Search Results
Found 2 results
510(k) Data Aggregation
(22 days)
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.
Ask a specific question about this device
(28 days)
The Ocu-Flex 55 Spherical, Toric, Thin Zone Toric, Aspherical, Toric Aspherical and Thin Zone Toric Aspherical (methafilcon A) Soft Contact Lenses are indicated for daily wear for the correction of refractive ametropia (myopia, hyperopia and astigmatism) in not-aphakic persons with non-diseased eyes.
The Ocu-Flex 55 Spherical (methafilcon A) Soft Contact Lens is indicated for daily wear for the correction of visual acuity in aphakic or not-aphakic persons with non-diseased eyes that are nearsighted (myopic) or farsighted (hyperopic) and may exhibit astigmatism of 1.50D or less that does not interfere with visual acuity.
The Ocu-Flex 55 Toric and Thin Zone Toric (methafilcon A) Soft Contact Lens is indicated for daily wear for the correction of visual acuity in aphakic or not-aphakic persons with non-diseased eyes that are myopic or hyperopic and is intended to correct astigmatism of 4.50D or less that does not interfere with visual acuity.
The Ocu-Flex 55 Aspherical (methafilcon A) Soft Contact Lens is indicated for daily wear for the correction of visual acuity in aphakic or not-aphakic persons with non-diseased eyes that are myopic, or hyperopic, and/or presbyopic, and which may exhibit astigmatism of up to 1.50D or less that does not interfere with visual acuity.
The Ocu-Flex 55 Toric Aspherical and Thin Zone Toric Aspherical (methafilcon A) Soft Contact Lens is indicated for daily wear for the correction of visual acuity in aphakic or not-aphakic persons with non-diseased eyes that are myopic, or hyperopic, and/or presbyopic and is intended to correct astigmatism of 4.50D or less that does not interfere with visual acuity.
The lens may be disinfected with chemical (not heat) disinfection system.
The Ocu-Flex 55 Spherical, Toric, Thin Zone Toric, Aspherical, Toric Aspherical and Thin Zone Toric Aspherical (methafilcon A) Soft Contact Lenses are fabricated from methafilcon 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.
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 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 ionic lens material (methafilcon A) is a hydrophilic co-polymer of 2-hydroxyethyl methacrylate and methacrylic acid crosslinked with ethylene glycol dimethacrylate. When fully hydrated in a 0.9% sodium chloride solution, the lens is 55% water by weight. In that fully hydrated state the lens is soft and readily wet by saline and aqueous solution.
The Ocu-Flex 55 Spherical, Toric, Thin Zone Toric, Aspherical, Toric Aspherical and Thin Zone Toric Aspherical (methafilcon A) Soft Contact Lenses are available as a spherical, toric, aspheric and toric aspheric design.
The physical properties of the lens are:
Refractive Index 1.4153
Light Transmission greater than 95% T
Specific Gravity 1.090 g/cc
Water Content 55%
Color Pigment Name Phthalocyanine Blue
Oxygen Permeability Dk=18x10-11 @ 35°C
This 510(k) premarket notification is for contact lenses, which are regulated as medical devices. The submission focuses on demonstrating "substantial equivalence" to a predicate device already on the market, rather than conducting a de novo clinical study with specific acceptance criteria and performance metrics in the way an AI/ML device would. Therefore, many of the requested fields are not applicable.
Here's an analysis based on the provided document:
1. Table of Acceptance Criteria and Reported Device Performance
For contact lenses seeking 510(k) clearance via substantial equivalence, the "acceptance criteria" are not reported as specific performance metrics derived from a clinical trial, but rather as demonstrating equivalence in critical characteristics to a predicate device. The "performance" is implicitly deemed acceptable if these characteristics are substantially equivalent.
| Characteristic | Acceptance Criteria (Predicate Device Value) | Reported Device Performance (Ocu-Flex 55) |
|---|---|---|
| Material | Hydrophilic (methafilcon A) | Hydrophilic (methafilcon A) |
| Water Content | 55% | 55% |
| Dk Value | $18 \times 10^{-11}$ @ 35°C | $18 \times 10^{-11}$ @ 35°C |
| Production Method | Lathe-cut | Lathe-cut |
| Lens Function | Refractive medium for vision correction | Refractive medium for vision correction |
| Indication | Correction of refractive ametropia | Correction of refractive ametropia |
| Refractive Index | Not explicitly stated for predicate but stated as "substantially equivalent" | 1.4153 |
| Light Transmission | Not explicitly stated for predicate but stated as "substantially equivalent" | > 95% T |
| Specific Gravity | Not explicitly stated for predicate but stated as "substantially equivalent" | 1.090 g/cc |
Study Proving Device Meets Acceptance Criteria:
The study proving the device meets the "acceptance criteria" is a comparative analysis demonstrating substantial equivalence to a legally marketed predicate device (Horizon 55). This is explicitly stated: "The following matrix illustrates that the production method, lens function and material of the Ocu-Flex 55... is substantially equivalent to the predicate device. In addition, the water content, polymer, Dk value, refractive index, specific gravity, and light transmission are as well substantially equivalent to the predicate device."
2. Sample Size Used for the Test Set and Data Provenance
Not applicable for this type of 510(k) submission. There was no "test set" in the context of an AI/ML or a new clinical performance study. The data provenance is a comparison of product specifications and intended use.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
Not applicable. Ground truth in the context of clinical expert consensus for a test set is not relevant for a substantial equivalence submission of a contact lens based on material and design specifications.
4. Adjudication Method for the Test Set
Not applicable.
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/ML diagnostic tool.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
Not applicable.
7. The Type of Ground Truth Used
The "ground truth" in this context is the established safety and effectiveness profile of the predicate device, Horizon 55, and other similar methafilcon A lenses (BENZ - MF). The manufacturer is demonstrating that the Ocu-Flex 55 matches the characteristics that have already been deemed safe and effective by the FDA through the predicate's prior clearance. This includes:
- Manufacturing/Chemistry Data: The production method (lathe-cut), material (methafilcon A), water content, Dk value, refractive index, specific gravity, and light transmission are all compared to the predicate.
- Intended Use Compatibility: The indications for use are aligned with the predicate device.
- Safety Profile: The submission references the established safety profile (pre-clinical toxicology) of BENZ - MF (methafilcon A), noting equivalence.
8. The Sample Size for the Training Set
Not applicable. There is no concept of a "training set" for this type of device submission.
9. How the Ground Truth for the Training Set Was Established
Not applicable.
Ask a specific question about this device
Page 1 of 1