(260 days)
EZvue (Ocufilcon D) 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..
Eye care practitioners may prescribe the contact lens for frequent replacement wear, with cleaning, rinsing and disinfection and scheduled replacement as prescribed by the eyecare professional. The contact lens may be disinfected using chemical (not heat) disinfection system.
EZvue (Ocufilcon D) Soft (hydrophilic) Contact Lens for Daily Wear are 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) 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 packs containing sterile isotonic phosphate buffered saline.
Here's an analysis of the provided text, focusing on the acceptance criteria and the study that proves the device meets them:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Specific Criteria/Test | Device Performance / Result |
|---|---|---|
| Clinical Performance | Vision Correction | Nearly a hundred percent of participants' vision was corrected. |
| Lens Satisfaction | Nearly all participants were satisfied with lens wearing and care. | |
| Overall Safety & Efficacy | Products are "good and safe for customers." | |
| Technological Characteristics Studies (Comparison to Predicate) | ||
| Diameter range | 13.80~14.40mm (Implicitly meets predicate, as "equivalent and comparable") | |
| Power range | +8.00D~-12.00D (Implicitly meets predicate, as "equivalent and comparable") | |
| Center thickness | Varies with power (0.080~0.150mm) (Implicitly meets predicate, as "equivalent and comparable") | |
| Refractive index | 1.410 (hydrated) (Implicitly meets predicate, as "equivalent and comparable") | |
| Light transmittance | >93% (Implicitly meets predicate, as "equivalent and comparable") | |
| Water content | 54 to 56 % (Implicitly meets predicate, as "equivalent and comparable") | |
| Oxygen permeability | 16×10^-15 (cm²/sec)(mlO₂/ml-mmHg)]@ 35℃ (Implicitly meets predicate, as "equivalent and comparable") | |
| Biocompatibility | Irritation Test (Rabbit Eye) | Extracts would be considered non-irritated. |
| Systemic Toxicity | Extracts would be considered non-toxic. | |
| Cytotoxicity | Lens is not cytotoxic under the conditions of the study. | |
| Microbiology | Sterilization (SAL) | Steam sterilization process validated to deliver a minimum SAL of 10⁻⁶, complying with FDA Group IV. |
| Shelf-life Stability | Data supports lens remains sterile through the expiration date. | |
| Leachability | Leachable Materials | No leachable monomers and addictive residues detected at reported levels. |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: 64 human eyes.
- Data Provenance: The document does not explicitly state the country of origin for the clinical study participants. It mentions the company is located in Taiwan, but this doesn't confirm where the study was conducted. The study was prospective as it involved testing the device on human eyes for a duration of 6 months.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
The document does not specify the number of experts or their qualifications for establishing ground truth in the clinical study. It only states that "Nearly a hundred percent of the participants' vision was corrected and nearly all were satisfied with the lens wearing and care of lenses," implying subjective and objective assessments were made, likely by participating clinicians/optometrists.
4. Adjudication Method (e.g. 2+1, 3+1, none) for the Test Set
The document does not describe any specific adjudication method for the test set.
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 such study was conducted or mentioned in the provided text. 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
This question is not applicable. The device is a medical device (contact lens) for vision correction, not an algorithm. Therefore, "standalone algorithm performance" is not relevant.
7. The Type of Ground Truth Used
For the clinical study, the ground truth was based on:
- Clinical Outcomes/Performance: Measured vision correction.
- Patient Reported Outcomes: Satisfaction with lens wearing and care.
- Expert Clinical Assessment: Implied assessment by the clinical practitioners involved in monitoring the 64 eyes.
For the non-clinical studies (technological characteristics, biocompatibility, microbiology, leachability), the ground truth was established through standardized laboratory testing and comparison to the predicate device's established characteristics.
8. The Sample Size for the Training Set
This question is not applicable. There is no concept of a "training set" for this type of medical device. The "training" for manufacturing would be quality control and process validation, not data-driven machine learning.
9. How the Ground Truth for the Training Set Was Established
This question is not applicable for the reasons stated above.
§ 886.5925 Soft (hydrophilic) contact lens.
(a)
Identification. A soft (hydrophilic) contact lens is a device intended to be worn directly against the cornea and adjacent limbal and scleral areas of the eye to correct vision conditions or act as a therapeutic bandage. The device is made of various polymer materials the main polymer molecules of which absorb or attract a certain volume (percentage) of water.(b)
Classification. (1) Class II if the device is intended for daily wear only.(2) Class III if the device is intended for extended wear.
(c)
Date PMA or notice of completion of a PDP is required. As of May 28, 1976, an approval under section 515 of the act is required before a device described in paragraph (b)(2) of this section may be commercially distributed. See § 886.3.