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510(k) Data Aggregation
(178 days)
- Aquamax (Etafilcon A) Daily Disposable Soft (Hydrophilic) Contact Lenses:
Spherical and Aspherical
Aquamax (Etafilcon A) SPHERE and ASPHERE Daily Disposable Soft (Hydrophilic) Contact Lenses are indicated for daily wear for the correction of ametropia (myopia and hyperopia) in aphakic and/or non-aphakic persons with non-diseased eyes in powers from +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
Aquamax (Etafilcon A) Toric Daily Disposable Soft (Hydrophilic) Contact Lenses are indicated for daily wear for the correction of ametropia (myopia or hyperopia with astigmatism) in 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
Aquamax (Etafilcon A) Multifocal Daily Disposable Soft (Hydrophilic) Contact Lenses are indicated for daily wear for the correction of refractive ametropia (myopia and hyperopia) and presbyopia in aphakic persons with non-diseased eyes in powers from -20.00 to +20.00 diopters and with non-diseased eyes who may require a reading addition of up to +3.00D. The lenses may be worn by persons who exhibit astigmatism of 2.00 diopters or less that does not interfere with visual acuity.
Aquamax (Etafilcon A) Daily Disposable Soft (Hydrophilic) Contact Lenses help protect against transmission of harmful UV radiation to the cornea and into the eye. The lenses are intended for single-use disposable wear. - Aquamax (Etafilcon A) Soft (Hydrophilic) Contact Lenses:
Spherical and Aspherical
Aquamax (Etafilcon A) SPHERE and ASPHERE Soft (Hydrophilic) Contact Lenses are indicated for daily wear for the correction of ametropia (myopia and hyperopia) in aphakic and/or 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
Aquamax (Etafilcon A) Toric Soft (Hydrophilic) Contact Lenses are indicated for daily wear for the correction of ametropia (myopia or hyperopia with astigmatism) in aphakic and/or 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
Aquamax (Etafilcon A) Multifocal Soft (Hydrophilic) Contact Lenses are indicated for daily wear for the correction of refractive ametropia (myopia and hyperopia) and presbyopia in aphakic and/or non-aphakic persons with non-diseased eyes in powers from -20.00 to +20.00 diopters and with non-diseased eyes who may require a reading addition of up to +3.00D. The lenses may be worn by persons who exhibit astigmatism of 2.00 diopters or less that does not interfere with visual acuity.
Aquamax (Etafilcon A) Soft (Hydrophilic) Contact Lenses help protect against transmission of harmful UV radiation to the cornea and into the eye.
The lenses are intended for 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 lens may be disinfected using a chemical (not heat) lens care system only.
Aquamax (Etafilcon A) Soft (Hydrophilic) Contact Lenses and Aquamax (Etafilcon A) Daily Disposable Soft (Hydrophilic) Contact Lenses are available as spherical, aspherical, toric and multifocal lenses. The model illuminated with high water (58 %). These hydrogel lens materials are random copolymer of 2-hydroxyethyl methacrylate (HEMA) and methacrylic acid (MAA), which were crosslinked with glycol dimethacrylate (EGDMA) and 1,1,1-trimethylolpropane ethylene e trimethacrylate (TMPTMA) via photo-polymerization. These lenses are tinted blue using C.I. reactive blue 19 to make them more visible for handling. These lenses contain UV blocker, a benzotriazole UV absorbing monomer to block UV radiation. The average transmittance characteristics of theses lenses are less than 5% in the UVB range of 280-315 nm and less than 50% in the UVA range of 316-380nm. Lenses are supplied sterile in sealed blister package containing sterile isotonic borate buffered saline solution with Tween 80, Sodium Hyaluronate and Polyethylene Glycol.
Here's an analysis of the provided text regarding the acceptance criteria and study for the Aquamax (Etafilcon A) Soft (Hydrophilic) Contact Lenses.
It's important to note that this document is a 510(k) summary, which focuses on demonstrating substantial equivalence to predicate devices rather than providing a full, detailed study report with all raw data. Therefore, some information, especially regarding detailed sample sizes for specific tests (like each biocompatibility test), expert qualifications, and adjudication methods, is not explicitly provided in the summary.
1. Table of Acceptance Criteria and Reported Device Performance
| Feature/Test | Acceptance Criteria (Predicate) | Reported Device Performance (Aquamax Etafilcon A) |
|---|---|---|
| Technological Characteristics | ||
| Production Method | Cast-Molded (K120028, K962804, K991134) | Cast-Molded |
| USAN Name | Etafilcon A (K120028, K962804, K991134) | Etafilcon A |
| Material Classification | Group 4 (High Water Ionic) (K120028, K962804, K991134) | Group 4 (High Water Ionic) |
| Water Content (%) | 58% (K120028, K962804, K991134) | 58% |
| Refractive Index | 1.402 (K120028), 1.40 (K962804, K991134) | 1.402 |
| Oxygen Permeability (Dk) (x 10⁻¹¹ (cm²/sec)(ml O₂/ml-mmHg) @ 35°C) (edge corrected) | 19.73 (K120028), 26 (K962804), 26.3 (K991134) | 19.73 |
| Percent Transmittance (% T) at 593nm | > 95% (K120028), > 85% (K962804, K991134) | > 95% |
| Percent Transmittance (% T) at 380-315nm (UVA) |
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(71 days)
NaturalVue (etafilcon A) Sphere Daily Disposable Soft (Hydrophilic) Contact Lenses are indicated for daily wear for the correction of ametropia (myopia and hyperopia) in aphakic and/or 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.
NaturalVue (etafilcon A) Toric Daily Disposable Soft (Hydrophilic) Contact Lenses are indicated for daily wear for the correction of ametropia (myopia or hyperopia with astigmatism) in 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.
NaturalVue (etafilcon A) Multifocal Daily Disposable Soft (Hydrophilic) Contact Lenses are indicated for daily wear for the correction of refractive ametropia (myopia and hyperopia) and presbyopia in aphakic persons with non-diseased eyes in powers from -20.00 to +20.00 diopters and with non-diseased eyes who may require a reading addition of up to +3.00D. The lenses may be worn by persons who exhibit astigmatism of 2.00 diopters or less that does not interfere with visual acuity.
NaturalVue (etafilcon A) Toric Multifocal Daily Disposable Soft (Hydrophilic) Contact Lenses are indicated for daily wear for the correction of refractive ametropia (myopia and presbyopia in aphakic and/or non-aphakic persons with non-diseased eyes in powers from -20.00 to +20.00 diopters and with non-diseased eyes who may require a reading addition of up to +3.00D. The lenses may be worn by persons who exhibit astigmatism of 10.00 diopters or less.
NaturalVue (etafilcon A) Daily Disposable Soft (Hydrophilic) Contact Lenses help protect against transmission of harmful UV radiation to the cornea and into the eye.
The lenses are intended for single-use disposable wear.
The NaturalVue (etafilcon A) Daily Disposable Soft (Hydrophilic) Contact Lenses are visibility-tinted, containing a UV blocker and are available in a spherical, aspheric, toric, multifocal, and multifocal toric designs. They are manufactured by cast molding method. The device is an ionic hydrogel lens derived from etafilcon A which is a co-polymer of 2-Hydroxyethylmethacrylate (2-HEMA) and Methacrylic Acid (MAA), cross-linked with ethylene glycol dimethacrylate (EGDMA) and 1,1,1-trimethylolpropane trimethacrylate (TMPTMA) via photo-polymerization. The copolymer consists of 42% etafilcon A and 58% water by weight when immersed in normal buffered saline solution. The lenses are tinted blue using C.I. Reactive Blue 19 to make them more visible for handling. The lenses contain a UV blocker, a benzotriazole UV absorbing monomer to block UV radiation. The average transmittance characteristics of the lenses are less than 5% in the UVB range of 280-315nm and less than 30% in the UVA range of 316-380mm. Lenses are supplied sterile in sealed blister package containing sterile isotonic borate buffered saline solution.
The provided text is a 510(k) summary for the NaturalVue (etafilcon A) Daily Disposable Soft (Hydrophilic) Contact Lenses. This document does not describe a study that uses AI or machine learning to determine performance against acceptance criteria. Instead, it describes non-clinical tests to demonstrate the safety and effectiveness of the contact lenses.
Therefore, many of the requested elements (e.g., sample size for test set, number of experts, adjudication method, MRMC study, standalone performance, training set size) are not applicable as they relate to AI/ML device evaluations.
However, I can extract the acceptance criteria and reported device performance from the non-clinical studies described in the document.
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria for the NaturalVue (etafilcon A) Daily Disposable Soft (Hydrophilic) Contact Lenses are based on demonstrating substantial equivalence to a predicate device (K140025 NaturalVue (etafilcon A) Daily Disposable Soft (Hydrophilic) Contact Lenses) and compliance with the May 1994 FDA Guidance Document for Daily Wear Contact Lenses. Where specific numerical acceptance criteria are not explicitly stated, the equivalence to the predicate device serves as the implicit acceptance criterion.
| Characteristic | Acceptance Criteria (Implicitly: Equivalent to Predicate K140025 or regulatory standards) | Reported Device Performance (NaturalVue (etafilcon A)) | Meets Acceptance Criteria? |
|---|---|---|---|
| Material Properties | |||
| Production Method | Cast-Molded (per predicate) | Cast-Molded | Yes |
| USAN Name | etafilcon A (per predicate) | etafilcon A | Yes |
| Material Classification | Group 4 high water ionic (per predicate) | Group 4 high water ionic | Yes |
| Water Content (%) | 58% (per predicate) | 58% | Yes |
| Refractive Index | 1.4023 (per predicate) | 1.4023 | Yes |
| Oxygen Permeability | 19.3 x 10-11 (cm²/sec)(ml O2/ml-mmHg) @ 35°C (per predicate) | 19.3 x 10-11 (cm²/sec)(ml O2/ml-mmHg) @ 35°C | Yes |
| % Transmittance at 593nm | > 95% (per predicate) | > 95% | Yes |
| % Transmittance at 380-315nm | -9 for steam sterilization. Sterility maintained through expiration. | Validated to deliver SAL of 10-9. Shelf-life stability supports sterility. | Yes |
| Bacteriostatic Validation | Uniformity of temperature in sterilizer; Tested microorganisms killed. | Demonstrated uniformity of temperature; Tested microorganisms killed. | Yes |
| Shelf-Life | Lenses remain sterile and packages remain tight for claimed expiration. | Lenses remained sterilized with no microbial growth for 4 years (accelerated conditions). Seal remained tight for 4 years (accelerated conditions). | Yes |
| Leachability | No leachable monomers and additive residues at detection levels. | No leachable monomers and additive residues at detection levels. | Yes |
2. Sample size used for the test set and the data provenance
The document does not specify a "test set" in the context of an AI/ML device. For non-clinical material property testing, the sample sizes are not explicitly stated. The biocompatibility, microbiology, and leachability studies were conducted on the predicate device (K140025) and applied to the current device due to substantial equivalence, so the specifics of their sample sizes are not in this document.
Data Provenance: The document refers to the predicate device (K140025), which was submitted by Pegavision Corporation, Taiwan. The current device is from Visioneering Technologies, Inc., and the non-clinical tests were performed to demonstrate equivalence. It's a non-clinical, retrospective comparison to previously established data and standards.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable. This is not an AI/ML device, and no "ground truth" established by experts for a test set is mentioned.
4. Adjudication method for the test set
Not applicable. No test set requiring expert adjudication is described for this type of device and study.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done
Not applicable. This is not an AI/ML device, and thus, no MRMC study was conducted.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is not an AI/ML device or an algorithm.
7. The type of ground truth used
Not applicable in the context of AI/ML. For the non-clinical tests, "ground truth" would be the established scientific and regulatory standards for contact lens material properties, biocompatibility, sterility, and leachability. For example:
- Material Properties: Direct measurements using laboratory techniques.
- Biocompatibility: Standardized in vitro and in vivo (animal, if applicable, though not specified here) tests.
- Microbiology: Validation of sterilization processes and sterility testing.
- Leachability: Analytical chemistry techniques.
8. The sample size for the training set
Not applicable. This is not an AI/ML device, so there is no "training set."
9. How the ground truth for the training set was established
Not applicable. No training set is described.
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(282 days)
- Aquamax (Etafilcon A) Daily Disposable Soft (Hydrophilic) Contact Lenses
Spherical and Aspheric: Aquamax (Etafilcon A) SPHERE and ASPHERE Daily Disposable Soft (Hydrophilic) Contact Lenses are indicated for daily wear for the correction of ametropia (myopia and hyperopia) in aphakic and/or 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: Aquamax (Etafilcon A) Toric Daily Disposable Soft (Hydrophilic) Contact Lenses are indicated for daily wear for the correction of ametropia (myopia or hyperopia with astigmatism) in aphakic and/or 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: Aquamax (Etafilcon A) Multifocal Daily Disposable Soft (Hydrophilic) Contact Lenses are indicated for daily wear for the correction of refractive ametropia (myopia and hyperopia) and presbyopia in aphakic and/or non-aphakic persons with non-diseased eyes in powers from -20.00 to +20.00 diopters and with non-diseased eyes who may require a reading addition of up to +3.00D. 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: Aquamax (Etafilcon A) Multifocal Toric Daily Disposable Soft (Hydrophilic) Contact Lenses are indicated for daily wear for the correction of refractive ametropia (myopia and hyperopia) and presbyopia in aphakic and/or non-aphakic persons with non-diseased eyes in powers from -20.00 to +20.00 diopters and with non-diseased eyes who may require a reading addition of up to +3.00D. The lenses may be worn by persons who exhibit astigmatism of 10.00 diopters or less.
Aquamax (Etafilcon A) Daily Disposable Soft (Hydrophilic) Contact Lenses help protect against transmission of harmful UV radiation to the cornea and into the eye. The lenses are intended for single-use disposable wear. - Aquamax (Etafilcon A) Soft (Hydrophilic) Contact Lenses for Frequent Replacement (Replacement Recommended Every 2 Weeks):
Spherical and Aspheric: Aquamax (Etafilcon A) SPHERE and ASPHERE Soft (Hydrophilic) Contact Lenses for Frequent Replacement are indicated for daily wear for the correction of ametropia (myopia and hyperopia) in aphakic and/or 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: Aquamax (Etafilcon A) Toric Soft (Hydrophilic) Contact Lenses for Frequent Replacement are indicated for daily wear for the correction of ametropia (myopia or hyperopia with astigmatism) in aphakic and/or 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: Aquamax (Etafilcon A) Multifocal Soft (Hydrophilic) Contact Lenses for Frequent Replacement are indicated for daily wear for the correction of refractive ametropia (myopia and hyperopia) and presbyopia in aphakic and/or non-aphakic persons with non-diseased eyes in powers from -20.00 to +20.00 diopters and with non-diseased eyes who may require a reading addition of up to +3.00D. 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: Aquamax (Etafilcon A) Multifocal Toric Soft (Hydrophilic) Contact Lenses for Frequent Replacement are indicated for daily wear for the correction of refractive ametropia (myopia and hyperopia) and presbyopia in aphakic and/or non-aphakic persons with non-diseased eyes in powers from -20.00 to +20.00 diopters and with non-diseased eyes who may require a reading addition of up to +3.00D. The lenses may be worn by persons who exhibit astigmatism of 10.00 diopters or less.
Aquamax (Etafilcon A) Soft (Hydrophilic) Contact Lenses for Frequent Replacement help protect against transmission of harmful UV radiation to the cornea and into the eye. The lenses are intended for frequent/planned replacement wear with cleaning, rinsing, disinfection and scheduled replacement as prescribed by the eye care professional. Pegavision recommends up to two week replacement for Etafilcon A lenses, or replacement as recommended by the eye care professional. When prescribed for frequent/planned replacement wear, the lens may be disinfected using a chemical (not heat) lens care system only. - NaturalVue (Etafilcon A) Daily Disposable Soft (Hydrophilic) Contact Lenses
Spherical and Aspheric: NaturalVue (Etafilcon A) Sphere and Asphere Daily Disposable Soft (Hydrophilic) Contact Lenses are indicated for daily wear for the correction of ametropia (myopia and hyperopia) in aphakic and/or 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: NaturalVue (Etafilcon A) Toric Daily Disposable Soft (Hydrophilic) Contact Lenses are indicated for daily wear for the correction of ametropia (myopia or hyperopia with astigmatism) in aphakic and/or 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: NaturalVue (Etafilcon A) Multifocal Daily Disposable Soft (Hydrophilic) Contact Lenses are indicated for daily wear for the correction of refractive ametropia (myopia and hyperopia) and presbyopia in aphakic and/or non-aphakic persons with non-diseased eyes in powers from -20.00 to +20.00 diopters and with non-diseased eyes who may require a reading addition of up to +3.00D. 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: NaturalVue (Etafilcon A)Toric Multifocal Daily Disposable Soft (Hydrophilic) Contact Lenses are indicated for daily wear for the correction of refractive ametropia (myopia and hyperopia) and presbyopia in aphakic and/or non-aphakic persons with non-diseased eyes in powers from -20.00 to +20.00 diopters and with non-diseased eyes who may require a reading addition of up to +3.00D. The lenses may be worn by persons who exhibit astigmatism of 10.00 diopters or less.
NaturalVue (Etafilcon A) Daily Disposable Soft (Hydrophilic) Contact Lenses help protect against transmission of harmful UV radiation to the cornea and into the eye. The lenses are intended for single-use disposable wear.
The Aquamax (Etafilcon A) Soft (Hydrophilic) Contact Lenses for Frequent Replacement, Aquamax (Etafilcon A) Daily Disposable Soft (Hydrophilic) Contact Lenses, and Natural/ue (Etafilcon A) Daily Disposable Soft (Hydrophilic) Contact Lenses are clear or visibility-tinted, containing a UV blocker and are available in a spherical, aspherical multifocal, and multifocal toric designs. They are manufactured by cast molding method. The device is an ionic hydrogel lens derived from Etafilcon A which is a co-polymer of 2-Hydroxyethylmethacrylate (2-HEMA) and Methacrylic Acid (MAA), cross-linked with ethylene glycol dimethacrylate (EGDMA) and 1,1,1-trimethylolpropane trimethacrylate (TMPTMA) via photo-polymerization. The copolymer consists of 42% Etafilcon A and 58% water by weight when immersed in normal buffered saline solution. The lenses are tinted blue using C.I. Reactive Blue 19 to make them more visible for handling. The lenses contain a UV blocker, a benzotriazole UV absorbing monomer to block UV radiation. The average transmittance characteristics of the lenses are less than 5% in the UVB range of 280-315nm and less than 30% in the UVA range of 316-380nm. Lenses are supplied sterile in sealed blister package containing sterile isotonic borate buffered saline solution.
This document is a 510(k) premarket notification for three types of soft contact lenses: Aquamax (Etafilcon A) Soft (Hydrophilic) Contact Lenses for Frequent Replacement, Aquamax (Etafilcon A) Daily Disposable Soft (Hydrophilic) Contact Lenses, and NaturalVue (Etafilcon A) Daily Disposable Soft (Hydrophilic) Contact Lenses. The submission aims to demonstrate substantial equivalence to previously cleared predicate devices.
Here's an analysis of the acceptance criteria and the study information provided:
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria are implicitly defined by demonstrating substantial equivalence to the predicate devices based on material properties, biocompatibility, microbiology, bacteriostatic validation, and leachability. There are no explicit quantitative acceptance criteria stated beyond "complying with the requirement of FDA Group 4" for sterilization. Differences in oxygen permeability and percent transmittance are evaluated against the predicate devices.
| Criteria/Property | Acceptance Criteria (Implied by Predicate) | Proposed Device (Aquamax/NaturalVue Etafilcon A) Reported Performance |
|---|---|---|
| Material Properties | ||
| Production Method | Cast-Molded (for K120028 & K962804 predicates) | Cast-Molded |
| USAN Name | Etafilcon A (for K120028 & K962804 predicates) | Etafilcon A |
| Material Classification | Group 4 high water ionic (for K120028 & K962804 predicates) | Group 4 high water ionic |
| Water Content (%) | 58% (for K120028 & K962804 predicates) | 58% |
| Refractive Index | 1.4023 (for K120028 predicate) | 1.4023 |
| Oxygen Permeability (Dk) @ 35°C | Approx. $19.73 \times 10^{-11}$ (K120028) to $21.4 \times 10^{-11}$ (K962804) | $19.73 \times 10^{-11}$ (cm²/sec)(ml O₂/ml-mmHg) |
| Percent Transmittance % T at 593nm | > 95% (for K120028 & K013445 predicates), > 85% (for K962804 predicate) | > 95% |
| % T at 380-315nm (UVA) |
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(63 days)
The ACUVUE Contact Lens (spherical) is indicated for daily wear for the correction of refractive ametropia (myopia and hyperopia) in aphakic or non-aphakic persons with non-diseased eyes who may have 1.00 D or less of astigmatism.
The ACUVUE BIFOCAL Contact Lens is indicated for daily wear for the correction of distance and near vision in presbyopic, aphakic or non-aphakic persons with non-diseased eyes who may have 0.75 D or less of astigmatism.
The ACUVUE TORIC Contact Lens is indicated for daily wear for the correction of visual acuity in aphakic or non-aphakic persons with non-diseased eyes that are hyperopic or myopic and may have 10.00 D or less of astigmatism.
The ACUVUE TORIC BIFOCAL Contact Lens is indicated for daily wear for the correction of distance and near vision in presbyopic aphakic or non-phakic persons with non-diseased eyes who may have 10.00 D of astigmatism or less.
ACUVUE Contact Lenses help protect against transmission of harmful UV radiation to the cornea and into the eye.
Eye care practitioners may prescribe the lens for either single-use disposable wear or for frequent/planned replacement wear, with cleaning, disinfection and scheduled replacement. When prescribed for frequent/planned replacement wear, the lens may be disinfected using a chemical disinfection system only.
The device description does not change from that cleared under K991134.
The provided 510(k) submission (K994324) for the ACUVUE (etafilcon A) soft contact lenses is a labeling modification submission, not a submission for a new device requiring a comprehensive performance study against acceptance criteria.
The purpose of this 510(k) is to revise the wear schedule in the labeling to include a statement about the reduced risk of giant papillary conjunctivitis (GPC) with frequent replacement.
Therefore, many of the typical elements of a performance study required for novel device clearance are not present or applicable in this document.
Here's an analysis based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
This 510(k) submission does not present a table of acceptance criteria or new device performance data in the way a new device would. The core claim is a labeling modification supported by existing clinical literature, not new performance metrics for the device itself.
The "acceptance criteria" in this context would be the FDA's acceptance of the scientific literature supporting the labeling change.
2. Sample Size Used for the Test Set and Data Provenance
- Test Set (for the labeling claim): The submission states that the labeling modification is supported by "clinical studies published in the July 1999 CLAO Journal (see Attachment A)." Attachment A is not provided in the document. Therefore, the sample size and data provenance of these specific studies are not detailed in this 510(k) submission.
- Data Provenance: The document does not specify the country of origin of the data mentioned in the CLAO Journal. It states the studies were "published," implying they are retrospective in terms of this 510(k) submission.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This information is not provided in the 510(k) submission. As the evidence relies on published clinical studies, the details about expert involvement in establishing ground truth would typically be found within those external publications, not in this regulatory submission.
4. Adjudication Method for the Test Set
This information is not provided in the 510(k) submission for the same reasons as above.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No, an MRMC comparative effectiveness study was not done, nor would it be relevant for a contact lens labeling modification based on GPC risk. This type of study is more common for diagnostic imaging or AI-assisted diagnostic devices.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
N/A. This device is a contact lens; there is no algorithm or human-in-the-loop performance component.
7. The Type of Ground Truth Used
The "ground truth" for the labeling modification regarding reduced GPC risk would be derived from the clinical outcomes data reported in the published studies cited (July 1999 CLAO Journal). This would include observations and diagnoses of GPC in patients using contact lenses with different replacement schedules.
8. The Sample Size for the Training Set
N/A. This device is a contact lens. There is no training set in the context of machine learning or algorithms. The "training data" for general contact lens safety and efficacy would have been the extensive clinical trials conducted for the original device clearance (K991134).
9. How the Ground Truth for the Training Set Was Established
N/A. See point 8. The ground truth for the original ACUVUE lens (K991134) would have been established through standard clinical trial methodologies, including patient examinations, objective measurements, and subjective patient feedback, reviewed and interpreted by qualified clinicians, to demonstrate the lens's safety and effectiveness for its intended use.
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