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The Largan U38 Color (Polymacon) Daily Wear Soft (hydrophilic) Contact Lens is a daily wear soft contact lens indicated for daily wear to enhance or alter the apparent color of the eye and/or for the correction of refractive ametropia (myopia and hyperopia) in phakic or non-aphakic persons with non-diseased eyes who exhibit refractive astigmatism of 1.00D 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 frequentl 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 U38 Color (Polymacon) Daily Wear Soft (hydrophilic) Contact Lens is available in hemispherical flexible shells for myopia. The Largan U38 Color (Polymacon) Daily Wear Soft (hydrophilic) Contact Lens is an aspherical design contact lens. The lens material (Polymacon) is a hydrophilic co-polymer by crosslinking 2-Hydroxyethyl methacrylate (HEMA). and Ethylene Glycol Dimethacrylate (EGDMA). The hydrated lens consists of 62.0% (Polymacon) and 38.0% water by weight of saline immersed in normal saline. A light blue color tinted with "reactive Blue 247" is for handling visibility purpose. 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 (Red, Yellow and Black),and Mica-based pearlscent pigment (Gold, Silver and Red). All color additives used are listed in 21 CFR 73 subpart D and 74 subpart D. It is supplied in a sterile package with buffered saline solution.

This document describes the premarket notification (510(k)) clearance for the Largan U38 Color (Polymacon) Daily Wear Soft (hydrophilic) Contact Lens. However, it does not contain information typically associated with acceptance criteria and a study that proves a device meets them in the context of an AI/ML medical device.

This type of FDA clearance (510(k)) is for a physical medical device (a contact lens) and relies on demonstrating substantial equivalence to a previously cleared predicate device, rather than a clinical study with quantifiable performance metrics against specific acceptance criteria for an algorithm.

Therefore, many of the requested elements for an AI/ML device (like sample size for test/training sets, ground truth establishment methods, expert qualifications, MRMC studies, or standalone performance) are not applicable or not provided in this document.

Here's the breakdown of what can be extracted and what cannot:

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

The document provides a comparative table (Table 8) against predicate devices, focusing on physical and chemical characteristics. It does not present a formal "acceptance criteria" table with reported performance in the way one would for an AI/ML algorithm. Instead, it demonstrates similarity to predicate devices.

Note on "Acceptance Criteria": For this type of device, the "acceptance criteria" effectively boil down to demonstrating that the device is as safe and effective as the predicate device(s) based on comparable technological characteristics and non-clinical and biocompatibility testing. The inclusion of color additives is a distinguishing feature, and the safety of these additives is addressed through biocompatibility testing and their listing in 21 CFR 73 subpart D and 74 subpart D.

2. Sample size used for the test set and the data provenance
Not applicable for this type of device (physical contact lens). The document describes non-clinical and biocompatibility tests, but not a "test set" for an algorithm.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable.

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.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable.

7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)
Not applicable. The "ground truth" here is the established safety and effectiveness of the predicate device, against which the new device's physical, chemical, and biocompatibility properties are compared.

8. The sample size for the training set
Not applicable.

9. How the ground truth for the training set was established
Not applicable.

Summary of the Study Proving Acceptance:

The device's acceptance is based on demonstrating substantial equivalence to legally marketed predicate devices (Largan U38 (Polymacon) Daily Wear Soft (hydrophilic) Contact Lens and Largan 55 UV Color (Ocufilcon D) Daily Wear Soft (hydrophilic) Contact Lens), as evidenced by:

• Identical Intended Use: Both the subject device and predicates are indicated for correction of refractive ametropia (myopia and hyperopia) in non-diseased eyes with limited astigmatism, for daily or frequent/planned replacement wear. The subject device adds the function of enhancing or altering eye color, which is already present in the secondary predicate (Largan 55 UV Color).
• Similar Technological Characteristics: The document provides a detailed comparison (Table 8) showing that the subject device shares many key physical and optical parameters (lens design, replacement schedule, chemical composition (with primary predicate), water content (with primary predicate), oxygen permeability (with primary predicate), base curve, diameter, center thickness, powers, refractive index (with primary predicate), light transmittance) with one or both predicate devices.
• Non-Clinical Testing: Various physical and optical properties were tested (Back Vertex Power, Radius of Curvature, Overall Diameter, Center Thickness, etc.) to ensure the device performs as expected.
• Biocompatibility Testing: Conducted in accordance with FDA guidance (Premarket Notification [510(k)] Guidance Document for Class II Daily Wear Contact Lenses (1994)), including:
  • In-Vitro Cytotoxicity (non-cytotoxic)
  • Ocular irritation testing (no ocular irritation)
  • Acute systemic toxicity (no acute systemic toxicity)
  • Skin Sensitization Study (no skin sensitization)
• Color Additives: The color additives used are listed in 21 CFR 73 subpart D and 74 subpart D, addressing the safety aspect of the color-enhancing feature.

The conclusion is that the "Largan U38 Color (Polymacon) Daily Wear Soft (hydrophilic) Contact Lens" is as safe, as effective, and performs as well as the predicate devices, thereby meeting the criteria for 510(k) clearance based on substantial equivalence.

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The Largan DB (ocufilcon D) Daily Wear Soft (hydrophilic) Contact Lens/ Largan DB Color (ocufilcon D) Daily Wear Soft (hydrophilic) Contact Lens is a daily wear soft (hydrophilic) contact lens indicated for the correction of refractive ametropia (myopia and hyperopia) in aphakic or non-aphakic persons with non-diseased eyes who exhibit refractive astigmatism of 1.00D or less where the astigmatism does not interfere with visual acuity.

The Largan DB (ocufilcon D) Daily Wear Soft (hydrophilic) Contact Lens for Astigmatism/ Largan DB Color (ocuffilcon D) Daily Wear Soft (hydrophilic) Contact Lens for Astigmatism is indicated daily wear for the correction of amercopia (myopia and hyperopia) with astigmatism in 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 DB (ocufilcon D) Daily Wear Soft (hydrophilic) Contact Lens for Presbyopial Largan DB Color (ocufilcon D) Daily Wear Soft (hydrophilic) Contact Lens for Presbyopia is indicated daily wear for the correction of ametropia (myopia 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 +0.25 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 disinfection system only. When prescribed for frequent replacement, it is recommended that the lenses be discarded and replaced with a new lens not more than every 1 month. However, the Eye Care Professional is encouraged to determine an appropriate replacement schedule based upon the response of the patient. The Largan DB Color (Ocufilcon D) Daily Wear Soft (hydrophilic) Contact Lens is also intended to enhance or alter the apparent color of the eye.

The Largan DB (Ocufilcon D) Daily Wear Soft (hydrophilic) Contact Lens/ Largan DB Color (Ocufilcon D) Daily Wear Soft (hydrophilic) Contact Lens is available as an aspherical lens, multifocal lens and as an astigmatic (toric) lens. The lens material (Ocufilcon D) is a hydrophilic co-polymer cross-linked with Ethylene Glycol Dimethacrylate (EGDMA). The hydrated lens consists of 45.0% (Ocufilcon D) and 55.0% water by weight of immersed in normal saline

The Largan DB (Ocufilcon D) Daily Wear Soft (hydrophilic) Contact Lens, Largan DB Color (Ocufilcon D) Daily Wear Soft (hydrophilic) Contact Lens, Largan DB (Ocufilcon D) Daily Wear Soft (hydrophilic) Contact Lens for ASTIGMATISM, Largan DB Color (Ocufilcon D) Daily Wear Soft (hydrophilic) Contact Lens for ASTIGMATISM, Largan DB (Ocufilcon D) Daily Wear Soft (hydrophilic) Contact Lens for PRESBYOPIA and Largan DB Color (Ocufilcon D) Daily Wear Soft (hydrophilic) Contact Lens for PRESBYOPIA is a hemispherical flexible shell, which covers the cornea and a portion of the adjacent sclera. UV absorbing monomer is used to filter UV radiation. Reactive Yellow 15 is used to tint the lens. The average transmittance characteristics (the thinnest lens measured by spectrophotometry as stated in ISO 18369) are less than 5% in the UVB range of 280 to 315 nm and less than 50% in the UVA range of 315 to 380 nm. The lenses are available with a visibility-handling tint or with a decorative tint intended to enhance or alter the apparent color of the eye.

This document describes a 510(k) premarket notification for contact lenses. No studies are presented that describe acceptance criteria and device performance in the context of AI/ML or image analysis. The document focuses on demonstrating substantial equivalence to a predicate device, which for contact lenses primarily relies on physicochemical and biocompatibility testing rather than clinical performance studies when the technological characteristics are comparable.

Therefore, I cannot provide a detailed answer to your request regarding acceptance criteria and study results in the context of device performance as you describe (e.g., sample size for test set, data provenance, number of experts, adjudication method, MRMC studies, standalone performance, training set sample size, ground truth establishment for AI/ML models) because this information is not present in the provided text.

The closest information provided related to "acceptance criteria" and "device performance" in this document is:

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

The document presents a comparison table between the new device and predicate devices. While not a strict "acceptance criteria" table with numerical thresholds for performance, it implicitly shows that the Largan DB (Ocufilcon D) Daily Wear Soft Contact Lenses meet the implied performance standards by being identical or highly similar to the legally marketed predicate devices across key technical and material characteristics.

Note: The color additives vary slightly between the new device and the predicate K181232, but are similar to K182523. This difference is addressed through nonclinical testing below.

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

Not applicable. The submission is for contact lenses, and no clinical test set for AI/ML performance is mentioned. The primary studies referenced are physicochemical and biocompatibility tests.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

Not applicable, as no clinical test set requiring expert ground truth is described.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not applicable.

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, as no AI or diagnostic imaging component is involved.

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

Not applicable.

7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)

Not applicable in the context of an AI/ML algorithm. The "ground truth" for contact lenses is established by meeting specified physical, chemical, and biological safety standards.

8. The sample size for the training set

Not applicable, as no AI/ML training set is mentioned.

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

Not applicable.

Studies that prove the device meets acceptance criteria:

The document states:

• Nonclinical Tests Performed:
  • Physiochemical studies were conducted according to ISO 18369-4 second edition 2017-08, Ophthalmic optics -Contact lenses (Ophthalmic). The report states: "The physical, optical and chemical properties of the lens are within established specification for the lenses."
  • Biocompatibility studies (cytotoxicity, acute ocular irritation, and acute systemic injection toxicity) of the subject lenses and primary package were conducted according to ISO 10993 series biocompatibility standard. The report states: "all of them are nontoxic and biocompatible." Specific standards referenced include:
    • ISO 10993 Biological evaluation of medical devices- Part 5: Tests for in vitro cytotoxicity. (2009)
    • ISO 10993 Biological evaluation of medical devices- Part 10: Tests for irritation and skin sensitization. (2010)
    • ISO 10993 Biological evaluation of medical devices- Part 11: Tests for Systemic toxicity. (2006)
    • ISO 10993 Biological evaluation of medical devices- Part 12: Sample preparation and reference materials. (2012)
• Clinical Studies: "The technical characteristics, formulation, manufacturing process of the subject device are equivalent to Largan 55 UV (Ocufilcon D) Daily Wear Soft (hydrophilic) Contact Lens (K181232) and Largan 55 UV Color (Ocufilcon D) Daily Wear Soft (hydrophilic) Contact Lens (K182523) current marketed by Largan Medical Co., Ltd, therefore no clinical data is required." This indicates that the equivalence to predicate devices, supported by nonclinical testing, is deemed sufficient to establish safety and effectiveness, meaning no new clinical trials were performed or required.

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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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