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Found 11 results
510(k) Data Aggregation
(54 days)
Innova Vision Inc.
Sphere/Asphere:
Innova Vision Sphere and Asphere (inifilcon A) Silicone Hydrogel Soft Contact lenses 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 2.00 diopters or less that does not interfere with visual acuity.
Toric:
Innova Vision Toric (inifilcon A) Silicone Hydrogel Soft Contact lenses 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:
Innova Vision Multifocal (inifilcon A) Silicone Hydrogel Soft Contact lenses 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.
Multifocal Toric:
Innova Vision Multifocal Toric (inifilcon A) Silicone Hydrogel Soft Contact lenses are indicated for the optic correction of distance and near vision in presbyopic phakic persons with nondiseased eyes in powers of -20.00 to +20.00 diopters with add powers from +0.25 to +4.00 diopters and astigmatism corrections from -0.25 to -2.25 diopters.
Eye Care Practitioners may prescribe the Innova Vision (inifilcon A) Silicone Hydrogel (Hydrophilic) Daily Wear Soft Contact lenses for frequent/planned replacement wear, with cleaning, disinfection and scheduled replacement or for single-use disposable wear.
When prescribed for frequent/planned replacement, the Innova Vision (inifilcon A) Silicone Hydrogel (Hydrophilic) Daily Wear Soft Contact Lens is to be cleaned, rinsed and disinfected each time the lens is removed. The contact lens is to be discarded after the recommended wearing period as prescribed by the Eye Care Professional. When prescribed for frequent/planned replacement wear, the lenses may be disinfected using a chemical disinfection only.
When prescribed for single-use disposable wear, Innova Vision (inifilcon A) Silicone Hydrogel (Hydrophilic) Daily Wear Soft Contact Lens is to be discarded after each removal.
The Innova Vision (inifilcon A) Silicone Hydrogel (Hydrophilic) Daily Wear Soft Contact Lens is a hemispherical shell with a molded spherical base curve and a molded front surface. The hydrophilic characteristics allow aqueous solutions to enter the lenses are fabricated from inifilcon A, which is a random co-polymer of silicone containing monomers and hydrophilic monomers. The lens consists of 60.0% inifilcon A and 40.0% water by weight when immersed in saline solution. The inifilcon A name has been adopted by the United States Adopted Names Council (USAN).
The Innova Vision (inifilcon A) Silicone Hydrogel (Hydrophilic) Daily Wear Soft Contact Lens contains C.I. Reactive Blue 247 (21 CFR Part 73.3100 ) for visibility and handling. The Innova Vision (inifilcon A) Silicone Hydrogel (Hvdrophilic) Daily Wear Soft Contact Lens incorporates a benzotriazole UV blocking monomer to help protect against transmission of harmful UV radiation. The lens blocks >95% in the UVB range (280nm - 315nm), and >50% in the UVA range (315mm - 380mm). The Innova Vision (inifilcon A) Silicone Hydrogel (Hydrophilic) Daily Wear Soft Contact Lens is manufactured in sphere/asphere, toric, multifocal and multifocal-toric design configurations.
This document is an FDA 510(k) summary for a contact lens, not an AI/ML medical device. Therefore, the information typically required for describing the acceptance criteria and study proving an AI/ML device meets those criteria (such as test sets, expert ground truth, MRMC studies, standalone performance, etc.) is not present in this document.
The document focuses on demonstrating substantial equivalence of a new contact lens (Innova Vision (inifilcon A) Silicone Hydrogel (Hydrophilic) Daily Wear Soft Contact Lens) to legally marketed predicate devices, primarily K232139, K222954, and K210436.
Instead of AI/ML performance metrics, the acceptance criteria for this medical device are related to its physical properties, biocompatibility, and intended use, demonstrating that it is as safe and effective as existing contact lenses.
Here's an attempt to extract relevant information from the provided text, reinterpreting "acceptance criteria" and "study" in the context of a contact lens submission:
Acceptance Criteria and Device Performance (Reinterpreted for a Contact Lens)
-
Acceptance Criteria: To demonstrate substantial equivalence, the new device must meet specific physical, chemical, and biological performance standards comparable to predicate devices. This includes demonstrating:
- Absence of cytotoxicity, systemic toxicity, and ocular irritation.
- Stability, sterility, and package integrity over the labeled shelf life.
- Compatibility with common cleaning and disinfection solutions.
- Consistent material properties (refractive index, water content, oxygen permeability, UV transmission, tensile strength, modulus, elongation to break, specific gravity) within acceptable tolerances.
- Similar indications for use and general function as the predicate devices.
-
Reported Device Performance: The document states that the non-clinical performance testing (toxicology, shelf life, solution compatibility, preservative uptake and release, and bench tests) supports the claim that the Innova Vision (inifilcon A) Silicone Hydrogel (Hydrophilic) Daily Wear Soft Contact Lens is substantially equivalent to the currently marketed predicate devices. Specific numerical results demonstrating compliance with each criterion are not provided in this summary, but the conclusion confirms they were met.
Table of Acceptance Criteria and Reported Device Performance (Reinterpreted)
| Acceptance Criterion (for Contact Lens Equivalence) | Reported Device Performance |
|---|---|
| Biocompatibility/Toxicology | |
| In-Vitro Cytotoxicity (ISO 10993-5) | Not cytotoxic |
| Systemic Toxicity (ISO 10993-11) | Meets systemic injection test requirements; no acute systemic toxicity |
| Acute Ocular Irritation (ISO 10993-10) | No ocular irritation |
| Biocompatibility of packaging materials/solution | Addressed in previously submitted assessments |
| Shelf Life | |
| Stability, Sterility, Package Integrity | Data supports establishment of proposed shelf life |
| Solution Compatibility | |
| Physical compatibility with cleaning/disinfection | Confirmed (peroxide and MPDS) |
| Preservative Uptake and Release | Referenced in K232139 (predicate) |
| Bench Performance (Material Properties) | |
| Refractive Index | Consistent with predicate |
| Water Content | Consistent with predicate |
| Oxygen Permeability (Dk) | Consistent with predicate |
| % Transmission (Visible & UV) | Consistent with predicate |
| Tensile Strength | Consistent with predicate |
| Modulus | Consistent with predicate |
| % Elongation to break | Consistent with predicate |
| Specific Gravity | Consistent with predicate |
| Quantification of Polymerization Residuals | Consistent with predicate |
Information Not Applicable or Not Found (as per AI/ML context):
- Sample size used for the test set and data provenance: Not applicable in the AI/ML sense. The "test set" here refers to the actual manufactured devices undergoing physical and biological testing. The number of batches or lenses tested for each criterion is not specified in this summary. The "data provenance" would refer to internal lab testing.
- Number of experts used to establish ground truth & qualifications: Not applicable. Ground truth for a contact lens is established through objective physical, chemical, and biological measurements, not expert consensus on images.
- Adjudication method for the test set: Not applicable. Compliance is measured objectively.
- Multi-Reader Multi-Case (MRMC) comparative effectiveness study: Not applicable. This is for evaluating changes in human reader performance with AI assistance.
- Standalone (algorithm-only) performance: Not applicable. This is a physical medical device.
- Type of ground truth used: For this device, the "ground truth" is derived from established standard test methods (e.g., ISO 10993 for biocompatibility, methods for Dk, water content, etc.) that yield objective measurements of the device's properties.
- Sample size for the training set: Not applicable. There is no AI model being trained.
- How the ground truth for the training set was established: Not applicable.
In summary, the provided document outlines the non-clinical and clinical (by reference to predicate) evidence used to demonstrate the substantial equivalence of a new contact lens. It does not contain the specific AI/ML-related details requested in the prompt because the device is a physical product, not an AI algorithm.
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(121 days)
Innova Vision Inc.
Sphere/Asphere: Innova Vision Sphere and Asphere (mifilcon A) Silicone Hydrogel Soft Contact lenses 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 2.00 diopters or less that does not interfere with visual acuity.
Toric: Innova Vision Toric (inifilcon A) Silicone Hydrogel Soft Contact lenses 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: Innova Vision Multifocal (inifilcon A) Silicone Hydrogel Soft Contact lenses 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 acuty.
Multifocal Toric: Innova Vision Multifocal Toric (inifiloon A) Silicone Hydrogel Soft Contact lenses are indicated for the optic correction of distance and near vision in presbyopic phakic persons with non-diseased eyes in powers of -20.00 to +20.00 diopters with add powers from +0.25 to +4.00 diopters and astigmatism corrections from -0.25 to -2.25 diopters.
Eye Care Practitioners may prescribe the Innova Vision (inifilcon A) Silicone Hydrogel Soft (Hydrophilic) Contact lenses for frequent/planned replacement wear, with cleaning, disinfection and scheduled replacement or for single-use disposable wear.
When prescribed for frequent/planned replacement, the Inifilcon A) Silicone Hydrogel Soft (Hydrophilic) Contact Lens is to be cleaned, rinsed and disinfected each time the lens is removed. The contact lens is to be discarded after the recommended wearing period as prescribed by the Eye Care Professional. When prescribed for frequent/planned replacement wear, the lenses may be disinfected using a chemical disinfection only.
When prescribed for single-use disposable wear, Innova Vision (inifilcon A) Silicone Hydrogel Soft (Hydrophilic) Contact Lens is to be discarded after each removal.
The Innova Vision (inifilcon A) Silicone Hydrogel Soft (Hvdrophilic) Contact Lens is a hemispherical shell with a molded spherical base curve and a molded front surface. The hydrophilic characteristics allow aqueous solutions to enter the lenses are fabricated from inifilcon A, which is a random co-polymer of silicone containing monomers and hydrophilic monomers. The lens consists of 60.0% inifilcon A and 40.0% water by weight when immersed in saline solution. The inifilcon A name has been adopted by the United States Adopted Names Council (USAN).
The Innova Vision (inifilcon A) Silicone Hydrogel Soft (Hydrophilic) Contact Lens contains C.I. Reactive Blue No. 19 (21 CFR Part 73.3127) for visibility and handling. The Innova Vision (inifilcon A) Silicone Hydrogel Soft (Hydrophilic) Contact Lens incorporates a benzotriazole UV blocking monomer to help protect against transmission of harmful UV radiation. The lens blocks >95% in the UVB range (280nm - 315nm), and >50% in the UVA range (316nm - 380nm).
The Innova Vision (inifilcon A) Silicone Hydrogel Soft (Hydrophilic) Contact Lens is manufactured in sphere/asphere, toric, multifocal and multifocal-toric design configurations.
The provided text describes the 510(k) premarket notification for the Innova Vision (inifilcon A) Silicone Hydrogel Soft (Hydrophilic) Contact Lens. The document focuses on demonstrating the substantial equivalence of this new device to legally marketed predicate devices rather than providing acceptance criteria and a study proving a device meets specific performance criteria for an AI/ML-based medical device.
The information requested in the prompt, related to AI/ML device performance metrics such as sample sizes for training/test sets, expert adjudication methods, MRMC studies, standalone algorithm performance, and ground truth establishment for AI/ML models, is not present in the provided 510(k) summary for a contact lens.
This document discusses:
- Non-Clinical Performance Testing: Including toxicology (in-vitro cytotoxicity, systemic toxicity, acute ocular irritation, skin sensitization, 22-day ocular irritation), shelf life, solution compatibility, preservative uptake and release, and bench performance tests (refractive index, water content, Dk, % transmission, tensile strength, modulus, % elongation to break, specific gravity, quantification of polymerization residuals).
- Clinical Testing: A single-masked, bilateral, multi-center, randomized concurrent-control study comparing the Innova Vision lenses to Acuvue Vita lenses.
Therefore, I cannot fulfill the request to describe the acceptance criteria and the study that proves the device meets the acceptance criteria for an AI/ML device based on the provided text. The prompt's questions are tailored for AI/ML device evaluations, which are distinct from the premarket notification requirements and testing specified for contact lenses in this document.
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(167 days)
Innova Vision Inc.
Sphere/Asphere
Innova Vision Sphere and Asphere (Etafilcon A) Soft Contact lenses 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 2.00 diopters or less that does not interfere with visual acuty.
Toric
Innova Vision Toric (Etafilcon A) Soft Contact lenses 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 -10.00 diopters.
Multifocal
Innova Vision Multifocal (Etafilcon A) Soft Contact lenses are indicated for the correction of refractive ametropia (myopia and hyperopia) and emmetropia with presbyopia in 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.
Multifocal Toric
Innova Vision Multifocal Toric (Etafilcon A) Soft Contact lenses are indicated for the optic correction of distance and near vision in presbyopic phakic persons with non-diseased eves in powers of -20.00 to +20.00 diopters with add powers from +0.25 to +4.00 diopters and astigmatism corrections from -0.25 to -10.00 diopters.
Eye Care Practitioners may prescribe the Innova Vision Hydrogel (Etafilcon A) Soft (Hydrophilic) Contact lenses for frequent/planned replacement wear, with cleaning, disinfection and scheduled replacement or for single-use disposable wear.
When prescribed for frequent/planned replacement, the Innova Vision Hydrogel (Etafficon A) Soft (Hydrophilic) Contact Lens is to be cleaned. rinsed and disinfected each time the lens is removed. The contact lens is to be discarded after the recommended wearing period as prescribed by the Eye Care Professional. When prescribed for frequent/planned replacement wear, the lenses may be disinfected using a chemical disinfection only.
When prescribed for single-use disposable wear, Innova Vision Hydrogel (Etafilcon A) Soft (Hydrophilic) Contact Lens is to be discarded after each removal.
Innova Vision Hydrogel (Etafilcon A) Soft (Hydrophilic) Contact Lens is available as spherical and aspherical lenses manufactured by cast-molding method. The material is a high water content (58% wt/wt) material. The hydrogel lens' material is a random copolymer of 2-hydroxyethyl methacrylate (HEMA) and methacrylic acid (MAA), cross-linked with ethylene glycol dimethacrylate (EGDMA) and 1,1,1-trimethylolpropane trimethacrylate (TMPTMA) a via UV photo-polymerization. Innova Vision Hydrogel (Etafilcon A) Soft (Hydrophilic) Contact Lens is tinted with Reactive Blue 19 to enhance the visibility for for handling and contains 2-[3-(2H-Benzotriazol-2-yl)-4-hydroxyl-phenyl]ethyl as an additive for ultraviolet blocking purpose. The average transmittance in the UVB region is less than 5% and less than 30% in the UVA region.
The properties of the lens are:
Chord Diameter: 13.00 mm to 15.00 mm
Center Thickness 0.080 mm to 0.580 mm
Base Curve: 8.0 mm to 9.8 mm
Power Range
Sphere Power: -20.00 D to +20.00 D in 0.25 D steps
Cylinder Power (Toric): -0.25 D to -2.25 D in 0.25 D steps
Cylinder Axis (Toric): 10 degrees to 180 degrees in 10 degrees steps
Multifocal Power: +0.25 D to +4.00 D in 0.25 D steps
Specific Gravity: 0.98 to 1.12
Refractive Index: 1.400 plus or minus 0.005
Visible Light Transmittance: > 95%
UVA (315 nm~380 nm) Absorbance
The provided text describes the regulatory submission for the Innova Vision Hydrogel (Etafilcon A) Soft (Hydrophilic) Contact Lens (K222954). The submission demonstrates substantial equivalence to predicate and reference devices, primarily through non-clinical testing.
Here's an analysis of the acceptance criteria and the study that proves the device meets them, based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly list acceptance criteria in a quantitative format for all aspects. Instead, it states that "All the test results met the requirements of product specification" and "The results complied with the testing guidance." It provides specific performance characteristics for the subject device and compares them to predicate and reference devices, asserting non-significant differences.
Based on the "Description of the Device" and the comparison tables, here's a summary of performance characteristics presented as implicit acceptance criteria and reported performance:
| Acceptance Criteria (Implied) | Reported Device Performance (Innova Vision Hydrogel (Etafilcon A) Soft (Hydrophilic) Contact Lens) |
|---|---|
| Geometric Parameters | |
| Chord Diameter | 13.00 mm to 15.00 mm |
| Center Thickness | 0.080 mm to 0.580 mm |
| Base Curve | 8.0 mm to 9.8 mm |
| Power Range (Sphere) | -20.00 D to +20.00 D in 0.25 D steps |
| Power Range (Cylinder, Toric) | -0.25 D to -2.25 D in 0.25 D steps |
| Cylinder Axis (Toric) | 10° to 180° in 10° steps |
| Multifocal Power | +0.25 D to +4.00 D in 0.25 D steps |
| Material Properties | |
| Specific Gravity | 0.98 to 1.12 |
| Refractive Index | 1.400 ± 0.005 |
| Visible Light Transmittance | > 95% |
| UVA (315 nm~380 nm) Absorbance |
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(228 days)
Innova Vision Inc.
Sphere/Asphere
Innova Vision Sphere and Asphere (Hioxifilcon A) Soft Contact lenses 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 2.00 diopters or less that does not interfere with visual acuity.
Toric
Innova Vision Toric (Hioxifilcon A) Soft Contact lenses 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 -10.00 diopters.
Multifocal
Innova Vision Multifocal (Hioxifilcon A) Soft Contact lenses 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.
Multifocal Toric
Innova Vision Multifocal Toric (Hioxifilcon A) Soft Contact lenses are indicated for the optic correction of distance and near vision in presbyopic phakic or aphakic persons with non-diseased eyes in powers of -20.00 to +20.00 diopters with add powers from +0.25 to +4.00 diopters and astigmatism corrections from -0.25 to -10.00 diopters.
Eye Care Practitioners may prescribe the Innova Vision Hydrogel (Hioxifilcon A) Soft (Hydrophilic) Contact lenses for frequent/planned replacement wear, with cleaning, disinfection and scheduled replacement or for single-use disposable wear.
When prescribed for frequent/planned replacement, the Innova Vision Hydrogel (Hioxifilcon A) Soft (Hydrophilic) Contact Lens is to be cleaned, rinsed and disinfected each time the lens is removed. The contact lens is to be discarded after the recommended wearing period as prescribed by the Eye Care Professional. When prescribed for frequent/planned replacement wear, the lenses may be disinfected using a chemical disinfection only.
When prescribed for single-use disposable wear, Innova Vision Hydrogel (Hioxifilcon A) Soft (Hydrophilic) Contact Lens is to be discarded after each removal.
Innova Vision Hydrogel (Hioxifilcon A) Soft (Hydrophilic) Contact Lens is available as spherical and aspherical lenses manufactured by cast-molding method. The material is a high water content (59% wt/wt) material. The hydrogel lens' material is a random copolymer of 2-hydroxyethyl methacrylate (HEMA) and glycerol methacrylate (GMMA) cross-linked with ethylene glycol dimethacrylate (EGDMA) via UV photo-polymerization. Innova Vision Hydrogel (Hioxifilcon A) Soft (Hydrophilic) Contact Lens is tinted with Reactive Blue 19 to enhance the visibility for handling and contains 2-[3-(2H-Benzotriazol-2-vl)-4-hydroxypheny]] ethyl methacrylate as an additive for ultraviolet blocking purpose. The average transmittance in the UVB region is less than 5% and less than 50% in the UVA region.
The document describes the Innova Vision Hydrogel (Hioxifilcon A) Soft (Hydrophilic) Contact Lens and its substantial equivalence determination, rather than a study proving the device meets specific acceptance criteria in a clinical trial setting. The substantial equivalence relies on non-clinical testing and comparison to predicate devices.
Here's an analysis of the provided information, framed to address your request for acceptance criteria and study details:
1. Table of Acceptance Criteria & Reported Device Performance:
The document doesn't explicitly list "acceptance criteria" in the typical quantitative sense for a clinical study with primary endpoints. Instead, it demonstrates compliance with recognized standards and similarity to predicate devices. The "reported device performance" is primarily the physical and chemical properties of the lens and the results of non-clinical tests meeting specific standard requirements.
| Characteristic / Test | Acceptance Criteria (Standard/Predicate Equivalence) | Reported Device Performance (Innova Vision Hydrogel) |
|---|---|---|
| Material | Hioxifilcon A (Same as predicates) | Hioxifilcon A (random copolymer of 2-hydroxyethyl methacrylate (HEMA) and glycerol methacrylate (GMMA) cross-linked with ethylene glycol dimethacrylate (EGDMA) via UV photo-polymerization, tinted with Reactive Blue 19, contains UV blocking additive 2-[3-(2H-Benzotriazol-2-vl)-4-hydroxypheny]] ethyl methacrylate) |
| Water Content | 59% ± 2% (Same as predicates) | 59% ± 2% |
| Oxygen Permeability | $20.76 \times 10^{-11} (cm^2/sec)(mlO_2/ml \times mm Hg)$ (Predicate Clalen 58), $25 \times 10^{-11} (cm^2/sec)(mlO_2/ml \times mmHg)$ (Reference UNICON Hydrogel) - "Not significantly different and meets the requirement" | $25 \times 10^{-11} (cm^2/s)/(ml O_2/[ml \cdot mmHg]) \pm 20%$ |
| Refractive Index | 1.403 (hydrated) (Predicate Clalen 58), 1.404 (hydrated) (Reference UNICON Hydrogel) - "Not significantly different and meets the requirement" | $1.400 \pm 0.005$ |
| UVB Absorbance | 95% (meaning 50% (meaning 95% | |
| Sterilization Validation & Shelf Life | Compliance with ISO 11138-1, -3, ISO 11137-1, -2, ISO 17665-1, ASTM F1929-15, ISO 18369-3, ISO 11987, ISO 11737-2, ASTM F2338-09 requirements. | All test results met the requirements of product specification. |
| Biocompatibility | Compliance with ISO 10993-1, -5, -12, -10, -11 and ASTM F750-87 requirements. | All test results met the requirements of product specification. |
| Performance (Oxygen Permeability, Tensile Strength, Refractive Index, Water Content, Specific Gravity, Extractables, Luminous Transmittance, Lens Compatibility with Multi-Purpose Solution, Osmolality Determination, pH Value Determination, Geometric Parameters) | Compliance with ISO 18369-4, ASTM D882-18, ASTM D1708-18, and ISO 18369-3 requirements. | All test results met the requirements of product specification. |
| Indications for Use | Substantially equivalent to predicate and reference devices, with "few different wordings [that] do not affect the equivalence." | See detailed indications on page 2, 5, 6, 10, 11, and 12 for Sphere/Asphere, Toric, Multifocal, and Multifocal Toric lenses. Powers from -20.00 to +20.00 diopters, astigmatic correction up to -10.00 diopters, add powers up to +4.00 diopters. Frequent/planned replacement wear or single-use disposable wear. |
2. Sample Size for the Test Set and Data Provenance:
- Sample Size: Not applicable. This submission relies on non-clinical testing (e.g., laboratory tests on lens samples) and a comparison to predicate devices, not a clinical "test set" of patients.
- Data Provenance: The tests were conducted internally by Innova Vision Inc. or contracted labs on samples of the device. The data is based on these non-clinical tests. The country of origin of the data is implicit to be Taiwan, where Innova Vision Inc. is located. It is prospective data in the sense that the tests were specifically performed for this 510(k) submission, but it's not "prospective clinical trial data."
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications:
- Not applicable. As no clinical test set was used, there was no ground truth for patient outcomes established by experts. Ground truth for the non-clinical tests would be the measurement standards themselves and the validation of the testing methodologies.
4. Adjudication Method for the Test Set:
- Not applicable. No clinical test set or adjudication of patient outcomes was performed.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
- No. This type of study is for image-based diagnostic devices comparing human readers' performance with and without AI assistance. This device is a contact lens and does not involve AI or diagnostic imaging.
6. Standalone (Algorithm Only) Performance Study:
- Not applicable. This device is a physical medical device (contact lens), not an algorithm or AI system.
7. Type of Ground Truth Used:
- The "ground truth" for this submission are the international and national standards for contact lens materials, manufacturing, biocompatibility, and performance, as well as the established safety and effectiveness profiles of the chosen predicate devices. The properties of the Innova Vision lens are compared to these established benchmarks and to the predicate devices. For example, oxygen permeability and refractive index values are compared to the predicate's values, and non-clinical tests conform to ISO and ASTM standards.
8. Sample Size for the Training Set:
- Not applicable. This submission does not involve machine learning or AI models with a "training set." The device is a physical product.
9. How the Ground Truth for the Training Set Was Established:
- Not applicable. See point 8.
In summary:
This 510(k) submission (K213119) for the Innova Vision Hydrogel Contact Lens is a Traditional 510(k) based on demonstrating substantial equivalence to existing legally marketed predicate devices (Clalen 58 and UNICON Hydrogel lenses). The "acceptance criteria" are compliance with established regulatory standards and the demonstration that the device's physical, chemical, and performance characteristics are either identical or not significantly different from the predicate devices. The "study" that proves this is a series of non-clinical laboratory tests performed on the contact lens samples, rather than a clinical trial with human subjects.
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(366 days)
INNOVA VISION INC.
Calaview Color (Etafilcon A) Soft (hydrophilic) Contact Lens is indicated for daily wear for the correction of visual acuity in not-aphakic persons with non-diseased eyes that are myopic or hyperopic and may exhibit refractive astigmatism up to 2.00 diopters that does not interfere with visual acuity.
Eye care practitioners may prescribe the lenses for either single-use daily disposable wear or frequent/planned replacement wear with cleaning, rinsing, disinfection and scheduled replacement as prescribed by the eye care professional. When prescribed for frequent/planned replacement wear The contact lens may be disinfected using chemical (not heat) disinfection system.
Calaview Color (Etafilcon A) Soft (hydrophilic) Contact Lens for Daily Wear is available as aspherical lenses manufactured by spin-casting method. The model illuminated with high water content (58 %). The hydrogel lens' material is a random copolymer composed of 2-hydroxyethyl methacrylate (HEMA) and methacrylic acid (MAA), which was cross-linked with 1,1-trimethylolpropane trimethacrylate (TMPTMA) and Ethylene Glycol Dimethacrylate (EGDMA) via UV photo- polymerization. The Calaview Color (Etafilcon A) Soft (hydrophilic) Contact Lens for Daily Wear contains pigments around the non-optic area that will mask or enhance the color of the natural iris without blocking the light transmittance. The lens is colored with one or more of the FDA-approval color additives: iron oxides, titanium dioxide, phthalocyaninato copper, phtalocyanine green, vat orange 1. The Calaview Color (Etafilcon A) Soft (hydrophilic) Contact Lens for Daily Wear is available in the following opaque colors: Blue, green, violet, gray, hazel, white, yellow, gold, orange red and black. Lenses are supplied sterile in sealed glass vials containing sterile isotonic phosphate buffered saline solution.
The provided document is a 510(k) summary for the Calaview Color (Etafilcon A) Soft (hydrophilic) Contact Lens for Daily Wear. It is a submission for a labeling modification to a previously cleared predicate device (Calaview (Etafilcon A) Soft (hydrophilic) Contact Lens for Daily Wear cleared via K073060).
The core argument for substantial equivalence is that there are no changes to the lens material, manufacturing process, parameters, or properties between the predicate and the subject device. The only difference is the packaging vehicle (glass vials for the subject device vs. PP blister packaging for the predicate). Therefore, the clinical and non-clinical data previously submitted for the predicate device are used to support the safety and effectiveness of the subject device.
This means the study described is not a new clinical trial for the Calaview Color lens, but rather a demonstration that the new device's characteristics are equivalent to the predicate device, thereby relying on the predicate's established safety and effectiveness.
Here's an attempt to answer your questions based on the provided text, acknowledging that a direct "study" as you might expect for a new device's acceptance criteria won't be found here:
1. A table of acceptance criteria and the reported device performance
Since this is a labeling modification with no change in material or fundamental properties, the "acceptance criteria" are implied to be the established performance characteristics of the predicate device, which the subject device is shown to match.
| Characteristic | Acceptance Criteria (Predicate Device) | Reported Device Performance (Subject Device) |
|---|---|---|
| %Water content | 57 to 59 | 57 to 59 |
| Refractive index | 1.407 | 1.407 |
| Specific Gravity | 1.05 | 1.05 |
| Oxygen permeability (edged corrected) @ 35°C | $24 \times 10^{-11}$ [(cm2/sec)(ml O2/ml-mmHg)] | $24 \times 10^{-11}$ [(cm2/sec)(ml O2/ml-mmHg)] |
| %Light Transmission | >93 | >93 |
| Base Curve Radius, mm | 8.00~9.00 | 8.00~9.00 |
| Diameter, mm | 13.8~14.2 | 13.8~14.2 |
| Center Thickness @-3.0D, mm | 0.08~0.12 | 0.08~0.12 |
| Power, Diopters | +6.0D~-12.0D | +6.0D~-12.0D |
| Biocompatibility | Non-toxic, not irritating, not cytotoxic (predicate) | No biocompatibility risks (due to identical material) |
| Sterility | SAL of 10-6 (validated steam sterilization) | SAL of 10-6 (validated steam sterilization) |
| Leachables | No leachable monomers or additive residues (predicate) | No leachable monomers or additive residues |
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 does not detail a new "test set" or clinical study with a specific sample size for the Calaview Color lens. Instead, it relies on the data from the predicate device (K073060). The provenance of that original data is not stated in this summary, but the company is based in Taiwan, R.O.C. The type of data would have been for a prospective clinical trial and non-clinical testing to achieve clearance for the predicate device. For the current submission, the "test" involved physical and chemical characterization of the subject device to demonstrate equivalence to the predicate.
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)
This is not applicable to this 510(k) submission. No new ground truth establishment is described or required as the submission relies on the established safety and effectiveness of the predicate device.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set
Not applicable. The submission focuses on demonstrating technical equivalence, not clinical adjudication of outcomes for a new clinical study.
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-assisted diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This device is a contact lens.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
For the predicate device, the "ground truth" would have come from standard clinical evaluations of contact lens wear, including visual acuity measurements, ocular health assessments by ophthalmologists/optometrists, and patient reported outcomes. However, for this specific submission, the "ground truth" is the established specifications and safety profile of the predicate device, against which the Calaview Color lens is compared for equivalence in its physical, chemical, and biological properties.
8. The sample size for the training set
Not applicable. This is not an AI or machine learning device requiring a training set.
9. How the ground truth for the training set was established
Not applicable. This is not an AI or machine learning device.
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(300 days)
INNOVA VISION INC.
Discon Plus (Etafilcon A) Contact Lens visibility tint with UV blocker is indicated for daily wear for the correction of refractive ametropia in not-aphakic persons with non-diseased eyes that are myopic or hyperopic and may exhibit refractive astigmatism up to 2.00 diopters that does not interfere with visual acuity.
Eye care practitioners may prescribe the lenses for either single-use daily disposable wear or frequent/planned replacement wear with cleaning, rinsing, disinfection and scheduled replacement as prescribed by the eyecare professional. When prescribed for frequent/planned replacement wear. The contact lens may be disinfected using chemical (not heat) disinfection system.
The Discon Plus (Etafilcon A) Contact Lens visibility tint with UV blocker is available as non-spherical fenses manufactured by spin-casting method. The model illuminated with high water content (58 %). `.te hydrogel lens' material is a random copolymer composed of 2-hydroxyethyl methacrylate (HEMA) Ind methacrylic acid (MAA), which was cross-linked with 1,1,1-trimethylolpropane trimethacrylate (TMPTMA) and Ethylene Glycol Dimethacrylate (EGDMA) via UV photo- polymerization. The Discon Plus (Etafilcon A) Contact Lens visibility tint with UV blocker is tinted blue using C.I Reactive blue 19 to make the lens more visible for handling In the Discon Plus Contact Lens with UV Blocker, a Benzophenone UV absorbing monomer is used to block UV radiation. The average transmittance characteristics for Discon Plus lens are less than 5% in the UVB range of 280nm - 315nm and less than 30% in the UVA range of 316nm - 380nm. Lenses are supplied sterile in sealed blister packers containing sterile isotonic phosphate buffered saline solution.
This document describes the Discon Plus (Etafilcon A) Contact Lens visibility tint with UV blocker. It is important to note that this 510(k) submission primarily relies on substantial equivalence to previously cleared predicate devices, rather than an independent de novo study with acceptance criteria being met by the device itself.
1. Table of Acceptance Criteria (Technological Characteristics) and Reported Device Performance
The acceptance criteria are implicitly defined by the properties of the predicate devices. The "reported device performance" refers to the characteristics of the Discon Plus lens, which are shown to be substantially equivalent to the predicates.
| Characteristic | Acceptance Criteria (Predicate: Discon (K051129) & Acuvue (K962804)) | Reported Device Performance (Discon Plus) |
|---|---|---|
| FDA group # | Group # 4 >50% Water, Ionic Polymers | Group # 4 >50% Water, Ionic Polymers |
| USAN name | Etafilcon A | Etafilcon A |
| Production method | Predicate 1 (Discon): Spin-casting | |
| Predicate 2 (Acuvue): Cast-molded | Spin-casting | |
| %Water content | 58 | 58 |
| Refractive index | 1.40 | 1.40 |
| Oxygen permeability (edged corrected) @ 35°C | Predicate 1 (Discon): $24 \times 10^{-11}$ | |
| Predicate 2 (Acuvue): $26 \times 10^{-11}$ | $24 \times 10^{-11}$ | |
| Power, Diopters | Predicate 1 (Discon): +6.0D~-12.0D | |
| Predicate 2 (Acuvue): +20.0D~-20.0D | +20.0D~-20.0D | |
| %Light transmission @381~700 nm | 93 minimum (for Discon) / 85 minimum (for Acuvue) | 93 minimum |
| %Light transmission @316~380 nm (UVA) | avg |
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(30 days)
INNOVA VISION INC.
Calaview (Etafilcon A) Soft (hydrophilic) Contact Lens is indicated for daily wear the correction of visual acuity in not-aphakic persons with non-diseased eyes that are myopic or hyperopic and may exhibit refractive astigmatism up to 2.00 diopters that does not interfere with visual acuity.
Eye care practitioners may prescribe the lenses for either single-use daily disposable wear or frequent/planned replacement wear with cleaning, rinsing , disinfection and scheduled replacement as prescribed by the eyecare professional.. When prescribed for frequent/planned replacement wear , The contact lens may be disinfected using chemical (not heat) disinfection system.
Calaview (Etafilcon A) Soft (hydrophilic) Contact Lens for Daily Wear is available as non-spherical lenses manufactured by spin-casting method. The model illuminated with high water content (58 %). The hydrogel lens' material is a random copolymer composed of 2-hydroxyethyl methacrylate (HEMA) and methacrylic acid (MAA), which was cross-linked with 1,1,1-trimethylolpropane trimethacrylate (TMPTMA) and Ethylene Glycol Dimethacrylate (EGDMA) via UV photo- polymerization. The Calaview (Etafilcon A) Soft (hydrophilic) Contact Lens for Daily Wear contains pigments around the non-optic area that will mask or enhance the color of the natural iris without blocking the light transmittance. The lens is colored with one or more of the FDA-approval color additives: iron oxides, titanium dioxide, phthalocyaninato copper, phtalocyanine green, vat orange 1. The Calaview (Etafilcon A) Soft (hydrophilic) Contact Lens for Daily Wear is available in the following opaque colors: Blue, green, violet, gray, hazel, white, yellow, gold, orange red and black. Lenses are supplied sterile in sealed blister packers containing sterile isotonic phosphate buffered saline solution.
This 510(k) submission (K073060) is a Special 510(k) for a labeling modification to an already cleared device, Calaview Colors (Etafilcon A) Soft (hydrophilic) Contact Lens for Daily Wear (K062541). The key takeaway is that no new clinical or non-clinical studies were conducted for this specific submission because the device itself (materials, manufacturing, parameters) is identical to the previously cleared predicate device. Therefore, the information requested below regarding new studies, sample sizes, and ground truth establishment is largely not applicable to this specific 510(k), as it relies on previous submissions.
However, I will extract the available information and clarify where it refers to prior studies.
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria are implicitly defined by the parameters and performance of the predicate devices. The "reported device performance" are the characteristics of the Calaview device that demonstrate equivalence to the predicate.
| Characteristic | Acceptance Criteria (Predicate) | Reported Device Performance (Calaview) |
|---|---|---|
| % Water content | 58% (Acuvue 2 Colors) | 57 to 59% |
| Refractive index | 1.40 (Acuvue 2 Colors) | 1.407 |
| Specific Gravity | 1.05 (Acuvue 2 Colors) | 1.05 |
| Oxygen permeability (edged corrected) @ 35°C | $21.4\times10^{-11}$ [(cm²/sec)(ml O₂/ml-mmHg)] (Acuvue 2 Colors) | $24\times10^{-11}$ [(cm²/sec)(ml O₂/ml-mmHg)] |
| % Light Transmission | >85% (Acuvue 2 Colors) | >93% |
| Base Curve Radius, mm | 7.85~10.00 (Acuvue 2 Colors) | 8.00~9.00 |
| Diameter, mm | 12.0~15.0 (Acuvue 2 Colors) | 13.8~14.2 |
| Center Thickness, mm | 0.06~1.00 (Acuvue 2 Colors) | 0.08~0.12 |
| Power, Diopters | +20.0D~-20.0D (Acuvue 2 Colors) | +6.0D~-12.0D |
| Biocompatibility | Non-toxic, non-irritating, non-cytotoxic | Non-toxic, non-irritating, non-cytotoxic (referencing prior studies) |
| Microbial Sterility (SAL) | Minimum SAL of 10⁻⁶ | Meets requirement (referencing prior validation) |
| Leachables | No leachable monomers/addictive residues | No leachable monomers/addictive residues (referencing prior studies) |
2. Sample size used for the test set and the data provenance
- For this specific 510(k) (K073060): No new clinical or non-clinical test sets were used. The submission explicitly states: "There is no change in lens material, the manufacturing process, nor the parameter and properties. therefore, the clinical data previously submitted in K062541 supports the clinical safety of the subject device." and "Therefore, the non-clinical data previously submitted in K062541 supports the clinical safety of the subject device."
- For the referenced predicate (K062541): This document does not provide details on the sample sizes or data provenance for the original clinical or non-clinical studies conducted for K062541. These details would be found within the K062541 submission itself.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Not applicable to this 510(k). No new clinical studies were conducted that would require expert ground truth establishment.
4. Adjudication method for the test set
- Not applicable to this 510(k). No new clinical studies were conducted.
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 diagnostic tool. No MRMC studies were performed.
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 algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- For this specific 510(k): No new ground truth was established. The safety and effectiveness are based on the established performance of the predicate device.
- For the referenced predicate (K062541): For contact lenses, "ground truth" for clinical safety and effectiveness typically involves ophthalmological examinations, visual acuity measurements, adverse event tracking (e.g., corneal staining, infiltrates, discomfort), and patient reported outcomes. Details would be in the K062541 submission. For non-clinical tests, ground truth is based on standard laboratory testing methodologies (e.g., ISO standards for biocompatibility, sterility testing).
8. The sample size for the training set
- Not applicable. This is a medical device (contact lens), not an AI model requiring a training set.
9. How the ground truth for the training set was established
- Not applicable. This is a medical device (contact lens), not an AI model.
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(281 days)
INNOVA VISION INC.
Calaview Colors (Etafilcon A) Soft (hydrophilic) Contact Lens is indicated for daily wear the correction of visual acuity in not-aphakic persons with non-diseased eyes that are myopic or hyperopic and may exhibit refractive astigmatism up to 2.00 diopters that does not interfere with visual acuity.
The eye care practitioner may prescribe the contact lens for frequent replacement wear, with cleaning, rinsing and disinfection and scheduled replacement as prescribed by the eyecare professional. The contact lens may be disinfected using chemical (not heat) disinfection system.
Calaview Colors Soft (hydrophilic) Contact Lens are available as non-spherical lenses manufactured by spin-casting method. The model illuminated with high water content (58 ± 1%). The hydrogel lens' material is a random copolymer composed of 2-hydroxyethyl methacrylate (HEMA) and methacrylic acid (MAA), which was cross-linked with 1,1,1-trimethylolpropane trimethacrylate (TMPTMA) and Ethylene Glycol Dimethacrylate (EGDMA) via UV photo- polymerization. The Calaview Colors Contact lens contains pigments around the non-optic area that will mask or enhance the color of the natural iris without blocking the light transmittance. The lens is colored with one or more of the FDA-approval color additives: iron oxides, titanium dioxide, phthalocyaninato copper, phtalocyanine green, vat orange 1. The Calaview Colors (Etafilcon A) Soft (hydrophilic) Contact Lens is available in the following opaque colors: Blue, green, violet, gray, hazel, white, yellow, gold, orange red and black. Lenses are supplied sterile in sealed blister packers containing sterile isotonic phosphate buffered saline solution.
The provided text describes the safety and effectiveness of Calaview Colors (Etafilcon A) Soft (hydrophilic) Contact Lens for Daily Wear. This is a premarket notification (510(k)) submission, which aims to demonstrate that a device is substantially equivalent to a legally marketed predicate device. Therefore, the "acceptance criteria" are implied by the characteristics and performance of the predicate devices.
Here's a breakdown of the requested information based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria for the Calaview Colors (Etafilcon A) Soft (hydrophilic) Contact Lens are implicitly set by the characteristics and performance of its predicate devices: ACUVUE 2 colours Brand (Etafilcon A) Contact Lens (K010114) and Discon (Etafilcon A) Soft (hydrophilic) Contact Lens for Daily Wear (K051129). The study demonstrates substantial equivalence to these predicates rather than explicitly stating acceptance criteria for each metric.
| Characteristic | Acceptance Criteria (Predicate Range/Values) | Reported Device Performance (Calaview Colors) |
|---|---|---|
| %Water content | 57 to 59 (Discon) / 58 (Acuvue Colors) | 57 to 59 |
| Refractive index | 1.407 (Discon) / 1.40 (Acuvue Colors) | 1.407 |
| Specific Gravity | 1.05 (Discon & Acuvue Colors) | 1.05 |
| Oxygen permeability (edged corrected) @ 35°C | 24 x 10^-11 [(cm²/sec)(ml O₂/ml-mmHg)] (Discon) / 22.4 x 10^-11 [(cm²/sec)(ml O₂/ml-mmHg)] (Acuvue Colors) | 24 x 10^-11 [(cm²/sec)(ml O₂/ml-mmHg)] |
| %Light Transmission | >93 (Discon) / >85 (Acuvue Colors) | >93 |
| Base Curve Radius, mm | 8.00 | 8.00~9.00 |
| Diameter, mm | 13.8 | 13.8~14.2 |
| Center Thickness, mm | 0.08 | 0.08~0.20 |
| Power, Diopters | +6.0D~-20.0D (Discon) / +20.0D~-20.0D (Acuvue Colors) | +6.0D~-20.0D |
| Biocompatibility | Non-toxic, non-irritating, non-cytotoxic (based on predicate standards) | Irritation test in rabbit eye: non-irritated. Systemic toxicity: non-toxic. Cytotoxicity: not cytotoxic. |
| Sterilization | Minimum SAL of 10⁻⁶ (based on FDA Group IV requirement) | Steam sterilization validated to deliver minimum SAL of 10⁻⁶ |
| Leachability | No leachable monomers and addictive residues at detection levels (based on predicate standards) | No leachable monomers and addictive residues |
| Clinical performance | "Good and safe" with corrected vision and satisfaction (from predicate experience) | Nearly 100% vision corrected, nearly all satisfied, generally stable condition without severe complication. |
2. Sample Size Used for the Test Set and Data Provenance
The clinical study involved a test set of 65 human eyes.
The data provenance mentions "Calaview Colors lenses have been wide-used around the world, including Taiwan. China, Europe, etc." and implies the study participants were part of this usage. The study appears to be retrospective in the sense that the lenses "have been wide-used" and observed, although the "65 human eyes ... within 6 months" could also indicate a prospective observational study. Without further details, it's difficult to definitively classify. The country of origin for the 65 human eyes is not explicitly stated within the document for the specific clinical study, but the submitter is based in Taiwan.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
The document does not provide information on the number or qualifications of experts used to establish a "ground truth" for the test set in the clinical study. The assessment of "vision corrected," "satisfied with the lens wearing," and "stable condition without severe complication" likely comes from the "eye care practitioner" mentioned, but no specifics are given.
4. Adjudication Method for the Test Set
The document does not specify any adjudication method (e.g., 2+1, 3+1, none) for the clinical study's test set.
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
No MRMC comparative effectiveness study was done. This device is a contact lens; therefore, it's not an AI-assisted diagnostic tool for which an MRMC study would be relevant.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
No standalone algorithm performance study was done. Again, this is a physical medical device (contact lens), not an algorithm.
7. The Type of Ground Truth Used
For the clinical study, the "ground truth" was based on clinical observation and patient reported outcomes (e.g., visual acuity correction, patient satisfaction, lack of adverse events/complications). For the technical characteristics, the "ground truth" was established by laboratory measurements against defined standards or measurements from predicate devices.
8. The Sample Size for the Training Set
This submission is for a physical medical device (contact lens); it does not involve a "training set" in the context of machine learning algorithms. The manufacturing process and material properties are developed and validated through engineering and scientific principles, not machine learning training.
9. How the Ground Truth for the Training Set Was Established
As there is no training set in the machine learning sense, this question is not applicable. The device's design and manufacturing rely on well-established principles of polymer chemistry and optics, and its safety and effectiveness are confirmed through non-clinical laboratory testing and clinical observation against predicate devices and regulatory requirements.
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(178 days)
INNOVA VISION INC.
Discon Daily (Etafilcon A) One-Day Soft (hydrophilic) Contact Lens is indicated for the correction of visual acuity in not-aphakic persons with non-diseased eyes that are myopia or hyperopia and may exhibited refractive astigmatism up to 2.00 diopters that does not interfere with visual acuity. The eye care practitioner may prescribe the contact lens for single-use daily disposable wear. The Discon Daily Lenses are not intended to be disinfected and should be discarded after a single use.
Discon daily Contact Lens are available as non-spherical fenses manufactured by spin-casting method. The model illuminated with high water content (58 The hydrogel lens' material is a random copolymer composed of %). 2-hydroxyethyl methacrylate (HEMA) and methacrylic acid (MAA), which was cross-linked with 1,1,1-trimethylolpropane trimethacrylate (TMPTMA) and Ethylene Glycol Dimethacrylate (EGDMA) via UV photo- polymerization. The Discon Daily Contact lens with visible tint is light tinted blue using Reactive Blue Dye #19 to make the lens more visible for handling. Lenses are supplied sterile in sealed blister packers containing sterile isotonic phosphate buffered saline. The compatibility and package integrity of the blister pack packaging system has been demonstrated and successfully used for other marketed lens products, and packaged lenses are effectively steam-sterilized in a validated autoclave.
This document is a 510(k) Pre-Market Notification for a contact lens, and it primarily focuses on establishing substantial equivalence to existing predicate devices rather than providing detailed acceptance criteria and a study proving device performance in the way one might expect for a novel AI/software medical device.
Based on the provided text, here's an analysis of the requested information:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance (Discon Daily) | Predicate Device (Discon K051129) Performance |
|---|---|---|
| Material/Composition | No change from predicate lens material (Etafilcon A, HEMA, MAA, TMPTMA, EGDMA) | Same (Etafilcon A, HEMA, MAA, TMPTMA, EGDMA) |
| Manufacturing Process | No change from predicate lens manufacturing process (spin-casting) | Same (spin-casting) |
| Diameter Range | 13.8 to 14.2 mm | No explicit range given, but implied same as predicate due to no change statement |
| Power Range | +6.00D to -12.00D | No explicit range given, but implied same as predicate due to no change statement |
| Center Thickness (-3.00D) | 0.08 to 0.12 mm | No explicit range given, but implied same as predicate due to no change statement |
| Refractive Index (hydrated) | 1.407 | No explicit value given, but implied same as predicate due to no change statement |
| Light Transmittance | >93% | No explicit value given, but implied same as predicate due to no change statement |
| Water Content | 56 to 60 % | No explicit value given, but implied same as predicate due to no change statement |
| Oxygen Permeability | 24 x 10^-11 [(cm² /sec)(ml 02/ml-mmHg)] @ 35℃ | No explicit value given, but implied same as predicate due to no change statement |
| Clinical Safety | "generally stable condition without severe complication," "no significant side effects and complaints" observed in wide usage. | Supported by prior submission K051129; deemed clinically safe. |
| Efficiency and Security of Use | Indicated to support efficiency and security as well as predicate devices. | Established by predicate device. |
Explanation of the Table:
The document repeatedly states "There is no change in lens material, the manufacturing process, nor the parameter and properties" and "These technological characteristics of Discon Daily Contact lenses do not change to that of predicate lenses previously submitted in K051129." Therefore, the acceptance criteria for these characteristics are implicitly that they are identical to the predicate device, K051129. The reported performance of the Discon Daily is the same as these predicate device characteristics. The only explicit change mentioned is a "slightly exchange of blue-tint concentration," which is not given a specific acceptance criterion.
2. Sample Size Used for the Test Set and Data Provenance
- Test Set Sample Size: Not explicitly stated as a defined "test set" with a numerical sample size. The document refers to "Discon Daily lenses have been wide-used around the world, including Taiwan, China, etc. Among the users being daily worn the Discon Daily lenses, all the procedures were in generally stable condition without severe complication." This implies a post-market surveillance type of observation rather than a structured clinical trial test set.
- Data Provenance: "wide-used around the world, including Taiwan, China, etc." The nature is observational/retrospective, based on existing usage data rather than a new prospective study for this 510(k).
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of those Experts
Not applicable. No formal "ground truth" establishment by experts for a specific test set is described. The assessment of "generally stable condition without severe complication" and "no significant side effects and complaints" appears to be an aggregation of real-world usage and reporting, rather than an expert panel review of individual cases.
4. Adjudication Method for the Test Set
Not applicable. No formal adjudication method is mentioned as there isn't a structured test set requiring such.
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/software device, so MRMC studies involving AI assistance are not relevant.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done
Not applicable. This is a contact lens, not an algorithm.
7. The Type of Ground Truth Used
The "ground truth" for showing clinical safety and effectiveness is primarily clinical outcomes/usage data (i.e., observation of "generally stable condition without severe complication" and "no significant side effects and complaints" from wide usage) and equivalence to predicate devices which had previously established safety and effectiveness. There is no mention of pathology or other objective diagnostic criteria as ground truth for a clinical study.
8. The Sample Size for the Training Set
Not applicable. This is not an AI/learning algorithm, so there is no concept of a "training set."
9. How the Ground Truth for the Training Set was Established
Not applicable. See point 8.
Summary of the Study:
The "study" in this 510(k) submission is not a new clinical trial but rather a demonstration of substantial equivalence to previously cleared predicate devices (K051129 and K013973). The key "study" elements are:
- Assertion of No Change: The core of the argument is that the device (Discon Daily) uses the same material and manufacturing process as a previously cleared device (Discon K051129). This implies that all non-clinical and most clinical performance data for the predicate device directly apply to the new device.
- Technological Characteristics Comparison: The document lists several key technological characteristics (diameter, power, thickness, refractive index, light transmittance, water content, oxygen permeability) and states they "do not change to that of predicate lenses."
- Clinical Data Leverage: The clinical data submitted in the predicate K051129 is leveraged to support the clinical safety of the subject device.
- Real-World Usage Observation: Complementing the equivalence, the document mentions that Discon Daily lenses have been "wide-used around the world" and "all the procedures were in generally stable condition without severe complication" with "no significant side effects and complaints." This serves as real-world observational evidence reinforcing safety.
In essence, for this 510(k), the "study" is a comparative analysis, relying heavily on the established safety and effectiveness of its predicate devices, combined with observational real-world data indicating no new safety concerns.
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(101 days)
INNOVA VISION INC.
Discon (Etafilcon A) Soft (hydrophilic) Contact Lens for Daily Wear is indicated for the correction of visual acuity in not-aphakic persons with non-diseased eyes that are myopia or hyperopia and may exhibited refractive astigmatism up to 2.00 diopters that does not interfere with visual acuity. The eye care practitioner may prescribe the contact lens for frequent replacement wear, with cleaning, rinsing and disinfection and scheduled replacement. The contact lens may be disinfected using a chemical (not heat) disinfection system only.
Discon (Etafilcon A) Soft (hydrophilic) Contact Lens for Daily Wear are available as non-spherical lenses manufactured by spin-casting method. The model illuminated with high water content (58 %). The hydrogel lens' material is a random copolymer composed of 2-hydroxyethyl methacrylate (HEMA) and methacrylic acid (MAA), which was cross-linked with 1,1,1-trimethylolpropane trimethacrylate (TMPTMA) and Ethylene Glycol Dimethacrylate (EGDMA) via UV photo- polymerization. The Discon Contact lens with visible tint is tinted blue using Reactive Blue Dye #19 to make the lens more visible for handling. Lenses are supplied sterile in sealed blister packers containing sterile isotonic phosphate buffered saline. The compatibility and package integrity of the blister pack packaging system has been demonstrated and successfully used for other marketed lens products, and packaged lenses are effectively steam-sterilized in a validated autoclave.
Here's a breakdown of the acceptance criteria and study information for the Discon (Etafilcon A) Soft (hydrophilic) Contact Lens for Daily Wear, based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance:
The document doesn't explicitly state "acceptance criteria" in a quantitative, measurable sense that would typically be found for a new, independent safety/efficacy study. Instead, it focuses on demonstrating substantial equivalence to predicate devices through various tests and a clinical summary. The "acceptance criteria" are implicitly met if the device's performance is comparable to or meets the established safety and effectiveness profile of the predicate devices.
| Acceptance Criteria (Implied by Substantial Equivalence to Predicates) | Reported Device Performance (Discon Lenses) |
|---|---|
| Clinical Performance (Safety & Efficacy) | - "Nearly a hundred percent of the participants' vision was corrected and nearly all were satisfied with the lens wearing and care of lenses." |
- "all the procedures were in generally stable condition without severe complication."
- "No significant side effects and complaints to be observed."
- Indicated for correction of visual acuity in non-aphakic persons with non-diseased eyes (myopia/hyperopia) and astigmatism up to 2.00 diopters. |
| Technological Characteristics | - Equivalent and comparable to predicate lenses in:- Diameter range: 13.8 to 14.2 mm
- Power range: +6.00D to -12.00D
- Center thickness: 0.08 to 0.12 mm for -3.00D
- Refractive index: 1.407 (hydrated)
- Light transmittance: >93%
- Water content: 56 to 60 %
- Oxygen permeability (edged corrected): 24x10-11 [(cm³/sec)(ml O2/ml-mmHg)] @ 35°C |
| Biocompatibility | - Non-toxic and non-irritated (rabbit eye irritation and systemic toxicity studies).
- Not cytotoxic (cytotoxicity testing). |
| Microbiology | - Steam sterilization process validated to deliver minimum SAL of 10-6. - Shelf-life stability data supports sterility through expiration date. |
| Leachability | - No leachable monomers and addictive residues detected above reported levels. |
2. Sample Size Used for the Test Set and Data Provenance:
- Sample Size: 65 human eyes
- Data Provenance: The study was conducted for 6 months. It also states that "Discon lenses have been wide-used around the world, including Taiwan, China, Europe, etc." and observations were made "Among the users being daily worn the Discon lenses". This suggests a combination of a prospective clinical study involving 65 eyes and potentially retrospective observations from wider market use, though the details of the latter are not specified as a formal study. The primary clinical study of 65 eyes provides prospective data. The submitter is based in Taiwan.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications:
The document does not explicitly state the number of experts used or their qualifications for establishing ground truth in the clinical study. It mentions the "eye care practitioner may prescribe the contact lens" in the 'Indications for Use', implying practitioners would be involved in patient assessment and data collection.
4. Adjudication Method for the Test Set:
The document does not specify any adjudication method for the test set (e.g., 2+1, 3+1).
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done:
No, a multi-reader multi-case (MRMC) comparative effectiveness study comparing human readers with and without AI assistance was not conducted. This 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 as the device is a contact lens, not a computational algorithm.
7. The Type of Ground Truth Used:
The ground truth for the clinical study seems to be based on clinical observation, patient feedback, and standard ophthalmological assessments of visual acuity and ocular health. Terms like "participants' vision was corrected," "satisfied with the lens wearing," "stable condition without severe complication," and "no significant side effects and complaints" indicate this. For the non-clinical studies (biocompatibility, microbiology, leachability), the ground truth is established through laboratory testing and established scientific methodologies/standards.
8. The Sample Size for the Training Set:
This document does not mention a training set in the context of device development or clinical validation, as it is not an AI/machine learning device. The 65 human eyes mentioned are for the clinical study/test set.
9. How the Ground Truth for the Training Set was Established:
This question is not applicable as there is no mention of a training set for this type of device.
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