Search Results
Found 37 results
510(k) Data Aggregation
(313 days)
P-CON (polymacon) Soft (hydrophilic) Contact Lenses (Tinted, Color)
P-CON (polymacon) Soft (hydrophilic) Contact Lenses (Tinted, Color) for daily wear are spherical lenses indicated for the correction of refractive error in not-aphakic persons with otherwise non-diseased eyes with myopia ranging from -0.00 diopters to -10.00 diopters.
The lenses may be worn by persons who exhibit refractive astigmatism of 1.50 diopters or less where the astigmatism does not interfere with visual acuity. The lenses are available clear or tinted and may be used to enhance or alter the apparent color of the eye.
Eye care practitioners may prescribe the lenses in a frequent/planned replacement program with cleaning, disinfection, and scheduled replacement. The lenses are intended for daily wear and are to be replaced every three months (quarterly). When prescribed for frequent/planned replacement wear, the lens may be disinfected using a chemical disinfecting system.
The P-CON (polymacon) Soft (hydrophilic) Contact Lenses (Tinted, Color) is manufactured using the cast molding method. The hydrophilic characteristics allow aqueous solutions to enter the lens. The lenses are fabricated from polymacon, which is a random copolymer of 2-hydroxyethyl methacrylate (HEMA) crosslinked with ethylene glycol dimethacrylate (EGDMA). The co-polymer consists of 62% polymacon and 38% water by weight when immersed in 0.9% saline solution. The polymacon name has been adopted by the United States Adopted Names Council (USAN).
The P-CON (polymacon) Soft (hydrophilic) Contact Lenses (Tinted, Color) is available clear or tinted for visibility using phthalocyanine blue, tinted in unique pattern to enhance or alter the apparent color of the eye. Each unique patterns may be distributed under unique or "private label" trade names. The lenses are processed to incorporate the 'listed' color additives and contain only the amount of the additive needed to accomplish the intended coloring effect. The lenses contain one or a combination of one or more of the following 'listed' color additives: C.I Reactive Black 5, Titanium Dioxide (TiO2), Carbazole Violet (i.e.,C.I Pigment Violet 23), Phthalocyanine green (i.e.,C.I PIgment Green 7), D&C Yellow No. 10, D&C Red No. 17, [Phthalocyaninato (2-)] Copper (i.e.,C.I PIgment Blue 15).
When producing the color lenses, the manufacturing process changes the specifications of the clear lens by pad-printing the color pigment(s)—entrapping the colorants in the interpenetrating network of the contact lens material—in a location that corresponds to the iris. The color pigments used are not removed by lens handling and cleaning/disinfecting procedures. Except for affecting the amount of light transmittance through the lens, the coloring process does not alter the original characteristics of the clear, pre-tinted lens.
Eye care practitioners may prescribe the lenses in a frequent/planned replacement program with cleaning, disinfection, and scheduled replacement. When prescribed for frequent/planned replacement wear, the lens may be disinfected using a chemical disinfecting system.
The provided text is a 510(k) clearance letter for contact lenses. While it details the device, its intended use, and substantial equivalence to a predicate device, crucial information regarding acceptance criteria for AI/algorithm performance and the study that proves the device meets the acceptance criteria (specifically in the context of AI/algorithm evaluation) is not present.
The document focuses on the physical and biological properties of contact lenses and manufacturing processes, not on an AI or algorithmic component that would require a study with an AI-specific acceptance criterion, ground truth establishment, or MRMC studies. The "Non-Clinical Test Conclusion" section primarily refers to biocompatibility, shelf life, and physicochemical/mechanical properties testing, all of which are standard for contact lenses and do not involve AI performance evaluation.
Therefore, I cannot fulfill the request as the input document does not contain the necessary information about AI/algorithm performance.
If this were a document for an AI-powered medical device, the information would typically be found in dedicated sections detailing "Clinical Performance Study," "Software Verification and Validation," or similar.
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(197 days)
Pegavision (Toufilcon B) Daily Disposable Soft (Hydrophilic) Contact Lenses; Pegavision (Toufilcon B)
Soft (Hydrophilic) Contact Lenses
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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(250 days)
Pegavision (Hioxifilcon A) One-Day Soft (Hydrophilic) Contact Lenses (59% Water)
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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(212 days)
TREVUES (polymacon) Soft (hydrophilic) Contact Lenses (Tinted, Color)
The TREVUES (polymacon) Soft (hydrophilic) Contact Lenses (Tinted, Color) are indicated for the correction of refractive ametropia (myopia) in aphakic and not-aphakic persons with non-diseased eyes. The lenses may be worn by persons who exhibit astigmatism of 2.00 diopters or less where the astigmatism does not interfere with visual acuity. The lens is available clear or tinted and may be used to enhance or alter the apparent color of the eye.
The 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 system.
The TREVUES (polymacon) Soft (hydrophilic) Contact Lenses (Tinted, Color) are manufactured using the cast molding method. The hydrophilic characteristics allow aqueous solutions to enter the lenses are fabricated from polymacon, which is a random copolymer of 2-hydroxyethyl methacrylate (HEMA) crosslinked with ethylene glycol dimethacrylate (EGDMA). The co-polymer consists of 62% polymacon and 38% water by weight when immersed in saline solution. The polymacon name has been adopted by the United States Adopted Names Council (USAN).
The TREVUES (polymacon) Soft (hydrophilic) Contact Lenses (Tinted, Color) are available clear, tinted for visibility, or tinted to enhance or alter the apparent color of the eye. The lenses are processed to incorporate the 'listed' color additives and contain only the amount of the additive needed to accomplish the intended coloring effect. The lenses contain one or a combination of one or more of the following 'listed' color additives: Iron Oxide, C.I. Reactive Blue No.4, Reactive Black 5, Titanium Dioxide.
When producing the color lenses, the manufacturing process changes the specifications to the clear contact lens by pad-printing the color pigment(s)-entrapping the colorants in the interpenetrating network of the contact lens material in a location that corresponds to the iris. The color pigments used are not removed by lens handling and cleaning/disinfecting procedures. Except for affecting the amount of light transmittance through the lens, the coloring process does not alter the original characteristics of the pre-tinted lens. The tinting pattern has a clear pupil diameter of 6.0 mm. The TREVUES (polymacon) Soft (hydrophilic) Contact Lenses (Tinted, Color) incorporate a UV absorbing monomer. The lenses block >95% in the UVB range (280nm - 315mm), and >50% in the UVA range (316nm - 380nm).
The TREVUES (polymacon) Soft (hydrophilic) Contact Lenses (Tinted, Color) are manufactured in an aspheric design configuration.
This document does not describe a study involving an AI/ML powered device. Instead, it is a 510(k) summary for a medical device called "TREVUES (polymacon) Soft (hydrophilic) Contact Lenses (Tinted, Color)," which are traditional contact lenses, not an AI or algorithm-driven product.
Therefore, I cannot provide the requested information regarding acceptance criteria and studies proving an AI device meets them, as the provided text does not contain that type of content. The document focuses on the substantial equivalence of the contact lenses to predicate devices based on material properties, manufacturing, indications for use, and non-clinical performance data (toxicology, shelf life, physicochemical & mechanical properties). It explicitly states that "Clinical testing is not required."
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(254 days)
Aquamax (Etafilcon A) Daily Disposable Soft (Hydrophilic) Contact Lenses, Aquamax (Etafilcon A) Soft
(Hydrophilic) Contact Lenses
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)
Aquamax (Etafilcon A) Daily Disposable Soft (Hydrophilic) Contact Lenses, Aquamax (Etafilcon A) Soft
(Hydrophilic) Contact Lenses
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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(162 days)
Ethos Aquell (Hioxifilcon A) One-Day Soft (Hydrophilic) Contact Lenses (59% Water)
Spherical and Aspheric
Ethos Aquell (Hioxifilcon A) Spherical and Aspheric One-Day Soft (Hydrophilic) Contact Lenses (59% Water) 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 +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.
Toric
Ethos Aquell (Hioxifilcon A) Toric One-Day Soft (Hydrophilic) Contact Lenses (59% Water) 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 +10.00 to -20.00 diopters and astigmatic corrections from -0.50 to -6.00 diopters.
The lenses are intended for single-use disposable wear.
The Ethos Aquell (Hioxifilcon A) One-Day Soft (Hydrophilic) Contact Lenses (59% Water) are clear, visibility-tinted and include UV blocker-containing. The lens is available in spherical, aspherical and toric designs. It is an non-ionic hydrogel lens Hioxifilcon derived from of 2-Hydroxyethylmethacrylate (2-HEMA) and 2,3-Dihydroxypropyl Methacrylate (GlycerolMethacrylate, 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 (Saline 2); another one is borate solution with sodium hyaluronate (Saline 1). The lens polymer 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.
This document is a 510(k) summary for a contact lens, not an AI/ML medical device. Therefore, the information typically required for an AI/ML device's acceptance criteria and study proving it meets those criteria (such as sample size for test/training sets, expert consensus, MRMC studies, etc.) is not present.
The document focuses on demonstrating substantial equivalence to a previously cleared predicate device, which is the standard pathway for many medical devices, including contact lenses. This involves showing similar technological characteristics and performance through non-clinical testing.
Here's an analysis of the provided text in relation to the requested information, highlighting why certain points cannot be addressed:
1. A table of acceptance criteria and the reported device performance
The document provides a comparative table of technological characteristics between the proposed device ("Ethos Aquell (Hioxifilcon A) One-Day Soft (Hydrophilic) Contact Lenses (59% Water)") and a predicate device (K040303). This isn't strictly "acceptance criteria" in the sense of performance metrics for an AI/ML algorithm, but rather a comparison for demonstrating substantial equivalence.
| Characteristic | Proposed Device (Ethos Aquell) | K040303 Predicate |
|---|---|---|
| Production Method | Cast-Molded | Cast-Molded |
| USAN Name | Hioxifilcon A | Hioxifilcon A |
| Material Classification | Group 2 (high water non-ionic) | Group 2 (high water non-ionic) |
| Water Content (%) | 59% | 59% |
| Refractive Index | 1.400 | 1.404 |
| Oxygen Permeability (edge corrected) @ 35°C | 20.6 x 10-11 (cm²/sec)(mlO2/ml-mmHg) | 18 x 10-11 (cm²/sec)(mlO2/ml-mmHg) |
| Transmittance: Visible light @ 380~780nm | > 95% | > 95% |
| Transmittance: UVA @ 380-315nm |
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(252 days)
Pegavision (Etafilcon A) Color Daily Disposable Soft (Hydrophilic) Contact Lenses, Pegavision (Etafilcon
A) Color Soft (Hydrophilic) Contact Lenses
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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(256 days)
ADORE (polymacon) Daily Wear Soft (hydrophilic) Contact Lenses (Tinted/color)
The ADORE (polymacon) Spherical Soft Contact Lenses are indicated for daily wear for the correction of refractive ametropia (myopia or hyperopia) in aphakic and not aphakic persons with non-diseased eyes. The lens may be worn by persons who exhibit refractive astigmatism of 0.75 diopters or less where the astigmatism does not interfere with visual acuity. The lens is available clear or tinted and may be used to enhance or alter the apparent color of the eye. Daily wear replacement schedules may vary from patient and should be decided by eyecare practitioners in consultation with their patients.
Frequent/Planned Replacement Wear:
Eyecare practitioners may prescribe any of the above lenses for frequent/planned replacement wear, with cleaning disinfection and scheduled replacement. When prescribed for frequent/planned replacement wear, the lens may be disinfected using a chemical disinfecting system.
Disposable Wear:
Eyecare practitioners may prescribe any of the above lenses for Daily Disposable Wear. When Prescribed for Daily Disposable Wear the lenses are not to be used with disinfecting systems as they are to be discarded after a single use.
The ADORE soft contact lenses are hemispherical shells with molded spherical base curves and molded front surfaces. The ADORE soft contact lenses are fabricated from polymacon, which has been adopted by the United States Adopted Names Council (USAN). The hydrophilic nature of this material allows the lens to become soft and pliable when immersed in an aqueous solution.
The nonionic lens material, (polymacon) is a hydrophilic polymer of 2-Hydroxyethyl methacrylate (2-HEMA) and cross-linked with ethylene glycol dimethacrylate (EGDMA), plus an initiator. The co-polymer consists of 62% polymacon and 38% water by weight when immersed in saline solution.
ADORE lenses are available clear, tinted for visibility/handling, and tinted to enhance or alter the apparent color of the eye. Tinted or color lens designs may be distributed under unique or "private label" trade names. ADORE lenses are available in gray, green, yellow, hazel, blue, white or black which are tinted with one or a combination of one or more of the following 'listed' color additives: D&C Yellow 10, Titanium Dioxide, Iron Oxide (Red), D&C Green No. 6, Reactive Blue 19, C.I. Reactive Black 5.
Lenses that contain a unique tinting pattern are subsequently processed to incorporate the 'listed' color additives, and contain only the amount of color additive needed to accomplish the intended coloring effect. When producing the tinted or color lenses, the manufacturing process alters and/or changes the specifications to the clear version of a contact lens by entrapment of the listed color additives in the center of the contact lens (surrounded by layers of contact lens material) in a location that corresponds to the iris. The color additives used are not removed by lens handling and cleaning/disinfecting procedures. Except for affecting the amount of light transmittance through the lens, the coloring process does not alter the original characteristics of the pre-tinted lens. The color lens tinting pattern has a minimum Clear Pupil diameter of 6.0 mm.
In the hydrated state, the lens conforms to the curvature of the eye covering the cornea and extending slightly beyond the limbus forming a transparent or colored optical surface. The (polymacon) soft hydrophilic contact lens has a spherical back 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 physical properties of the lens are: Refractive Index 1.435, Light Transmission (clear) greater than 98%, Light Transmission (tinted/color) greater than 98% (at clear region corresponding to pupil, minimum 6.0 mm diameter); Opaque or 0-10% (at tinted region corresponding to iris), Surface Character hydrophilic, Water Content 38±2%, Specific Gravity 1.17 (hydrated), Oxygen Permeability 11.15x10-11 (cm²/sec)(ml O₂)(ml x mm Hg @ 35°C) (revised Fatt method).
The hydrophilic characteristics allow aqueous solution to enter the lens, and in its fully hydrated state the lens is approximately 38% water by weight. ADORE (polymacon) Spherical Soft Contact lenses are available in the spherical configuration with the following features and properties: Chord Diameter 14.00 mm, Center Thickness 0.08 mm (to – 3.00D), Base Curve 8.6 mm, Power Range From D. 0.00 to D. -16.00 (from D. -5.00 a D. -16.00 with 0.50 steps) From D. +0.25 to D. +10.00 (from D. +5.00 to D. +10.00 with 0.50 steps), Colors available Grey, Hazel, Yellow, Blue, White, Green.
ADORE lenses are supplied sterile in saline solution containing blister packages with a base made from polypropylene and a laminated foil seal on top. Blister package labeling is printed with the appropriate lot numbering, expiration dating, and lens parameter identification. Expiration dating has been established based on studies of product stability, package integrity, and validation of the sterilization process.
The provided text describes the ADORE (polymacon) Daily Wear Soft (hydrophilic) Contact Lenses and its substantial equivalence to a predicate device, ChicView (Polymacon) Daily Wear Soft (Hydrophilic) Contact Lenses. The submission focuses on non-clinical testing and refers to the previously established clinical performance of the lens material.
Here's an analysis of the requested information based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly state "acceptance criteria" in a pass/fail quantifiable manner for the device performance. Instead, it compares the physical and material properties of the new device (ADORE) to its predicate device (ChicView) to demonstrate substantial equivalence. The "reported device performance" refers to the measured properties of the ADORE lenses.
| Property | Acceptance Criteria (Predicate Device - ChicView) | Reported Device Performance (ADORE) |
|---|---|---|
| Water content | 38±2% | 38±2% |
| Light transmittance (clear) | >98% | >98% |
| Refraction Index | 1.435 | 1.435 |
| Oxygen permeability | $11.15 \times 10^{-11}$ (cm²/sec)(ml O₂)(ml x mm Hg @ 35°C) (revised Fatt method) | $11.15 \times 10^{-11}$ (cm²/sec)(ml O₂)(ml x mm Hg @ 35°C) (revised Fatt method) |
| Specific Gravity (hydrated) | 1.17 | 1.17 |
| Sterilization | Steam Validated Autoclave | Steam Validated Autoclave |
| Production method | Fully-molded | Fully-molded |
| USAN name | Polymacon | Polymacon |
| Indications for Use | Equivalent | Corrective, cosmetic use |
| Functionality | Equivalent | Refractive medium |
The acceptance rationale for these properties appears to be that the ADORE device properties are identical to those of the legally marketed predicate device, ChicView, thus demonstrating substantial equivalence. The document states, "The established safety profile (pre-clinical toxicology and manufacturing/chemistry data) of the ADORE contact lens material is equivalent to the predicate devices identified previously."
2. Sample size used for the test set and the data provenance
The document states: "A series of in vitro and in vivo preclinical toxicology and biocompatibility tests were performed to assess the safety and effectiveness of the ADORE (polymacon) Daily Wear Soft (hydrophilic) Contact Lenses." However, it does not specify the sample size for these tests.
Regarding data provenance: "All non-clinical toxicology tests were conducted in accordance with the GLP regulation. All other testing was conducted according to valid scientific protocols." The document does not explicitly state the country of origin of the data, nor does it specify if the non-clinical tests were retrospective or prospective. Given the nature of pre-clinical in vitro and in vivo tests for a new device, they are typically prospective.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
This information is not provided in the document. The document describes non-clinical testing (toxicology, biocompatibility, physical properties) which usually involves laboratory measurements and standardized protocols rather than expert ground truth establishment in the same way clinical studies would. For the comparison to the predicate device, it is based on documented properties of the predicate device rather than expert review of the new device against a ground truth.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set
This information is not provided in the document. Adjudication methods are typically relevant for clinical studies where subjective assessments might be involved, or for establishing ground truth in diagnostic studies. The testing performed for this device appears to be primarily objective non-clinical measurements.
5. If a multi-reader, multi-case (MRMC) comparative effectiveness study was done, if so, what was the effect size of how much human readers improve with AI vs without AI assistance
No, an MRMC comparative effectiveness study was not done. This device is a contact lens, not an AI-assisted diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
Not applicable. This device is a contact lens, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
For the non-clinical testing, the "ground truth" would be established by the results of standardized laboratory tests and measurements, following valid scientific protocols and GLP regulations. For example, sterility tests, material property measurements (water content, oxygen permeability), and toxicology assays provide objective data.
For the clinical aspect, the document states: "The clinical performance of the (polymacon) lens material has been previously established, and therefore was not required for this 510(k)." This implies that the clinical "ground truth" for the material's safety and effectiveness was based on prior clinical studies and outcomes data for the polymacon material, likely involving patient wear experience and clinical evaluations.
8. The sample size for the training set
Not applicable. This device is a contact lens; it does not involve machine learning or a "training set."
9. How the ground truth for the training set was established
Not applicable. As stated above, there is no training set for this type of device.
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(54 days)
Desio (hioxifilcon D) Daily Wear Soft (hydrophilic) Contact Lenses (Clear and Tinted)
The Desio (hioxifilcon D) Spherical Soft Contact Lenses for daily wear are indicated for the correction of refractive error in aphakic and not aphakic persons with myopia or hyperopia. The lens may be worn by persons who exhibit refractive astigmatism of 0.75 diopters or less where the astigmatism does not interfere with visual acuity. The lens is available clear or tinted and may be used to enhance or alter the apparent color of the eye.
The Desio (hioxifileon D) Toric Soft Contact Lenses for daily wear are indicated for the correction of refractive error in aphakic and not aphakic persons with non-diseased eyes with myopia or hyperopia and/or possesses refractive astigmatism not exceeding 5.00 diopters. The lens is available clear or tinted and may be used to enhance or alter the apparent color of the eye.
Daily wear replacement schedules may vary from patient and should be decided by eye care practitioners in consultation with their patients.
Eye care practitioners may prescribe any of the above lenses for frequent/planned replacement wear, with cleaning disinfection and scheduled replacement. When prescribed for frequent/planned replacement wear, the lens may be disinfected using a chemical disinfecting system.
Eye care practitioners may prescribe any of the above lenses for single use daily disposable wear. When prescribed for daily disposable wear the lens is to be discarded after each removal.
The Desio (hioxifilcon D) Daily Wear Soft (hydrophilic) Contact Lenses are hemispherical shells with molded spherical base curves and molded front surfaces. The hydrophilic characteristics allow aqueous solutions to enter the lenses are fabricated from hioxifilcon D, which is a copolymer of 2-hydroxyethyl methacrylate (2-HEMA) and 2,3- Dihydroxypropyl Methacrylate (Glycerol Methacrylate, GMA), and cross-linked with ethylene glycol dimethacrylate (EGDMA). The co-polymer consists of 46% hioxifilcon D and 54% water by weight when immersed in saline solution. The hioxifilcon D name has been adopted by the United States Adopted Names Council (USAN).
The Desio (hioxifilcon D) Daily Wear Soft (hydrophilic) Contact Lenses are available clear or tinted to enhance or alter the apparent color of the eye. Lenses are tinted with one or a combination of one or more of the following 'listed' color additives: Titanium Dioxide, Phthalocyanine Green, Carbazole Violet, Reactive Blue 19, C.I. Reactive black 5.
Lenses that contain a unique tinting pattern are subsequently processed to incorporate the 'listed' color additives and contain only the amount of color additive needed to accomplish the intended coloring effect. When producing the tinted lenses, the pad-printing manufacturing process alters and/or changes the specifications to the clear version of a contact lens by affixing a listed reactive color additive in the center of the contact lens (between layers of contact lens material) in a location that corresponds to the iris. The color additives used are not removed by lens handling and cleaning/disinfecting procedures. Except for affecting the amount of light transmittance through the lens, the coloring process does not alter the original characteristics of the pre-tinted lens. The tinting pattern has a standard Clear Pupil diameter of 6.0 mm.
The Desio (hioxifilcon D) Daily Wear Soft (hydrophilic) Contact Lenses incorporate a UV absorbing monomer. The lenses block >95% in the UVB range (280nm - 315nm), and >67% in the UVA range (316nm - 380nm).
The Desio (hioxifilcon D) Daily Wear Soft (hydrophilic) Contact Lenses will be manufactured in the sphere and toric design configurations.
Here's a breakdown of the acceptance criteria and the study information for the Desio (hioxifilcon D) Daily Wear Soft (hydrophilic) Contact Lenses, based on the provided text:
Acceptance Criteria and Reported Device Performance
| Parameter | Acceptance Criteria (Tolerance*) | Reported Device Performance |
|---|---|---|
| Chord Diameter | ±0.20 mm | Not explicitly reported as a single value, but range 12.80 mm to 15.00 mm |
| Center Thickness | When ≤ 0.10 mm → ±0.010 mm + 10% | |
| When > 0.10 mm → ±0.015 mm + 5% | Not explicitly reported as a single value, but range 0.05 mm to 0.210 mm | |
| Base Curve | ±0.20 mm | Not explicitly reported as a single value, but range 7.85 mm to 10.0 mm |
| Back Vertex Power (F'v) | When 0.00 1.50 D → ±5° | Not explicitly reported as a single value, but range 10° to 180° |
| Surface Appearance | Lenses should be clear with no surface defect | Not explicitly reported, but implied by compliance with acceptance criteria. |
| Oxygen Permeability (x 10-11(cm²/sec)(mlO2)/(ml x mmHg)) | ±20% (relative to a specific value) | 21.50 |
| Light Transmission - Clear (@ 380-780nm) | ±5% (relative to a specific value) | >98% |
| Light Transmission - Tinted (@ 380-780nm) | ±5% (relative to a specific value) | >96% (at pupil); Opaque or 0-10% (at iris) |
| Ultraviolet Radiation Transmittance | TUVB (280 to 315 nm) 95% UVB and >67% UVA) | |
| Water Content | ±2% | 54% |
| Refractive Index (hydrated) | ±0.005 | 1.400 |
*Note: The "Tolerance" column is directly from the provided text and represents the acceptance criteria for each parameter. The "Reported Device Performance" column directly states the device's measured or designed values for these parameters. The document implies that the device performance meets these tolerances without explicitly stating "passed" for each one.
Study Details
-
Sample size used for the test set and the data provenance:
- The document describes non-clinical testing including toxicology, shelf-life, and physicochemical & mechanical properties. However, it does not specify explicit sample sizes for these tests beyond general statements like "A series of preclinical testing was performed."
- Data Provenance: The toxicology tests were conducted "in accordance with the GLP regulation." The overall testing was conducted in laboratories, with the data determined to be scientifically valid under 21 CFR 860.7. No specific country of origin for the test data is mentioned, but the submitter is Qualimed SRL in Italy. The tests are considered retrospective as they are performed on the manufactured product to demonstrate its properties.
-
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- No information is provided regarding experts establishing ground truth for the non-clinical tests. These tests typically rely on standardized laboratory procedures and measurements rather than expert human interpretation.
-
Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not applicable/Not mentioned, as the reported tests are objective measurements for physical and chemical properties and toxicology, not requiring adjudication of human interpretations.
-
If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
- No, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. This type of study is relevant for diagnostic or AI-assisted devices where human interpretation is a key component. This device is a contact lens.
-
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.
-
The type of ground truth used (expert concensus, pathology, outcomes data, etc):
- For the non-clinical tests, the "ground truth" is based on objective measurements and standardized test protocols. For example:
- Cytotoxicity: Measured by ISO 10993-5.
- Systemic Toxicity: Measured by ISO 10993-11.
- Acute Ocular Irritation: Measured by ISO 10993-10.
- Physicochemical & Mechanical Properties: Measured to assess refractive index, water content, Dk, % transmission, tensile strength, modulus, % elongation to break, specific gravity, and polymerization residuals against established material standards (implied, as they support substantial equivalence).
- For the non-clinical tests, the "ground truth" is based on objective measurements and standardized test protocols. For example:
-
The sample size for the training set:
- Not applicable. This document describes the testing for a physical medical device (contact lenses) and does not involve AI or machine learning algorithms that require training sets.
-
How the ground truth for the training set was established:
- Not applicable, as no training set was used.
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