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510(k) Data Aggregation
(111 days)
VIZIONFOCUS INC.
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(108 days)
VizionFocus Inc.
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 |
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(125 days)
VizionFocus Inc.
Sphere/Asphere:
The VizionFocus and VizionFocus Color (mififilcon A) Silicone Hydrogel Daily Disposable Soft (hydrophilic) Contact Lenses in the spherical/aspheric design are indicated for the correction of ametropia (myopia and hyperopia) in aphakic and non-aphakic persons with non-diseased eyes in powers from -20.00 to +20.00 diopters. The lenses may be worn by persons who exhibit astigmatism of 1.00 diopters or less that does not interfere with visual acuity.
Toric:
The VizionFocus and VizionFocus Color (mififilcon A) Silicone Hydrogel Daily Disposable Soft (hydrophilic) Contact Lenses in the toric design are indicated for the correction of ametropia (myopia or hyperopia with astigmatism) in aphakic and non-aphakic persons with non-diseased eyes in powers from -20.00 to +20.00 diopters and astigmatic corrections from -0.25 to -2.25 diopters.
Multifocal:
The VizionFocus and VizionFocus Color (mififilcon A) Silicone Hydrogel Daily Disposable Soft (hydrophilic) Contact Lenses in the multifocal design are indicated for the correction of refractive ametropia (myopia and hyperopia) and emmetropia with presbyopia in aphakic and non-aphakic persons with non-diseased eyes in powers from -20.00 to +20.00 diopters and with add powers from +0.25 to +4.00 diopters. The lenses may be worn by persons who exhibit astigmatism of 2.00 diopters or less that does not interfere with visual acuity.
The VizionFocus and VizionFocus Color (mififilcon A) Silicone Hydrogel Daily Disposable Soft (hydrophilic) Contact Lenses are to be prescribed for single use, daily disposable wear. The lenses are not intended to be cleaned or disinfected and should be discarded after a single use. The VizionFocus Color (mififilcon A) Silicone Hydrogel Soft (hydrophilic) Daily Disposable Contact Lenses are tinted to enhance or alter the apparent color of the eye.
The VizionFocus and VizionFocus Color (mififilcon A) Silicone Hydrogel Soft (hydrophilic) Daily Disposable Contact Lenses are hemispherical shells with molded base curves and molded front surfaces. The hydrophilic characteristics allow aqueous solutions to enter the lenses are fabricated from mififilcon A. which is a random co-polymer of silicone containing monomers and hydrophilic monomers. The lenses consist of 40.0% mififilcon A and 60.0% water by weight when immersed in saline solution. The mififilcon A name has been adopted by the United States Adopted Names Council (USAN).
The VizionFocus (mififilcon A) Silicone Hydrogel Soft (hydrophilic) Daily Disposable Contact Lens contains phthalocyanine blue (21 CFR Part 74.3045) for visibility and handling. The VizionFocus Color (miffilcon A) Silicone Hydrogel Soft (hydrophilic) Daily Disposable Contact Lenses are 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, Mica.
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 VizionFocus and VizionFocus Color (mififilcon A) Silicone Hydrogel Soft (hydrophilic) Daily Disposable Contact Lenses incorporate a benzotriazole UV blocking monomer to help protect against transmission of harmful UV radiation. The lenses block >95% in the UVB range (280mm - 315nm), and >80% in the UVA range (316mm - 380mm). The VizionFocus and VizionFocus Color (mififilcon A) Silicone Hydrogel Soft (hydrophilic) Daily Disposable Contact Lenses are manufactured in spherical/aspheric, toric, and multifocal design configurations.
The provided text describes the 510(k) submission for VizionFocus contact lenses, demonstrating their substantial equivalence to predicate devices. However, this submission does not contain acceptance criteria or study details for an AI/ML powered medical device. The document pertains to contact lenses, which are physical medical devices, not software-based AI/ML devices. Therefore, a table of acceptance criteria and study proving an AI device meets acceptance criteria cannot be extracted from this text.
The information provided describes:
- Device Type: VizionFocus (mififilcon A) Silicone Hydrogel Soft (hydrophilic) Daily Disposable Contact Lens; VizionFocus Color (mififilcon A) Silicone Hydrogel Soft (hydrophilic) Daily Disposable Contact Lens. These are physical contact lenses, not an AI/ML powered device.
- Study Purpose: To demonstrate the safety and effectiveness of the contact lenses by comparing them to legally marketed predicate devices, establishing substantial equivalence. This is a typical regulatory pathway for physical medical devices.
- Studies Conducted: Non-clinical performance testing (biocompatibility/toxicology, shelf life, bench tests like refractive index, water content, Dk, % transmission, tensile strength, modulus, % elongation to break, specific gravity, and polymerization residuals) and a clinical study.
- Clinical Study Design: Multi-center, single-masked (examiner), bilateral, randomized concurrent-control study with 91-day treatment follow-up.
- Clinical Study Sample Size: 120 subjects enrolled (60 test, 60 control), 117 completed.
- Clinical Study Data Provenance: Not explicitly stated, but typically clinical trials for FDA submissions are conducted in the US or in compliance with international standards that are accepted by the FDA. The indication of a multi-center study implies diverse geographic recruitment within the study's operational regions.
- Ground Truth: For the clinical study, the ground truth was established through biomicroscopy findings, symptoms, adverse reactions, and vision safety measures (keratometry changes, refractive changes, best corrected visual acuity) observed and recorded by examiners. There is no mention of expert consensus, pathology, or outcomes data in the context of establishing ground truth for an AI model.
The prompt specifically asks for details around an AI/ML powered medical device's acceptance criteria and study, which are not present in the provided text.
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(115 days)
VizionFocus, Inc.
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 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) |
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(53 days)
VizionFocus, Inc.
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 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) |
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