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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% (< 0.05Tv) in the UVB range of 280-315nm and 22.36 % (< 0.5Tv) in the UVA range of 316-380nm. It is supplied in a sterile state packaged in a buffered saline solution.

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% (< 5%) in the UVB range of 280-315nm and14.2 % (< 50%) in the UVA range of 316-380nm. It is supplied in a sterile state packaged in a buffered saline solution.

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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