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510(k) Data Aggregation
(260 days)
EZVUE (OCUFILCON D) 1-DAY SOFT (HYDROPHILIC)CONTACT LENS
EZvue(Ocufilcon D)1-day Soft (hydrophilic) Contact Lens for daily wear is indicated for daily wear for the correction of refractive ametropia (myopia and hyperopia) in aphakic and/or not-aphakic persons with non-diseased eyes who may exhibited refractive astigmatism up to 2.00 diopters that does not interfere with visual acuity.
Eyecare practitioners may prescribe the contact lens for single-use disposable daily wear. The EZvue(Ocufilcon D)1-day Soft (hydrophilic) Contact Lenses are not intended to be disinfected and should be discarded after a single use.
EZvue (Ocufilcon D) 1-Day Soft (hydrophilic) Contact Lens for Daily Wear is available as spherical lenses manufactured by cast molded method. The lens is made from a lens material that is approximately 55% water. The hydrogel lens' material is a copolymer composed of 2-hydroxyethyl methacrylate (HEMA) and methacrylic acid (MAA), which was cross-linked with Ethylene Glycol Dimethacrylate (EGDMA) via UV photopolymerization. The EZvue (Ocufilcon D) 1-Day Soft (hydrophilic) Contact Lens with visible tint is tinted blue using Reactive Blue Dye #19 to make the lens more visible for handling. Lenses are supplied sterile in sealed blister packers containing sterile isotonic phosphate buffered saline.
Here's a breakdown of the acceptance criteria and study information for the EZvue (Ocufilcon D) 1-Day Soft (hydrophilic) Contact Lens, based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
The submission primarily focuses on demonstrating substantial equivalence to a predicate device, rather than establishing specific quantitative acceptance criteria for de novo performance. The "acceptance criteria" are implied by the performance of the predicate device and the non-inferiority demonstrated through testing.
| Acceptance Criteria (Implied by Predicate/Testing) | Reported Device Performance (EZvue Ocufilcon D) |
|---|---|
| Technological Characteristics: | |
| Diameter range: Equivalent to predicate | 13.90 ~ 14.30mm |
| Power range: Equivalent to predicate | +8.00D ~ -12.00D |
| Center thickness: Equivalent to predicate | Varies with power (0.080 ~ 0.150mm) |
| Refractive index (hydrated): Equivalent to predicate | 1.410 |
| Light transmittance: >93% | >93% |
| Water content: 53-57% (Ocufilcon D) | 53 to 57 % |
| Oxygen permeability (Dk/t): Equivalent to predicate | 16 x 10^-14 [(cm²/sec)(mlO₂/ml-mmHg)]@ 35℃ |
| Biocompatibility: | |
| Non-toxic and non-irritating | Irritation test (rabbit), Systemic toxicity (non-toxic, non-irritating) |
| Non-cytotoxic | Cytotoxicity testing (not cytotoxic) |
| Microbiology: | |
| Sterility Assurance Level (SAL): 10^-6 | Validated SAL of 10^-6 |
| Shelf-life stability for sterility | Shelf-life stability data supports sterility through expiration date |
| Leachability: | |
| No detectable leachable monomers or additive residues | No leachable monomers and addictive residues at detection levels |
| Clinical Performance: | |
| Vision correction and patient satisfaction comparable to standard/predicate | Nearly 100% participants' vision corrected; nearly all satisfied with lens wearing |
| Safety comparable to standard/predicate | Products are "good and safe for customers" |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: "over 60 human eyes"
- Data Provenance: The study was conducted on human eyes. The submitter company is I-SEE VISION TECHNOLOGY INC. based in Hisnchu, Taiwan, so it is highly probable the data originated from Taiwan. The study is prospective as it involved testing the device on human eyes.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
The document does not explicitly state the number of experts or their qualifications used to establish ground truth for the clinical study. It mentions that "Nearly a hundred percent of the participants' vision was corrected and nearly all were satisfied with the lens wearing and care of lenses." This suggests assessment by eye care practitioners, but specific expert count or qualifications are not provided.
4. Adjudication Method for the Test Set
The document does not describe a formal adjudication method (e.g., 2+1, 3+1). The statement implies direct observation and assessment by eye care professionals, rather than a separate adjudication process for ground truth.
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 study described is a clinical study on the device's performance, not a comparison of human reader performance with and without AI assistance.
6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done
This device is not an AI algorithm. It is a soft contact lens. Therefore, the concept of a "standalone" algorithmic performance study is not applicable.
7. The Type of Ground Truth Used
For the clinical study, the "ground truth" was based on:
- Observational Clinical Outcomes: Corrected vision (presumably measured by visual acuity tests)
- Patient Reported Outcomes: Patient satisfaction with lens wearing and care.
For the nonclinical studies, ground truth was established by direct physical and chemical measurements (e.g., diameter, power, refractive index, water content, oxygen permeability) and standardized biological testing (irritation tests, cytotoxicity assays, sterility validation, leachability analysis).
8. The Sample Size for the Training Set
This device is not an AI algorithm, so there is no "training set." The materials used for manufacturing the lens were characterized.
9. How the Ground Truth for the Training Set Was Established
Not applicable, as this is not an AI device.
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