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510(k) Data Aggregation
(30 days)
Unilens Corp., USA
The CVUE ADVANCED (hioxifilcon D) Single Vision Contact Lenses are indicated for daily wear for the correction of refractive ametropia (myopia, hyperopia and astigmatism) and presbyopia in aphakic and/or not-aphakic persons with nondiseased eyes. The lens may be worn by persons who require up to 3.00 Diopters of add and who exhibit astigmatism of up to 0.75 Diopters that does not interfere with visual acuity.
The CVUE ADVANCED (hioxifilcon D) Toric and Multifocal Toric Contact Lenses are indicated for daily wear for the correction of refractive ametropia (myopia and hyperopia), presbyopia and astigmatism up to 4.00 diopters in aphakic and/or notaphakic persons with non-diseased eyes.
Eye care practitioners may prescribe the lens for frequent/planned replacement wear, with cleaning, disinfection and scheduled replacement. When prescribed for frequent/planned replacement wear, the lens may be disinfected using a chemical disinfection system.
CVUE ADVANCED (hioxifilcon D) soft contact lenses are semi-scleral flexible shells which cover the cornea and may cover a portion of the adjacent sclera and are available as aspheric single vision, multifocal, toric multifocal designs. Torics have a toroidal posterior optic zone, and multifocals have the most plus power is in the center of the lens, with the power progressively becoming more minus towards the periphery. Torics have the option of dynamic axis stabilization (double slab off) or prism ballast stabilization. All lenses share a base curve with a flattened peripheral curve which approximates the curvature of the sclera. The lens material, (hioxifilcon D), is a non-ionic copolymer of 2-hydroxyethyl methacrylate (2-HEMA) and 2, 3-dihydroxypropyl methacrylate (Glycerol Methacrylate, GMA) and crosslinked with ethylene glycol dimethacrylate (EGDMA). It consists of 46% hioxifilicon D and 54% water by weight when immersed in normal buffered saline solution. The lens is available with or without a blue visibility handling tint, phthalocyanato (2) -(copper).
The CVUE ADVANCED (hioxifilcon D) soft contact lens is a hemispherical shell of the following dimensions:
Chord diameter: 12.5 to 17.0mm
Center thickness: 0.13 to 0.73; varies with power
Base curve: 7.0 to 10.5mm
Powers: -20.00 to +20.00 diopters
ADD powers (multifocal): Up to +3.00 diopters
Cylinder (toric): Up to 4.00 diopters
Axis (toric): 0° to 180° in 1° steps
Axis stabilization (toric): prism ballast; or dynamic (double slab off)
Optical zone diameters: 5.0 to 10.0mm
The physical/optical properties of the lens are:
Refractive Index 1.408 (hydrated)
Light Transmission – tinted greater than 90%
Water Content 54%
Specific Gravity 1.299 (dry)
Oxygen Permeability (Dk Value) 23 x 10-11 Fatt Units (cm2/sec) (ml O2/ml x mm Hg @ 35°C), ANSI Z80.20:2004 upgraded polarographic method corrected for boundary-layer and edge effects
This document is a 510(k) Premarket Notification for a contact lens device, not an AI/ML medical device. Therefore, the information typically requested regarding acceptance criteria, study design, and performance metrics for AI/ML models (e.g., sample sizes for training/test sets, ground truth establishment, expert qualifications, MRMC studies, standalone performance) is not applicable or present in this submission.
The document discusses the substantial equivalence of the C-VUE® Advanced™ (hioxifilcon D) Soft (hydrophilic) Contact Lens for Daily Wear to predicate devices based on intended use, manufacturing, safety profile, physical construction, and indications for use. It asserts that the device does not raise any new or different questions of safety and effectiveness.
However, to respond to the prompt's structure where possible, I will extract relevant compliance information assuming a direct mapping, even if the context is different.
Acceptance Criteria and Study for C-VUE® Advanced™ (hioxifilcon D) Soft (hydrophilic) Contact Lens
This document describes the regulatory submission for a contact lens, not an AI/ML medical device. Therefore, the acceptance criteria and study details are related to demonstrating substantial equivalence for a physical medical device. The information provided does not align with the typical data requested for AI/ML device performance.
Here's an attempt to answer the prompt's questions based on the provided text, noting where the information is not applicable:
1. A table of acceptance criteria and the reported device performance
The document does not explicitly state "acceptance criteria" in the context of quantifiable performance metrics for a study or "reported device performance" in a numerical sense as would be found for an algorithm. Instead, it refers to demonstrating "substantial equivalence" to predicate devices. The "performance" discussed relates to the physical and optical properties of the lens and its "safety and effectiveness" being equivalent to existing devices.
| Acceptance Criterion (Implicit) | Reported Device Performance (Implicit) |
|---|---|
| Intended Use: Device's intended use matches predicate. | "The C-VUE® Advanced™ (hioxifilcon D) Soft (hydrophilic) Contact Lens for Daily Wear is substantially equivalent to the predicate device identified below in terms of intended use." |
| Safety Profile: Established safety (pre-clinical toxicology, manufacturing/chemistry data) is equivalent to predicate. | "The established safety profile (pre-clinical toxicology and manufacturing/chemistry data) of the device the same to the CVUE ADVANCED (hioxifilcon D), 510(k) K082853." |
| Physical Construction: Physical construction is equivalent to predicate. | "Physical construction and safety and effectiveness do not change from the predicate devices." |
| Indications for Use: Indications for use are equivalent to predicate. | "The CVUE ADVANCED (hioxifilcon D) Single Vision Contact Lenses indications for use do not change." |
| Manufacturing/Packaging/Sterilization: Procedures are the same as currently marketed devices. | "The device will undergo manufacturing, packaging and sterilization procedures that are the same as devices currently manufactured, marketed and distributed by Unilens Corp., USA." |
| No New Questions of Safety/Effectiveness: Device does not raise new questions. | "This meets the requirements per section 510(k) of the act regarding substantial equivalence and does not raise any new or different questions of safety and effectiveness than the predicate devices identified above." |
| Physical/Optical Properties: Meet specified ranges/values. | Refractive Index: 1.408 (hydrated) |
| Light Transmission – tinted: greater than 90% | |
| Water Content: 54% | |
| Specific Gravity: 1.299 (dry) | |
| Oxygen Permeability (Dk Value): 23 x 10^-11 Fatt Units (cm²/sec) (ml O2/ml x mm Hg @ 35°C), ANSI Z80.20:2004 upgraded polarographic method corrected for boundary-layer and edge effects |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Sample Size: Not applicable. This is a 510(k) submission for a physical medical device demonstrating substantial equivalence, not an AI/ML device with a test set of data. The "study" here is a comparison to predicate devices, not clinical trial data with specific patient sample sizes for performance evaluation in the typical sense.
- Data Provenance: Not applicable in the context of an AI/ML test set. The submission refers to a previous 510(k) for the safety profile (K082853), implying existing data from that submission.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Not applicable. There is no "test set" of data or "ground truth" (as in expert-labeled data for an algorithm) established by experts in this type of submission. The evaluation is based on established regulatory standards and comparison to predicate devices.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not applicable. No test set or expert adjudication related to algorithm performance is present.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
- Not applicable. This relates to an AI/ML device, which this contact lens is not.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable. This relates to an AI/ML device, which this contact lens is not.
7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)
- Not applicable. The concept of "ground truth" as it applies to AI/ML model training and validation is not relevant here. The "truth" for this submission is regulatory compliance and demonstrating equivalence to legally marketed predicate devices, supported by manufacturing data, physical properties, and a previously established safety profile.
8. The sample size for the training set
- Not applicable. There is no "training set" as this is not an AI/ML device.
9. How the ground truth for the training set was established
- Not applicable. There is no "training set" or "ground truth" for it, as this is not an AI/ML device.
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(122 days)
UNILENS CORP., USA
The CVue Advanced HydraVUE Irregular Cornea (efrofilcon A) Silicone Hydrogel Soft Contact Lenses for daily wear are indicated for the correction of visual acuity in aphakic and not aphakic persons with non-diseased eyes with myopia or hyperopia and may be prescribed in otherwise non-diseased eyes that require a Soft Contact Lens for the management of irregular corneal conditions such as keratoconus and post graft fitting.
Eyecare practitioners may prescribe the lenses for frequent/planned replacement wear, with cleaning, disinfection and scheduled replacement. When prescribed for frequent/planned replacement wear, the lens may be cleaned and disinfected using a chemical (not heat) lens care system or hydrogen peroxide disinfection systems.
The CVue Advanced HydraVUE (efrofilcon A) Soft (hydrophilic) Silicone Hydrogel contact lenses for daily wear are fabricated from efrofilcon A, which in the dry (unhydrated) state may be machined and polished. The hydrophilic nature of this material allows the lens to become soft and pliable when immersed in an aqueous solution. The non-ionic lens material, (efrofilcon A) is a daily wear silicone hydrogel contact lens that is not surface treated and characterized by a high water content. The lens material is composed of silicone monomers cross linked with other monomers and optionally incorporates D&C Green 6 as an integrated handling tint. The lenses are lathe-cut and made to order for individual prescriptions. Each lens consists of 26% efrofilcon A and 74% water by weight when immersed in a buffered saline solution. In the hydrated state, the lens conforms to the curvature of the eye covering the cornea and extending slightly beyond the limbus forming a colorless, transparent optical surface. The (efrofilcon A) 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 lenses will be manufactured in spherical, toric, multifocal toric and irregular cornea configurations. The lens is supplied sterile in vials containing a buffered saline solution.
This 510(k) summary describes the CVue Advanced HydraVUE Irregular Cornea (efrofilcon A) Soft (hydrophilic) Silicone Hydrogel contact lenses for daily wear. The device is being submitted for an expanded indication to include the management of irregular corneal conditions like keratoconus and post-graft fitting, in addition to the correction of visual acuity in aphakic and non-aphakic persons with myopia or hyperopia.
The submission claims substantial equivalence to three predicate devices: IntelliWave3, Metro Soft, and CVue Advanced Definitive, all of which are efrofilcon A silicone hydrogel contact lenses for daily wear.
Here's a breakdown 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 numerical or threshold format for clinical efficacy. Instead, it relies on the established performance of the predicate devices and the material properties. The acceptance is implied by demonstrating substantial equivalence in material, manufacturing, and intended use as the predicates that have already met regulatory requirements.
| Characteristic | Acceptance Criteria (Implied by Predicate Equivalence) | Reported Device Performance (CVue Advanced HydraVUE) |
|---|---|---|
| Intended Use | Same as predicate devices for irregular cornea management and ametropia correction | Indicated for correction of ametropia and management of irregular corneal conditions (keratoconus, post-graft fitting) |
| Material | efrofilcon A | efrofilcon A |
| Manufacturing Process | Lathe-cut, custom manufactured | Lathe-cut, made to order for individual prescriptions |
| Water Content | 74% | 74% |
| Oxygen Permeability | 60 x 10⁻¹¹ (cm²/sec)(ml O₂/ml x mm Hg@35 °C) | 60 x 10⁻¹¹ (cm²/sec)(ml O₂/ml x mm Hg@35 °C) (Note: reported as 59.8 x 10⁻¹¹ in description) |
| Specific Gravity | 1.130 (predicate table) | 1.048 (hydrated) (description), 1.130 (predicate table) |
| Sterility | Sterile for indicated shelf-life | Lenses supplied in glass vials are sterile for the indicated shelf-life |
| Physical/Material Properties | Consistent with marketed lenses | Lens physical and material properties are consistent with currently marketed lenses |
| Clinical Performance | Previously established for efrofilcon A material | Clinical performance of efrofilcon A lens material has been previously established |
| Biocompatibility | Previously established | Preclinical toxicology and biocompatibility were previously established |
| Shelf-life Stability | Follows scientific protocols | Shelf-life stability studies followed scientific protocols, data scientifically valid |
2. Sample Size Used for the Test Set and the Data Provenance
The document does not describe a specific "test set" or clinical study with patient sample sizes for the CVue Advanced HydraVUE Irregular Cornea lenses itself. Instead, it relies on substantial equivalence to predicate devices, whose clinical performance and material properties were previously established.
Therefore, no new clinical study was conducted for this specific 510(k) submission to demonstrate performance based on a new test set. The data provenance for the previously established clinical performance and material data related to efrofilcon A is not detailed in this document. It references Master File MAF #1708 for the efrofilcon A material.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts
Not applicable, as no new clinical study (test set) was performed for this 510(k) submission. Clinical performance was established through previous submissions for the efrofilcon A material itself.
4. Adjudication Method for the Test Set
Not applicable, as no new clinical study (test set) was performed for this 510(k) submission.
5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
Not applicable. This device is a contact lens, not an AI-powered diagnostic or assistive technology. No MRMC study was conducted.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This device is a contact lens. No algorithm-only or standalone performance study was done.
7. The Type of Ground Truth Used
For the safety and effectiveness of the efrofilcon A material, the "ground truth" was established through:
- Preclinical toxicology and biocompatibility studies: These tests assess the material's interaction with biological systems.
- Clinical performance data for the efrofilcon A lens material: This would involve patient studies from previous submissions to demonstrate the material's safety and effectiveness in-vivo. The document references Master File MAF #1708 for this data.
- Physical and material property testing: Laboratory measurements of water content, oxygen permeability, light transmission, etc., with established benchmarks for safe and effective contact lenses.
- Sterility and shelf-life stability studies: Laboratory validation that the product remains sterile and effective over its shelf life.
8. The Sample Size for the Training Set
Not applicable. This device is a contact lens, not an AI model.
9. How the Ground Truth for the Training Set was Established
Not applicable. This device is a contact lens, not an AI model.
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(63 days)
UNILENS CORP., USA
For parametric release from Moist Heat Sterilization of Hydrophilic Contact Lenses
Not Found
The provided document is a 510(k) premarket notification decision letter from the FDA to UNILENS Corporation, USA. It concerns the conversion of soft (hydrophilic) daily wear contact lenses to parametric release from moist heat sterilization.
This document does not contain the information requested regarding specific acceptance criteria, device performance studies, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, ground truth types, or training set details.
The letter acknowledges the submission and clarifies regulatory aspects but does not include the detailed study results or performance metrics one would expect in a clinical study report or verification and validation documentation. It lists numerous previously cleared products and their approval numbers but does not delve into the studies supporting the parametric release change.
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(253 days)
UNILENS CORP., USA
The C.VUE Advanced Definitive, sphere (efrofilcon A) Silicone Hydrogel Soft Contact Lenses for daily wear are indicated for the correction of ametropia (myopia and hyperopia) in aphakic and non-aphakic persons with non-diseased eyes. The lens may be worn by persons who exhibit refractive astigmatism of .75 diopters or less where the astigmatism does not interfere with visual acuity.
The C.VUE Advanced Definitive, toric (efrofilcon A) Silicone Hydrogel Soft Contact Lenses for daily wear are indicated for the correction of ametropia (myopia and hyperopia) in aphakic and non-aphakic persons with non-diseased eyes and/or possesses refractive astigmatism not exceeding 10 diopters.
The C.VUE Advanced Definitive, multifocal (efrofilcon A) Silicone Hydrogel Soft Contact Lenses for daily wear are indicated for the correction of ametropia (myopia and hyperopia) in aphakic and nonaphakic persons with non-diseased eyes and/or possesses refractive astigmatism not exceeding .75 diopters and are presbyopic requiring add power of up to +4.00 diopters.
The C.VUE Advanced Definitive, multifocal toric (efrofilcon A) Silicone Hydrogel Soft Contact Lenses for daily wear are indicated for the correction of ametropia (myopia and hyperopia) in aphakic and nonaphakic persons with non-diseased eyes and/or possesses refractive astigmatism not exceeding 4 diopters and are presbyopic requiring add power of up to +4.00 diopters.
Eyecare practitioners may prescribe the lenses for frequent/planned replacement wear, with cleaning, disinfection and scheduled replacement. When prescribed for frequent/planned replacement wear, the lens may be cleaned and disinfected using a chemical (not heat) lens care system or hydrogen peroxide disinfection systems.
The C.VUE Advanced Definitive Silicone Hydrogel Soft Contact Lenses are fabricated from efrofileon A, which in the dry (unhydrated) state may be machined and polished. The hydrophilic nature of this material allows the lens to become soft and pliable when immersed in an aqueous solution.
The non-ionic lens material, (efrofilcon A) is a daily wear silicone hydrogel contact lens that is not surface treated and characterized by a high water content. The lens material is composed of silicone monomers cross linked with other monomers and optionally incorporates D&C Green 6 as an integrated handling tint. The lenses are made by lathe-cut for custom RX. It consists of 26% efrofilcon A and 74% water by weight when immersed in a buffered saline solution. The (efrofilcon A) name has been adopted by the United States Adopted Names Council (USAN).
In the hydrated state, the lens conforms to the curvature of the eye covering the cornea and extending slightly beyond the limbus forming a colorless, transparent optical surface. The (efrofilcon A) 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 document describes the acceptance criteria and the study conducted for the C.VUE Advanced Definitive, Silicone Hydrogel Daily Wear Soft Contact Lens (efrofilcon A).
1. Table of Acceptance Criteria and Reported Device Performance
The provided document does not explicitly list "acceptance criteria" in a quantitative manner for specific performance metrics that would be compared to reported device performance. Instead, the submission focuses on demonstrating substantial equivalence to predicate devices based on material properties, intended use, and manufacturing process.
However, we can infer some key device properties and compare them across the new device and predicate devices.
| Property | Acceptance Criteria (Inferred from Predicate "IntelliWave" which the new device is identical to) | Reported Device Performance (C.VUE Advanced Definitive) |
|---|---|---|
| USAN Name | efrofilcon A | efrofilcon A |
| Water Content | 74% | 74% |
| Oxygen Permeability | 60 x 10^-11 (cm2/sec) (ml O2/ml x mm Hg @ 35°C), (revised Fatt method) | 59.8 x 10^-11 (cm2/sec) (ml O2/ml x hPa @ 35°C), (revised Fatt method) |
| Specific Gravity | 1.139 (hydrated) | 1.048 (hydrated) (Note: Discrepancy observed between page 2 and page 5 for specific gravity, with 1.048 on page 2 and 1.139 on page 5) |
| Production Method | Lathe-Cut, custom manufactured | Lathe-Cut, custom manufactured |
| Intended Use & Indications | Daily wear for correction of ametropia, including astigmatism and presbyopia | Matches the predicate IntelliWave indications |
Note on Specific Gravity: There is a discrepancy in the reported Specific Gravity for the C.VUE Advanced Definitive. On page 2, it states "1.048 (hydrated)", while in the table on page 5, it lists "1.139" and identifies it as "same as IntellliWave³". This suggests a potential transcription error or an oversight in the consistency of data presentation within the document. Given the claim of being identical to IntelliWave³, the value of 1.139 from the equivalence table might be the intended point of comparison for acceptance.
2. Sample Size Used for the Test Set and Data Provenance
The document states: "The clinical performance of the (efrofilcon A) lens material has been previously established, and therefore was not required for this 510(k)." It explicitly mentions that the C.VUE Advanced Definitive is identical in material and manufacturing process to the cleared Intelliwave³ (efrofilcon A) Silicone Hydrogel Daily Wear Soft Contact Lens (K100221).
Therefore, no new clinical test set (sample size or provenance) was used for this specific 510(k) submission. The reliance is on the prior establishment of clinical performance for the efrofilcon A material through the predicate device. The document does not provide details about the sample size or provenance of the original clinical studies for the Intelliwave³ lens that established the performance of the efrofilcon A material.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
As no new clinical studies were conducted for this submission, there were no experts specifically used to establish ground truth for a new test set for the C.VUE Advanced Definitive lens.
4. Adjudication Method for the Test Set
Since no new clinical studies were conducted, there was no adjudication method applied to a new test set for this submission.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. The submission did not involve new clinical trials comparing human readers with and without AI assistance or any other form of MRMC study, as the device is a contact lens and not an AI-driven diagnostic tool.
6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done
This question is not applicable. The device is a contact lens, not an algorithm or AI system. Therefore, no standalone algorithm performance study was conducted.
7. The Type of Ground Truth Used
The "ground truth" for the safety and effectiveness of the efrofilcon A material was established through previous clinical performance data (presumably clinical trials, expert evaluations, and outcomes data) for the predicate Intelliwave³ lens, which used the same material. The current submission relies on the established safety and effectiveness of this material and manufacturing process.
Additionally, non-clinical testing on the C.VUE Advanced Definitive lenses contributed to the evidence, including:
- In vivo preclinical toxicology and biocompatibility tests
- Sterility testing
- Packaging material and extract toxicity/irritation tests
- Physical and material property consistency tests
These non-clinical tests were conducted according to GLP regulations and valid scientific protocols to confirm the device's properties.
8. The Sample Size for the Training Set
This question is not applicable. The device is a contact lens and does not involve an AI algorithm that requires a training set.
9. How the Ground Truth for the Training Set Was Established
This question is not applicable, as there is no training set for an AI algorithm.
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(23 days)
UNILENS CORP., USA
The CVUE ADVANCED (hioxifilcon D) Single Vision and Multifocal Contact Lenses are indicated for daily wear for the correction of refractive ametropia (myopia, hyperopia and astigmatism) and presbyopia in aphakic and/or not-aphakic persons with non-diseased eyes. The lens may be worn by persons who require up to 3.00 Diopters of add and who exhibit astigmatism of up to 0.75 Diopters that does not interfere with visual acuity.
The CVUE ADVANCED (hioxifilcon D) Toric and Multifocal Toric Contact Lenses are indicated for daily wear for the correction of refractive ametropia (myopia and hyperopia), presbyopia and astigmatism up to 4.00 diopters in aphakic and/or not-aphakic persons with non-diseased eyes.
Eye care practitioners may prescribe the lens for frequent/planned replacement wear, with cleaning, disinfection and scheduled replacement. When prescribed for frequent/planned replacement wear, the lens may be disinfected using a chemical disinfection system.
CVUE ADVANCED (hioxifilcon D) soft contact lenses are semi-scleral flexible shells which cover the cornea and may cover a portion of the adjacent sclera and are available as aspheric single vision, multifocal, toric multifocal designs. Torics have a toroidal posterior optic zone, and multifocals have the most plus power is in the center of the lens, with the power progressively becoming more minus towards the periphery. All lenses share a base curve with a flattened peripheral curve which approximates the curvature of the sclera. The lens material, (hioxifilcon D), is a non-ionic copolymer of 2-hydroxyethyl methacrylate (2-HEMA) and 2, 3dihydroxypropyl methacrylate (Glycerol Methacrylate, GMA) and cross-linked with ethylene glycol dimethacrylate (EGDMA). It consists of 46% hioxifilcon D and 54% water by weight when immersed in normal buffered saline solution. The lens is available with or without a blue visibility handling tint, phthalocyanato (2) -(copper).
The CVUE ADVANCED (hioxifilcon D) soft contact lens is a hemispherical shell of the following dimensions:
Chord diameter: 12.5 to 17.0mm
Center thickness: 0.13 to 0.73; varies with power
Base curve: 7.0 to 10.5mm
Powers: -20.00 to +20.00 diopters
ADD powers (multifocal): Up to +3.00 diopters
Cylinder (toric): Up to 4.00 diopters
Axis (toric): 0° to 180° in 1° steps
Optical zone diameters: 5.0 to 10.0mm
The physical/ootical properties of the lens are:
Refractive Index 1.408 (hydrated)
Light Transmission - tinted greater than 90%
Water Content 54%
Specific Gravity 1.299 (dry)
Oxygen Permeability (Dk Value) 23 x 10-11 Fatt Units (cm2/sec) (ml O2/ml x mm Hg @ 35°C), ANSI Z80.20:2004 upgraded polarographic method corrected for boundary-layer and edge effects
The provided text is a 510(k) summary for the C-VUE® Advanced™ (hioxifilcon D) Soft (hydrophilic) Contact Lens. It does not contain information about specific acceptance criteria or a study proving the device meets those criteria in the context of performance metrics like sensitivity, specificity, or accuracy that would typically be associated with AI/ML medical devices.
Instead, this document focuses on demonstrating substantial equivalence to predicate devices for a contact lens. The "study" mentioned is the established safety profile and manufacturing/chemistry data, which were deemed equivalent to the predicate device.
Therefore, many of the requested sections (e.g., sample sizes for test/training sets, number of experts, adjudication methods, MRMC studies) are not applicable to this type of submission.
Here's a breakdown of the available information:
1. A table of acceptance criteria and the reported device performance
No explicit acceptance criteria in terms of accuracy, sensitivity, or specificity are provided for this medical device submission. The substantial equivalence argument relies on the inherent properties of the contact lens material and design being comparable to already approved devices.
The "performance" is implicitly demonstrated through the device's physical/optical properties and the claim of substantial equivalence.
| Characteristic | Reported Performance (C-VUE® Advanced™) |
|---|---|
| Refractive Index | 1.408 (hydrated) |
| Light Transmission - tinted | greater than 90% |
| Water Content | 54% |
| Specific Gravity | 1.299 (dry) |
| Oxygen Permeability (Dk Value) | 23 x 10-11 Fatt Units (cm2/sec) (ml O2/ml x mm Hg @ 35°C), ANSI Z80.20:2004 upgraded polarographic method corrected for boundary-layer and edge effects |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
Not applicable. This submission relies on substantial equivalence to predicate devices, not a new clinical performance study with a test set in the conventional AI/ML sense. The "safety profile (pre-clinical toxicology and manufacturing/chemistry data)" of the device is stated to be equivalent to the predicate device (BENZ-G 4X (hioxifilcon D), 510(k) K062854). This implies that previous data collected for the predicate device forms the basis of comparison, but specific sample sizes and data provenance for that data are not detailed in this document.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
Not applicable. Ground truth establishment with experts is not relevant for this type of substantial equivalence submission for a contact lens.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. This is not a study requiring adjudication of expert opinions.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
Not applicable. An MRMC study is not relevant for a contact lens submission focused on substantial equivalence. There is no AI component mentioned.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This device is a physical contact lens, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
Not applicable. The concept of "ground truth" as typically applied to performance studies (like for AI/ML devices) is not directly addressed here. The "truth" is established by the known physical, chemical, and optical properties of the material and the established safety and effectiveness of the predicate devices.
8. The sample size for the training set
Not applicable. There is no "training set" in the context of an AI/ML device.
9. How the ground truth for the training set was established
Not applicable. There is no "training set" or "ground truth for a training set" in this context.
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(23 days)
UNILENS CORP., USA
The Aquaflex 2 Contact Lens is indicated for daily wear for the correction of refractive ametropia (myopia and hyperopia) and astigmatism up to 1.50 diopters or less in aphakic and/or not-aphakic persons with non-diseased eyes. The lens may be disinfected using either a heat or chemical disinfection system.
The Aquaflex 2 (tefilcon) Soft (hydrophilic) Contact Lens is available as a spherical lens. The lens material, tefilcon, is a hydrophilic polymer of 2-hydroxyethyl methacrylate crosslinked with ethylene glycol dimethacrylate. The Aquaflex 2 Contact Lens is a hemispherical shell.
Here's an analysis of the provided text regarding the acceptance criteria and study for the Aquaflex 2 (tefilcon) Soft (hydrophilic) Contact Lens, structured to address your specific points:
Note: The provided document is a 510(k) summary for a contact lens, which primarily focuses on demonstrating substantial equivalence to a predicate device rather than presenting a novel device's performance against specific acceptance criteria in a detailed clinical study report. Therefore, some of your requested information, particularly around detailed study methodology (sample sizes, expert qualifications, adjudication, MRMC, training sets), is not present in this type of regulatory submission. The information provided heavily relies on the equivalence to a previously cleared device.
Acceptance Criteria and Device Performance Study for Aquaflex 2 (tefilcon) Soft (hydrophilic) Contact Lens
1. Table of Acceptance Criteria and Reported Device Performance
As this is a 510(k) submission based on substantial equivalence, explicit "acceptance criteria" for novel performance metrics are not typically presented in this format. Instead, the document asserts equivalence to a predicate device across several key characteristics. The performance of the Aquaflex 2 is described by its physical/optical properties, which are implicitly accepted if they are comparable to the predicate and meet established safety and effectiveness profiles for contact lenses.
| Characteristic | Acceptance Criteria (Implied by Substantial Equivalence to Predicate) | Reported Device Performance (Aquaflex 2) |
|---|---|---|
| Physical/Optical Properties | Comparable to predicate device (BayVue polymacon lens) and within established safe ranges for daily wear contact lenses. | Specific Gravity: 1.18 |
| Refractive Index (wet): 1.43 | ||
| Light Transmittance: 98% | ||
| Water Content: 37.5% | ||
| Oxygen Permeability: 8.9 x 10^-11 (cm/sec)(ml O2/ml x mm Hg) @ 21°C (Fatt Method) | ||
| Intended Use | Matching the intended use of the predicate device for daily wear, correction of refractive ametropia (myopia, hyperopia), and astigmatism |
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(22 days)
UNILENS CORP., USA
The C-Vue's Toric Multifocal Contact Lens is indicated for daily wear for the correction of refractive ametropia (myopia and hyperopia), presbyopia and astigmatism up to 4.00 diopters in aphakic and/or not-aphakic persons with non-diseased eyes.
Eyecare practitioners may prescribe the lens for daily wear in a Planned Replacement Program. The lens may be disinfected using a chemical disinfection system.
The C-Vue's Tonc (methafilcon A) Soft (hydrophilic) Multifocal Contact Lens is a front surface asphere consisting of multiple aspheric zones with an eccentric lenticulation for ballast and axis stabilization. The base curve has a toroidal posterior optic zone and a flattened peripheral curve which approximates the curvature of the sclera. The most plus power is in the center of the lens, with the power progressively becoming more minus towards the periphery. The lens material, (methafilcon A), is a copolymer of 2-hydroxyethyl methacrylate and methacrylic acid, crosslinked with ethyleneglycol dimethacrylate.
The C-Vue35 Toric Multifocal Contact Lens is a hemispherical shell of the following dimensions:
Chord diameters: 14.0 to 15.0mm
Center thickness: 0.10 to 0.60mm; varies with power
Base curves: 8.4 to 9.3mm
Powers: -20.00 to +20.00 diopters
Add powers: Up to +3.00 diopters
Cylinder: Up to 4.00 diopters
Axis: 1° to 180° in 1° steps
Optical zone diameters: 5.0 to 10.0mm
The physical/optical properties of the lens are:
specific gravity: 1.09
refractive index (wet): 1.415
light transmittance (clear and tint): greater than 90% in the visible light region
water content: 55%
oxygen transmissibility: 18.83 x 10^-11 (cm²/sec)(ml O2/ml x mm Hg)*
- as measured by Schema Versatae Model 920 connected to a polargraphic cell
Here's a breakdown of the acceptance criteria and study information for the C-Vue35 Toric (methafilcon A) Soft (hydrophilic) Multifocal Contact Lens, based on the provided 510(k) summary:
This device is a medical device, and the provided document is a 510(k) summary for premarket notification to the FDA. For such devices, particularly contact lenses, "acceptance criteria" usually refer to meeting established safety and effectiveness standards, often demonstrated through comparison to a legally marketed predicate device rather than complex performance metrics against a specific numerical threshold. Clinical studies for contact lenses primarily focus on demonstrating comparable safety and effectiveness, including patient comfort, vision correction, and lack of adverse events.
1. Table of Acceptance Criteria and Reported Device Performance
The provided document does not explicitly list distinct "acceptance criteria" in the format of numerical targets. Instead, the demonstration of substantial equivalence to a predicate device serves as the primary "acceptance criterion" for marketing approval. The document asserts that the device meets the safety and effectiveness profile of its predicate.
| Acceptance Criterion Type | Description of Criterion | Reported Device Performance (as implied by the 510(k)) |
|---|---|---|
| Material Properties | Similar or equivalent physical/optical properties to established, safe contact lens materials, ensuring biocompatibility, oxygen supply, and optical clarity. | The device utilizes "methafilcon A," a copolymer with established safety. Specific properties like water content (55%), oxygen transmissibility ($18.83 \times 10^{-11}$), refractive index (1.415), specific gravity (1.09), and light transmittance (>90%) are reported and are presumed to be within acceptable ranges. |
| Intended Use | Capability to correct refractive ametropia (myopia and hyperopia), presbyopia, and astigmatism up to 4.00 diopters in aphakic and/or non-aphakic persons with non-diseased eyes for daily wear in a Planned Replacement Program, and to be disinfected chemically. | The device's design (aspheric zones, eccentric lenticulation, toroidal posterior optic zone) directly supports its intended use for multifocal and toric correction. The 510(k) states the device is indicated for these uses. |
| Safety Data | Comparable safety profile (pre-clinical toxicology and manufacturing/chemistry data) to a legally marketed predicate device. This implies demonstrating non-toxicity, appropriate material stability, and lack of adverse biological reactions. | The device is stated to have an "established safety profile (pre-clinical toxicology and manufacturing/chemistry data) ... equivalent to the BENZ-MF (methafilcon A), 510(k) K003861" (which is also listed as a legally marketed device). |
| Manufacturing/Quality | Manufactured according to specified process controls and a quality management system. The manufacturing, packaging, and sterilization procedures must be similar to those of currently marketed devices. | The device "will be manufactured according to specified process controls and a quality management system currently in place." It will undergo "manufacturing, packaging and sterilization procedures similar to devices currently manufactured, marketed and distributed by Unilens Corp., USA." |
| Substantial Equivalence | The device must not raise different questions of safety and effectiveness than a legally marketed predicate device (LifeStyle MV2™ Toric (polymacon) Soft (hydrophilic) Multifocal Contact Lens). This is the overarching regulatory "acceptance criterion." | The 510(k) directly states the device is "substantially equivalent to the predicate device identified below in terms of intended use and design." It further confirms this by adding, "Being similar with respect to indications for use, materials, physical construction and safety and effectiveness to the predicate device, this meets the requirements per section 510(k) of the act regarding substantial equivalence and does not raise different questions of safety and effectiveness than the predicate device identified above." |
2. Sample Size Used for the Test Set and Data Provenance
The provided 510(k) summary does not explicitly mention a specific clinical test set, its sample size, or data provenance (country, retrospective/prospective). For 510(k) submissions of contact lenses, particularly when demonstrating substantial equivalence, clinical data might be leveraged from the predicate device or a previous similar device, or new limited clinical trials might be conducted. However, this summary only refers to "pre-clinical toxicology and manufacturing/chemistry data" and states equivalence to an existing 510(k) device (BENZ-MF, K003861). It implies that the type of material has an established track record.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
Given the lack of explicit clinical trial data in this summary, there's no information provided on the number of experts used to establish ground truth or their qualifications.
4. Adjudication Method for the Test Set
Again, due to the absence of detailed clinical trial data, no adjudication method is mentioned.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No MRMC comparative effectiveness study is mentioned in this document. This type of study is more common for diagnostic imaging AI devices, rather than contact lenses, where the primary focus is on direct vision correction and ocular health as opposed to interpretive accuracy.
6. Standalone (Algorithm Only) Performance
Not applicable. This device is a physical contact lens, not a software algorithm. Therefore, "standalone performance" in the context of AI algorithms is not relevant.
7. Type of Ground Truth Used
For the purpose of substantial equivalence in a 510(k) for contact lenses, the "ground truth" is largely established by:
- Established Material Properties and Biocompatibility: The known safety and performance of the methafilcon A material itself, as demonstrated in prior approvals (like K003861).
- Clinical Performance of Predicate Device: The safety and effectiveness of the predicate device (LifeStyle MV2™ Toric), implying that a device with similar design and materials should yield similar clinical outcomes.
- Manufacturing and Quality Control Data: Internal testing to ensure the lens meets its physical and optical specifications.
There's no mention of pathology or outcomes data from a specific de novo clinical study in this summary.
8. Sample Size for the Training Set
Not applicable. As a physical medical device (contact lens) and not an AI algorithm, there is no "training set."
9. How the Ground Truth for the Training Set Was Established
Not applicable. As there is no training set mentioned, there is no information on how its ground truth would have been established.
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(71 days)
UNILENS CORP., USA
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(35 days)
UNILENS CORP., USA
Not Found
The Power Plus (polymacon) Soft (Hydrophilic) Aspheric Contact Lens is an aspheric lens design the same as many other lenses on the market, such as the Unilens 38 (polymacon) Aspheric Contact Lens (510(k) K941836), Ideal Optics PS (polymacon) Aspheric Contact Lens (PMA No. P830012-S003), the Fulfocus (polymacon) Aspheric Contact Lens manufactured by Contact Lens Corporation of America (PMA No. P830006-S005), the Allvue (polymacon) Aspheric Contact Lens manufactured by Salvatori Ophthalmics (PMA No. P840006-S007) and the VX Soft Lens (polymacon) Aspheric Contact Lens manufactured by GBF Contact Lens (PMA No. P780013-S004 approved August 13, 1991).
The Power Plus (polymacon) Aspheric Contact Lens is a front surface asphere consisting of multiple aspheric zones with a spherical base. The most plus power is in the center of the lens. with the power becoming more minus towards the periphery. This is a similar design as the other aspheric lenses listed above and the Unilens (hefilcon A) Soft (Hydrophilic) Aspheric Contact Lens which has been manufactured at this facility since our approval June 6, 1990 under PMA No. P850002-S005. The lenses have been designed so as to allow about 1 mm movement on the blink. This movement of the lens provides tear exchange to increase the oxygen under the lens and will assist in the removal of corneal metabolic wastes.
This document is a 510(k) summary for a contact lens, which is a premarket notification to the FDA for medical devices. It does not contain information about acceptance criteria or a study proving that a device meets acceptance criteria in the context of an AI/ML medical device.
The document discusses:
- The material of the contact lens (polymacon) and its history of use.
- The manufacturing process.
- The aspheric design of the lens and its similarities to other approved lenses.
- The safety rationale based on the use of a known polymer and accepted design.
- The manufacturer's experience.
Therefore, I cannot extract the requested information as it is not present in the provided text.
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(62 days)
UNILENS CORP., USA
Not Found
The SeeSoft (polymacon) Soft (Hydrophilic) Aspheric Contact Lens is an aspheric lens design the same as many other lenses on the market, such as the Unilens 38 (polymacon) Aspheric Contact Lens (510(k) K941836), Ideal Optics PS (polymacon) Aspheric Contact Lens (PMA No. P830012-S003), the Fulfocus (polymacon) Aspheric Contact Lens manufactured by Contact Lens Corporation of America (PMA No. P830006-S005), the Allvue (polymacon) Aspheric Contact Lens manufactured by Salvatori Ophthalmics (PMA No. P840006-S007) and the VX Soft Lens (polymacon) Aspheric Contact Lens manufactured by GBF Contact Lens (PMA No. P780013-S004 approved August 13, 1991).
The SeeSoft (polymacon) Aspheric Contact Lens is a front surface asphere with a spherical base. The most plus power is in the center of the lens, with the power becoming more minus towards the periphery. This is a similar design as the other lenses listed above and the Unilens (hefilcon A) Soft (Hydrophilic) Aspheric Contact Lens which has been manufactured at this facility since our approval June 6, 1990 under PMA No. P850002-S005. The lenses have been designed so as to allow about 1 mm movement on the blink. This movement of the lens provides tear exchange to increase the oxygen under the lens and will assist in the removal of corneal metabolic wastes.
This document is a 510(k) summary for a contact lens. It describes the lens's material, design, and manufacturing process, and asserts its similarity to other FDA-approved lenses. However, it does not contain any information about acceptance criteria or a study proving the device meets those criteria, and therefore cannot be used to answer the above questions.
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