-A Transmittance | < 20 % | < 20 % |
| Water Content | 55% (±2% tolerance) | 55% (±2% tolerance) |
| Refractive Index (hydrated) | 1.410 (±0.005 tolerance) | 1.410 (±0.005 tolerance) |
| In-Vitro Cytotoxicity | Not cytotoxic | Not cytotoxic |
| Systemic Toxicity | No acute systemic toxicity | No acute systemic toxicity |
| Acute Ocular Irritation | No ocular irritation | No ocular irritation |
| Shelf Life | Stability, sterility, and package integrity maintained | Stability, sterility, and package integrity maintained over labeled expiration date |
2. Sample size used for the test set and the data provenance
The document does not specify a "test set" in the context of an AI/ML algorithm for image analysis or diagnostics. Instead, the "testing" refers to a series of non-clinical (laboratory) studies:
- Toxicology: "All non-clinical toxicology tests were conducted in accordance with the GLP regulation." This includes In-Vitro Cytotoxicity, Systemic Toxicity, and Acute Ocular Irritation tests. The sample sizes for these biological tests would be defined by the relevant ISO standards (ISO 10993-5, ISO 10993-11, ISO 10993-23) but are not explicitly reported in this summary.
- Shelf Life: Testing was performed to evaluate stability, sterility, and package integrity. Sample sizes are not specified for this summary.
- Physicochemical & Mechanical Properties: Tests for refractive index, water content, Dk, % transmission, tensile strength, modulus, % elongation to break, specific gravity, and polymerization residuals. Sample sizes are not specified.
Data Provenance: The studies were non-clinical, implying laboratory-based testing rather than patient data from a specific country. They were conducted under "Good Laboratory Practice (GLP) regulations," indicating a controlled, high-quality laboratory environment. There is no mention of retrospective or prospective patient data from a clinical test set.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
This information is not applicable as the device is a contact lens, not an AI/ML diagnostic or image analysis device requiring expert-established ground truth on a test set of images or clinical cases. The ground truth for device properties is established by scientific measurement and adherence to defined standards.
4. Adjudication method for the test set
This information is not applicable for the same reasons as point 3. Adjudication methods like 2+1 or 3+1 are used for establishing ground truth in clinical or image-based studies, which are not described here.
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 information is not applicable. An MRMC study is relevant for AI/ML diagnostic devices where human readers (e.g., radiologists) interpret cases with or without AI assistance. This device is a contact lens. The document explicitly states: "Clinical testing is not required. The clinical performance of soft (hydrophilic) contact lenses manufactured from (ocufilcon D) materials has been demonstrated previously."
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This information is not applicable. This device is a contact lens, not an AI/ML algorithm.
7. The type of ground truth used
For this contact lens device, the "ground truth" (or basis for evaluation) comes from:
- Established scientific standards and methodologies: For physicochemical properties (e.g., water content, Dk, light transmission) and mechanical properties (e.g., tensile strength, modulus).
- Biological safety standards: Adherence to ISO 10993 series for biocompatibility (cytotoxicity, systemic toxicity, ocular irritation).
- Comparison to a legally marketed predicate device: "Substantial equivalence" is demonstrated by showing that the new device has the same fundamental scientific technology, materials, and performs comparably to a predicate device, which itself has established safety and effectiveness.
8. The sample size for the training set
This information is not applicable. This device is a contact lens, not an AI/ML algorithm that requires a "training set."
9. How the ground truth for the training set was established
This information is not applicable for the same reason as point 8.
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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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