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The Clariti 1 Day Multifocal (somofilcon A) Soft (Hydrophilic) Daily Disposable Contact Lens with UV Blocker is indicated for daily wear single use only for the optical correction of refractive ametropia (myopia and hyperopia) and/or presbyopia in phakic persons with non-diseased eyes that may require a reading addition of +3.00 Diopters or less and may exhibit astigmatism up to 1.50 Diopters or less.

Clariti 1 Day Multifocal (somofilcon A) Soft (Hydrophilic) Daily Disposable Contact Lens with UV Blocker is a hydrophilic co-polymer of silicone containing monomers and hydrophilic monomers which is cross-linked with tetraethyleneglycol dimethacrylate and difunctional methacryloxypropyl-terminated poly(dimethylsiloxane).

When hydrated the lens consists of 44.0% somofilcon A and 56.0% water by weight of saline immersed in normal saline. A benzophenone UV absorbing monomer is used in the contact lens to help protect against transmission of harmful UV radiation and Clariti 1 Day Multifocal (somofilcon A) Soft (Hydrophilic) Daily Disposable Contact Lens with UV Blocker help protect against transmission of harmful UV radiation to the cornea and into the eye.

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 316-380mm.

The lens has a hemispherical flexible shell, which covers the cornea and a portion of the adjacent sclera.

The provided text is a 510(k) summary for a medical device, specifically a soft contact lens. It describes the device, its intended use, and compares it to a predicate device to establish substantial equivalence. However, it does not contain information about acceptance criteria or a study proving the device meets specific acceptance criteria in the context of an AI/ML medical device.

Based on the document, here's what can be inferred and what information is missing:

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

• Acceptance Criteria (Implied): The document refers to "performance testing specifications" and states that "non-clinical data presented are adequate to support substantial equivalence." This implies that the device met certain pre-defined performance specifications for physical and optical properties like water content and dimensional/optical parameters, as outlined in BS EN ISO 18369-2:2017 and BS EN ISO 18369-4:2017. However, the specific quantitative acceptance criteria (e.g., precise ranges for water content or diameter tolerance) are not explicitly listed in this summary.
• Reported Device Performance:
  • Refractive Index: 1.4003
  • %Transmittance @ 590nm: 98.13
  • %Transmittance @ 280-315nm: 0.71 (less than 5% as per device description)
  • %Transmittance @ 316-380nm: 20.62 (less than 50% as per device description)
  • Water Content: 56%
  • Oxygen Permeability (DK): 60 x 10^-11 (cm^2/sec) (ml O2/ml x mmHg) at 35°C
  • Specific Gravity: 1.17

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 / Not Provided: This information is typically relevant for studies validating AI/ML algorithms. The provided document is for a physical medical device (contact lens) and refers to non-clinical performance testing. It does not describe a "test set" in the context of algorithm validation.

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 / Not Provided: This is not relevant for the type of device and testing described in the document.

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

• Not Applicable / Not Provided: This is not relevant for the type of device and testing described in the document.

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 document describes a physical medical device (contact lens), not an AI/ML-driven diagnostic or assistive device that would involve human readers.

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

• Not Applicable: This document describes a physical medical device (contact lens), not an AI/ML algorithm.

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

• Not Applicable / Implied: For physical and optical properties of a contact lens, the "ground truth" would be established by validated measurement techniques and scientific protocols (e.g., using specialized equipment to measure water content, dimensions, oxygen permeability). The document states, "All tests were conducted in accordance with the GLP regulation (21 CFR Part 58) or according to valid scientific protocols."

8. The sample size for the training set

• Not Applicable / Not Provided: This is not relevant for the type of device and testing described. The device doesn't have a "training set" in the AI/ML sense.

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

• Not Applicable / Not Provided: This is not relevant for the type of device and testing described.

In summary, the provided text does not describe an AI/ML device or a study validating an AI/ML algorithm. Instead, it is a regulatory submission for a contact lens, focusing on demonstrating substantial equivalence to a predicate device through non-clinical performance testing of physical and optical properties. The acceptance criteria are implicitly derived from ISO standards, and device performance is reported quantitatively for these physical properties.

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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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Sphere/Asphere:

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.

Toric:

AVAIRA VITALITY (fanfilcon A) TORIC Soft Contact lenses are indicated for the correction of ametropia (myopia or hyperopia with astigmatism) in aplakic 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.

Multifocal:

AVAIRA VITALITY (fanfilcon A) MULTIFOCAL Soft lenses are indicated for the correction of refractive ametropia (myopia and hyperopia) and emmetropia with presbyopia in aphakic persons with non-diseased 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.

Multifocal Toric:

AVAIRA VITALITY (fanfilcon A) MULTIFOCAL TORIC Soft Contact lenses are indicated for the optic correction of distance and near vision in presbyopic phakic persons with non-diseased eyes in powers from -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 fo 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.

The Avaira Vitality (fanfilcon A) Contact Lens visibility tinted with UV blocker is available as sphere/asphere lens, toric lens, multifocal lens, and multifocal toric lens.

The lenses are made of a silicone hydrogel material which is not surface treated and is characterized by high oxygen permeability (Dk). The Avaira Vitality (fanfilcon A) Contact Lens is tinted blue using Reactive Blue #246 to make the lens more visible for handling. A Norbloc UV blocker is used to reduce the amount of ultraviolet light transmitted into the eye. The Avaira Vitality (fanfilcon A) lens is supplied sterile, packaged in a phosphate buffered saline solution. The composition of the lens is 45% fanfilcon A and 55% water by weight when hydrated and stored in buffered saline solution.

In its hydrated state, the Avaira Vitality (fanfilcon A) Contact Lens visibility tinted, with UV blocker, when placed on the cornea, acts as a refracting medium to focus light rays on the retina.

The lens has a hemispherical flexible shell, which covers the cornea and a portion of the adjacent sclera, with the following dimensions:

• Diameter: 13.5 mm to 15.0 mm
• Base Curve: 8.2 mm to 9.2 mm
• Center Thickness: 0.06 mm to 0.6 mm (varies with power)
• Powers: -20.00 D to +20.00 D
• Cylinder Powers (Toric): -0.25 D to -10.00 D
• Axis (Toric): 0° to 180°
• Add Power Range (Multifocal) +0.25 D to +4.00 D

The physical/optical properties of the lenses are:

• Specific Gravity: 1.026
• Refractive Index: 1.398 ± 0.005
• Light Transmittance: 98% +2/-5%
• Surface Character: Hydrophilic
• Water Content: 55% ± 2%
• Oxygen Permeability: 90x10-11 [(cm²/sec) x (ml O2)/ (ml x mm Hg)]

This document is a 510(k) Premarket Notification from CooperVision, Inc. to the FDA regarding their Avaira Vitality (fanfilcon A) Soft (Hydrophilic) Contact Lens (K213164).

Based on the provided text, the device in question is a contact lens, not an AI/ML powered device, therefore, many of the requested criteria are not applicable (N/A) or cannot be extracted from this document, as they pertain to the evaluation of AI/ML software performance.

Here's an analysis of the acceptance criteria and study information that can be extracted, and where the information is N/A:

Acceptance Criteria and Reported Device Performance

The document describes the device, its properties, and compares it to a legally marketed predicate device (K160803). The "performance data" section focuses on physical and optical properties rather than diagnostic performance metrics typically seen with AI/ML devices.

Study Details (Focusing on AI/ML Criteria - Mostly N/A for this device)

1. Sample size used for the test set and the data provenance:

   • Not applicable (N/A). This document is for a physical medical device (contact lens), not an AI/ML software device that would require a "test set" of data in the context of algorithm evaluation. The document states, "The modification does not warrant performance testing to support substantial equivalence." This implies a lack of new clinical performance studies on the finished device in general.

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

   • Not applicable (N/A). No "ground truth" establishment in the context of diagnostic agreement is described for this physical device.

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

   • Not applicable (N/A). No adjudication method is necessary for a physical contact lens.

4. 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 (N/A). This is a contact lens, not an AI-assisted diagnostic tool.

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

   • Not applicable (N/A). This is a physical device, not an algorithm.

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

   • Not applicable (N/A). The evaluation for this device focuses on physical properties, material composition, manufacturing, and biocompatibility, not diagnostic 'ground truth.' The basis for substantial equivalence is primarily the identical material and manufacturing process to the predicate device, along with limited biocompatibility testing.

7. The sample size for the training set:

   • Not applicable (N/A). No AI/ML model for which a "training set" would be used is described.

8. How the ground truth for the training set was established:

   • Not applicable (N/A). No AI/ML model or training set is described.

Summary of the Study Proving Substantial Equivalence for the Contact Lens:

The submission for K213164 (Avaira Vitality (fanfilcon A) Soft (Hydrophilic) Contact Lens) is a 510(k) application for substantial equivalence to a predicate device (K160803), which is an earlier version of the same product.

The core of the "study" proving the device meets acceptance criteria for substantial equivalence relies on:

• Demonstrating Technological Characteristics are Identical: The subject device shares the exact same material (fanfilcon A), manufacturing method (Molded), sterilization method (Moist Heat), primary packaging, packaging solution, and visibility tint with the predicate device.
• Demonstrating Performance Specifications are Identical: Key physical and optical properties like water content, refractive index, specific gravity, oxygen permeability (Dk), base curve, and diameter are listed as "Same" as the predicate device.
• Limited Biocompatibility Testing: In accordance with GLP regulation (21 CFR Part 58), biocompatibility testing was performed on the lens and packaging solution, specifically:
  • ISO 10993-5:2009 (Tests for in vitro cytotoxicity)
  • ISO 10993-10:2010 (Tests for irritation and skin sensitization)
    The document states that "limited biocompatibility testing is adequate to support substantial equivalence" because the predicate device's lens material characteristics, primary packaging materials, and packaging solution are identical.
• Regulatory Basis: The 510(k) is submitted in accordance with the May 12, 1994 Premarket Notification [510(k)] Guidance Document for Daily Wear Contact Lenses. The modification (a "lens extract non-polymeric residuals specification change") was deemed by the submitter to not warrant performance testing to support substantial equivalence due to the fundamental similarities with the predicate.

In conclusion, for this specific medical device, the "acceptance criteria" revolve around demonstrating the device is fundamentally the same as a previously cleared device, supported by the specific physical and chemical properties and basic biocompatibility testing, rather than a clinical performance study with AI-specific metrics.

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The CLARITI 1 DAY (somofilcon A) Soft (hydrophilic) Daily Disposable Contact Lens with UV blocker is indicated for daily wear single use only for the correction of refractive ametropia (myopia and hyperopia) in phakic persons with non-diseased eves that may exhibit astigmatism up to 2.00 Diopters that does not interfere with visual acuty.

The CLARITI 1 DAY TORIC (somofilcon A) Soft (hydrophilic) Daily Disposable Contact Lens with UV blocker is indicated for daily wear single use only for the optical correction of refractive ametropia (myopia) in phakic or aphakic persons with non-diseased eyes that may exhibit astigmatism up to 10.00 Diopters.

The CLARITI 1 DAY MULTIFOCAL (somofilcon A) Soft (hydrophilic) Daily Disposable Contact Lens with UV blocker is indicated for daily wear single use only for the optical corrective ametropia (myopia and hyperopia) and/or presbyopia in phakic persons with non-diseased eyes that may require a reading addition of +3.00 Diopters or less and may exhibit astigmatism up to 1.50 Diopters or less.

The CLARITI 1 DAY MULTIFOCAL TORIC (somofilcon A) Soft (hydrophilic) Daily Disposable Contact Lens with UV blocker is indicated for daily wear single use only for the optical corrective ametropia (myopia and hyperopia) and/or presbyopia in phakic persons with non-diseased eyes that may exhibit astigmatism up to 10.00 Diopters and require a reading addition of +3.00 Diopters or less.

The Clariti 1 day (somofilcon A) Soft (Hydrophilic) Daily Disposable Contact Lens with UV Blocker is available as sphere lens, toric lens, multifocal lens, and multifocal toric lens.

In its hydrated state, Clariti 1 day (somofilcon A) Soft (hydrophilic) Daily Disposable Contact Lens with UV Blocker when placed on the cornea acts as a refracting media to focus light rays on the retina.

Clariti 1 day (somofilcon A) Soft (hydrophilic) Contact Lenses for Daily Wear Single Use are a hydrophilic co-polymer of silicone containing monomers and hydrophilic monomers which is cross-linked with tetraethyleneglycol dimethacrylate and di-functional methacryloxypropyl-terminated poly(dimethylsiloxane).

When hydrated the lens consists of 44.0% somofilcon A and 56.0% water by weight of saline immersed in normal saline. A benzophenone UV absorbing monomer is used in the contact lens to help protect against transmission of harmful UV radiation and Clariti 1 day (somofilcon A) Soft contact lenses help protect against transmission of harmful UV radiation to the cornea and into the eye.

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 316-380nm.

The lens has a hemispherical flexible shell, which covers the cornea and a portion of the adjacent sclera, with the following dimensions:
• Chord Diameter: 13.0mm to 15.5mm
• Centre Thickness: 0.03mm to 0.50mm
• Base Curve: 7.5mm to 9.30mm
• Powers: -20.00 DS to +20.00 DS
• Toric Cylinder options: -0.75, -1.25, -1.75 and -2.25
• Toric Axis options: 10° to 180° (10° steps)
• Multifocal Add:
Lens "LOW" = "low" for spectacle near ADD lens (Max +2.25 ADD)
Lens "HIGH" = "high" for spectacle near ADD lens (+2.50 ADD or greater)

The physical/optical properties of the lenses are:
• Refractive Index: 1.4003
• %Transmittance @ 590nm: 98.13
• %Transmittance @ 280-315nm: 0.71
• %Transmittance @ 316-380nm: 20.62
• Surface Character: Hydrophilic
• Water Content: 56%
• Oxygen Permeability (DK): 60 x 10-11 (cm²/sec)(ml O2/ml x mmHg) at 35°C (Fatt Method for determination of oxygen permeability)
• Specific Gravity: 1.17

The provided document describes a 510(k) premarket notification for a contact lens, Clariti 1 day (somofilcon A) Soft (Hydrophilic) Daily Disposable Contact Lens with UV Blocker. The submission asserts substantial equivalence to a predicate device and does not involve performance testing to support this claim, but rather a change from biological release to parametric release of the finished product. Therefore, the document does not describe a study testing the acceptance criteria of the device.

However, it does list several performance specifications/parameters for the device, which can be interpreted as acceptance criteria based on its equivalence to the predicate device.

Here's the information derived from the document, with explanations for aspects not explicitly stated:

1. A table of acceptance criteria and the reported device performance (based on the predicate device's performance properties):

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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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The CLARITI 1 DAY (somofilcon A) Soft (hydrophilic) Daily Disposable Contact Lens with UV blocker is indicated for daily wear single use only for the correction of refractive ametropia (myopia and hyperopia) in phakic persons with non-diseased eyes that may exhibit astigmatism up to 2.00 Diopters that does not interfere with visual acuity.

The CLARITI 1 DAY TORIC (somofilcon A) Soft (hydrophilic) Daily Disposable Contact Lens with UV blocker is indicated for daily wear single use only for the optical correction of refractive ametropia (myopia) in phakic or aphakic persons with non-diseased eyes that may exhibit astigmatism up to 10.00 Diopters.

The CLARITI 1 DAY MULTIFOCAL (somofilcon A) Soft (hydrophilic) Daily Disposable Contact Lens with UV blocker is indicated for daily wear single use only for the optical correction of refractive ametropia (myopia and hyperopia) and/or presbyopia in phakic persons with non-diseased eyes that may require a reading addition of +3.00 Diopters or less and may exhibit astigmatism up to 1.50 Diopters or less.

The CLARITI 1 DAY MULTIFOCAL TORIC (somofilcon A) Soft (hydrophilic) Daily Disposable Contact Lens with UV blocker is indicated for daily wear single use only for the optical correction of refractive ametropia (myopia and hyperopia) and/or presbyopia in phakic persons with non-diseased eyes that may exhibit astigmatism up to 10.00 Diopters and require a reading addition of +3.00 Diopters or less.

The Clarti 1 Day (somofilcon A) Soft (hydrophilic) Contact Lenses are indicated for daily wear single use only. The lenses are to be discarded upon removal; therefore, no cleaning or disinfection is required.

The Clariti 1 day (somofilcon A) Soft (Hydrophilic) Daily Disposable Contact Lens with UV Blocker is available as sphere lens, toric lens, multifocal lens, and multifocal toric lens.

In its hydrated state, Clariti 1 day (somofilcon A) Soft (hydrophilic) Daily Disposable Contact Lens with UV Blocker when placed on the cornea acts as a refracting media to focus light rays on the retina.

Clariti 1 day (somofilcon A) Soft (hydrophilic) Contact Lenses for Daily Wear Single Use are a hydrophilic co-polymer of silicone containing monomers and hydrophilic monomers which is cross-linked with tetraethyleneglycol dimethacrylate and di-functional methacryloxypropyl-terminated poly(dimethylsiloxane).

When hydrated the lens consists of 44.0% somofilcon A and 56.0% water by weight of saline immersed in normal saline. A benzophenone UV absorbing monomer is used in the contact lens to help protect against transmission of harmful UV radiation and Clariti 1 day (somofilcon A) Soft contact lenses help protect against transmission of harmful UV radiation to the cornea and into the eye.

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 316-380nm.

The lens has a hemispherical flexible shell, which covers the cornea and a portion of the adjacent sclera, with the following dimensions:

• Chord Diameter: 13.0mm to 15.5mm
• Centre Thickness: 0.03mm to 0.50mm
• Base Curve: 7.5mm to 9.30mm
• Powers: -20.00 DS to +20.00 DS
• Toric Cylinder options: -0.75, -1.25, -1.75 and -2.25
• Toric Axis options: 10° to 180° (10° steps)
• Multifocal Add: Lens "LOW" = "low" for spectacle near ADD lens (Max +2.25 ADD) Lens "HIGH" = "high" for spectacle near ADD lens (+2.50 ADD or greater)

Here's a summary of the acceptance criteria and study information for the Clariti 1 day (somofilcon A) Soft (Hydrophilic) Daily Disposable Contact Lens with UV Blocker, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance & Device Description

The document states that the performance specifications/parameters for both the subject and predicate device are identical. Therefore, the acceptance criteria are implicitly those listed under "Performance Specifications/Parameters Comparison" in the Predicate Device column, and the reported device performance for the subject device is stated as "Same" for each parameter.

Key Differences Between Subject and Predicate Device:
There were two technological differences between the subject device (K181920) and the predicate device (K130331) that required performance data:

1. Addition of 4,4'-Diallyoxyl benzophenone (DAB): The subject device includes both UV416 and DAB as UV blockers, whereas the predicate only had UV416.
2. Change from borate to phosphate buffered packaging solution: The subject device uses Phosphate Buffered Saline Solution containing 0.020% w/v Poloxamer 407, while the predicate used Borate Buffered Saline Solution containing 0.005% w/v Poloxamer 407.

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

The document states that "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 physiochemical properties, especially water content, oxygen permeability, modulus, and toughness of the lens."

For the performance testing (bench testing), the document mentions that "Each test was conducted according to the ANSI, ISO, and/or ASTM standard indicated." However, specific sample sizes for the test set are not provided in the given text.

The data provenance is not explicitly stated as country of origin, but the testing was conducted in accordance with international standards (ISO, ANSI, ASTM) and FDA guidance documents (e.g., Use of International Standard ISO 10993-1, Premarket Notification [510(k)] Guidance Document for Daily Wear Contact Lenses). This implies that standard laboratory testing was performed, likely at the manufacturer's or a contract research organization's facilities. The studies appear to be prospective in nature, as they were conducted to support the substantial equivalence claim for the subject device.

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 this submission. The "ground truth" in this context refers to the defined physical, chemical, and optical properties of the contact lenses, as measured by standardized bench tests, and biocompatibility evaluations. These measurements do not rely on expert interpretation in the way that image-based diagnostic devices might.

4. Adjudication Method for the Test Set

This is not applicable. The performance testing involves direct physical, chemical, and optical measurements against established standards, not subjective assessments requiring adjudication.

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

An MRMC comparative effectiveness study was not done. This type of study is relevant for AI-powered diagnostic devices where human readers interpret medical images. This submission is for a medical device (contact lens) where performance is assessed through bench and biocompatibility testing, not human interpretation of data. The document explicitly states: "clinical performance data was not required to be submitted in this 510(k)."

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

This is not applicable. This is not an algorithm or AI-powered device. The device's performance is assessed through its physical characteristics and biological safety.

7. The Type of Ground Truth Used

The "ground truth" for the performance criteria was established through:

• Bench Testing: Measurements of physical, chemical, and optical properties (e.g., water content, oxygen permeability, refractive index, mechanical properties, light transmittance, specific gravity, contact angle, total extractables, non-polymeric residuals) using established ANSI, ISO, and ASTM standards.
• Biocompatibility Testing: Evaluation according to ISO 10993 series for cytotoxicity, irritation, systemic toxicity, and sensitization.
• Comparison to Predicate: The key ground truth was the established performance of the legally marketed predicate device (Clariti 1 day, K130331), demonstrating that the subject device's performance was "Same" or equivalent across all measured parameters despite minor material and packaging solution changes.

8. The Sample Size for the Training Set

This is not applicable. This submission is for a physical medical device (contact lens), not an AI algorithm. Therefore, there is no "training set" in the context of machine learning.

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

This is not applicable for the reasons stated above.

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Sphere/Asphere: 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.

Toric: AVAIRA 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 eyes in powers from -20.00 to +20.00 diopters and astigmatic corrections from -0.25 to -10.00 diopters.

Multifocal: AVAIRA VITALITY (fanfilcon A) MULTIFOCAL Soft lenses are indicated for the correction of refractive ametropia (myopia and hyperopia) and emmetropia with presbyopia in aphakic persons with non-diseased 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.

Multifocal Toric: 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.

The AVAIRA VITALITY (fanfilcon A) Contact Lens visibility tinted with UV blocker is available as a sphere/asphere lens, toric lens, multifocal lens, and multifocal toric lens. The lenses are made of a silicone hydrogel material which is not surface treated and is characterized by high oxygen permeability (Dk). The AVAIRA VITALITY (fanfilcon A)) Contact Lens is tinted blue using Reactive Blue #246 to make the lens more visible for handling. A Norbloc UV blocker is used to reduce the amount of ultraviolet light transmitted into the eye. The AVAIRA VITALITY (fanfilcon A) lens is supplied sterile, packaged in a buffered saline solution. The composition of the lens is 45% fanfilcon A and 55% water by weight when hydrated and stored in buffered saline solution.

This document is a 510(k) premarket notification for a medical device (contact lenses), not an algorithm-driven AI/ML device. Therefore, the detailed requirements regarding AI/ML device acceptance criteria, study design, expert involvement, and ground truth establishment are not applicable.

However, I can extract and structure the information related to the device's assessment for its intended purpose, which is proving substantial equivalence to predicate devices for contact lenses.

Here's an attempt to adapt the requested structure as much as possible, reinterpreting the questions for a non-AI/ML medical device context:

Device: Avaira Vitality (fanfilcon A) Soft (hydrophilic) Contact Lenses

1. Table of Acceptance Criteria and the Reported Device Performance

The concept of "acceptance criteria" for this contact lens is substantial equivalence to legally marketed predicate devices, meaning it is as safe and effective. The performance is assessed through non-clinical (material properties, toxicology, biocompatibility) and clinical testing.

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

• Sample Size for Clinical Study (Test Set): 90 subjects (60 subjects for Test lenses, 30 subjects for Control lenses).
• Data Provenance: A multi-center clinical study (exact geographic location not specified, but typically US-based for FDA submissions). The study was conducted retrospectively to collect the data from the clinical trial.

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

• This is not applicable in the context of a contact lens study seeking substantial equivalence. The "ground truth" for safety and efficacy in this clinical trial would be established by the clinical findings (e.g., slit lamp examinations, visual acuity measurements) as assessed by the participating clinical investigators/ophthalmic professionals, not by a multi-expert panel establishing a "ground truth" for diagnostic accuracy as for an AI/ML algorithm.

4. Adjudication Method for the Test Set

• Not explicitly described as an "adjudication method" in the AI/ML sense. The clinical study was a "randomized, masked, concurrent control study." This implies that the assessment of primary and secondary outcomes was done by investigators blinded to the lens type where possible, and comparisons were made between the test and control groups.

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/ML device, and no MRMC study or human-in-the-loop performance evaluation was conducted.

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

• Not applicable. This is a contact lens, not an algorithm.

7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.)

• In the context of this contact lens study, the "ground truth" for determining safety and efficacy was based on clinical outcomes data (e.g., slit lamp findings, adverse event rates, visual acuity measurements) observed in the study subjects. This data was collected by the clinical investigators involved in the multi-center trial.

8. The Sample Size for the Training Set

• Not applicable. This is not an AI/ML device that requires a training set.

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

• Not applicable. This is not an AI/ML device that requires a training set.

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AVAIRA (enfilcon A) SPHERE Soft (Hydrophilic) Contact Lenses are indicated for the correction of ametropia (myopia and hyperopia) in aphakic and non-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.

AVAIRA (enfilcon A) TORIC Soft (Hydrophilic) Contact Lenses are indicated for the correction of visual ametropia (myopia or hyperopia 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.

DAILY DISPOSABLE:

The AVAIRA (enfilcon A) Soft (hydrophilic) Contact Lenses are indicated for single-use disposable wear.

FREQUENT REPLACEMENT:

The AVAIRA (enfilcon A) Soft (hydrophilic) Contact Lenses are indicated for daily wear. When prescribed for planned replacement the lens may be disinfected using a chemical or hydrogen peroxide disinfecting system.

The Avaira (enfilcon A) soft contact lens is a daily wear silicone hydrogel contact lens that is not surface treated and is characterized by a high oxygen permeability (Dk). The lens material, enfilcon A, is composed of silicone macromers cross linked with other monomers, incorporating phthalocyanine blue as an integrated handling tint. A UV blocker is added to reduce the amount of ultraviolet light transmitted into the eye. The Avaira (enfilcon A) Soft (hydrophilic) contact lenses are a hemispherical shell. This 510(k) submission covers a process modification to add a step to the preparation of the monomer mixture. The physical properties and dimensions of the finished lenses are unchanged from predicate 510(k)s.

The provided text describes the acceptance criteria and the study conducted for the CooperVision AVAIRA (enfilcon A) Sphere and Toric Contact Lenses.

Here's a breakdown of the requested information:

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

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

• Test Set Sample Size: The document does not specify a distinct "test set" sample size for clinical studies because it explicitly states that "In-vivo clinical studies were not required for this change." The evaluation was based on physiochemical studies.
• Data Provenance: The physiochemical studies were "conducted by CooperVision following scientific protocols." No specific country of origin or whether it was retrospective or prospective is mentioned, but it implies internal, prospective laboratory testing.

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

• Not applicable. Since in-vivo clinical studies were not required and the assessment was based on physiochemical properties, there was no "ground truth" established by experts in a clinical context for a test set. The ground truth was based on physical and chemical measurements against established specifications for contact lenses and comparison to predicate devices.

4. Adjudication method for the test set:

• Not applicable. No clinical test set involving human judgment was used. The physiochemical studies would involve laboratory measurements conforming to predefined technical specifications.

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 contact lenses, not an AI-assisted diagnostic device.

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

• Not applicable. This submission is for contact lenses, not an algorithm.

7. The type of ground truth used:

• The "ground truth" for the physiochemical studies was based on physical and chemical measurements of the lens properties (e.g., refractive index, oxygen permeability, water content, modulus, etc.) against established scientific standards and comparison to the characteristics of the predicate device (AVAIRA Sphere and Toric Soft Contact Lenses, K071736/K113759).

8. The sample size for the training set:

• Not applicable. This submission is for a physical medical device (contact lenses), not a machine learning or AI device that requires a training set.

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

• Not applicable. As above, no training set was used.

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SUS (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 -20.00D to +20.00D diopters. The lenses may be worn by persons who exhibit astigmatism of -2.00 diopters or less that does not interfere with visual acuity.
SUS (stenfilcon 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 eyes in powers from -20.00 to +20.00 diopters and astigmatic corrections from -0.25 to -10.00 diopters.
SUS (stenfilcon A) MULTIFOCAL Soft Contact lenses are indicated for the correction of refractive ametropia (myopia and hyperopia) and emmetropia with presbyopia in aphakic and non-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.
SUS (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.

The SUS (stenfilcon A) Contact Lens Visibility Tinted with UV Blocker is available as an aspherical lens, toric lens, multifocal lens, and multifocal toric lens. The lenses are made of a silicone hydrogel material which is not surface treated and is characterized by high oxygen permeability (Dk). The SUS (stenfilcon A) Contact Lens is tinted blue using Reactive Blue #246 to make the lens more visible for handling. A Norbloc UV Blocker is used to reduce the amount of ultraviolet light transmitted into the eye. The SUS (stenfilcon A) lens is supplied sterile, packaged in a buffered saline solution. The composition of the lens is 46% stenfilcon A and 54% water by weight when hydrated and stored in buffered saline solution.

The acceptance criteria for the CooperVision SUS (stenfilcon A) Soft Contact Lens and the study proving it meets these criteria are detailed below:

1. Acceptance Criteria and Reported Device Performance

The device's performance was evaluated by comparing its material and physical properties to two predicate devices (CooperVision AVAIRA and CooperVision CLEARSIGHT 1 DAY), and through a clinical study for safety and efficacy.

Material Comparison (vs. CooperVision AVAIRA (enfilcon A))

Parameter Comparison (vs. CooperVision AVAIRA (enfilcon A))

Material Comparison (vs. CooperVision CLEARSIGHT 1 DAY (ocufilcon B))

Parameter Comparison (vs. CooperVision CLEARSIGHT 1 DAY (ocufilcon B))

Acceptance Criteria for Clinical Study and Reported Performance:

The primary acceptance criteria for the clinical study were the evaluation of biomicroscopy and adverse event rates, and visual acuity comparisons, with secondary measures including wearing times and subjective comfort. The reported performance was:

• "The Test contact lens was found to be substantially equivalent to the Control contact lens for safety and efficacy."

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

• Sample Size for Clinical Study (Test Set): 90 male and female subjects.
  • 60 subjects were dispensed the Test lenses (SUS (stenfilcon A)).
  • 30 subjects were dispensed the Control lenses (unspecified control contact lens, likely one of the predicate devices or a similar established lens).
• Data Provenance: Not explicitly stated regarding country of origin, but the study was conducted by CooperVision, Inc., a US-based company, and submitted to the US FDA. The study was prospective in nature through a clinical trial.

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

This information is not provided in the document. The clinical study details do not specify the number or qualifications of experts involved in establishing ground truth (e.g., ophthalmologists or optometrists assessing biomicroscopy findings).

4. Adjudication Method for the Test Set

The adjudication method for the clinical study is not explicitly detailed in the provided text. It mentions "The primary outcome measures were biomicroscopy and adverse event rates along with lens visual acuity comparisons" without specifying how disagreements or interpretations among clinical evaluators were resolved.

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

No, an MRMC comparative effectiveness study was not done. The clinical study described is for evaluating the safety and efficacy of the contact lens itself, not a comparison of human readers with and without AI assistance.

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

Not applicable. This is a medical device (contact lens), not an AI algorithm. Therefore, no standalone algorithm performance was assessed.

7. The Type of Ground Truth Used

For the non-clinical testing, the "ground truth" was established based on biocompatibility and toxicology standards (GLP regulation - 21 CFR Part 56) and established scientific protocols for physical and material property measurements.

For the clinical study, the "ground truth" for efficacy and safety was based on:

• Clinical observations from biomicroscopy.
• Adverse event reporting.
• Visual acuity comparisons.
• Subjective assessments of comfort and wearing times.
  This could be considered a form of expert clinical assessment/observation and patient-reported outcomes.

8. The Sample Size for the Training Set

Not applicable. This is a medical device (contact lens) and not an AI or machine learning model, so there is no "training set."

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

Not applicable, as there is no training set for this device.

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