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MyDay (stenfilcon A) ASPHERE Soft Contact lenses are indicated for the correction of ametropia (myopia and hyperopia) in aphakic and non-aphakic persons with non-diseased eyes in powers from -20.00 diopters. The lenses may be worn by persons who exhibit astigmatism of -2.00 diopters or less that does not interfere with visual acuty.

MyDay (stenfilcon A) TORIC Soft Contact lenses are indicated for the correction of ametropia with astigmatism) in aphakic and non-aphakic persons with non-diseased eyes in powers from -20.00 to +20.00 diopters and astigmatic corrections from -0.25 to -10.00 diopters.

MyDay (stenfilcon A) MULTIFOCAL Soft Contact lenses are indicated for the correction of refractive ametropia (myopia and hyperopia) and emmetropia with presbyopia in aphakic persons with non-diseased eyes. The lenses may be worn by persons who exhibit astigmatism of -2.00 diopters or less that does not interfere with visual acuity.

MyDay (stenfilcon A) MULTIFOCAL TORIC Soft Contact lenses are indicated for the optical correction of distance and near vision in presbyopic phakic persons with non-diseased eyes who may have -10.00 diopters of astigmatism or less.

AVAIRA VITALITY SPHERE and ASPHERE (fanfilcon A) Soft Contact lenses are indicated for the correction of ametropia (myopia and hyperopia) in aphakic and non-aphakic persons with non-diseased eyes in powers from -20.00 to +20.00 diopters. The lenses may be worn by persons who exhibit astigmatism of 2.00 diopters or less that does not interfere with visual acuity.

A VAIRA VITALITY (fanfilcon A) TORIC Soft Contact lenses are indicated for the correction of ametropia (myopia or hyperopia with astigmatism) in aphakic and non-aphakic persons with non-diseased eves in powers from -20.00 to +20.00 diopters and astigmatic corrections from -0.25 to -10.00 diopters.

AVAIRA VITALITY (fanfilcon A) MULTIFOCAL Soft lenses are indicated for the correction of refractive ametropia (myopia and hyperopia) and emmetropia with presbyopia in aphakic and non-aphakic persons with nondiseased eyes in powers from -20.00 to +20.00 diopters and with add powers from +0.25 to +4.00 diopters. The lenses may be worn by persons who exhibit astigmatism of 2.00 diopters or less that does not interfere with visual acuity.

AVAIRA VITALITY (fanfilcon A) MULTIFOCAL TORIC Soft Contact lenses are indicated for the optic correction of distance and near vision in presbyopic phakic or aphakic persons with non-diseased eyes in powers of -20.00 to +20.00 diopters with add powers from +0.25 to +4.00 diopters and astigmatism corrections from -0.25 to -10.00 diopters.

Eye Care Practitioners may prescribe the Avaira Vitality (fanfilcon A) Soft Contact lenses for frequent/planned replacement wear, with cleaning, disinfection and scheduled replacement or for single-use disposable wear. When prescribed for frequent/planned replacement, the Avaira Vitality (fanfilcon A) Soft Contact lens is to be cleaned, rinsed and disinfected each time the lens is removed. The contact lens is to be discarded after the recommended wearing period as prescribed by the Eye Care Professional. When prescribed for frequent/planned replacement wear, the lenses may be disinfected using a chemical disinfection only. When prescribed for single-use disposable wear, the Avaira Vitality (fanfilcon A) Soft Contact lens is to be discarded after each removal.

MyDay Contact Lenses are available as Asphere, Toric, Multifocal, and Multifocal Toric lens designs. The MyDay material, stenfilcon A, is primarily a random copolymer of polydimethylsiloxane methacrylate and vinylmethyl acetamide. The lenses have a blue tint which is added to make the lens more visible for handling. The lenses also contain a UV absorbing monomer, benzotriazolyl methacrylate, which is used to block UV radiation. When placed on the cornea in its hydrated state, the MyDay Soft (Hydrophilic) Contact Lens acts as a refracting medium to focus light rays on the retina.

Avaira Vitality Contact Lenses are available as Sphere, Asphere, Toric, Multifocal, and Multifocal Toric lens designs. The Avaira Vitality material, fanfilcon A. is primarily a random copolymer of polydimethylsiloxane methacrylate and vinylmethyl acetamide. The lenses have a blue tint which is added to make the lens more visible for handling. The lenses also contain a UV absorbing monomer, benzotriazolyl methacrylate, which is used to block UV radiation. When placed on the cornea in its hydrated state, the Avaira Vitality Soft (Hydrophilic) Contact Lens acts as a refracting medium to focus light rays on the retina.

The provided text describes a 510(k) premarket notification for two soft contact lenses: MyDay (stenfilcon A) and Avaira Vitality (fanfilcon A). The submission aims to demonstrate substantial equivalence to previously cleared predicate devices, primarily due to a manufacturing process change and a change to the purity specification.

Here's an analysis of the acceptance criteria and study information based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state "acceptance criteria" in a quantitative, pass/fail format with specific targets. Instead, it refers to "performance testing" conducted according to established standards. The reported device performance is presented as the results of these tests, which presumably align with the expectations of the referenced standards for substantial equivalence.

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

The document states that "non-clinical studies were provided in support of the substantial equivalence determination." However, it does not specify the sample sizes used for the test set for any of the performance tests.

Regarding data provenance, the studies were "conducted in accordance with the GLP regulation (21 CFR Part 58) or according to valid scientific protocols." This indicates that the data is from prospective studies designed to meet regulatory standards. The country of origin of the data is not specified, but given it's a US FDA submission, it's typically assumed to be generated in compliance with US regulatory frameworks.

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

This information is not applicable to the type of device and study described. The performance tests for contact lenses (contact angle, water content, mechanical properties, etc.) involve objective measurements rather than subjective expert interpretation for ground truth establishment.

4. Adjudication Method for the Test Set

This information is not applicable as the studies are focused on objective physical and chemical properties of the contact lenses, which do not involve subjective interpretation or adjudication by multiple readers to establish ground truth.

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

No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. This type of study is relevant for diagnostic imaging devices where human readers interpret images, and AI might assist in that interpretation. For contact lenses, the evaluation focuses on physical, chemical, and biological properties, not human interpretation of medical images.

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

This question is not applicable as the device is a physical medical device (contact lens), not an AI algorithm. Therefore, there is no "algorithm only" performance to evaluate.

7. The Type of Ground Truth Used

The "ground truth" for the performance tests on contact lenses is established through objective, standardized measurements according to the specified ANSI, ISO, and ASTM standards. For example, water content is measured using a defined gravimetric method, and mechanical properties are determined through tensile testing. For biocompatibility, chemical profiling (against ISO 10993-18:2020) was used to establish equivalence to the unmodified lenses (which presumably had established biocompatibility).

8. The Sample Size for the Training Set

This information is not applicable. The device is not an AI/ML algorithm that requires a training set. The studies described are traditional non-clinical performance and material characterization tests.

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

This information is not applicable as there is no training set for this device.

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MyDay (stenfilcon A) ASPHERE Soft Contact lenses are indicated for the correction of ametropia (myopia and hyperopia) in aphakic and non-aphakic persons with non-diseased eyes in powers from -20.00 diopters. The lenses may be worn by persons who exhibit astigmatism of -2.00 diopters or less that does not interfere with visual acuty.

MyDay (stenfilcon A) TORIC Soft Contact lenses are indicated for the correction of ametropia with astigmatism) in aphakic and non-aphakic persons with non-diseased eyes in powers from -20.00 to +20.00 diopters and astigmatic corrections from -0.25 to -10.00 diopters.

MyDay (stenfilcon A) MULTIFOCAL Soft Contact lenses are indicated for the correction of refractive ametropia (myopia and hyperopia) and emmetropia with presbyopia in aphakic persons with non-diseased eyes. The lenses may be worn by persons who exhibit astigmatism of -2.00 diopters or less that does not interfere with visual acuity.

MyDay (stenfilcon A) MULTIFOCAL TORIC Soft Contact lenses are indicated for the optical correction of distance and near vision in presbyopic phakic or aphakic persons with non-diseased eyes who may have -10.00 diopters of astigmatism or less.

MyDay (stenfilcon A) Soft (Hydrophilic) Daily Disposable Contact Lens is available as an Asphere, Toric, Multifocal, and Multifocal Toric lens designs.

The MyDay material, stenfilcon A, is primarily a random copolymer of polydimethylsiloxane methacrylate and vinylmethyl acetamide. The UV blocker used is a benzotriazolyl methacrylate. The lenses have a blue tint which is added to make the lens more visible for handling. The lenses also contain a UV absorbing monomer which is used to block UV radiation.

When placed on the cornea in its hydrated state, the MyDay Soft (Hydrophilic) Contact Lens acts as a refracting medium to focus light rays on the retina.

This document is an FDA 510(k) clearance letter for a contact lens, not a medical device that relies on AI or complex algorithms requiring extensive performance studies with human readers or AI-specific acceptance criteria. Therefore, most of the requested information regarding acceptance criteria, study design for AI models (e.g., sample size for test/training sets, ground truth establishment, expert adjudication, MRMC studies) is not applicable to this submission.

However, I can extract the relevant performance data and the conclusion regarding substantial equivalence for this specific device.

Device Name: MyDay (stenfilcon A) Soft (Hydrophilic) Daily Disposable Contact Lens (with e-PL in the packaging solution)

Predicated Device: MyDay (stenfilcon A) Soft (Hydrophilic) Daily Disposable Contact Lens (K131378)

Acceptance Criteria and Reported Device Performance (Non-Clinical/Bench Testing):

The submission aimed to demonstrate substantial equivalence to a predicate device, with the primary difference being the addition of 100 ppm Epsilon-Polylysine (e-PL) to the blister packing solution as a preservative. The acceptance criteria are implicitly met by demonstrating that the physical, mechanical, optical, and toxicological properties of the new device are equivalent to the predicate device and comply with relevant standards.

Here's a table summarizing the types of performance testing done and the overall conclusion:

Regarding the other requested information (which is not directly applicable to this non-AI device submission):

2. Sample size used for the test set and the data provenance: Not explicitly stated as a distinct "test set" in the context of an AI model. The bench testing data would involve samples of the manufactured contact lenses. Data provenance is implied to be from laboratory testing conducted by the manufacturer.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth for a contact lens's physical properties is established by objective measurements based on specified standards, not expert consensus on interpretations.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not applicable. Evaluation is done by standardized laboratory testing.
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 or imaging device.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: Not applicable. This is not an AI or algorithmic device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Ground truth was established through adherence to recognized international and industry standards (ISO, ANSI, ASTM) for measuring physicochemical properties and conducting biocompatibility tests (e.g., specific gravity, refractive index, water content, cytotoxicity).
8. The sample size for the training set: Not applicable. This device does not involve a training set as it's not an AI/machine learning product.
9. How the ground truth for the training set was established: Not applicable.

Overall Conclusion from the Submission:

"Conclusive evidence was provided to demonstrate that the subject device lens material is equivalent to the currently marketed predicate device lens material through the statistical analysis of the physical/mechanical/optical properties of the lens. Based on the performance testing and the fact that the subject device has the same manufacturing process as the marketed predicate device lens, clinical performance data was not required to be submitted in this 510(k). The performance testing demonstrates that the subject device is as safe, as effective, and performs as well as the predicate device."

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MyDay (stenfilcon A) ASPHERE Soft Contact lenses are indicated for the correction of ametropia (myopia and hyperopia) in aphakic and non-aphakic persons with non-diseased eyes in powers from -20.00 diopters. The lenses may be worn by persons who exhibit astigmatism of -2.00 diopters or less that does not interfere with visual acuty.

MyDay (stenfilcon A) TORIC Soft Contact lenses are indicated for the correction of ametropia with astigmatism) in aphakic and non-aphakic persons with non-diseased eyes in powers from -20.00 to +20.00 diopters and astigmatic corrections from -0.25 to -10.00 diopters.

MyDay (stenfilcon A) MULTIFOCAL Soft Contact lenses are indicated for the correction of refractive ametropia (myopia and hyperopia) and emmetropia with presbyopia in aphakic persons with non-diseased eyes. The lenses may be worn by persons who exhibit astigmatism of -2.00 diopters or less that does not interfere with visual acuity.

MyDay (stenfilcon A) MULTIFOCAL TORIC Soft Contact lenses are indicated for the optical correction of distance and near vision in presbyopic phakic persons with non-diseased eyes who may have - 10.00 diopters of astigmatism or less.

MyDay Contact Lenses are available as an Asphere, Toric, Multifocal, and Multifocal Toric lens designs.

The MyDay material, stenfilcon A, is primarily a random copolymer of polydimethylsiloxane methacrylate and vinylmethyl acetamide. The UV blocker used is a benzotriazolyl methacrylate. The lenses have a blue tint which is added to make the lens more visible for handling. The lenses also contain a UV absorbing monomer which is used to block UV radiation.

When placed on the cornea in its hydrated state, the MyDay Soft (Hydrophilic) Contact Lens acts as a refracting medium to focus light rays on the retina.

The provided text is a 510(k) summary for the MyDay (stenfilcon A) Soft (hydrophilic) Daily Disposable Contact Lens. It outlines testing performed and conclusions regarding its substantial equivalence to a predicate device. However, it does not contain information about acceptance criteria and a study proving a device meets those criteria in the context of AI/ML or diagnostic performance.

The document mainly focuses on:

• Device Description: Material, physical parameters, and optical properties of the contact lens.
• Performance Testing (Non-clinical): A battery of tests performed according to ANSI, ISO, and ASTM standards to characterize physical/mechanical/optical properties (e.g., contact angle, light transmittance, water content, mechanical properties, refractive index, total extractables, non-polymeric residuals).
• Biocompatibility Testing: Extractable residual analysis to compare current and modified stenfilcon A formulations.
• Clinical Testing: A statement that clinical performance data was not required because the subject device and predicate device are equivalent in technical characteristics, manufacturing, and sterilization processes, and the non-clinical performance testing demonstrates equivalence.

Therefore, I cannot provide the requested information because the document describes a contact lens and its regulatory submission, not an AI/ML-driven device with diagnostic performance criteria and a study to prove it meets them.

If this were a document about an AI/ML device, the requested information would typically include:

1. Table of Acceptance Criteria and Reported Device Performance: This would list metrics like sensitivity, specificity, AUC, recall, precision, F1-score, accuracy, or other relevant AI performance indicators, along with the predefined acceptance thresholds and the actual performance achieved by the device in a validation study.
2. Sample Size for Test Set and Data Provenance: Details on the number of cases/samples in the independent test set used to evaluate the AI, and information about where this data came from (e.g., specific hospitals, countries, whether it was collected retrospectively or prospectively).
3. Number of Experts and Qualifications: How many human experts reviewed the test data to establish the ground truth, and their professional qualifications (e.g., board-certified radiologists, pathologists, clinical specialists, with specified years of experience).
4. Adjudication Method: The process used to reconcile disagreements among experts when establishing ground truth (e.g., a "2+1" method where two experts agree, or a third expert resolves disagreements; a "3+1" method; or if no adjudication was used).
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study: Whether a study was performed to compare human performance with and without AI assistance, and if so, the effect size (e.g., how much the readers' sensitivity or specificity improved, or reduction in reading time).
6. Standalone Performance: Whether the AI algorithm's performance was evaluated independently without human intervention.
7. Type of Ground Truth: How the definitive diagnosis or reference standard was established for the test set (e.g., consensus of multiple experts, pathological confirmation, long-term clinical outcome data, surgical findings).
8. Sample Size for Training Set: The number of cases/samples used to train the AI model.
9. How Ground Truth for Training Set was Established: The method used to label or annotate the data used for training the AI model (often similar to the test set ground truth establishment but might involve different scales or processes).

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