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The VISTAKON® (senofilcon A) Contact Lens is indicated for daily wear for the correction of refractive ametropia (myopia and hyperopia) in phakic or aphakic persons with non-diseased eyes who may have 1.00D or less of astigmatism.

The VISTAKON® (senofilcon A) Multifocal Contact Lens is indicated for daily wear for the correction of distance and near vision in presbyopic, phakic or aphakit persons with non-diseased eyes who may have 0.75 D of astigmatism or less.

The VISTAKON® (senofilcon A) Toric Contact Lens is indicated for daily wear for the correction of visual acuity in phakic or aphakic persons with non-diseased eyes that are hyperopic or myopic and may have 10.00 D of astigmatism or less.

The VISTAKON® (senofilcon A) Multifocal-Toric Contact Lens is indicated for daily wear for the correction of distance and near vision in presby opic phakic or apakic persons with non-diseased eyes who may have 10.00 D of astigmatism or less.

VISTAKON® (senofilcon A) UV Blocking Contact Lenses help protect against transmission of harmful UV radiation to the cornea and into the eye.

Eye Care Practitioners may prescribe the lenses either for single-use disposable wear or frequent/planned replacement wear with cleaning, disinfection and scheduled replacement. When prescribed for frequent/planned replacement wear, the lenses may be disinfected using a chemical disinfection system only.

• The VISTAKON® (senofilcon A) Contact Lens Clear and Visibility Tint with UV Blocker is available as a spherical lens, a multifocal lens, a toric lens and a multifocal-toric lens.
• The lenses are made of a silicone hydrogel material containing an internal wetting agent.
• The VISTAKON® (senofilcon A) Contact Lens may be tinted blue using Reactive Blue Dye #4 to make the lens more visible for handling.
• A benzotriazole UV absorbing monomer is used to block UV radiation. The transmittance characteristics are less than 1% in the UVB range of 280 – 315nm and less than 10% in the UVA range of 316 – 380nm.
• The VISTAKON® (senofilcon A) Contact Lens is a hemispherical or hemitoric shell.
• The lens is supplied in a sterile state, packaged in a buffered saline solution with 0.005% methyl ether cellulose.
• The composition of the lens is 62% senofilcon A and 38% water by weight when hydrated and stored in the buffered saline solution.

Here's a summary of the acceptance criteria and study information for the VISTAKON® (senofilcon A) Contact Lens, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The submission focuses on establishing substantial equivalence to a predicate device rather than setting specific numeric acceptance criteria for revolutionary performance. The "acceptance criteria" here are implied through comparative performance to the predicate and general safety/effectiveness.

2. Sample Size for Test Set and Data Provenance

• Sample Size: "at least 50 patients" were evaluated in the clinical study.
• Data Provenance: The document does not explicitly state the country of origin for the clinical study. It was a prospective clinical study conducted over "three (3) months".

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications

The document does not specify the number of experts or their qualifications for establishing ground truth within the clinical study. The clinical study evaluated parameters like adverse reactions, keratometry changes, reasons for discontinuations, and unscheduled lens replacements, which would typically be assessed by eye care professionals.

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 data or outcomes.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

No. This type of study (MRMC for AI assistance) is not applicable to this device, which is a contact lens and not an AI-powered diagnostic or assistive tool. The study was a clinical trial comparing the new contact lens to a predicate lens.

6. Standalone (Algorithm Only) Performance

Not applicable. This device is a contact lens and does not involve an algorithm.

7. Type of Ground Truth Used

The ground truth for the clinical study appears to be based on clinical assessments and observations by investigators during the study, evaluating parameters such as visual acuity, ocular health, comfort, and fit, as well as adverse reactions. For toxicology and biocompatibility, the ground truth was established through in vitro and in vivo preclinical toxicology and biocompatibility tests following GLP regulations.

8. Sample Size for the Training Set

Not applicable. This device is a contact lens and does not involve an AI algorithm with a training set.

9. How the Ground Truth for the Training Set Was Established

Not applicable. As there is no AI algorithm, there is no training set or ground truth for a training set.

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The ACUVUE® 2 COLOURS Contact Lenses are 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 aphakic or not aphakic persons with non-diseased eyes who may have 1.00D or less of astigmatism. ACUVUE® 2 COLOURS contact lenses are available in 0.00D for those patients who do not need vision correction but desire the cosmetic benefits of opaque or enhancer cosmetic contact lenses.

The ACUVUE® 2 COLOURS (etafilcon A) Soft (hydrophilic) BIFOCAL Contact Lens is indicated for daily wear for the correction of distance and near vision in presbyopic, aphakic or not aphakic persons with non-diseased eyes who may have 0.75 D of astigmatism or less.

The ACUVUE® 2 COLOURS (etafilcon A) Soft (hydrophilic) TORIC Contact Lens is indicated for daily wear for the correction of visual acuity in aphakic or not aphakic persons with non-diseased eyes that are hyperopic or myopic and may have 10.00 D of astigmatism or less.

The ACUVUE® 2 COLOURS (etafilcon A) Soft (hydrophilic) TORIC-BIFOCAL Contact Lens is indicated for daily wear for the correction of distance and near vision in presbyopic aphakic or not aphakic persons with non-diseased who may have 10.00 D of astigmatism or less.

ACUVUE® 2 COLOURS UV Blocking Contact Lenses help protect against transmission of harmful UV radiation to the cornea and into the eye.

The ACUVUE 2 COLOURS Contact Lenses may be prescribed for daily wear. Eye Care Practitioners may prescribe the lenses either for single-use disposable wear or frequent/planned replacement wear with cleaning, disinfection and scheduled replacement (see "Wearing Schedule"). When prescribed for frequent/planned replacement wear, the lenses may be disinfected using a chemical disinfection system only.

The device description is identical to that cleared under K010114 and K024177.

The provided 510(k) summary for the ACUVUE® 2 COLOURS™ Brand (etafilcon A) Soft Hydrophilic Contact Lens with UV Blocker does not describe any acceptance criteria or the results of a study to prove the device meets such criteria related to AI or algorithm performance.

Instead, this submission is for a medical device (contact lens) where the manufacturer states that no clinical studies were required to demonstrate the safety and effectiveness of the device. This is because the device is deemed "substantially equivalent" to a predicate device already cleared by the FDA (K024177 and K010114).

Therefore, the requested information regarding acceptance criteria, device performance, sample sizes for test/training sets, expert qualifications, ground truth, and comparative effectiveness studies for an AI/algorithm is not applicable based on the provided document.

The document focuses on non-clinical studies typically required for contact lenses, such as:

• Toxicology: USP Ocular Irritation, USP Systemic Toxicity, In-Vitro Cytotoxicity
• Chemistry/Leachables: Formulation and Process, Physical and Mechanical Properties, Leachable Monomer and Additives

The conclusion is that the modified contact lens is substantially equivalent to the previously cleared predicate device, meaning it has the same intended use and technological characteristics, and thus does not require new clinical data to prove safety and effectiveness.

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The ACUVUE® Brand Contact Lens (spherical) are indicated for daily wear to enhance or alter the apparent color of the eye for lenses with cosmetic tint and/or for the correction of refractive ametropia (myopia and hyperopia) in aphakic or not-aphakic persons with non-diseased eyes who may have 1.00 D or less of astigmatism.

The ACUVUE® Brand (etafilcon A) Soft (hydrophilic) BIFOCAL Contact Lenses are indicated for daily wear to enhance or alter the apparent color of the eye for lenses with cosmetic tint and for the correction of distance and near vision in presbyopic, aphakic or not-aphakic persons with non-diseased eyes who may have 0.75 D or less of astigmatism.

The ACUVUE® Brand (etafilcon A) Soft (hydrophilic) TORIC Contact Lenses are indicated for daily wear to enhance or alter the apparent color of the eye for lenses with cosmetic tint and for the correction of visual acuity in aphakic or not-aphakic persons with non-diseased eyes that are hyperopic or myopic and may have 10.00 D or less of astigmatism.

The ACUVUE® Brand (etafilcon A) Soft (hydrophilic) TORIC BIFOCAL Contact Lenses are indicated for daily wear to enhance or alter the apparent color of the eye for lenses with cosmetic tint and for the correction of distance and near vision in presbyopic aphakic or not-aphakic persons with non-diseased eyes who may have 10.00 D of astigmatism or less.

ACUVUE® Brand (etafilcon A) Soft (hydrophilic) UV Blocking Contact Lenses help protect against transmission of harmful UV radiation to the cornea and into the eye.

Eye Care Practitioners may prescribe the lens for single-use disposable wear (See "Wearing Schedule").

The device descriptions do not change from those cleared under K994324 and K010114.

1. Acceptance Criteria and Reported Device Performance:

2. Sample Size and Data Provenance:

The document does not explicitly state the sample size used for the additional clinical study supporting the labeling modification. However, it mentions that this study demonstrated improved comfort for "2 out of 3 patients." This implies a small, likely prospective clinical study. The country of origin for the data is not specified, but given the submitter's location (Jacksonville, Florida) and the FDA submission, it likely originates from the United States or a region following similar clinical guidelines.

3. Number of Experts and Qualifications:

Not applicable. This device is a contact lens, and the study focuses on patient-reported comfort, not diagnostic image interpretation. The "experts" would be the patients themselves reporting on their comfort levels.

4. Adjudication Method:

Not applicable. The study's focus is on patient-reported comfort, not on expert adjudication of diagnostic findings. Patient comfort is a subjective measure, and adjudication in the traditional sense (e.g., by multiple clinical experts) is not typically used for such outcomes.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:

No, an MRMC comparative effectiveness study was not done. This type of study is relevant for diagnostic imaging devices where human readers interpret results, and the AI's impact on their performance is being evaluated. This submission is for a contact lens and focuses on patient comfort.

6. Standalone Performance Study:

A standalone performance study was done in the sense that the clinical research directly assessed the comfort provided by the ACUVUE® Brand (etafilcon A) Soft (hydrophilic) Contact Lenses when worn on a daily disposable basis. This was an "algorithm only" equivalent as the device itself is the intervention being tested, without human-in-the-loop interpretation.

7. Type of Ground Truth Used:

The ground truth for this study was patient-reported outcomes (PROs), specifically patient comfort and the experience of itching and mild discomfort associated with allergies during contact lens wear.

8. Sample Size for the Training Set:

Not applicable. This is not an AI/ML device that requires a training set. The clinical study directly evaluated the performance of the physical contact lens.

9. How Ground Truth for the Training Set was Established:

Not applicable. As noted above, this is not an AI/ML device, so there is no training set in the context of machine learning. The "ground truth" (patient comfort) for the clinical study was established through patient self-reporting.

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The ACUVUE Contact Lens (spherical) is indicated for daily wear for the correction of refractive ametropia (myopia and hyperopia) in aphakic or non-aphakic persons with non-diseased eyes who may have 1.00 D or less of astigmatism.

The ACUVUE BIFOCAL Contact Lens is indicated for daily wear for the correction of distance and near vision in presbyopic, aphakic or non-aphakic persons with non-diseased eyes who may have 0.75 D or less of astigmatism.

The ACUVUE TORIC Contact Lens is indicated for daily wear for the correction of visual acuity in aphakic or non-aphakic persons with non-diseased eyes that are hyperopic or myopic and may have 10.00 D or less of astigmatism.

The ACUVUE TORIC BIFOCAL Contact Lens is indicated for daily wear for the correction of distance and near vision in presbyopic aphakic or non-phakic persons with non-diseased eyes who may have 10.00 D of astigmatism or less.

ACUVUE Contact Lenses help protect against transmission of harmful UV radiation to the cornea and into the eye.

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 frequent/planned replacement wear, the lens may be disinfected using a chemical disinfection system only.

The device description does not change from that cleared under K991134.

The provided 510(k) submission (K994324) for the ACUVUE (etafilcon A) soft contact lenses is a labeling modification submission, not a submission for a new device requiring a comprehensive performance study against acceptance criteria.

The purpose of this 510(k) is to revise the wear schedule in the labeling to include a statement about the reduced risk of giant papillary conjunctivitis (GPC) with frequent replacement.

Therefore, many of the typical elements of a performance study required for novel device clearance are not present or applicable in this document.

Here's an analysis based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

This 510(k) submission does not present a table of acceptance criteria or new device performance data in the way a new device would. The core claim is a labeling modification supported by existing clinical literature, not new performance metrics for the device itself.

The "acceptance criteria" in this context would be the FDA's acceptance of the scientific literature supporting the labeling change.

2. Sample Size Used for the Test Set and Data Provenance

• Test Set (for the labeling claim): The submission states that the labeling modification is supported by "clinical studies published in the July 1999 CLAO Journal (see Attachment A)." Attachment A is not provided in the document. Therefore, the sample size and data provenance of these specific studies are not detailed in this 510(k) submission.
• Data Provenance: The document does not specify the country of origin of the data mentioned in the CLAO Journal. It states the studies were "published," implying they are retrospective in terms of this 510(k) submission.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

This information is not provided in the 510(k) submission. As the evidence relies on published clinical studies, the details about expert involvement in establishing ground truth would typically be found within those external publications, not in this regulatory submission.

4. Adjudication Method for the Test Set

This information is not provided in the 510(k) submission for the same reasons as above.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

No, an MRMC comparative effectiveness study was not done, nor would it be relevant for a contact lens labeling modification based on GPC risk. This type of study is more common for diagnostic imaging or AI-assisted diagnostic devices.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

N/A. This device is a contact lens; there is no algorithm or human-in-the-loop performance component.

7. The Type of Ground Truth Used

The "ground truth" for the labeling modification regarding reduced GPC risk would be derived from the clinical outcomes data reported in the published studies cited (July 1999 CLAO Journal). This would include observations and diagnoses of GPC in patients using contact lenses with different replacement schedules.

8. The Sample Size for the Training Set

N/A. This device is a contact lens. There is no training set in the context of machine learning or algorithms. The "training data" for general contact lens safety and efficacy would have been the extensive clinical trials conducted for the original device clearance (K991134).

9. How the Ground Truth for the Training Set Was Established

N/A. See point 8. The ground truth for the original ACUVUE lens (K991134) would have been established through standard clinical trial methodologies, including patient examinations, objective measurements, and subjective patient feedback, reviewed and interpreted by qualified clinicians, to demonstrate the lens's safety and effectiveness for its intended use.

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The VISTAKON Contact Lens (spherical) is indicated for daily wear for the correction of refractive ametropia (myopia and hyperopia) in aphakic or non-aphakic persons with non-diseased eves who may have 1.00 D or less of astigmatism.

The VISTAKON BIFOCAL Contact Lens is indicated for daily wear for the correction of distance and near vision in presbyopic, aphakic or non-aphakic persons with nondiseased eyes who may have 0.75 D or less of astigmatism.

The VISTAKON TORIC Contact Lens is indicated for daily wear for the correction of visual acuity in aphakic or non-aphakic persons with non-diseased eyes that are hyperopic or myopic and may have 10.00 D or less of astigmatism.

The VISTAKON TORIC BIFOCAL Contact Lens is indicated for daily wear for the correction of distance and near vision in presbyopic aphakic or non-phakic persons with non-diseased eyes who may have 10.00 D of astigmatism or less.

VISTAKON Contact Lenses help protect against transmission of harmful UV radiation to the cornea and into the eye.

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 frequent/planned replacement wear, the lens may be disinfected using a chemical disinfection system only.

The device description does not change from that cleared under K991163.

Here's an analysis of the provided text regarding the acceptance criteria and study for the VISTAKON contact lenses:

1. Table of Acceptance Criteria and Reported Device Performance

The provided text does not explicitly state specific quantitative acceptance criteria or detailed device performance metrics in the way typically seen for new medical device clearances. This 510(k) submission is for a labeling modification to an already cleared device (K991163), not for a new device or a significant change in its design or performance.

The "acceptance criteria" here are implicitly related to demonstrating that the revised labeling (specifically, the claim about reduced risk of giant papillary conjunctivitis) is supported by existing clinical evidence.

However, based on the information, we can infer the "performance" goal as demonstrating the established safety and efficacy for the original device, as the current submission relies on that prior clearance.

2. Sample Size Used for the Test Set and Data Provenance

• Test Set Sample Size: Not explicitly stated in this document. The submission references "clinical studies published in the July 1999 CLAO Journal" (Attachment A) as the basis for the labeling modification. The sample size would be found within those external publications, but is not provided here.
• Data Provenance: The document does not specify the country of origin of the data. It refers to "clinical studies published in the July 1999 CLAO Journal," which could be from various locations. The studies are assumed to be prospective given they are clinical studies, likely trials, investigating the impact of wear schedules.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications

This information is not provided in the submission. The "ground truth" for the claims about GPC risk reduction would have been established by the methods described in the referenced clinical studies (e.g., clinical examination, diagnosis by ophthalmologists/optometrists). The number and qualifications of the experts involved in those studies are not detailed in this 510(k).

4. Adjudication Method for the Test Set

This information is not provided. As the submission refers to external clinical studies, the adjudication methods (if any, for outcomes like GPC diagnosis) would be detailed within those publications.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

No, an MRMC comparative effectiveness study was not done for this submission. MRMC studies are typically used to evaluate the impact of AI-assisted diagnostic devices on human reader performance. This submission concerns a contact lens, not a diagnostic AI system.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done

No, a standalone performance evaluation was not done. This is not an AI/algorithm-based device. The "performance" being evaluated is related to the clinical outcomes associated with the wear schedule of the contact lens.

7. The Type of Ground Truth Used

The ground truth used for the claims about the reduction of giant papillary conjunctivitis (GPC) would have been clinical diagnosis by eye care professionals. This would involve direct observation and examination of the patient's eyes for signs of GPC as per established diagnostic criteria. It is a form of "expert consensus" or "clinical diagnosis" based on observable medical conditions.

8. The Sample Size for the Training Set

This information is not applicable as this is not an AI/machine learning device that requires a training set. The clinical studies supporting the claims would have involved a patient cohort, but it's not a "training set" in the context of an algorithm.

9. How the Ground Truth for the Training Set Was Established

This information is not applicable as there is no training set for an AI/ML algorithm. For the clinical studies, the "ground truth" for GPC diagnosis would have been established by the clinical assessments and diagnoses of the investigators or study clinicians.

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The VISTAKON Contact Lens (spherical) is indicated for daily wear for the correction of refractive ametropia (myopia and hyperopia) in aphakic or non-aphakic persons with non-diseased eyes who may have 1.00 D or less of astigmatism.

The VISTAKON BIFOCAL Contact Lens is indicated for daily wear for the correction of distance and near vision in presbyopic, aphakic or non-aphakic persons with non-diseased eyes who may have 0.75 D or less of astigmatism.

The VISTAKON TORIC Contact Lens is indicated for daily wear for the correction of visual acuity in aphakic or non-aphakic persons with non-diseased eyes that are hyperopic or myopic and may have 10.00 D or less of astigmatism.

The VISTAKON TORIC BIFOCAL Contact Lens is indicated for daily wear for the correction of distance and near vision in presbyopic aphakic or non-phakic persons with non-diseased eyes who may have 10.00D of astigmatism or less.

VISTAKON UV Blocking Contact Lenses help protect against transmission of harmful UV radiation to the cornea and into the eye.

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 frequent/planned replacement wear, the lens may be disinfected using a chemical disinfection system only.

The device description does not change from that cleared under K983912.

The provided 510(k) submission (K991163) for the VISTAKON (lenefilcon A) soft (hydrophilic) contact lenses does not describe a study involving acceptance criteria and device performance in the typical sense of a new medical device efficacy study. Instead, this submission is a labeling modification for an already cleared device (K983912).

Therefore, the following information is largely not applicable or directly extractable from the provided text, as the focus is on the equivalence of the device and its existing data to support new indications, rather than a de novo study demonstrating meeting new acceptance criteria.

Here's an analysis based on the provided document:

1. Table of Acceptance Criteria and Reported Device Performance

The submission does not present a table of acceptance criteria or new device performance data. The core of this 510(k) is that the device material and manufacturing process are unchanged from a previously cleared device (K983912). The only new "performance" mentioned relates to UV blocking, which was also established in a prior submission or existing data.

• UV Blocking:
  • UVA: 95%
  • UVB: 99.9%
  • Acceptance Criteria for UV Blocking: Not explicitly stated in this document, but implied to be met based on the reported values. Generally, contact lenses classified as UV-blocking must meet certain FDA-defined percentages for UVA and UVB absorption.

2. Sample Sizes Used for the Test Set and Data Provenance

• Test Set Description: Not applicable, as no new clinical or non-clinical studies were conducted specifically for this 510(k) to establish performance against new acceptance criteria.
• Data Provenance: The submission explicitly states: "There is no change in lens material, the manufacturing process, nor the parameters and properties, therefore, the clinical data previously submitted in K983912 supports the clinical safety of the subject device." This means any performance data supporting the indications would stem from studies related to K983912. The provenance for those original studies is not detailed in this document.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications

• Not applicable, as no new test set was created for a study mentioned in this 510(k). The clinical safety is supported by prior data.

4. Adjudication Method for the Test Set

• Not applicable, as no new test set was created for a study mentioned in this 510(k).

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

• No MRMC study was done. This device is a contact lens, and the 510(k) is for an expanded indication statement, not for an AI diagnostic or interpretive device. Therefore, a human reader improvement effect size is not relevant.

6. Standalone Performance Study (Algorithm Only)

• No standalone performance study was done. This device is a contact lens. The concept of an "algorithm only" performance is not applicable.

7. Type of Ground Truth Used

• For the original submission (K983912) that established the safety and efficacy of the lens material, the "ground truth" would have likely been based on clinical outcomes data from human subjects wearing the contact lenses (e.g., visual acuity, comfort, adverse events, fit characteristics, etc.) as evaluated by optometrists or ophthalmologists.
• For the UV blocking claim, the ground truth would be based on laboratory measurements of UV transmission through the lens material.

8. Sample Size for the Training Set

• Not applicable. This 510(k) is not for a machine learning or AI device that requires a training set. The clinical data from K983912 would have involved a cohort of human subjects. The details of that sample size are not in this document.

9. How the Ground Truth for the Training Set Was Established

• Not applicable, as there is no "training set" in the context of this 510(k). For the original clinical data from K983912, the ground truth would have been established by clinical investigators (eye care professionals) assessing patient outcomes and device performance against defined endpoints in clinical trials.

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The ACUVUE Contact Lens (spherical) is indicated for daily wear for the correction of refractive ametropia (myopia and hyperopia) in aphakic or nonaphakic persons with non-diseased eyes who may have 1.00 D or less of astigmatism.

The ACUVUE BIFOCAL Contact Lens is indicated for daily wear for the correction of distance and near vision in presbyopic, aphakic or non-aphakic persons with non-diseased eyes who may have 0.75 D or less of astigmatism.

The ACUVUE TORIC Contact Lens is indicated for daily wear for the correction of visual acuity in aphakic or non-aphakic persons with non-diseased eyes that are hyperopic or myopic and may have 10.00 D or less of astigmatism.

The ACUVUE TORIC BIFOCAL Contact Lens is indicated for daily wear for the correction of distance and near vision in presbyopic aphakic or non-phakic persons with non-diseased eyes who may have 10.00D of astigmatism or less.

ACUVUE UV Blocking Contact Lenses help protect against transmission of harmful UV radiation to the cornea and into the eye.

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 frequent/planned replacement wear, the lens may be disinfected using a chemical disinfection system only.

The device description does not change from that cleared under K962804.

The provided text describes a 510(k) submission for ACUVUE (etafilcon A) soft (hydrophilic) contact lenses. This submission is for a labeling modification to add an additional Indications Statement. It is not an AI/ML device, and therefore, many of the requested criteria regarding AI/ML device performance and studies are not applicable.

Here's an analysis of the available information:

1. Table of Acceptance Criteria and Reported Device Performance

The submission does not provide specific acceptance criteria or reported device performance for an AI/ML device. Instead, it refers to the existing clearance of the same lens material (etafilcon A) and its associated performance as sufficient due to the nature of the 510(k) being a labeling modification.

2. Sample Size Used for the Test Set and Data Provenance

Not applicable as this is not an AI/ML device requiring a test set for algorithm performance evaluation. The submission relies on existing clinical and non-clinical data for the lens material itself from previous submissions (N18-033/S31 and K962804). The provenance of that historical data is not detailed in this document.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications

Not applicable as this is not an AI/ML device using a test set with ground truth established by experts.

4. Adjudication Method for the Test Set

Not applicable as this is not an AI/ML device using a test set.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

No, an MRMC comparative effectiveness study was not done. This is not an AI/ML device, so such a study to evaluate human reader improvement with AI assistance is not relevant.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done

No, a standalone performance study was not done. This is not an AI/ML device.

7. The Type of Ground Truth Used

The concept of "ground truth" as typically applied to AI/ML device performance (e.g., expert consensus, pathology, outcomes data) is not directly applicable here. The demonstration of safety and effectiveness for a contact lens material (etafilcon A) generally relies on:

• Clinical safety and efficacy data: Data from human trials assessing visual acuity, comfort, ocular health, and adverse events.
• Non-clinical data: Laboratory testing for material properties, microbiology, toxicology, chemistry, shelf-life, and leachability.

The submission states that this data was sufficient for the predicate devices and supports the current device due to no changes in material or manufacturing process.

8. The Sample Size for the Training Set

Not applicable as this is not an AI/ML device requiring a training set.

9. How the Ground Truth for the Training Set Was Established

Not applicable as this is not an AI/ML device requiring a training set with established ground truth.

Conclusion:

This 510(k) submission is for a labeling modification for an existing contact lens product. The "device" in question is a contact lens, not an AI/ML diagnostic or therapeutic system. Therefore, most of the requested information pertaining to AI/ML device acceptance criteria, studies, and ground truth establishment is not relevant to this specific document. The submission relies on the previously established safety and effectiveness of the etafilcon A material clear in prior 510(k)s and PMAs.

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The VISTAKON Contact Lens is indicated for daily wear for the correction of refractive ametropia (myopia and hyperopia) in aphakic or non-aphakic persons with non-diseased eyes who may have 1.00 D of astigmatism or less.
The VISTAKON MULTIFOCAL Contact Lens is indicated for daily wear for the correction of distance and near vision in presbyopic aphakic or non-aphakic persons with non-diseased eyes who may have 0.75 D of astigmatism or less.
The VISTAKON TORIC Contact Lens is indicated for daily wear for the correction of visual acuity in aphakic or non-aphakic persons with non-diseased eyes that are hyperopic or myopic and may have 10.00 D of astigmatism or less.
The VISTAKON TORIC MULTIFOCAL Contact Lens is indicated for daily wear for the correction of distance and near vision in presbyopic aphakic or non-aphakic persons with non-aphakic persons with non-diseased eyes who may have 10.00 D of astigmatism or less.
Eye care practitioners may prescribe the lens either for single-use disposable wear or 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 disinfection system only.

The VISTAKON (lenefilcon A) Soft (hydrophilic) Contact Lens is available as a spherical lens, a multifocal lens, a toric lens and a toric multifocal lens.
The lens material (lenefilcon A) is a copolymer of 2-hydroxyethyl 2-methyl-2 propenoate and 2-propenic acid, 2-methyl-2,3-dihydroxypropyl ester cross-linked with poly (oxy-1,2-ethanediyl) (4) bis (2-methyl-2-propenoate). The VISTAKON Contact Lens Visibility Tint with UV Blocker is tinted blue using Reactive Blue Dye #4 to make the lens more visible for handling. A benzotriazole UV-absorbing monomer is used to block UV radiation. The transmittance characteristics are less than 1% in the UVB range of 280nm to 315nm and less than 10% in the UVA range of 316nm to 380nm. The VISTAKON Contact Lens is a hemispherical or hemitoric shell.

The VISTAKON (lenefilcon A) Soft Contact Lens is a contact lens with various designs (spherical, multifocal, toric, and toric multifocal) intended for daily wear to correct refractive ametropia. The study for this device did not involve an AI component, nor did it involve the evaluation of expert performance with or without AI assistance. Instead, it was a clinical and non-clinical study to demonstrate substantial equivalence to a predicate device.

1. Table of Acceptance Criteria and Reported Device Performance

Notes on Acceptance Criteria:

• The acceptance criteria for the material properties and physical dimensions are implied by demonstrating substantial equivalence to the predicate device. The performance data for the VISTAKON lens is compared directly to the predicate device's data.
• For non-clinical studies (toxicology, chemistry, microbiology), the acceptance criteria are based on established standards and previous demonstrations of compatibility (e.g., ISO studies, validated sterilization processes).

2. Sample Size for Test Set and Data Provenance

• Sample Size for Test Set: At least 50 patients participated in the clinical trial. The ratio of subject device to predicate device was 2:1.
• Data Provenance: Not explicitly stated, but clinical trials for US FDA submissions are typically conducted in the US. The study evaluated "Daily Wear contact lens materials with a new USAN name according to the Premarket Notification (510(k)) Guidance Document for Daily Wear Contact Lenses (May 1994)," which implies US-centric regulatory guidelines. The study was prospective as it involved a clinical trial.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications

The submission does not specify the number or qualifications of experts (e.g., ophthalmologists, optometrists) involved in establishing the ground truth or evaluating patient outcomes in the clinical trial. However, clinical trials for contact lenses typically involve qualified eye care professionals for examinations and assessments.

4. Adjudication Method for the Test Set

The submission does not explicitly describe an adjudication method for the clinical study's evaluations (e.g., 2+1, 3+1). Clinical trials generally involve standardized protocols for examinations and reporting adverse events, which implicitly serve as a form of "ground truth" establishment by the clinical investigators.

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 performed or is applicable to this device. This submission is for a medical device (contact lens), not an AI-powered diagnostic or assistive tool.

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

Not applicable. This device is a contact lens and does not involve an algorithm or AI.

7. The Type of Ground Truth Used

For the clinical study:

• The "ground truth" was established through direct clinical observation and measurement of various parameters in patients wearing the contact lenses. These parameters included:
  • Adverse reactions
  • Symptoms
  • Problems and complaints reported by patients
  • Slit lamp evaluations (objective assessment of ocular health)
  • Visual acuity (objective measurement of vision correction)
  • Lens wear time
  • Fit assessment
  • Discontinuations from the study
• For non-clinical studies (chemistry, toxicology, microbiology), the ground truth was based on established scientific protocols, validated methods, and regulatory standards (e.g., ISO studies, validated sterilization processes).

8. The Sample Size for the Training Set

Not applicable. This device is a contact lens, not an AI model requiring a training set. The "training" for the device would be its manufacturing process and design, refined through R&D.

9. How the Ground Truth for the Training Set Was Established

Not applicable, as there is no training set for an AI model. The development of the VISTAKON contact lens material and design would have involved extensive R&D, material characterization, and design optimization based on scientific principles and previous knowledge of contact lens technology.

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