(260 days)
EZvue (Polymacon) 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 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 (Polymacon) 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 38% water. The hydrogel lens' material is a copolymer composed of 2-hydroxyethyl methacrylate (HEMA), which was cross-linked with Ethylene Glycol Dimethacrylate (EGDMA) via UV photo- polymerization. The EZvue (Polymacon) 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.
The provided 510(k) summary for the EZvue (Polymacon) Soft (hydrophilic) Contact Lens for Daily Wear describes a clinical study and nonclinical tests to demonstrate safety and effectiveness. However, it does not explicitly state "acceptance criteria" in a quantitative manner for specific performance metrics. Instead, it focuses on demonstrating substantial equivalence to predicate devices.
Interpretation of Acceptance Criteria and Reported Performance:
For a contact lens, "acceptance criteria" would typically relate to factors like visual acuity correction, comfort, safety (lack of adverse events), and various optical and material properties. The document implies that the "acceptance criteria" are met if the device performs comparably to the predicate devices and demonstrates safety and effectiveness.
Here's an attempt to extract the implied acceptance criteria and reported performance based on the provided text, recognizing that these are not explicitly presented as pass/fail thresholds but rather as general findings.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Clinical Performance: | |
| Correction of refractive ametropia (myopia and hyperopia) | "Nearly a hundred percent of the participants' vision was corrected." |
| Patient satisfaction with wear and care | "Nearly all were satisfied with the lens wearing and care of lenses." |
| Overall safety and good performance | "In general, these products are good and safe for customers." |
| Biocompatibility: | |
| Non-toxic and non-irritating | "The Irritation test in the rabbit eye and Systemic toxicity studies indicate the extracts would be considered as non-toxic and nor irritated." |
| Non-cytotoxic | "The Cytotoxicity testing demonstrates the lens is not cytotoxic under the conditions of the study." |
| Sterilization Assurance: | |
| Sterility Assurance Level (SAL) of $10^{-6}$ | "Steam sterilization process has been validated to deliver a minimum SAL of $10^{-6}$." |
| Shelf-life stability for sterility | "There is shelf-life stability data supporting that the lens remains sterile through the expiration date claimed for the product." |
| Leachability: | |
| No detectable leachable monomers or additive residues | "The results show that, at the levels of the detection reported, there are no leachable monomers and addictive residues." |
| Technological Characteristics (Substantial Equivalence): | |
| Comparable to predicate lenses in: | |
| - Diameter range | - 13.90~14.30mm (Reported) |
| - Power range | - -0.50D~-12.00D (Reported) |
| - Center thickness | - Varies with power (0.080~0.150mm) (Reported) |
| - Refractive index | - 1.430 (hydrated) (Reported) |
| - Light transmittance | - >93% (Reported) |
| - Water content | - 38 % (Reported) |
| - Oxygen permeability | - 9×10⁻¹⁵ (cm²/sec)(mlO2/ml-mmHg)]@ 35℃ (Reported) |
| "These characterizations of EZvue (Polymacon) Soft (hydrophilic) Contact Lens for Daily Wear are equivalent and comparable to those of predicate lenses." (General statement of equivalence) | |
| Overall Safety and Effectiveness | "Testing performed on the EZvue (Polymacon) Soft (hydrophilic) Contact Lens for Daily Wear indicated that it can support the efficiency and security use as well as the predicate devices... The risks and benefits of the subject device are the same as soft contact lenses for to the daily wear." (Conclusion of equivalence) |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size for Clinical Study: 60 human eyes.
- Data Provenance: The document does not explicitly state the country of origin for the clinical study data or if it was retrospective or prospective. Given the submitter information (I-SEE VISION TECHNOLOGY INC. based in Taiwan), it is likely the study was conducted in Taiwan, but this is not explicitly stated. The study type is implicit as a prospective clinical trial.
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 used or their qualifications for establishing ground truth in the clinical study. The clinical study summary describes participants' vision being corrected and satisfaction, which are likely assessed by an optometrist or ophthalmologist involved in the study, but no details on their role as "ground truth" experts or their qualifications are provided.
4. Adjudication Method for the Test Set
- The document does not describe any specific adjudication method (e.g., 2+1, 3+1) for the clinical study results. Clinical studies for contact lenses typically involve direct measurements and patient feedback, rather than expert adjudication of a "ground truth" derived from images or complex diagnoses.
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, an MRMC comparative effectiveness study was not done. This type of study is relevant for AI-powered diagnostic tools where human readers might integrate AI outputs. This submission is for a medical device (contact lens) and does not involve AI assistance for human readers.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done
- Not applicable. This device is a physical medical device (contact lens), not an algorithm or AI product. Its performance is inherent in its physical properties and clinical effect on the wearer, not as a standalone algorithm.
7. The Type of Ground Truth Used
- For the clinical study, the "ground truth" implicitly refers to:
- Corrected visual acuity: Assessed by standard optometric methods.
- Patient satisfaction: Subjective feedback from participants.
- Safety observations: Clinical examination for adverse events.
- For the nonclinical studies, the ground truth was based on:
- Standardized laboratory tests and analytical measurements: For material properties, biocompatibility (e.g., irritation tests), sterilization validation, and leachability. These are objective measurements following established protocols.
8. The Sample Size for the Training Set
- This submission describes a medical device approval through the 510(k) pathway, which primarily focuses on demonstrating substantial equivalence to a predicate device. It does not involve machine learning or AI models that require a "training set." Therefore, there is no training set sample size.
9. How the Ground Truth for the Training Set was Established
- As stated above, there is no training set for this type of device submission.
§ 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.