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510(k) Data Aggregation
(197 days)
Pegavision Corporation
Sphere/ Asphere
Pegavision (Toufilcon B) Daily Disposable Soft (Hydrophilic) Contact Lenses and Pegavision (Toufilcon B) Soft (Hydrophilic) Contact Lenses are indicated for daily wear for vision correction of refractive ametropia (myopia or hyperopia) in aphakic or non-aphakic persons with non-diseased eyes. The lenses may be worn by person who exhibit refractive astigmatism of 2.00 diopters (D) or less where the astigmatism does not interfere with visual acuity. The lens may be prescribed in spherical powers ranging from +6.00D to -12.00D
Toric
Pegavision (Toufilcon B) Daily Disposable Soft (Hydrophilic) Contact Lenses and Pegavision (Toufilcon B) Soft (Hydrophilic) Contact Lenses with Toric designs are indicated for daily wear for vision correction of refractive ametropia (myopia or hyperopia with astigmatism) in aphakic or non-aphakic persons with non-diseased eyes. The lens may be prescribed in spherical powers ranging from +6.00D to -12.00D and astigmatic corrections from -0.25D to -3.50D.
Multifocal
Pegavision (Toufilcon B) Daily Disposable Soft (Hydrophilic) Contact Lenses and Pegavision (Toufilcon B) Soft (Hydrophilic) Contact Lenses with Multifocal designs are indicated for daily wear for the correction of refractive ametropia (myopia or hyperopia) with presbyopia in aphakic or non-aphakic person with non-diseased eyes who may have +0.25D to +3.00D of ADD powers or less. The lens may be prescribed in spherical powers ranging from +6.00D to -12.25D. The lenses may be worn by persons who exhibit astigmatism of 2.00 diopters or less that does not interfere with visual acuity.
Pegavision (Toufilcon B) Daily Disposable Soft (Hydrophilic) Contact Lenses are intended for single-use disposable wear.
Pegavision (Toufilcon B) Soft (Hydrophilic) Contact Lenses are intended for frequent/planned replacement wear with cleaning, rinsing, disinfecting 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.
Pegavision (Toufilcon B) Daily Disposable Soft (Hydrophilic) Contact Lenses and Pegavision (Toufilcon B) Soft (Hydrophilic) Contact Lenses are clear and visibility tint with UV blocker are available as a spherical lens. The lens material, Toufilcon B is a co-polymer of 2-Hydroxyethylmethacrylate (2-HEMA), N-Vinyl-2-Pyrrolidinone (NVP), N,N-Dimethylcarylamide (DMA), Methacrylic Acid (MAA), (3-Methacryloxy-2-hydroxypropoxy)propyl-bis(trimethylsiloxy)methylsilane (SiGMA) and Polydimethylsiloxane macromer (monofunctional Polydimethylsiloxane) (PDMS macromer), cross-linked with Ethylene glycol dimethacrylate (EGDMA) and
Triallyl isocyanurate (TAIC) via photo-polymerization. The copolymer consists 50% Toufilcon B and 50% water by weight when immersed in buffered borate solution. The lens further contains a benzotriazole UV absorbing monomer and thus is able to block UV radiation. The lens is visibly tined with "Reactive Blue19" color additive, 21 CFR part 73.3121. The UV Blocking averages 95% in the UVB range of 280 nm to 315 nm and 50% in the UVA range of 315 nm to 380 nm. The Toufilcon B name has been adopted by the United States Adopted Names Council (USAN).
This document describes the regulatory clearance of contact lenses, not a medical AI device requiring the kind of rigorous AI-specific validation outlined in your request. The provided text is a 510(k) clearance letter for contact lenses, which focuses on demonstrating substantial equivalence to a predicate device through physicochemical, biocompatibility, and clinical performance in human subjects, rather than AI model performance metrics.
Therefore, many of the requested elements for an AI device's acceptance criteria and accompanying study (e.g., sample size for test set, data provenance for AI, number of experts for ground truth, adjudication method, MRMC studies, standalone AI performance, training set details) are not applicable to this document as it does not relate to an AI device.
However, I can extract the relevant information from the provided document concerning the contact lens study and present it in a similar structured format, adapting where necessary.
Device: Pegavision (Toufilcon B) Daily Disposable Soft (Hydrophilic) Contact Lenses; Pegavision (Toufilcon B) Soft (Hydrophilic) Contact Lenses
Nature of Study: Clinical trial demonstrating substantial equivalence of a new contact lens product to an existing predicate device, focusing on safety and effectiveness for vision correction. This is not an AI device study.
1. Table of Acceptance Criteria (for Contact Lenses) and Reported Device Performance
Given this is a contact lens, the "acceptance criteria" are related to clinical efficacy (visual acuity) and safety (adverse events, slit lamp findings), and various physicochemical properties. The study aims to show non-inferiority or comparability to the predicate device rather than meeting specific numerical thresholds for many of the elements you'd expect in an AI performance table (e.g., sensitivity, specificity).
| Acceptance Criteria Category (for Contact Lenses) | Specific Metric / Criterion | Reported Device Performance |
|---|---|---|
| Clinical Efficacy (Primary Endpoint) | Corrected contact lens visual acuity of 1.0 decimal (0.0 logMAR) or better at final visit | "no difference in control group and test group." "test and control groups are comparable in corrected contact lens visual acuity." |
| Clinical Safety (Secondary Endpoints) | Absence of serious and significant adverse device events (ADE) | "no serious and significant adverse device event occurred during the conduct of the study in both control and test group." |
| Slit Lamp Findings > Grade 2 | "No subject with adverse device effects accompanying Slit Lamp Findings > Grade 2 was reported in the control group and test group." | |
| Physicochemical Properties | Met established specifications and requirements (e.g., Refractive Index, Oxygen Permeability, Water content, Light Transmittance, Mechanical Property, Shelf Life, Solution Compatibility, Preservative Uptake and Release) | "The results demonstrated that the lens met all established specifications and requirements for physical, optical, and chemical properties." (Specific values for some properties are provided in the "Technological characteristics studies" table, indicating they were assessed against the predicate). |
| Biocompatibility | Exhibit no cytotoxicity, no ocular irritation, no skin sensitization, and no acute systemic toxicity. Product does not contain any toxic or harmful substances. | "All biocompatibility tests yielded passing results, confirming that the product does not contain any toxic or harmful substances that may pose a risk to biological systems." |
2. Sample Size Used for the Test Set and Data Provenance
- Test Set Sample Size:
- Screened: 75 subjects
- Enrolled: 56 subjects (39 wore test lenses, 17 wore control lenses)
- Completed Study: 54 subjects (2 subjects in test group discontinued)
- Data Provenance: Prospective, randomized, double-blind, parallel, active-controlled clinical trial conducted in Taiwan.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications
Not explicitly stated for establishing "ground truth," as this was a clinical trial involving patient outcomes and examinations. Clinical assessments were likely performed by eye care professionals involved in the study (e.g., ophthalmologists, optometrists), but a specific number or their detailed qualifications are not provided in the summary. The "ground truth" for contact lenses is physiological response, visual acuity, and safety outcomes from direct patient observation.
4. Adjudication Method for the Test Set
Not explicitly stated. Clinical trials typically have protocols for adverse event reporting and assessment, often by an independent safety committee or study investigators.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No, an MRMC study was not done. This type of study is specifically designed for evaluating diagnostic performance of imaging modalities or AI systems where multiple readers interpret cases. This document describes a clinical trial for a contact lens, comparing direct patient outcomes between a new lens and a predicate.
6. If a Standalone (i.e. algorithm only without human-in-the loop performance) Was Done
Not Applicable. This is a physical medical device (contact lens), not an algorithm or AI system.
7. The Type of Ground Truth Used
The "ground truth" for this contact lens study was based on:
- Clinical Outcomes Data: Corrected visual acuity measurements.
- Safety Data: Adverse event reporting, assessment of slit lamp findings (direct observation of ocular health by clinicians).
- Physicochemical and Biocompatibility Test Results: Objective laboratory measurements demonstrating material properties and biological safety.
8. The Sample Size for the Training Set
Not Applicable. This is not an AI/machine learning study, so there is no training set in that context. The "training" for the device would be the manufacturing process and quality control.
9. How the Ground Truth for the Training Set Was Established
Not Applicable. See point 8.
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(251 days)
Pegavision Corporation
Sphere and Asphere
Pegavision (Hioxifilcon A) Daily Disposable Soft Contact Lenses with Sphere designs are indicated for daily wear for the correction of refractive ametropia (myopia and hyperopia) in aphakic and/or non-aphakic persons with nondiseased eyes in powers from +6.00 diopters. The lenses may be worn by persons who exhibit astigmatism of 1.00 diopters or less that does not interfere with visual acuity.
Toric
Pegavision (Hioxifilcon A) Daily Disposable Soft Contact Lenses with Toric designs are indicated for the correction of refractive ametropia with astigmatism) in aphakic and/or non-aphakic persons with non-diseased eyes in powers from +6.00 to -12.00 diopters and astigmatic corrections from -0.50 to -3.50 diopters.
Multifocal
Pegavision (Hioxifilcon A) Daily Disposable Soft Contact Lenses with Multifocal designs 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 +6.00 to -12.00 diopters and with non-diseased eyes who may require a reading addition from +0.25D to +3.00D. The lenses may be worn by persons who exhibit astigmatism of 1.00 diopters or less that does not interfere with visual acuity.
The lenses are intended for single-use disposable wear.
The Pegavision (Hioxifilcon A) Daily Disposable Soft Contact Lenses are visibility-tinted and include UV blocker-containing. The lens is available in sphere, asphere, toric and multifocal designs. It is a non-ionic hydrogel lens derived from Hioxifilcon A material which is a co-polymer of 2-Hydroxyethyl methacrylate (HEMA) and 2,3-Dihydroxypropyl methacrylate (Glycerol methacrylate, GMA), cross-linked with Ethylene glycol dimethacrylate (EGDMA) and made by photo-polymerization. It consists of 41% Hioxifilcon A and 59% water by weight when immersed in buffered solution. There are two types of buffer solution, one is borate solution another one is borate solution with Tween 80, Hyaluronic Acid and Polyethylene Glycol. The lens further contains a benzotriazole UV absorbing monomer and thus is able to block UV radiation. The lens is visibly tinted with "Reactive Blue 19" and "Reactive Red 180" color additive, 21 CFR part 73.3121. Besides, Reactive Yellow 15, 21 CFR part 73.3121, is also used to reduce light in the range from 380 nm to 450 mm. The UV Blocking averages 95% in the UVB range of 280 nm to 315 nm and 50% in the UVA range of 315 nm to 380 nm. The lens reduces transmittance by less than or equal to 35% in the light range from 380 nm to 450 nm.
The provided text describes a 510(k) submission for Pegavision (Hioxifilcon A) Daily Disposable Soft Contact Lenses. It outlines the device's characteristics and compares it to a predicate device to establish substantial equivalence. However, the document does not contain information about acceptance criteria and a study that proves the device meets those criteria in the context of a diagnostic or AI-powered medical device.
This submission is for soft contact lenses, which are regulated differently from diagnostic software/AI. The "studies" mentioned are non-clinical performance and biocompatibility tests, not clinical performance studies with acceptance criteria for diagnostic accuracy metrics (e.g., sensitivity, specificity, AUC).
Therefore, I cannot fulfill your request to provide a table of acceptance criteria and reported device performance, nor details about sample sizes, ground truth establishment, expert qualifications, adjudication methods, or MRMC/standalone studies, because this information is not present in the provided FDA 510(k) summary for a contact lens.
The document mainly focuses on:
- Technological characteristics comparison to a predicate device (K222885).
- Non-clinical testing (physicochemical properties, biocompatibility, shelf life, sterility) to demonstrate safety and effectiveness for a contact lens.
- Substantial equivalence based on material, design, intended use, and performance claims to the predicate device, with differences in dye and light transmittance being compared to another reference device (ACUVUE® OASYS MAX 1-DAY K210930).
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(250 days)
Pegavision Corporation
Pegavision (Hioxifilcon A) One-Day Soft (Hydrophilic) Contact Lenses (59% Water) with Sphere and Asphere designs are indicated for daily wear for the correction of ametropia (myopia and hyperopia) in aphakic and/or non-aphakic persons with non-diseased eves in powers from +10.00 to -20.00 diopters. The lenses may be worn by persons who exhibit astigmatism of 1.00 diopters or less that does not interfere with visual acuity.
Pegavision (Hioxifilcon A) One-Day Soft (Hydrophilic) Contact Lenses (59% Water) with Toric designs are indicated for daily wear for the correction of ametropia with astigmatism) in aphakic and/or non-aphakic persons with non-diseased eyes in powers from +10.00 to -20.00 diopters and astigmatic corrections from -0.50 to -6.00 diopters.
Pegavision (Hioxifilcon A) One-Day Soft (Hydrophilic) Contact Lenses (59% Water) with Multifocal designs 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 +6.00 to -12.25 diopters and with non-diseased eyes who may require a reading addition from +0.25D to +3.00D. The lenses may be worn by persons who exhibit astigmatism of 1.00 diopters or less that does not interfere with visual acuity.
The lenses are intended for single-use disposable wear.
The Pegavision (Hioxifilcon A) One-Day Soft (Hydrophilic) Contact Lenses (59% Water) are clear, visibility-tinted and include UV blocker-containing. The lens is available in sphere, asphere, toric and multifocal designs. It is a non-ionic hydrogel lens derived from Hioxifilcon A material which is a co-polymer of 2-Hydroxyethyl methacrylate (HEMA) and 2,3-Dihydroxypropyl methacrylate (Glycerol methacrylate, GMA), cross-linked with Ethylene glycol dimethacrylate (EGDMA) and made by photo-polymerization. It consists of 41% Hioxifilcon A and 59% water by weight when immersed in buffered solution. There are two types of buffer solution, one is borate solution another one is borate solution with Tween 80, Hyaluronic Acid and Polyethylene Glycol. The lens further contains a benzotriazole UV absorbing monomer and thus is able to block UV radiation. The lens is visibly tined with "Reactive Blue19" color additive, 21 CFR part 73.3121. The UV Blocking averages 95% in the UVB range of 280 nm to 315 nm and 50% in the UVA range of 315 nm to 380 nm. The Hioxifilcon A name has been adopted by the United States Adopted Names Council (USAN).
The provided document (K222885) is a 510(k) Premarket Notification for contact lenses, specifically Pegavision (Hioxifilcon A) One-Day Soft (Hydrophilic) Contact Lenses (59% Water).
It is crucial to understand that this document describes a submission for a medical device (contact lenses), NOT an AI/ML-powered diagnostic device. Therefore, the standard acceptance criteria and study designs typically associated with AI/ML systems (such as those involving test sets, ground truth establishment by experts, MRMC studies, etc.) do not apply to this submission.
The "study that proves the device meets the acceptance criteria" in this context refers to the non-clinical performance tests conducted to demonstrate the safety and effectiveness of the contact lenses. The acceptance criteria are based on established standards for contact lens properties and safety.
Here's an interpretation based on the provided document, framed within the context of a traditional medical device submission, rather than an AI/ML algorithm:
Acceptance Criteria and Study for Pegavision (Hioxifilcon A) One-Day Soft (Hydrophilic) Contact Lenses (59% Water)
The device, Pegavision (Hioxifilcon A) One-Day Soft (Hydrophilic) Contact Lenses (59% Water), is a Class II medical device. Its acceptance criteria and proof of meeting them are primarily based on demonstrating substantial equivalence to legally marketed predicate devices through a combination of non-clinical (laboratory) testing and established material safety.
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria for this contact lens device are derived from the performance characteristics of predicate devices and general industry standards for soft contact lenses. The reported device performance is compared against these benchmarks to demonstrate substantial equivalence.
| Characteristic / Acceptance Criteria | Predicate Device K201268 (Ethos Aquell) | Predicate Device K213119 (Innova Vision Hydrogel) | Proposed Device (Pegavision) |
|---|---|---|---|
| Production Method | Cast-Molded | Cast-Molded | Cast-Molded |
| USAN Name | Hioxifilcon A | Hioxifilcon A | Hioxifilcon A |
| Material Classification | Group II (high water non-ionic) | Group II (high water non-ionic) | Group II (high water non-ionic) |
| Water Content (%) | 59% | 59% | 59% |
| Refractive Index | 1.400 | 1.400 | 1.400 |
| Oxygen Permeability (edge corrected) @ 35°C ($\text{cm}^2/\text{sec} \cdot \text{mlO}_2/\text{ml} \cdot \text{mmHg}$) | $20.6 \times 10^{-11}$ | $25 \times 10^{-11}$ | $23.2 \times 10^{-11}$ |
| Transmittance Visible light @ 380-780nm | > 95% | > 95% | > 95% |
| Transmittance UVA @ 380-315nm |
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(254 days)
Pegavision Corporation
Aquamax (Etafilcon A) Daily Disposable Soft (Hydrophilic) Contact Lenses and Aquamax (Etafilcon A) Soft (Hydrophilic) Contact Lenses with Sphere designs 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 +6.00 to -12.00 diopters. The lenses may be worn by persons who exhibit astigmatism of 2.00 diopters or less that does not interfere with visual acuity.
Aquamax (Etafilcon A) Daily Disposable Soft (Hydrophilic) Contact Lenses and Aquamax (Etafilcon A) Soft (Hydrophilic) Contact Lenses with Toric designs are indicated for the correction of ametropia (myopia or hyperopia with astigmatism) in aphakic and/or non-aphakic persons with non-diseased eyes in powers from +6.00 to -12.25 diopters and astigmatic corrections from -0.25 to -3.50 diopters.
Aquamax (Etafilcon A) Daily Disposable Soft (Hydrophilic) Contact Lenses and Aquamax (Etafilcon A) Soft (Hydrophilic) Contact Lenses with Multifocal designs 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 +6.00 to -12.25 diopters and with non-diseased eyes who may require a reading addition form +0.25 to +3.00 diopters. The lenses may be worn by persons who exhibit astigmatism of 2.00 diopters or less that does not interfere with visual acuity.
Aquamax (Etafilcon A) Daily Disposable Soft (Hydrophilic) Contact Lenses and Aquamax (Etafilcon A) Soft (Hydrophilic) Contact Lenses with Multifocal-Toric designs are indicated for daily wear for the correction of refractive ametropia (myopia and hyperopia) in aphakic and/or non-aphakic persons with non-diseased eyes in powers from +6.00 to -12.25 diopters who may need up to +3.00 diopters of ADD power and have -3.50 diopters of astigmatism or less.
Aquamax (Etafilcon A) Daily Disposable Soft (Hydrophilic) Contact Lenses are intended for single-use disposable wear. Aquamax (Etafilcon A) Soft (Hydrophilic) Contact Lenses are intended for frequent/planned replacement wear with cleaning, disinfecting 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.
The Aquamax (Etafilcon A) Daily Disposable Soft (Hydrophilic) Contact Lenses and Aquamax (Etafilcon A) Soft (Hydrophilic) Contact Lenses are clear, visibility-tinted, UV absorber-containing and are available in sphere, asphere, toric, multifocal and multifocal-toric designs. It is an ionic hydrogel lens derived from Etafilcon A material which is a co-polymer of 2-Hydroxyethyl Methacrylate (2-HEMA) and Methacrylic Acid (MAA), cross-linked with Ethylene Glycol Dimethacrylate (EGDMA) and 1,1,1-Trimethylolpropane Trimethacrylate (TMPTMA) and made by photo-polymerization. The lens consists of 42% Etafilcon A and 58% water by weight when immersed in buffered saline solution. The lens polymer further contains a benzotriazole, a UV absorbing monomer, thus is able to block the UV radiation to the ocular. 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 315-380mm. The lens is visibly tined with "Reactive Blue19" color additive, 21 CFR part 73.3121. Lenses are supplied sterile in the sealed blister package containing sterile isotonic borate buffered saline solution with Tween 80, Sodium Hyaluronate and Polyethylene Glycol.
The provided document is a 510(k) premarket notification for Aquamax (Etafilcon A) soft contact lenses. It asserts substantial equivalence to existing predicate devices rather than presenting a novel device that requires a new clinical study with specific acceptance criteria and performance data. Therefore, the information typically requested regarding acceptance criteria, study design, and performance metrics for a new device's clinical efficacy is not present in this document.
Instead, the submission relies on the established safety and effectiveness of the predicate devices.
Here's an breakdown of the available information regarding testing:
1. A table of acceptance criteria and the reported device performance:
This document does not provide a table of acceptance criteria for a new clinical study. Instead, it performed non-clinical tests to demonstrate that the proposed device is comparable to the predicate devices. The "Technological characteristics studies" table (page 8) presents a comparison of the proposed device's physical properties with those of the predicate devices.
| Characteristic | Proposed Device (Aquamax) | K200296 Predicate (Pegavision) | K141670 Predicate (ACUVUE®) |
|---|---|---|---|
| Production Method | Cast-Molded | Cast-Molded | Cast-Molded |
| Lens Designs | Sphere & Asphere, Toric, Multifocal, Multifocal-Toric | Sphere & Asphere, Toric, Multifocal | Multifocal, Multifocal-Toric |
| USAN Name | Etafilcon A | Etafilcon A | Etafilcon A |
| Material Classification | Group IV high water ionic | Group IV high water ionic | Group IV high water ionic |
| Water Content (%) | 58% | 58% | 58% |
| Refractive Index | 1.402 | 1.402 | 1.402 |
| Oxygen Permeability (edge corrected) @ 35°C | $19.73 \times 10^{-11}$ (cm²/sec)(mlO2/ml-mmHg) | $19.73 \times 10^{-11}$ (cm²/sec)(mlO2/ml-mmHg) | $21.4 \times 10^{-11}$ (cm²/sec)(mlO2/ml-mmHg) |
| Cosmetically tinted | N/A | To enhance or alter the appearance of the eye | To enhance or alter the appearance of the eye |
| Percent Transmittance: | |||
| % T at 380~780nm | > 95% | > 95% | > 95% |
| % T at 315-380nm |
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(210 days)
Pegavision Corporation
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 nondiseased eyes in powers from +6.00 diopters. The lenses may be worn by persons who exhibit astigmatism of 2.00 diopters or less that does not interfere with visual acuity.
Aquamax (Etafilcon A) Toric Daily Disposable Soft (Hydrophilic) Contact Lenses are indicated for daily wear for the correction of ametropia (myoropia with astigmatism) in aphakic and/or non-aphakic persons with non-diseased eyes in powers from +6.00 to -12.25 diopters and astigmatic corrections from -0.25 to -3.50 diopters.
Aquamax (Etafilcon A) 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 +6.00 to -12.25 diopters and with non-diseased eyes who may require a reading addition from +0.25D 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 are intended for single-use disposable wear.
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 +6.00 to -12.00 diopters. The lenses may be worn by persons who exhibit astigmatism of 2.00 diopters or less that does not interfere with visual acuity.
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 +6.00 to -12.25diopters and astigmatic corrections from -0.25 to -3.50 diopters.
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 persons with non-diseased eyes in powers from +6.00 to -12.25 diopters and with non-diseased eyes who may require a reading addition from +0.25D 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.
The lenses are intended for frequent/planned replacement wear with cleaning, rinsing, disinfection and scheduled replacement as prescribed by the eve care professional. When prescribed for frequent/planned replacement wear, the lens may be disinfected using a chemical (not heat) lens care system only.
The Aquamax (Etafilcon A) Daily Disposable Soft (Hydrophilic) Contact Lenses and Aquamax (Etafilcon A) Soft (Hydrophilic) Contact Lenses are clear, visibility-tinted, UV absorber-containing and are available in spherical, aspherical, toric and multifocal designs. It is an ionic hydrogel lens derived from Etafilcon A material which is a co-polymer of 2-Hydroxyethyl Methacrylate (HEMA) and Methacrylic Acid (MAA), cross-linked with Ethylene Glycol Dimethacrylate (EGDMA) and 1,1,1-Trimethylolpropane Trimethacrylate (TMPTMA) and made by photo-polymerization. The lens consists of 42% Etafilcon A and 58% water by weight when immersed in buffered saline solution. The lens polymer further contains benzotriazole, a UV absorbing monomer, thus is able to block the UV radiation to the ocular. . 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 315-380mm. The lens is visibly tined with "Reactive Blue19" color additive, 21 CFR section 73.3121. Lenses are supplied sterile in the sealed blister package containing sterile isotonic borate buffered saline solution with Tween 80, Sodium Hyaluronate, Polyethylene Glycol, and Cyanocobalamin as a color indicator to induce the package solution as pink color.
The provided document is a 510(k) premarket notification for Aquamax (Etafilcon A) contact lenses. It does not describe a study that involves an AI/ML device, nor does it contain information about acceptance criteria and reported device performance in the context of an AI/ML device.
The document discusses the substantial equivalence of the Aquamax contact lenses to previously cleared predicate devices based on non-clinical studies (physicochemical properties, biocompatibility, packaging solution, plastic container, extractable, shelf life, and sterility tests) and the fact that Etafilcon A lenses have been widely used and their safety/effectiveness well documented.
Therefore, I cannot extract the requested information about acceptance criteria and a study proving device performance for an AI/ML device from this document. The questions provided are specifically tailored for AI/ML device evaluations.
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(252 days)
Pegavision Corporation
Pegavision (Etafilcon A) Color 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 eves in powers from +6.00 to -12.00 diopters. The lenses may be worn by persons who exhibit astigmatism of 2.00 dioters or less that does not interfere with visual acuity. The lens is available tinted and may be used to enhance or alter the apparent color of the eye.
Pegavision (Etafilcon A) Color Toric Daily Disposable Soft (Hydrophilic) Contact Lenses are indicated for daily wear for the correction of ametropia (myopia with astigmatism) in aphakic and/or non-aphakic persons with non-diseased eves in powers from +6.00 to -12.00 diopters and astigmatic corrections from -0.25 to -3.50 diopters. The lens is available tinted and may be used to enhance or alter the apparent color of the eye.
Pegavision (Etafilcon A) Color 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 +6.50 to -12.25 diopters and with non-diseased eyes who may require a reading addition from +0.25 to +3.00 diopters. The lenses may be worn by persons who exhibit astigmatism of 2.00 diopters or less that does not interfere with visual acuity. The lens is available tinted and may be used to enhance or alter the apparent color of the eye.
Pegavision (Etafilcon A) Color Daily Disposable Soft (Hydrophilic) Contact Lenses are intended for single-use disposable wear.
Pegavision (Etafilcon A) Color SPHERE Soft (Hydrophilic) Contact Lenses are indicated for daily wear for the correction of ametropia (myopia and hyperopia) in aphakic persons with non-diseased eyes in powers from +6.00 to -12.00 diopters. The lenses may be worn by persons who exhibit astigmatism of 2.00 diopters or less that does not interfere with visual acuity. The lens is available tinted and may be used to enhance or alter the apparent color of the eye.
Pegavision (Etafilcon A) Color Toric 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 +6.00 to -12.00 diopters and astigmatic corrections from -0.25 to -3.50 diopters. The lens is available tinted and may be used to enhance or alter the apparent color of the eye.
Pegavision (Etafilcon A) Color Multifocal Soft (Hydrophilic) Contact Lenses are indicated for daily wear for the correction of refractive ametropia) and hyperopia) and presbyopia in aphakic and/or non-aphakic persons with non-diseased eyes in powers from +6.50 to -12.25 diopters and with non-diseased eyes who may require a reading. addition from +0.25 to +3.00 diopters. The lenses may be worn by persons who exhibit astigmatism of 2.00 diopters or less that does not interfere with visual acuity. The lens is available tinted and may be used to enhance or alter the apparent color of the eye.
Pegavision (Etafilcon A) Color Soft (Hydrophilic) Contact 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.
Pegavision (Etafilcon A) Color Soft (Hydrophilic) Contact Lenses and Pegavision (Etafilcon A) Color Daily Disposable Soft (Hydrophilic) Contact Lenses are available as spherical, aspherical, toric and multifocal designs 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 and 1,1,1-trimethylolpropane trimethacrylate (TMPTMA) via photo-polymerization. These lenses are tinted blue using C.I. reactive blue 19 to make them more visible for handling. The contact lens color additives use FDA approved colorants and combination pigmented area that will mask or enhance the apparent color of the eyes.
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 315-380nm. Lenses are supplied sterile in sealed blister package containing sterile isotonic borate buffered saline solution with Tween 80. Sodium Hyaluronate and Polyethylene Glycol.
The provided text contains information about the regulatory clearance of contact lenses, specifically Pegavision (Etafilcon A) Color Daily Disposable Soft (Hydrophilic) Contact Lenses and Pegavision (Etafilcon A) Color Soft (Hydrophilic) Contact Lenses.
*However, the document does not describe an AI/ML-based device and therefore does not contain information about acceptance criteria, test sets, ground truth establishment, or clinical studies involving human readers and AI assistance for such a device.
Instead, it focuses on demonstrating substantial equivalence to predicate contact lenses through:
- Physicochemical Properties Tests: Measuring properties like water content, refractive index, oxygen permeability, and light transmittance.
- Biocompatibility Tests: Including cytotoxicity, maximization sensitization, and ocular irritation tests.
- Shelf Life Test and Sterility Test.
- Extractable Test.
- Compatibility Test of Care Solution.
The document explicitly states: "Clinical studies for Pegavision (Etafilcon A) Color Soft (Hydrophilic) Contact Lenses of the present device are not required for the premarket notification as the USAN name and process or color additive are the same as the above mentioned predicate devices." This indicates that the safety and effectiveness were established through non-clinical testing and comparison to already cleared devices, not through a clinical trial with human subjects/readers.
Therefore, I cannot provide the requested information about acceptance criteria for an AI/ML device, test set details, ground truth, expert adjudication, or MRMC studies, as these concepts are not applicable to the content of the provided regulatory filing for contact lenses.
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(178 days)
PEGAVISION CORPORATION
- 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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(282 days)
Pegavision Corporation
- 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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(118 days)
Pegavision Corporation
Aquamax (polymacon) Quarterly Disposable Soft (hydrophilic) Contact Lenses and Aquamax (polymacon) Monthly Disposable Soft (hydrophilic) Contact Lenses are indicated for daily wear for vision correction of refractive ametropia in aphakic or not-aphakic persons with non-diseased eyes that are myopic or hyperopic. The lens may be worn by persons who exhibit refractive astigmatism of 2.00 diopters (D) or less where the astigmatism does not interfere with visual acuity. The lens may be prescribed in spherical powers ranging from +20.00 D to -20.00 D. Eye practitioners may prescribe the lens 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. Lenses help protect against transmission of harmful UV radiation to the cornea and into the eve.
Aquamax (Polymacon) Ouarterly Disposable Soft (Hydrophilic) Contact Lenses and Aquamax (Polymacon) Monthly Disposable Soft (Hydrophilic) Contact Lenses are available as spherical lenses manufactured by cast molding method. The model illuminated with water content of 38%. These hydrogel lens materials are homo-polymer of 2-hydroxyethyl methacrylate (HEMA) crosslinked with ethylene glycol dimethacrylate (EGDMA) 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 UV 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.
Here's an analysis of the provided text regarding the acceptance criteria and supporting studies for the Aquamax (Polymacon) Soft (Hydrophilic) Contact Lenses:
The submission K123973 refers to a 510(k) premarket notification for contact lenses, which are inherently different from typical medical devices that might involve AI, image analysis, or complex algorithms requiring extensive performance criteria like sensitivity, specificity, or reader studies. This document, therefore, focuses on demonstrating substantial equivalence to existing, legally marketed predicate devices rather than proving performance against specific acceptance criteria for a novel technology.
As such, many of the requested categories (like sample sizes for test sets, number of experts, adjudication methods, MRMC studies, standalone AI performance, and training set information) are not applicable to this type of regulatory submission for contact lenses, which relies on the established safety and effectiveness of the material and manufacturing process. The "acceptance criteria" here are implicitly about matching the characteristics of the predicate devices and fulfilling non-clinical testing requirements.
Acceptance Criteria and Reported Device Performance
The "acceptance criteria" for this device are largely defined by its resemblance and comparable performance to the predicate devices. The study demonstrates substantial equivalence through a comparison of technological characteristics and non-clinical testing.
1. Table of Acceptance Criteria and Reported Device Performance:
| Characteristic | Acceptance Criteria (Predicate Devices: Soflens Multifocal K020927 & Frequency 38 K042824) | Aquamax (Polymacon) Reported Performance (Quarterly & Monthly) |
|---|---|---|
| Technological Characteristics | ||
| FDA Group | Group I ( 96 % (Soflens); > 97 % (Frequency 38) | > 95 % |
| % T at 380-316 nm (UV-A) | Not specified for predicates (but Aquamax states UV blocker) |
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(104 days)
Pegavision Corporation
- PEGAVISION Aquamax (Etafilcon A) Daily Disposable Soft (Hydrophilic) Contact Lenses are indicated for daily wear for vision correction of refractive ametropia in aphakic or not-aphakic persons with non-diseased eyes that are myopic or hyperopic. The lens may be worn by persons who exhibit refractive astigmatism of 2.00 diopters (D) or less where the astigmatism does not interfere with visual acuity. The lens may be prescribed in spherical powers ranging from 0.00D to -12.00D. Eye Care Practitioners may prescribe the lens for single-use daily disposable wear. The lens is intended for single-use disposable wear.
- PEGAVISION Aquamax (Etafilcon A) Bi-weekly Disposable Soft (Hydrophilic) Contact Lenses are indicated for daily wear for vision correction of refractive ametropia in aphakic or not-aphakic persons with non-diseased eyes that are myopic or hyperopic. The lens may be worn by persons who exhibit refractive astigmatism of 2.00 diopters (D) or less where the astigmatism does not interfere with visual acuity. The lens may be prescribed in spherical powers ranging from 0.00D to -12.00D. The lens is 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) Bi-Weekly Disposable Soft (Hydrophilic) Contact Lenses and Aquamax (Etafilcon A) Daily Disposable Soft (Hydrophilic) Contact Lenses are available as spherical lenses manufactured by cast molding method. 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 ethylene glycol dimethacrylate (EGDMA) and 1.1.1-trimethylolpropane trimethacrylate (TMPTMA) via photo-polymerization. These lenses are tinted blue using C.I. reactive blue 19 to make them more visible for These lenses contain UV blocker, a benzotriazole UV absorbing monomer handling. to block UV radiation. The average transmittance characteristics of theses lenses are less than 5 % in the UV range of 280-315 nm and less than 30% in the UVA range of 315-380mm. Lenses are supplied sterile in sealed blister package containing sterile isotonic borate buffered saline solution.
This is a 510(k) premarket notification for cosmetic contact lenses, not an AI/ML device. Therefore, the requested information about acceptance criteria and study design for an AI/ML device is not applicable here.
The document discusses the substantial equivalence of the Aquamax (Etafilcon A) contact lenses to existing predicate devices (ACUVUE and Discon Plus contact lenses) based on non-clinical performance tests and technological characteristics.
The document does not contain information about:
- Acceptance criteria for an AI/ML device.
- A "study that proves the device meets the acceptance criteria" in the context of AI/ML performance metrics.
- Sample sizes for test sets and data provenance for AI/ML.
- Number of experts, their qualifications, or adjudication methods for ground truth in an AI/ML context.
- Multi-reader multi-case (MRMC) comparative effectiveness studies.
- Standalone algorithm performance.
- Training set information for an AI/ML model.
Instead, it focuses on demonstrating substantial equivalence through:
- Technological characteristics comparison: This involves comparing physical and chemical properties of the lenses (e.g., water content, refractive index, oxygen permeability, transmittance) to predicate devices.
- Biocompatibility tests: Standard tests for cytotoxicity, sensitization, and ocular irritation with negative responses.
- Microbiology tests: Validation of steam sterilization process and shelf-life stability to ensure sterility.
- Bacteriostatic validation: Verification of sterilizer effectiveness and lens sterility over time.
- Leachability studies: Confirmation of no leachable monomers or additive residues from the finished lenses.
The document states, "Clinical studies for Aquamx Bi-Weekly Disposable Soft (Hydrophilic) Contact Lenses and Aquamax (Etafilcon A) Daily Disposable Soft (Hydrophilic) Contact Lenses are not required for the premarket notification as the USAN name and process are the same as the above mentioned predicate devices." This further confirms that no clinical studies (and by extension, no AI/ML specific performance studies) were conducted or reported for this submission.
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