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The Largan 55 UV Color (Ocufilcon D) Daily Wear Soft (hydrophilic) Contact Lens is a daily wear soft contact lens indicated for the correction of refractive ametropia (myopia and hyperopia) in phakic persons with nondiseased eyes who exhibit refractive astigmatism of 1.00D or less where the astigmatism does not interfere with visual acuity.

The Largan 55 UV Color (Ocufilcon D) Daily Wear Soft (hydrophilic) Contact Lens for Astigmatism is indicated for daily wear for the correction of ametropia (myopia and hyperopia) with astigmatism in aphakic and non-aphakic persons with non-diseased eyes and whose powers are from -10.00 to +3.00 diopters and astigmatic corrections are from -0.25 to -5.00 diopters.

The Largan 55 UV Color (Ocufilcon D) Daily Wear Soft (hydrophilic) Contact Lens for Presbyopia is indicated for daily wear for the correction of ametropia) and hyperopia) and emmetropia with presbyopia in aphakic persons with non-diseased eyes and whose powers are from -10.00 to +3.00 diopters with add powers from +0.75 to +3.50 diopters. The lenses may be worn by persons who exhibit astigmatism of 1.00 diopters or less where the astigmatism does not interfere with visual acuity.

Eye care practitioners may prescribe the lens for either single-use disposable wear, or for frequent/planned replacement wear, with cleaning, disinfection, and scheduled replacement. When prescribed for single-use disposable wear, the lens is to be discarded after each removal, therefore no cleaning or disinfecting is required. When prescribed for frequent replacement, the lens may be disinfected using a chemical disinfection system only.

The Largan 55 UV Color (Ocufilcon D) Daily Wear Soft (hydrophilic) Contact Lens is available in hemispherical flexible shells for myopia, hyperopia. astigmatisam and presbyopia. The Largan 55 UV Color (Ocufilcon D) Daily Wear Soft (hydrophilic) Contact Lens is an aspherical design contact lens. The lens material (Ocufilcon D) is a hydrophilic co-polymer by cross-linking 2-Hydroxyethyl methacrylate (HEMA), Methacrylic acid (MAA) and Ethylene Glycol Dimethacrylate (EGDMA). The hydrated lens consists of 45.0% (Ocufilcon D) and 55.0% water by weight of saline immersed in normal saline. A benzophenone UV absorbing monomer is used to block UV radiation. The average transmittance characteristics are less than 5% in the UVB range of 280 to 315nm and less than 50% in the UVA range of 315 to 380 nm. The lenses contain a combination of the following color additives: Phthalocyanine green, Carbazole violet. [Phthalocyaninato (2-)] copper, Titanium dioxide, Iron oxides, Mica-based pearlscent pigment, and Chromium-cobalt-aluminum oxide. All color additives used are listed in 21 CFR 73 Subpart D and 74 Subpart D.

The provided text describes a 510(k) premarket notification for a medical device, the "Largan 55 UV Color (Ocufilcon D) Daily Wear Soft Contact Lens". It focuses on establishing substantial equivalence to previously cleared predicate devices rather than presenting a novel study demonstrating specific acceptance criteria with performance metrics for this particular device.

Therefore, much of the requested information regarding acceptance criteria, device performance, sample sizes, ground truth establishment, expert adjudication, and MRMC studies is not available in the provided document, as it is a 510(k) summary for a contact lens rather than a study report for an AI-powered diagnostic device.

However, I can extract information related to the nonclinical tests performed and the rationale for not requiring clinical studies.

Here's a breakdown of the available information:

1. Table of Acceptance Criteria and Reported Device Performance:

The document doesn't explicitly state "acceptance criteria" in the format of a table with specific numerical thresholds for performance metrics. Instead, it refers to the device meeting "established specifications for the lenses" based on nonclinical tests.

2. Sample size used for the test set and the data provenance:

• Sample size for test set: Not applicable/not provided. The document states that "no clinical data is required" for the subject device due to its equivalence to predicate devices, thus no dedicated "test set" in the context of clinical performance evaluation was used for this 510(k) submission.
• Data provenance: Not applicable/not provided for a clinical test set. The nonclinical tests were presumably performed by Largan Medical Co. Ltd. (Taiwan).

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

• Not applicable/not provided. No clinical test set was used requiring expert ground truth establishment.

4. Adjudication method for the test set:

• Not applicable/not provided.

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:

• Not applicable/not provided. This is a contact lens, not an AI-powered diagnostic device.

6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:

• Not applicable/not provided. This is a contact lens, not an algorithm.

7. The type of ground truth used:

• Not applicable/not provided for clinical performance. For nonclinical tests, the "ground truth" would be the established scientific and engineering standards and methods for assessing material properties, toxicity, and biocompatibility.

8. The sample size for the training set:

• Not applicable/not provided. This is a contact lens, not a machine learning algorithm that requires a training set.

9. How the ground truth for the training set was established:

• Not applicable/not provided.

Summary of the study/submission:

The document outlines a 510(k) submission (K182523) for the Largan 55 UV Color (Ocufilcon D) Daily Wear Soft Contact Lens. The core of this submission is to demonstrate substantial equivalence to existing legally marketed predicate devices, rather than presenting a de novo study proving new acceptance criteria.

The justification for "no clinical data required" is based on the following:

• The lens material (Ocufilcon D) is the same as Largan 55 UV (Ocufilcon D) Daily Wear Soft (hydrophilic) Contact Lens (predicate device K181232).
• The color additives are equivalent to BIOMEDICS® UV Colors (Ocufilcon D) Soft (Hydrophilic) Contact Lens (predicate device K013377).

Therefore, the "study" demonstrating the device meets "acceptance criteria" (implicitly, the safety and effectiveness standards of the predicate devices) consists of:

• Nonclinical studies: These included physicochemical studies conducted according to ISO 18369, which confirmed the physical, optical, and chemical properties of the lens are within established specifications. Toxicology studies reported the lenses as non-toxic, and biocompatibility results were acceptable.
• Comparison to predicate devices: A detailed comparison table (Section 1.8) highlights similarities in intended use, lens design, replacement schedule, chemical composition, classification, water content, oxygen permeability, base curve range, diameter, center thickness, powers, and refractive index with Largan 55 UV (K181232). The color additives are compared to BIOMEDICS® UV Colors (K013377).

The conclusion is that based on the comparison to predicate devices and the nonclinical testing, the "Largan 55 UV Color (Ocufilcon D) Daily Wear Soft (hydrophilic) Contact Lens" is "as safe, as effective and performs as well as the predicate devices."

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