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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.

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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 U38(Polymacon) 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 non-diseased eyes who exhibit refractive astigmatism of 1.00D or less where the astigmatism does not interfere with visual acuity.

The Largan U38(Polymacon) 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 persons with nondiseased 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 U38(Polymacon) Daily Wear Soft (hydrophilic) Contact Lens for Presbyopia is indicated for daily wear for the correction of ametropia (myopia) and emmetropia with presbyopia in aphakic and non-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 U38(Polymacon) Daily Wear Soft (hydrophilic) Contact Lens is available in hemispherical flexible shells for myopia, astigmatisam and presbyopia. The Largan U38 (Polymacon) Daily Wear Soft (hydrophilic) Contact Lens is an aspherical design contact lens. The lens material (Polymacon) is a hydrophilic co-polymer by cross-linking 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. It is supplied in a sterile package with buffered saline solution.

The provided text describes a 510(k) premarket notification for a soft contact lens, which means the device (Largan U38 (Polymacon) Daily Wear Soft (hydrophilic) Contact Lens) is being compared to a legally marketed predicate device (Frequency 38 and Silver 07 (polymacon) Soft (hydrophilic) Contact Lens, K042824). In this context, the acceptance criteria are generally that the new device is "substantially equivalent" to the predicate device in terms of safety and effectiveness, based on comparable technological characteristics and non-clinical performance data.

Here's an breakdown of the information requested, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria are implicitly that the Largan U38 contact lens's characteristics and performance are comparable to the predicate device (Frequency 38 and Silver 07 (polymacon) Soft (hydrophilic) Contact Lens). The "Reported Device Performance" in this case refers to the characteristics and non-clinical test results of the Largan U38 lens, which were presented to demonstrate this comparability.

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

The document indicates that no clinical data was required for the Largan U38 contact lens because "The lens material is the same as Frequency 38 and Silver 07 (polymacon) Soft (hydrophilic) Contact Lens (K042824)." This implies that the "test set" for proving substantial equivalence primarily relied on non-clinical tests comparing the physical, chemical, and optical properties of the Largan U38 lens to established standards and the predicate device.

• Sample Size for Non-Clinical Tests: Not explicitly stated for each test, but typically these involve a sufficient number of units to demonstrate reproducibility and meet statistical requirements for the specific ISO standards cited (e.g., ISO18369-2, ISO18369-3, ISO18369-4, ISO11987, ISO17665-1, ISO17665-2).
• Data Provenance: The manufacturing company is Largan Medical Co., Ltd. located in Taichung, Taiwan, so the non-clinical test data would originate from their facilities or contracted labs, likely in Taiwan. The data is reported in the context of a 510(k) submission, confirming it's a prospective submission of data collected for this device.

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

Since no clinical studies were performed for the Largan U38, there isn't a "ground truth" established by external experts in the traditional sense of clinical trial adjudication (e.g., radiologists interpreting images). The "ground truth" for the non-clinical tests would be the accepted scientific and engineering standards (e.g., ISO standards) and the performance characteristics of the legally marketed predicate device.

• Experts: The expertise would reside in the engineers and scientists performing the non-clinical tests and the regulatory reviewers at the FDA. The FDA's Ophthalmic and Ear, Nose, and Throat Devices panel would review the submission. No specific number or qualifications of "experts establishing ground truth" are detailed as would be for a clinical study.

4. Adjudication method for the test set

No formal adjudication method (like 2+1 or 3+1 consensus) is described because no specific clinical test set requiring expert interpretation or consensus was performed for the Largan U38's substantial equivalence determination. The assessment was based on comparing the non-clinical test results against predefined specifications and the predicate device's characteristics.

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. This submission is for a medical device (contact lens), not an AI/CAD system. Therefore, no MRMC study or AI-assistance evaluation was performed.

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

Not applicable. This submission is for a medical device (contact lens), not an AI algorithm.

7. The type of ground truth used

The "ground truth" for demonstrating substantial equivalence for the Largan U38 contact lens was primarily:

• Established scientific and engineering specifications: Adherence to relevant ISO standards (e.g., ISO18369, ISO11987, ISO17665).
• Predicate device characteristics: The established safety and effectiveness profile of the legally marketed Frequency 38 and Silver 07 (polymacon) Soft (hydrophilic) Contact Lens (K042824).
• Non-clinical test results: Data from physical, optical, chemical, and sterility tests performed on the Largan U38.
• Material composition: The fact that the lens material (Polymacon) is identical to the predicate device was a key factor in waiving clinical studies.

8. The sample size for the training set

Not applicable. There is no "training set" in the context of this contact lens submission, as it's not a machine learning or AI device.

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

Not applicable. As there is no training set, there is no ground truth established for one.

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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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The Largan 55 UV (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 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 55 UV (ocufilcon D) Daily Wear Soft (hydrophilic) Contact Lens for Astigmatism is indicated daily wear for the correction of ametropia (myopia and hyperopia) with astigmatism in aphakic persons with nondiseased 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 (ocufilcon D) Daily Wear Soft (hydrophilic) Contact Lens for Presbyopia is indicated daily wear for the correction of ametropia (myopia) and emmetropia with presbyopia in aphakic and non-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 disinfected using a chemical disinfection system only.

The Largan 55 UV (ocufilcon D) Daily Wear Soft (hydrophilic) Contact Lens is in hemispherical flexible shells for myopia, hyperopia, astigmatisam and Presbyopia. The lens is made from HEMA containing UV blocker. The composition of the lens is 45% ocufilcon D and 55% water. The lens is tinted with "Reactive Blue 246" to make a light blue color for handling visibility purpose. A Benzophenone UV absorbing monomer is used to block UV radiation. The transmittance characteristics are less than 5% in the UVB range of 280-315nm and less than 50% in the UVA range of 316-380mm. It is supplied in a sterile package with buffered saline solution.

This document is a 510(k) Pre-Market Notification from Largan Medical Co. Ltd. to the FDA for their Largan 55 UV (ocufilcon D) Daily Wear Soft (hydrophilic) Contact Lenses. It seeks to demonstrate substantial equivalence to a predicate device, the Biomedics 55 (ocufilcon D) Soft (hydrophilic) Contact Lens (K091339) manufactured by CooperVision, Inc.

Here's an analysis of the acceptance criteria and the study that proves the device meets them, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance:

The document doesn't explicitly state "acceptance criteria" in a quantitative performance metric for the device itself (e.g., a specific visual acuity improvement percentage). Instead, the acceptance is based on demonstrating substantial equivalence to a legally marketed predicate device. This means the new device must be as safe and effective as the predicate.

The comparison table below outlines key characteristics of the new device and the predicate device, highlighting their similarities and differences. The implied acceptance criteria for most metrics are that the new device's specifications should be comparable or within acceptable ranges to the predicate.

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

The document explicitly states: "no clinical data is required." This indicates that there was no test set (as in, a set of subjects on whom clinical performance was specifically tested for this 510(k)). The determination of substantial equivalence was based on a comparison of characteristics to the predicate device and non-clinical laboratory testing. Therefore, there is no sample size for a test set, nor data provenance in the context of a clinical study.

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)

Since no clinical test set was used, there were no experts used to establish ground truth in the context of clinical performance data for the Largan 55 UV contact lenses. The ground truth for the safety and effectiveness is largely established by the predicate device's prior approval and the general understanding of contact lens materials and designs.

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

As there was no clinical test set, there was no adjudication method employed.

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

This is not applicable. The device in question is a contact lens, not an AI-powered diagnostic tool. Therefore, no MRMC study or assessment of human reader improvement with/without AI assistance was performed or reported.

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

This is not applicable. The device is a physical contact lens, not an algorithm.

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

The "ground truth" in this context is the established safety and effectiveness of the predicate device (Biomedics 55, K091339) and the scientific understanding of the materials (ocufilcon D) and design principles for contact lenses. The evaluation relies on:

• Physical and chemical properties: Assessed according to ISO 18369.
• Toxicology/Biocompatibility: Demonstrated through non-clinical studies.
• Comparison of characteristics: To a legally marketed predicate device.

Essentially, the ground truth is that if the new device is sufficiently similar to an already approved, safe, and effective device in its critical characteristics, then it is also considered safe and effective.

8. The sample size for the training set

This is not applicable. The device is a contact lens and does not involve AI or machine learning models that require a training set.

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

This is not applicable, as there is no training set for an AI/ML algorithm involved with this medical device submission.

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The Largan 55 (methafilcon A) 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 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 (methafilcon A) Daily Wear Soft (hydrophilic) Contact Lens for Astigmatism is indicated daily wear for the correction of ametropia (myopia and hyperopia) with astigmatism in aphakic persons with nondiseased 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 (methafilcon A) Daily Wear Soft (hydrophilic) Contact Lens for Presbyopia is indicated daily wear for the correction of ametropia (myopia and hyperopia) and emmetropia in aphakic and non-aphakic persons with non-diseased eyes and whose powers are from -10.00 to +3.00 diopters 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 disinfected using a chemical disinfection system only.

The Largan 55 (methafilcon A) Daily Wear Soft (hydrophilic) Contact Lens is in hemispherical flexible shells for myopia, hyperopia, astigmatisam and presbyopia. The lens is made from HEMA containing UV blocker. The composition of the lens is 45% methafilcon A and 55% water. A light blue color tinted with "reactive Blue 246" is for handling visibility purpose. Benzotriazole UV absorbing monomer is used to block UV radiation. The transmittance characteristics are 1.53% (

The provided text does not contain information about acceptance criteria and a study proving a device meets these criteria for an AI/ML medical device.

The document is a 510(k) premarket notification for a soft (hydrophilic) contact lens, specifically the "Largan 55 (methafilcon A) Daily Wear Soft (hydrophilic) Contact Lens." It focuses on demonstrating substantial equivalence to a legally marketed predicate device (CooperVision's Frequency 55 series) based on physical, chemical, and optical properties, and manufacturing process.

Therefore, I cannot extract the requested information regarding AI/ML device acceptance criteria and study details from this document. If you have a different document related to an AI/ML medical device, please provide it.

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The Largan (hioxifilcon A) 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 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 (hioxifilcon A) Daily Wear Soft (hydrophilic) Contact Lens for Astigmatism is indicated daily wear for the correction of ametropia (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 (hioxifilcon A) Daily Wear Soft (hydrophilic) Contact Lens for Presbyopia is indicated daily wear for the correction of ametropia (myopia and hyperopia) and emmetropia in aphakic and non-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 disinfected using a chemical disinfection system only.

The Largan (hioxifilcon A) Daily Wear Soft (hydrophilic) Contact Lens is in hemispherical flexible shells for myopia, hyperopia, astigmatisam and Presbyopia. The lens is made from HEMA containing UV blocker. The composition of the lens is 41% hioxifilcon A and 59% water. A light blue color tinted with "reactive Blue 247" is for handling visibility purpose. A benzotriazole UV absorbing monomer is used to block UV radiation. The transmittance characteristics are 1.3% (

This document does not contain an acceptance criteria table or a study proving the device meets specific acceptance criteria in the manner you've requested for an AI/CADe device. This document is a 510(k) premarket notification for a soft contact lens, demonstrating substantial equivalence to a predicate device rather than presenting a novel algorithm's performance against defined metrics.

Here's a breakdown of why the requested information isn't available in this document:

• Device Type: The device is a "Largan (hioxifilcon A) Daily Wear Soft (hydrophilic) Contact Lens," not an AI/CADe device.
• Approval Pathway: This is a 510(k) submission, which aims to demonstrate that a new device is "substantially equivalent" to a legally marketed predicate device. This pathway generally relies on demonstrating similar technological characteristics and performance to the predicate, rather than conducting new efficacy studies with acceptance criteria for a novel algorithm.
• "No clinical data is required" statement: The document explicitly states: "The technical characteristics, formulation, manufacturing process of the subject device are equivalent to AQUASOFT ALL-DAY & ALL-DAY T Daily Wear Contact Lens (K0052290) current marketed by CearLab Pte Ltd, therefore no clinical data is required." This directly indicates that the type of study you're asking for (one proving performance against acceptance criteria) was not performed for this submission.

However, I can extract information related to the device and its comparison to a predicate, which are analogues to some of your requested points:

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

This document does not provide acceptance criteria in the typical "pass/fail" sense for a novel device feature's performance. Instead, it provides a comparison table of characteristics between the applicant's device and the predicate device to demonstrate equivalence. One could interpret the predicate device's established characteristics as the "acceptance criteria" for the new device to be considered substantially equivalent.

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

• The document explicitly states: "no clinical data is required." Therefore, there is no test set, sample size, or data provenance information of this nature. Non-clinical physiochemical and toxicology studies were performed, but these are for material properties, not a performance evaluation in a test set as you imply for an AI/CADe device.

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. No clinical test set.

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

• Not applicable. No clinical 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

• Not applicable. This is not an AI device. No MRMC study was done.

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

• Not applicable. This is not an algorithm/AI device.

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

• For the non-clinical tests: The "ground truth" for physiochemical studies would be established specifications and reference standards (e.g., ISO 18369). For toxicology, it would be standard biocompatibility testing protocols, showing the lenses are "non-toxic and biocompatible."

8. The sample size for the training set

• Not applicable. This is not an AI device, so there is no training set in this context.

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

• Not applicable. No training set.

In summary, this document is a regulatory submission for a medical device (contact lens) through the 510(k) pathway, which focuses on demonstrating substantial equivalence. The specific types of acceptance criteria and studies you've requested are characteristic of AI/CADe devices or PMA submissions for novel devices, neither of which applies here.

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