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The EZvue UV (ocufilcon D) Spherical Soft Contact Lenses for daily wear are indicated for the correction of refractive error in aphakic and not aphakic persons with non-diseased eyes with myopia or hyperopia. The lens may be worn by persons who exhibit refractive astigmatism of 2.00 diopters or less where the astigmatism does not interfere with visual acuity.

The EZvue Colors (ocufilcon D) Spherical Soft Contact Lenses for daily wear are indicated for the correction of refractive error in aphakic and not aphakic persons with non-diseased eyes with myopia or hyperopia. The lens may be worn by persons who exhibit refractive astigmatism of 2.00 diopters or less where the astigmatism does not interfere with visual acuity. The lens is available clear or tinted and may be used to enhance or alter the apparent color of the eye.

Daily wear replacement schedules may vary from patient and should be decided by eyecare practitioners in consultation with their patients.

Frequent/Planned Replacement Wear:

Eyecare practitioners may prescribe any of the above lenses for frequent/planned replacement wear, with cleaning disinfection and scheduled replacement. When prescribed for frequent/planned replacement wear, the lens may be disinfected using a chemical disinfecting system.

Disposable Wear:

Eyecare practitioners may prescribe any of the above lenses for single use Daily Disposable Wear. When Prescribed for Daily Disposable Wear the lens is to be discarded after each removal.

The EZvue UV soft contact lenses are hemispherical shells with molded spherical base curves and molded front surfaces. The nonionic lens material (ocufilcon D) is a hydrophilic co-polymer of 2-Hydroxyethyl methacrylate (2-HEMA) and methacrylic acid, cross-linked with ethylene glycol dimethacrylate (EGDMA), plus an initiator. The co-polymer consists of 45% ocufilcon D and 55% water by weight when immersed in saline solution. A UV absorbing monomer-2-(Benzoyl-3-hydroxyphenoxy)ethyl acrylate-is incorporated in the contact lens material to block UV radiation. EZvue UV lenses are available clear and visibility tinted (for handling) using C.I. Reactive Blue Dye #19.

The EZvue Colors soft contact lenses are hemispherical shells with molded spherical base curves and molded front surfaces. The nonionic lens material (ocufilcon D) is a hydrophilic co-polymer of 2-Hydroxyethyl methacrylate (2-HEMA) and methacrylic acid, cross-linked with ethylene glycol dimethacrylate (EGDMA), plus an initiator. The co-polymer consists of 45% ocufilcon D and 55% water by weight when immersed in saline solution. EZvue Colors lenses are tinted to enhance or alter the apparent color of the eye. Lenses are tinted with a combination of one or more of the following 'listed' color additives: C.I. Reactive Blue 19, C.I. Pigment Green 7, Iron oxides, C.I. Reactive Yellow 86, C.I. Reactive Black 5, C.I. Pigment Violet 23, Titanium dioxide. The imprinted color pattern is surrounded on both sides by layers of contact lens material (ocufilcon D). The tinting pattern has a Clear Pupil diameter of 5.5 to 9.0 mm.

In the hydrated state, both lenses conform to the curvature of the eye covering the cornea and extending slightly beyond the limbus forming a transparent or colored optical surface. The (ocufilcon D) soft hydrophilic contact lens has a spherical back surface.

This document describes the 510(k) premarket notification for EZvue UV and EZvue Colors Soft Daily Wear Contact Lenses. The submission asserts substantial equivalence to predicate devices, thus avoiding the need for extensive new clinical studies.

Here's an analysis based on your questions:

1. A table of acceptance criteria and the reported device performance

The document does not explicitly state "acceptance criteria" in the typical sense of quantitative benchmarks for device performance in a clinical study. Instead, it focuses on demonstrating substantial equivalence to predicate devices through physical properties, material composition, and intended use. The "reported device performance" refers to these physical characteristics and the results of non-clinical testing.

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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

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.

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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.

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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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

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.

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