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Found 25 results
510(k) Data Aggregation
(27 days)
MVN
DAILIES AquaComfort Plus and DAILIES AquaComfort Plus FreshTech (nelfilcon A) One-Day Contact Lenses are indicated for daily wear for the optical correction of refractive ametropia (myopia and hyperopia) in not-aphakic persons with non-diseased eyes with up to approximately 1.50 diopters (D) of astigmatism that does not interfere with visual acuity.
DAILIES AquaComfort Plus Toric (nelfilcon A) One-Day Contact Lenses are indicated for daily wear for the optical correction of refractive ametropia (myopia and hyperopia) in not-aphakic persons with non-diseased eyes with 6.00 diopters (D) or less of astigmatism.
DAILIES AquaComfort Plus Multifocal (nelfilcon A) One-Day Contact Lenses are indicated for daily wear for the optical correction of refractive ametropia (myopia or hyperopia) and/or presbyopia in not-aphakic persons with non-diseased eyes who may require a reading addition of +3.00 diopters (D) or less and who may have 2.00 diopters (D) or less of astigmatism that does not interfere with visual acuity.
All DAILIES AquaComfort Plus (nelfilcon A) One-Day Contact Lenses are to be prescribed for single use, daily disposable wear. The lenses are not intended to be cleaned or disinfected and should be discarded after a single use.
DAILIES AquaComfort Plus are soft contact lenses, intended for the optical correction of refractive error. The lenses are available in spherical, toric and multifocal designs.
The DAILIES AquaComfort Plus lens material is nelfilcon A, a high water, non-ionic hydrophilic lens material consisting of approximately 31% PVA (polyviny) alcohol partially acetalized with N-formylmethyl acrylamide) and 69% water.
The lens material is considered a Group II high water, non-ionic contact lens material per the 1994 FDA Premarket Notification (510(k)) guidance document for daily wear contact lenses. The lens material further contains non-functionalized high and ultra-high molecular weight PVA and the color additive phthalocyanine blue to create a light blue edge to edge tint (Visitint™) to make the lenses easier to see when handling.
DAILIES AquaComfort Plus soft contact lenses are supplied sterile. The lenses immersed in buffered saline solution are packaged in individual foil-blister-packs primary packaging system and are terminally sterilized in a validated autoclave (moist heat, steam under pressure).
The foil-blister pack primary packaging system consists of an injection molded polypropylene blister shell sealed with a polyester coated aluminum foil lidding material top.
The lenses are supplied in strips of five foil sealed blister packs each containing approximately 0.65 ml phosphate-acetate buffered saline solution. The packaging saline may contain up to 0.05% Poloxamer 108. The package saline additionally contains the comfort additives hydroxypropylmethyl cellulose (HPMC) and polyethylene glycol 400 (PEG 400). Sealed blister strips are provided in secondary packaging carton boxes containing 5, 30 or 90 lenses each.
This document describes the 510(k) submission for Alcon Laboratories, Inc.'s DAILIES AquaComfort Plus contact lenses, focusing on an extension of their expiration dating. As such, the study described is primarily related to shelf-life stability and not clinical performance or artificial intelligence (AI) device performance. Therefore, many of the requested categories are not applicable (N/A) or cannot be extracted from this document, as it does not describe a clinical performance study with human readers or an AI algorithm.
Here's a breakdown of the available information based on your request:
1. Table of Acceptance Criteria and Reported Device Performance
| Feature/Test | Acceptance Criteria (Predicate Device) | Reported Device Performance (Modified Device) |
|---|---|---|
| Shelf-life | 60 months | 84 months (confirmed by shelf-life stability testing) |
| Biocompatibility | Biocompatible (as confirmed by biocompatibility testing) | Biocompatible (cytotoxicity testing by Cell Growth Inhibition (CGI) and Modified ISO/USP Elution (MEL) methods completed, all acceptance criteria met to verify equivalence to predicate device) |
| Refractive Index | 1.38 | Same |
| Light Transmittance | $\ge$ 92%T | Same |
| Oxygen Permeability (Dk) | 26 | Same |
| Elastic Modulus | 0.9 MPa | Same |
| (Other material properties, manufacturing method, packaging, etc.) | Same as predicate | Same |
2. Sample Size Used for the Test Set and the Data Provenance
This document does not specify a distinct "test set" in the context of an AI algorithm or traditional clinical trial. The testing performed was primarily non-clinical stability testing.
- Sample Size: Not explicitly stated for stability testing within this document. Stability studies involve testing multiple samples over time.
- Data Provenance: The document implies in-house testing by Alcon Laboratories, Inc., as part of the manufacturing and regulatory compliance process. The country of origin of the data is not specified beyond Alcon's location (Fort Worth, TX for the company, and the contact person in Germany). The data is retrospective in the sense that it's gathered over time as part of a stability study.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts
N/A. This submission focuses on shelf-life and biocompatibility, not clinical expert-based ground truth for device performance in diagnosis or image interpretation.
4. Adjudication Method for the Test Set
N/A. Adjudication methods are typically employed in clinical studies or for ground truth establishment for AI where multiple experts might disagree. This is not relevant to the non-clinical stability testing described.
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
N/A. This device is a contact lens, and the submission is for an extended shelf-life. There is no AI component or human reader comparative effectiveness study involved.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
N/A. This is not an AI algorithm.
7. The Type of Ground Truth Used
For the non-clinical tests:
- Shelf-life: The "ground truth" is derived from established laboratory testing protocols and standards for contact lens stability (e.g., measuring physical and chemical properties over time).
- Biocompatibility: The "ground truth" is based on recognized in vitro cytotoxicity testing methods (Cell Growth Inhibition and Modified ISO/USP Elution methods) and their pre-defined acceptance criteria for biocompatibility, often benchmarked against predicate devices or regulatory standards.
8. The Sample Size for the Training Set
N/A. There is no AI model or training set described.
9. How the Ground Truth for the Training Set Was Established
N/A. Not applicable as there is no AI model or training set.
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(29 days)
MVN
Focus DAILIES and Focus DAILIES Toric (nelfilcon A) One-Day soft contact lenses are indicated for the optical correction of refractive ametropia (myperopia and astigmatism) in not-aphakic persons with nondiseased eyes.
Focus DAILIES Progressives (nelfilcon A) One-Day soft contact lenses are indicated for daily wear for the optical correction of refractive ametropia (myperopia) and/or presbyopia in not-aphakic persons with non-diseased eyes who require a reading addition of +3.00 diopters (D) or less and who may have 2.00 diopters (D) or less of astigmatism that does not interfere with visual acuity.
The lenses are to be prescribed for single use, daily disposable wear. The lenses are not intended to be cleaned or disinfected and should be discarded after a single use.
DAILIES AquaComfort Plus and DAILIES AquaComfort Plus FreshTech (nelfilcon A) One-Day Contact Lenses are indicated for daily wear for the optical correction of refractive ametropia (myopia and hyperopia) in not-aphakic persons with non-diseased eyes with up to approximately 1.50 diopters (D) of astigmatism that does not interfere with visual acuity.
DAILIES AquaComfort Plus Toric (nelfilcon A) One-Day Contact Lenses are indicated for daily wear for the optical correction of refractive ametropia (myopia and hyperopia) in not-aphakic persons with non-diseased eyes with 6.00 diopters (D) or less of astigmatism.
DAILIES AquaComfort Plus Multifocal (nelfilcon A) One-Day Contact Lenses are indicated for the optical correction of refractive ametropia (myperopia) and/or presbyopia in not-aphakic persons with non-diseased eyes who may require a reading addition of +3.00 diopters (D) or less and who may have 2.00 diopters (D) or less of astigmatism that does not interfere with visual acuity.
All DAILIES AquaComfort Plus (nelfilcon A) One-Day Contact Lenses are to be prescribed for single use, daily disposable wear. The lenses are not intended to be cleaned or disinfected and should be discarded after a single use.
Focus DAILIES and DAILIES AquaComfort Plus are soft contact lenses, intended for the optical correction of refractive error. The lenses are available in spherical, toric and multifocal designs.
The Focus DAILIES and DAILIES AquaComfort Plus lens material is nelfilcon A, a high water, non-ionic hydrophilic lens material consisting of approximately 31% PVA (polyvinyl alcohol partially acetalized with N-formylmethyl acrylamide) and 69% water.
The lens material is considered a Group II high water, non-ionic contact lens material per the 1994 FDA Premarket Notification (510(k)) guidance document for daily wear contact lenses. The lens material further contains non-functionalized high molecular weight PVA (for Focus DAILIES lenses) and/or ultra-high molecular weight PVA (for Dailies AquaComfort Plus lenses) and the color additive phthalocyanine blue to create a light blue edge to edge tint (Visitint™) to make the lenses easier to see when handling.
Focus DAILIES and DAILIES AquaComfort Plus soft contact lenses are supplied sterile. The lenses immersed in buffered saline solution are packaged in individual foilblister-packs primary packaging system and are terminally sterilized in a validated autoclave (moist heat, steam under pressure).
The foil-blister pack primary packaging system consists of an injection molded polypropylene blister shell sealed with a polyester coated aluminum foil lidding material top.
The lenses are supplied in strips of five foil sealed blister packs each containing approximately 0.65 ml (DAILIES AquaComfort Plus products) and/or 0.85 ml (Focus DAILIES products) phosphate-acetate buffered saline solution. The packaging saline may contain up to 0.05% Poloxamer 108. For DAILIES AquaComfort Plus lenses the package saline additionally contains the comfort additives hydroxypropylmethyl cellulose (HPMC) and polyethylene glycol 400 (PEG 400). Sealed blister strips are provided in secondary packaging carton boxes containing 5, 30 or 90 lenses each.
The provided text does not describe the acceptance criteria and the study that proves the device meets the acceptance criteria for an AI/ML powered medical device.
Instead, it is a 510(k) summary for contact lenses (Focus DAILIES and DAILIES AquaComfort Plus) which outlines a modification to an alternate foil lidding material for their primary packaging. The document primarily focuses on demonstrating substantial equivalence to a predicate device, as required for traditional medical devices under the 510(k) pathway, not AI/ML performance.
Therefore, I cannot extract the requested information regarding acceptance criteria and study details relevant to an AI/ML device from this document.
Here's why and what information is missing:
- No AI/ML Component: The device described is a soft contact lens, a physical medical device. There is no mention of any AI or machine learning component, software, or algorithm in its functionality or development.
- No Performance Metrics for AI: Consequently, there are no AI/ML-specific performance metrics like sensitivity, specificity, AUC, F1-score, etc., nor any acceptance criteria for these.
- No Study Design for AI Validation: The "Performance Data" section discusses:
- Non-clinical Testing: Stability, biocompatibility, and process validation, referencing ISO standards relevant to material safety and manufacturing for contact lenses. These are not AI/ML validation studies.
- Clinical Testing: States that clinical testing was not required for this specific modification (changing packaging material), which further confirms the absence of AI/ML validation studies.
- No Mention of Ground Truth, Training Data, Experts: Since there's no AI, there's no need for ground truth establishment, training data, or expert adjudication as would be required for an AI/ML device.
- No MRMC Study: A Multi-Reader Multi-Case (MRMC) study is relevant for evaluating the impact of AI assistance on human reader performance, which is not applicable here.
In summary, the provided document is not about an AI/ML medical device and therefore does not contain the information you requested.
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(96 days)
MVN
The Eye Secret 38 UV Aspheric (polymacon) Soft (hydrophilic) Contact Lens for Daily Wear is indicated for the correction of refractive ametropia (myopia) in aphakic and not-aphakic persons with non-diseased eyes. The lenses may be worn by person who exhibit astigmatism of 2.00 diopters or less that does not interfere with visual acuity.
The Eye Secret 38 UV Aspheric (polymacon) Soft (hydrophilic) Contact Lens for Daily Wear helps protect against transmission of harmful UV radiation to the cornea and into the eye.
The eye care professionals may prescribe the lens for single use daily disposable or daily wear in a Frequent Replacement Program. As prescribed for planned replacement, the lens should be disinfected using a chemical or hydrogen peroxide disinfecting systems.
The Eye Secret 38 UV Aspheric (polymacon) Soft (hydrophilic) Contact Lens for Daily Wear is manufactured by using cast molding method. The lens material, polymacon, is a random copolymer of 2-hydroxyethyl methacrylate (HEMA) crosslinked with ethylene glycol dimethacrylate (EGDMA). A UV absorbing monomer is used to block UV radiation. The average transmittance characteristics are less than 5% in the UVB range of 280 to 315 nm and less than 50% in the UVA range of 316 to 380 nm. The lenses are tinted blue for visibility purposes with the color additives, C.I. Reactive Blue No.4.
The lenses are available as aspheric lenses. Each finished lens is supplied in a plastic blister container with a sterile isotonic phosphate buffered saline solution containing sodium hyaluronate and trehalose wetting agents.
The provided document describes the predicate device "Eye Secret 38 UV Aspheric Color (polymacon) Soft (hydrophilic) Contact Lens for Daily Wear" (K143052) and the new device "Eye Secret 38 UV Aspheric (polymacon) Soft (hydrophilic) Contact Lens for Daily Wear." The acceptance criteria are based on demonstrating substantial equivalence to the predicate device through non-clinical testing.
Here's a breakdown of the requested information based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
The document presents a comparison to the predicate device, serving as the de-facto acceptance criteria. The subject device must match or perform equivalently to the predicate device across various parameters.
| Parameter | Acceptance Criteria (Predicate Device K143052) | Reported Device Performance (Subject Device) |
|---|---|---|
| Intended Use | Correction of ametropia (myopia) in aphakic and not-aphakic persons with non-diseased eyes. Lenses may be worn by persons who exhibit astigmatism of 2.00 diopters or less that does not interfere with visual acuity. Helps protect against transmission of harmful UV radiation. Prescribed for single use daily disposable or daily wear in a Frequent Replacement Program, disinfected using chemical or hydrogen peroxide systems. | Correction of refractive ametropia (myopia) in aphakic and not-aphakic persons with non-diseased eyes. Lenses may be worn by person who exhibit astigmatism of 2.00 diopters or less that does not interfere with visual acuity. Helps protect against transmission of harmful UV radiation. Prescribed for single use daily disposable or daily wear in a Frequent Replacement Program, disinfected using chemical or hydrogen peroxide systems. |
| Material | Polymacon | Polymacon |
| Manufacturing Method | Cast Molded | Cast Molded |
| Water Content | 38 % | 38 % |
| Powers | -0.00 ~ -20.00 D | -0.50 D ~ -20.00 D |
| Light Transmittance | 95 % (± 5 %) | 95 % (± 5 %) |
| UV-A |
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(72 days)
MVN
The Eye Secret 38 UV Aspheric (polymacon) 1-Day Soft (hydrophilic) Contact Lens is indicated for daily wear single use only for the correction of refractive ametropia (myopia) in aphakic and not-aphakic persons with non-diseased eyes. The lenses may be worn by person who exhibit astigmatism of 2.00 diopters or less that does not interfere with visual acuity. The eye care professional should prescribe the lenses for daily wear single use only. The lenses are to be discarded upon removal: Therefore no cleaning or disinfecting is required. The Eye Secret 38 UV Aspheric (polymacon) 1-Day Soft (hydrophilic) Contact Lenses help protect against transmission of harmful UV radiation to the cornea and into the eye.
The Eye Secret 38 UV Aspheric (polymacon) 1-Day Soft (hydrophilic) Contact Lens is manufactured by using cast molding method. The lens material, polymacon, is a random copolymer of 2-hydroxyethyl methacrylate (HEMA) crosslinked with ethylene glycol dimethacrylate (EGDMA). A UV absorbing monomer is used to block UV radiation. The average transmittance characteristics are less than 5 % in the UVB range of 280 to 315 nm and less than 50 % in the UVA range of 316 to 380 nm. The lenses are tinted blue for visibility purposes with the color additives, C.I. Reactive Blue No. 4.
The Lenses are available as aspheric lenses. Each finished lens is supplied in a plastic blister container with a sterile isotonic phosphate buffered saline solution containing 0.01 % sodium hyaluronate and 0.1 % trehalose wetting agents.
The document provided describes the Eye Secret 38 UV Aspheric (polymacon) 1-Day Soft (hydrophilic) Contact Lens and its substantial equivalence to a predicate device, K132854. The submission focuses on non-clinical testing to demonstrate safety and effectiveness.
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 "Eye Secret 38 UV Aspheric (polymacon) 1-Day Soft (hydrophilic) Contact Lens" are established by demonstrating equivalence to the predicate device, "Eye Secret 38 UV Aspheric (polymacon) Soft (hydrophilic) Contact Lens for Daily Wear (K132854)." Performance is shown through comparative testing against the predicate's established characteristics.
| Test Item / Characteristic | Acceptance Criteria (Predicate Device K132854) | Reported Device Performance (Eye Secret 38 UV 1-Day) |
|---|---|---|
| Material | Polymacon | Polymacon |
| Manufacturing Method | Cast molding | Cast molding |
| Water Content | 38 % | 38 % |
| Powers | -0.50 D ~ -12.00 D | -0.50 D ~ -20.00 D |
| Light Transmittance (Overall) | 95 ± 5 % | 95 ± 5 % |
| UV-A Transmittance |
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(165 days)
MVN
The SAUFLON CLARITI 1-DAY (somofilcon A) Soft (hydrophilic) Daily Disposable Contact Lens with UV Blocker is indicated for daily wear single use only for the correction of refractive ametropia (myopia and hyperopia) in phakic or aphakic persons with non-diseased eyes that may exhibit astigmatism up to 2.00 Diopters that does not interfere with visual acuity.
The SAUFLON CLARITI 1-DAY TORIC (somofilcon A) Soft (hydrophilic) Daily Disposable Contact Lens with UV Blocker is indicated for daily wear single use only for the optical correction of refractive ametropia (myopia and hyperopia) and/or presbyopia in phakic or aphakic persons with non-diseased eyes that may exhibit astigmatism up to 10.00 Diopters.
The SAUFLON CLARITI 1-DAY MULTIFOCAL (somofilcon A) Soft (hydrophilic) Daily Disposable Contact Lens with UV Blocker is indicated for daily wear single use only for the optical correction of refractive ametropia (myopia and hyperopia) and/or presbyopia in phakic or aphakic persons with non-diseased eyes that may require a reading addition of +3.00 Diopters or less and may exhibit astigmatism up to 1.50 Diopters or less.
The SAUFLON CLARITI 1-DAY MULTIFOCAL TORIC (somofilcon A) Soft (hydrophilic) Daily Disposable Contact Lens with UV Blocker is indicated for daily wear single use only for the optical correction of refractive ametropia (myopia and hyperopia) and/or presbyopia in phakic or aphakic persons with non-diseased eyes that may exhibit astigmatism up to 10.00 Diopters and require a reading addition of +3.00 Diopters or less.
The eye care professional should prescribe the lenses for daily wear single use only. The lenses are to be discarded upon removal; therefore, no cleaning or disinfecting is required. Sauflon Clariti 1-Day (somofilcon A) Soft (hydrophilic) Daily Disposable Contact Lenses with UV Blocker help protect against transmission of harmful UV radiation to the cornea and into the eye.
The Sauflon Clariti I Day (somofileon A) Soft (hydrophilic) Daily Disposable Contact Lens with UV Blocker is available as a single vision, toric and multifocal The lens material (somofileon A) is a hydrophilic co-polymer of silicone lens. containing monomers and hydrophilic monomers which is cross-linked with tetraethyleneglycol dimethacrylate. When hydrated the lens consists of 44.0% somofilcon A and 56,0%, water by weight of saline immersed in normal saline. A benzophenone UV absorbing monomer is used to block UV radiation:
The average transmittance characteristics are less than 5% in the UVB range of 280 to 315nm and less than 30% in the UVA range of 316-380nm
The Sauffon Clariti 1 Day (somofileon A) Soft (hydrophilic) Daily Disposable Contact Lens with UV Blocker is a hemispherical flexible shell, which covers the cornea and a portion of the adjacent sciera, with the following dimensions;
• Chord Diameter: 13.0mm to 15.5mm
• Centre Thickness: 0.03mm to 0.50mm
• Base Curve: 7.5mm to 9.30mm
• Powers: -20.00 DS to +20.00 DS
• Toric Cylinder options: -0.75, -1.25, -1.75 and -2.25
• Toric Axis options: 10° to 180° (10° steps).
- Multifocal Add: .
Lens "LOW" = "low" for spectacle near ADD lens (Max +2.25 ADD) Lens "HIGH" = "high" for spectacle near ADD lens (+2.50 ADD or greater)
The physical/optical properties of the lenses are:
Refractive Index: 1.4003
%Transmittance @ 590nm: 98.13
%Transmittance @ 280-315nm: 0.71
%Transmittance @ 316-380nm: 20.62
Surface Character: Hydrophilic
Water Content: 56%
Oxygen Permeability (DK): 60 x 10-11 (cm2/sec) (ml O2/ml x mmHg at 35°C (Fatt Method for determination of oxygen permeability).
Specific Gravity: 1.17
The provided document is a 510(k) summary for the SAUFLON CLARITI 1 DAY Contact Lens, not an AI/ML device. Therefore, it does not contain the specific information requested about acceptance criteria for an AI device, a study proving device meeting acceptance criteria, sample sizes for test/training sets, data provenance, expert ground truth establishment, adjudication methods, MRMC studies, or standalone algorithm performance.
Instead, the document focuses on demonstrating substantial equivalence to existing predicate devices based on physicochemical properties, toxicology studies, and human clinical studies for a medical device (contact lens).
Here's an attempt to interpret the request's structure in the context of the provided document, but be aware that it won't directly answer for AI device specifics:
1. A table of acceptance criteria and the reported device performance
Since this is a contact lens, the "acceptance criteria" are implied by the properties matching or being superior to predicate devices, and demonstrating safety and efficacy in various tests.
| Acceptance Criteria (Implied) | Reported Device Performance (SAUFLON CLARITI 1 DAY) |
|---|---|
| Material Composition | Somofilcon A (hydrophilic co-polymer) |
| Water Content | 56% |
| Oxygen Permeability (Dk) | 60 x 10^-11 (cm^2/sec) (ml O2/ml x mmHg at 35°C) |
| UVB Transmittance (280-315nm) | 0.71% (less than 5% required for UV blocker) |
| UVA Transmittance (316-380nm) | 20.62% (less than 30% required for UV blocker) |
| Refractive Index | 1.4003 |
| % Transmittance @ 590nm | 98.13% |
| Modulus (MPa) | 0.55 |
| Tensile Strength (MPa) | 1.05 |
| Elongation at Break % | 163 |
| Safety (Cytotoxicity, Sensitization, Ocular Irritation, Systemic Toxicity) | Passed (no evidence of adverse clinical effects) |
| Efficacy (Clinical Study) | Demonstrated safety, acceptability, and substantial equivalence to predicate. |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Sample Size for Test Set: The document states "A clinical study was conducted...", but the specific number of subjects (sample size) for this study is not provided in the summary.
- Data Provenance: The location of the clinical study is not explicitly stated in the provided abstract. It is a "clinical study" which implies prospective data collection, but no further details are given.
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 concept is not applicable to this type of medical device submission. "Ground truth" for a contact lens primarily comes from direct measurement of physical properties and clinical outcomes from patient use, not expert interpretation of outputs.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable for a contact lens clinical study. Adjudication methods like 2+1 are typically used for disagreements in expert readings for AI/ML performance evaluation.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
Not applicable. This is not an AI-assisted diagnostic device submitting an MRMC study. The clinical study was a comparison of contact lenses, not human readers.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
For the clinical study, the "ground truth" would be related to clinical outcomes data (safety, comfort, visual acuity, acceptability, etc.) derived from direct patient observation and measurements during lens wear. For physicochemical properties, the ground truth is direct measurement of those properties using standardized testing methods.
8. The sample size for the training set
Not applicable. This is a manufactured product, not an AI/ML model that undergoes a "training" phase with data.
9. How the ground truth for the training set was established
Not applicable. There is no training set mentioned or implied for this device.
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(88 days)
MVN
The Bausch + Lomb Naturelle Daily Disposable (hilafilcon B) Cosmetically Tinted Contact Lens is indicated for the daily wear correction of refractive ametropia (myopia and hyperopia) in aphakic and not-aphakic persons with non-diseased eyes, exhibiting astigmatism of 2.00 diopters or less, that does not interfere with visual acuity. The lens may be prescribed in spherical powers ranging from +20.00D to -20.00D.
The lens is to be prescribed for single-use disposable wear, and is to be discarded after each removal.
The Bausch + Lomb Naturelle Cosmetically Tinted daily disposable (hilafilcon B) Contact Lens is a hemispherical flexible shell which covers the cornea and may cover a portion of the adjacent sclera. The printed ink pattern consists of a copolymer of 2-hydroxyethyl methacrylate and N-vinyl pyrrolidone, and the lens is 59% water by weight when immersed in a sterile saline solution. The lens monomer may be tinted blue with Reactive Blue Dye 246 (1,4-Bis[4-(2methacryloxyethyl) phenylamino] anthraquinone, CFR Part 73.3106).
The provided document describes a 510(k) submission for the Bausch & Lomb Naturelle Daily Disposable (hilafilcon B) Cosmetically Tinted Contact Lens. The submission claims substantial equivalence to a predicate device, Bausch & Lomb SofLens® Daily Disposable (hilafilcon B) Visibility Tinted Contact Lens (K061157).
This submission is for a cosmetic contact lens, which is typically evaluated for safety and effectiveness through non-clinical testing rather than complex clinical studies involving AI. Therefore, many of the requested categories related to AI performance, multi-reader studies, and ground truth establishment will not be applicable.
Here's the information extracted from the document, with "N/A" (Not Applicable) for categories that don't fit this type of device submission:
Acceptance Criteria and Device Performance for Bausch & Lomb Naturelle Daily Disposable (hilafilcon B) Cosmetically Tinted Contact Lens
1. Table of Acceptance Criteria and the Reported Device Performance:
The document states that "conformity to predetermined specifications" was part of the performance testing. However, it does not explicitly list quantitative acceptance criteria with corresponding performance results in a table format. Instead, it relies on demonstrating that the device's functional characteristics are equivalent to the predicate device and that non-clinical testing ensures safety and effectiveness. The table below presents the comparative technological characteristics provided, which serve as the basis for demonstrating equivalence to the predicate. The "Acceptance Criteria" here are implied to be "same as predicate" or within acceptable ranges for cosmetic differences.
| Property | Acceptance Criteria (Implicit: Same as Predicate/FDA Guidance) | Reported Device Performance (Naturelle Daily Disposable) |
|---|---|---|
| Water Content % | 59% (Same as Predicate) | 59% (Same) |
| Refractive Index | 1.4036 (Same as Predicate) | (Assumed same, not explicitly stated as "Same") |
| Oxygen Permeability (Dk) | 22 x 10^-11 [cm³O₂(STP) x cm]/(sec x cm² x mmHg)@35°C (Same as Predicate) | (Assumed same, not explicitly stated as "Same") |
| Light Transmittance | Approx. 95% C.I.E. Y value (Same as Predicate) | (Assumed same, not explicitly stated as "Same") |
| Specific Gravity | 1.119 (Same as Predicate) | (Assumed same, not explicitly stated as "Same") |
| Diameter mm | 13.5 to 15.0 mm (Same as Predicate) | (Assumed same, not explicitly stated as "Same") |
| Base Curve mm | 7.8 mm to 9.5 mm (Same as Predicate) | (Assumed same, not explicitly stated as "Same") |
| Spherical Power, Diopters | +20.00 D to -20.00 D (Same as Predicate) | +20.00 D to -20.00 D (Same) |
| Center Thickness mm | 0.05 mm to 0.75 mm (Same as Predicate) | (Assumed same, not explicitly stated as "Same") |
| Print Pattern | NA for Predicate (Visibility Tint) | Cosmetically Tinted Print area 8.2 to 13.0 mm (Difference noted, addressed by non-clinical testing) |
Study Proving Device Meets Acceptance Criteria:
The device's conformity is established through non-clinical testing, which includes:
- Toxicology / Biocompatibility:
- ISO Ocular Irritation Study
- ISO Systemic Toxicity
- In-Vitro Cytotoxicity
- Chemistry / Leachables:
- Leachable Monomer and Additives
- Physical and Mechanical Properties
The document states: "The testing performed on the Bausch + Lomb Naturelle Daily Disposable (hilafilcon B) Cosmetically Tinted Contact Lens demonstrated that the device continues to function in a safe and effective manner. Performance testing included conformance to predetermined specifications, functional test results verify that the device performs as expected and is equivalent to the predicate without creating additional risk to the user."
2. Sample Size Used for the Test Set and Data Provenance:
- Sample Size: Not specified in the provided document. For non-clinical tests like toxicity and physical property measurements, standard laboratory sample sizes are typically used (e.g., number of animals for in-vivo tests, number of lenses for physical property tests), but these are not detailed here.
- Data Provenance: Not specified, but generally, such tests are conducted in controlled laboratory environments, often in the country of manufacture or certified testing facilities. The tests are prospective in nature, meaning they are performed specifically for this device evaluation.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of those Experts:
- N/A. This device does not involve a "ground truth" established by human experts in the way AI algorithms do. Safety and performance are assessed through objective laboratory tests and comparison to established standards and the predicate device.
4. Adjudication Method for the Test Set:
- N/A. Adjudication methods like 2+1 or 3+1 are used for human expert review of imaging or clinical cases, which is not relevant to the non-clinical testing of a contact lens.
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:
- N/A. This is not an AI-assisted device. No MRMC study was conducted.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- N/A. This is not an AI algorithm.
7. The Type of Ground Truth Used:
- For the non-clinical tests, the "ground truth" is defined by established scientific principles, validated testing methodologies (e.g., ISO standards), and the performance characteristics of the legally marketed predicate device. For example, for biocompatibility, the ground truth is "no significant ocular irritation" or "no significant systemic toxicity," as determined by the specific ISO tests.
8. The Sample Size for the Training Set:
- N/A. This device does not involve a training set as it is not an AI algorithm or a device requiring machine learning.
9. How the Ground Truth for the Training Set was Established:
- N/A. This device does not involve a training set.
Summary of Equivalence Claim and Lack of Clinical Studies:
The submission relies heavily on the claim of "substantial equivalence" to the predicate device (K061157). The key statement is: "The technological characteristics, formulation, manufacturing and sterilization processes are the same as the predicate device, therefore, no clinical studies were required to demonstrate the safety or effectiveness of the subject device." The addition of the cosmetic tint was specifically addressed through "appropriate testing... to demonstrate that the differences do not impact the safety or efficacy of the device." This indicates that the non-clinical tests were crucial for validating that the cosmetic feature did not introduce new risks or alter the lens's fundamental performance characteristics.
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(224 days)
MVN
The Clearl-day® (hioxifilcon A) Daily Disposable Soft Contact Lens is indicated for daily wear single use only for the optical correction of refractive ametropia (myopia and hyperopia) in phakic or aphakic persons with non-diseased eyes who may have 1.00D or less of astigmatism.
The lens is intended to be worn once and then discarded at the end of each wearing period on a daily basis. The patient should be instructed to start the next wearing period with a new lens.
The Clearl-day® (hioxifilcon A) Daily Disposable Soft Contact Lens is available as a single vision spherical lens. The hydrophilic nature of this material allows the lens to become soft and pliable when immersed in an aqueous solution.
The non-ionic lens material, (hioxifilcon A) is a ultra high molecular weight random copolymer of 2hydroxyethyl methacrylate (2-HEMA) and 2,3-Dihydroxpropyl Methacrylate (Glycerol Methacrylate, GMA) cross-linked with ethylene glycol dimethacrylate. It consists of 42% hioxifilcon A and 58% water by weight when immersed in a buffered saline solution. The lens is available with a pale blue visibilityhandling tint, color additive 'Reactive Blue # 4', 21 CFR part 73.3121. The United States Adopted Names Council (USAN) has adopted the (hioxifilcon A) name,
In the hydrated state, the lens conforms to the curvature of the eye covering the cornea and extending slightly beyond the limbus forming a coloriess, transparent optical surface. The hydrophilic properties of the lens require that it be maintained in a fully hydrated state in a solution compatible with the eye. If the lens dries out, it will become hard and appear somewhat warped however, it will return to its proper configuration when completely rehydrated in the proper storage solution.
The hydrophilic characteristics allow aqueous solutions to enter the lens and in its fully hydrated state the lens is approximately 58% water by weight. The physical properties of the lens are:
Refractive Index at 21ºC: 1.4011(wet)
Light Transmission: > 95%
Surface Character: Hydrophilic
Water Content at 21ºC: 59.77 %
Specific Gravity at 21ºC: 1.086(wet)
Oxygen Permeability at 34-36°C: 25.38 x 10-11(cm2/sec) (ml O2/ml x mm Hg), (revised Fatt method).
The provided text describes a 510(k) summary for a soft contact lens and does not contain information about a study that tests the device against acceptance criteria in the context of AI/medical imaging performance. Instead, it focuses on demonstrating substantial equivalence to predicate devices based on technological characteristics and intended use.
Therefore, I cannot provide the requested information about acceptance criteria, study details, sample sizes, expert involvement, adjudication methods, MRMC studies, standalone performance, or ground truth for a device performance study.
The document is a regulatory submission for a contact lens, which is a physical medical device, not an AI or imaging diagnostic tool. The "acceptance criteria" discussed in such a submission would typically relate to manufacturing specifications, material properties, and clinical safety/performance in human trials (bio-compatibility, visual acuity achieved, adverse event rates), rather than statistical metrics like sensitivity, specificity, or F1-scores derived from an AI model's output compared to ground truth.
Specifically, the document states:
- "The Clearl-day® (hioxifilcon A) Daily Disposable Soft Contact Lenses are substantially equivalent to the following predicate devices: Extreme H2O (hioxifilcon A), K992692, Manufactured by Hydrogel Vision Corp. and Clear All Day (hioxifilcon A), K052290, Manufactured by Clearlab SG Pte Ltd."
- The comparison is made on "Technological Characteristics" such as intended use, functionality, indications, production method, FDA group #, USAN name, water uptake (%), oxygen permeability (Dk), and specific gravity (wet).
These are not acceptance criteria or performance metrics related to an AI device's diagnostic accuracy.
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(85 days)
MVN
The SofLens® daily disposable toric (hilafilcon B) Visibility Tinted Contact Lens is indicated for the daily wear correction of refractive ametropia (myopia, hyperopia, and astigmatism) in not-aphakic persons with non-diseased eyes, exhibiting astigmatism of 5.00 diopters or less, that does not interfere with visual acuity. The lens may be prescribed in spherical powers ranging from +20.00D to -20.00D.
The lens is to be prescribed for single-use disposable wear, and is to be discarded after each removal.
The SofLens® daily disposable toric (hilafilcon B) Visibility Tinted Contact Lens is a soft hydrophilic contact lens which is available in a toric lens design for the correction of astigmatism. The lens is made from the hilafilcon B material, a hydrophilic copolymer of 2-hydroxyethyl methacrylate and N-vinyl pyrrolidone, and is 59% water by weight when immersed in a sterile saline solution. This lens is tinted blue with Reactive Blue Dye 246.
The provided document describes the SofLens® daily disposable toric (hilafilcon B) Visibility Tinted Contact Lens, and its substantial equivalence to previously cleared predicate devices. The document explicitly states that preclinical and clinical studies were completed and previously submitted for the predicate devices. It does not provide new acceptance criteria or specific study results for the SofLens® daily disposable toric (hilafilcon B) Visibility Tinted Contact Lens itself, but rather leverages the data from its predicates.
Therefore, for aspects like acceptance criteria, device performance, sample sizes, expert qualifications, and ground truth establishment, the information presented below reflects what would have been applicable to the predicate devices, or what can be inferred from the nature of the device and regulatory process.
1. Table of Acceptance Criteria and Reported Device Performance
Since this submission relies on substantial equivalence and refers to previous studies, specific acceptance criteria and reported performance for the new device are not explicitly detailed. However, for contact lenses, acceptance criteria typically revolve around visual acuity, fitting characteristics, oxygen permeability, comfort, and safety endpoints (e.g., adverse events). The "reported device performance" for the new lens is broadly understood to be equivalent to its predicates.
| Acceptance Criteria Category | Typical Acceptance Criteria (Inferred for Contact Lenses) | Reported Device Performance (Inferred as equivalent to predicates) |
|---|---|---|
| Visual Acuity | Maintenance or improvement of corrected visual acuity; no significant loss of best-corrected visual acuity. | Expected to provide sharp and stable vision, equivalent to or better than spectacles for the indicated correction of refractive ametropia (myopia, hyperopia, and astigmatism). |
| Fit & Stability | Proper centering, movement, and coverage; stable axis orientation for toric lenses; minimal discomfort from fit. | Stable and comfortable fit with adequate movement and oxygen transmission, consistent with the hilafilcon B material and toric design. |
| Safety | Absence of significant adverse events (e.g., corneal ulcer, infiltrates, severe conjunctivitis); biocompatibility of material. | Biologically safe and well-tolerated, as established for the hilafilcon B material and daily disposable modality in predicate devices. |
| Material Properties | Oxygen transmissibility, water content, modulus, tensile strength meeting established standards for extended wear. | Meets established standards for hilafilcon B (59% water content) to ensure corneal health. |
| Sterility | Maintenance of sterility throughout shelf life. | Demonstrates continued sterility for its stated shelf-life (5 years). |
| Discomfort/Wear Time | Acceptable comfort during daily wear. | Comfortable for daily wear, consistent with the "daily disposable" modality. |
2. Sample Size Used for the Test Set and Data Provenance
The document states: "A series of preclinical and clinical studies were completed and previously submitted in Premarket Notifications K061157, K994125 and K941370."
- Test Set Sample Size: Not specified for the current device's assessment, as it leverages prior studies. For the predicate devices, sample sizes would have been determined based on statistical requirements for non-inferiority or equivalence trials for contact lenses.
- Data Provenance: The document does not explicitly state the country of origin or whether the data was retrospective or prospective for the predicate studies. However, clinical trials for medical devices like contact lenses are typically prospective multicenter studies conducted in various countries, with the US often being a primary location.
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 supplied text for the current device, as it relies on substantial equivalence to predicate devices. For the predicate clinical studies, the ground truth (e.g., visual acuity measurements, slit lamp examinations for ocular health, subjective comfort ratings) would have been established by:
- Optometrists and Ophthalmologists: Qualified eyecare professionals (often with several years of experience) who conducted clinical examinations, performed refractions, assessed lens fit, and evaluated adverse events. The specific number is not disclosed in this summary.
4. Adjudication Method for the Test Set
The document does not describe any specific adjudication method for the test set, as no new primary clinical study data is presented for this specific 510(k) submission. In multi-center clinical trials for the predicate devices, adjudication of adverse events or ambiguous findings would typically involve:
- Independent Clinical Monitors: To ensure protocol adherence and data accuracy.
- Clinical Endpoints Committee (CEC): A small group of clinicians who independently review and adjudicate key clinical endpoints, especially adverse events, often blinded to treatment assignment.
- Data Safety Monitoring Board (DSMB): For ongoing monitoring of patient safety in larger trials.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, what was the effect size of how much human readers improve with AI vs without AI assistance
N/A. This device is a contact lens and does not involve AI assistance or "human readers" in the context of diagnostic interpretation. Therefore, an MRMC comparative effectiveness study regarding improvement with AI assistance is not applicable.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done
N/A. This device is a contact lens and does not involve any algorithm that operates in a standalone manner without human intervention.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
For the predicate clinical studies, the ground truth would have been established through a combination of:
- Clinical Examination Findings: Objective measurements by eye care professionals (e.g., visual acuity charts, slit lamp biomicroscopy for corneal health, keratometry for corneal shape, lens fit assessment).
- Patient Reported Outcomes (PROs): Subjective data regarding comfort, vision quality, and overall satisfaction.
- Refractive Measurements: Objective and subjective refraction to determine the lens's corrective power.
- Adverse Event Reporting: Detailed documentation and classification of any ocular or systemic adverse events.
8. The Sample Size for the Training Set
The document does not mention a "training set" in the context of the 510(k) submission, as it leverages previous clinical data on predicate devices rather than developing a new algorithm with a training/test split. For contact lenses, "training set" is not a standard term unless referring to material development or specific design optimization, which wouldn't typically be a detailed part of a 510(k) summary. The "training" for such devices is based on extensive research and development in materials science and optical design.
9. How the Ground Truth for the Training Set was Established
As explained in point 8, the concept of a "training set" with established ground truth is not directly applicable in the context of this 510(k) summary for a physical medical device like a contact lens. The "ground truth" for the development of contact lens materials (hilafilcon B) and designs (toric, daily disposable) would have been built upon decades of ophthalmological and optometric understanding, extensive material testing, and prior clinical trials for predecessors. This continuous feedback loop from clinical performance and patient outcomes informs the iterative design process in contact lens development.
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(30 days)
MVN
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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(135 days)
MVN
Sphere and Aspheric: (omafilcon A) Soft (hydrophilic) Contact Lenses are indicated for daily wear for the correction of visual acuity in not aphakic persons with non-diseased eves that are myopic or hyperopic and exhibit astigmatism of 2.00D or less that does not interfere with visual acuity.
Toric: (omafilcon A) Soft (hydrophilic) Contact Lenses are indicated for daily wear for the correction of visual acuity in not aphakic persons with non-diseased eyes that are myopic or hyperopic. The lens may be worn by persons who have astigmatism of 5.00D or less.
Multifocal: (omafilcon A) Soft (hydrophilic) Contact Lenses are indicated for daily wear for the correction of refractive ametropia (myopia, hyperopia, and astigmatism) and presbyopia in not aphakic persons with non-diseased eves. The lens may be worn by persons who have astigmatism of 2.00D or less that does not interfere with visual acuity.
Multifocal Toric: (omafilcon A) Soft (hydrophilic) Contact Lenses are indicated for daily wear for the correction of visual acuity in not aphakic persons with non-diseased eyes that are myopic or hyperopic, possess astigmatism of 10.00 diopters or less, and are presbyopic.
Proclear XC and Proclear 1 Day (omafilcon A) Soft (hydrophilic) Contact lenses may provide improved comfort for contact lens wearers who experience mild discomfort or symptoms related to dryness during lens wear associated with Evaporative Tear Deficiency or from Aqueous Tear Deficiency (non-Sjogren's only).
Daily wear replacement schedules may vary from patient and should be decided by eyecare practitioners in consultation with their patients.
FREQUENT/PLANNED REPLACEMENT WEAR
When prescribed for Frequent/Planned replacement the lenses are to be cleaned, rinsed and disinfected each time they are removed from the patient's eye and discarded after the recommended wearing period prescribed by the eye care practitioner. The lens may be disinfected using a chemical disinfection system.
DISPOSABLE WEAR
When prescribed for Daily Disposable Wear the lens is to be discarded after each removal.
The Proclear (omafilcon A) are Daily Wear soft contact lenses intended for single use daily disposable wear or Scheduled Replacement wear. The Proclear (omafilcon A) Soft (hydrophilic) contact lenses are a hemispherical shell. The Proclear lens is available in several designs. Spherical or aspherical soft contact lens; Toric is a back surface toric; Multifocal has multiple curves with complementary reverse geometry (N and D) which allows for correction of presbyopia in persons who are myopic or hyperopic; Multifocal Toric has an aspheric front surface with anterior having two multifocal zones with a toric generated surface for the purpose of correcting vision in an eye that is astigmatic. The omafilcon A lens material is equivalent to other omafilcon A daily wear hydrophilic contact lenses cleared under several 510(k) notifications. Omafilcon A is composed of polymer of 2-hydroxy-ethylmethacylate and 2-metacryloloyoxyethyl phosphoryIcholine cross linked with ethylmethacrylate. The lenses are tinted from edge to edge for visibility purposes with the color additive Vat Blue 6.
This document is a 510(k) premarket notification for contact lenses, which primarily focuses on demonstrating substantial equivalence to previously cleared devices rather than extensive new clinical studies with acceptance criteria for device performance. Therefore, many of the requested elements for describing acceptance criteria and a study proving device adherence are either not applicable, not explicitly detailed as a separate "study" in the traditional sense, or are referred to through equivalence to predicate devices.
Here's an attempt to answer the questions based on the provided text, highlighting where information is not present or not directly applicable:
1. A table of acceptance criteria and the reported device performance
The document does not explicitly present a table of "acceptance criteria" against which "reported device performance" is measured in a comparative fashion, as it is a substantial equivalence submission. Instead, the device's physical and material properties are compared to predicate devices for equivalency. The implied acceptance criterion for the subject device is that its characteristics fall within ranges considered equivalent and safe, as demonstrated by the predicate devices.
| Characteristic | Acceptance Criteria (Implied: Equivalent to Predicate) | Reported Device Performance (Subject Device) |
|---|---|---|
| Material USAN Name | Omafilcon A | Omafilcon A |
| FDA Category | Group II (Non-Ionic, High Water Content) | Group II (Non-Ionic, High Water Content) |
| Manufacturing method | Cast Molded | Cast Molded |
| Sterilization | Steam: validated autoclave | Steam: validated autoclave |
| Packaging | Blister Pack | Blister Pack |
| Labeled Water Content | 60-62% (referencing predicates) | 60% |
| Visibility Tint | Vat Blue 6 or C.I Reactive Blue 4 or Clear | Vat Blue 6 |
| Color Process | Entrapment or Reactive or No tint | Entrapment |
| Intended Use (Sphere/Asphere) | Correction of visual acuity in myopic/hyperopic persons, astigmatism ≤ 2.00D. Non-aphakic, non-diseased eyes. | Same |
| Intended Use (Toric) | Correction of visual acuity in myopic/hyperopic persons, astigmatism ≤ 5.00D. Non-aphakic, non-diseased eyes. | Same |
| Intended Use (Multifocal) | Correction of refractive ametropia (myopia, hyperopia, astigmatism) and presbyopia. Astigmatism ≤ 2.00D. Non-aphakic, non-diseased eyes. | Same |
| Intended Use (Multifocal Toric) | Correction of visual acuity in myopic/hyperopic persons, astigmatism ≤ 10.00D, presbyopic. Non-aphakic, non-diseased eyes. | Same |
| Improved Comfort Claim | Provide improved comfort related to dryness (Evaporative Tear Deficiency or Aqueous Tear Deficiency). | Same |
| Daily Disposable Indication | Discarded after each removal. | Same |
| Physiochemical Studies | Substantial equivalency with predicate devices, within established specifications. | "Results... show substantial equivalency with the predicate devices, and are within established specifications." |
| Toxicology Studies | Non-toxic and biocompatible with the ocular environment. | "Results... verify that lenses remain nontoxic and biocompatible with the ocular environment." |
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 states, "The technical characteristics, formulation, manufacturing, and sterilization processes of this lens are equivalent to omafilcon A soft contact lenses currently marketed by CooperVision, therefore no clinical data is required." This indicates that a separate, formal "test set" and a clinical study to prove the device meets acceptance criteria in a new cohort were not performed for this submission. The "test set" implicitly refers to the data and studies associated with the predicate devices which established their safety and effectiveness.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
Not applicable, as no new clinical study with a "test set" requiring ground truth establishment by experts was conducted for this 510(k) submission.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable, for the same reason as point 3.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
Not applicable. This is a contact lens submission, not an AI or imaging device, and no MRMC study was performed.
6. If a standalone (i.e. algorithm only, without human-in-the-loop performance) was done
Not applicable. This is a contact lens submission, not an AI or algorithm-based device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
Not applicable, as no new clinical study with a "test set" requiring ground truth establishment was conducted for this 510(k) submission. The "ground truth" for demonstrating safety and effectiveness relies on the previously established regulatory clearances of the predicate devices based on their initial studies (which presumably included clinical trials and robust testing at the time).
8. The sample size for the training set
Not applicable. This is a contact lens submission and does not involve a training set for an algorithm. The "training" in this context refers to the accumulated knowledge and testing performed on the predicate devices over time.
9. How the ground truth for the training set was established
Not applicable, for the same reason as point 8. The "ground truth" for the predicate devices' safety and efficacy would have been established through a combination of physical/chemical testing, toxicology studies, and likely clinical trials performed at the time of their original submissions.
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