Search Results

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.

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