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The SAUFLON CLARITI (somofilcon A) Soft (hydrophilic) Contact Lens with UV blocker and handling tint is indicated for daily wear 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 SAUFLON CLARITI TORIC (somofilcon A) Soft (hydrophilic) Contact Lens with UV blocker and handling tint is indicated for daily wear for the optical correction of refractive ametropia (myopia and hyperopia) in phakic or aphakic persons with non-diseased eyes that may exhibit astigmatism up to 10.00 Diopters.

The SAUFLON CLARITI MULTIFOCAL (somofilcon A) Soft (hydrophilic) Contact Lens with UV blocker and handling tint is indicated for daily wear for the optical correction of refractive ametropia (myopia and hyperopia) and/or presbyopia in phakic or aphakic persons with non-diseased eyes that may require a reading addition of +4.00 Diopters or less.

The SAUFLON CLARITI MULTIFOCAL TORIC (somofilcon A) Soft (hydrophilic) Contact Lens with UV blocker and handling tint is indicated for daily wear for the optical correction of refractive ametropia (myopia and hyperopia) and/or presbyopia in phakic or aphakic persons with non-diseased eyes that may exhibit astigmatism up to 10.00 Diopters and that may require a reading addition of +4.00 Diopters or less.

The lenses may be prescribed for daily wear for up to one month with removal for cleaning and disinfection (chemical, not heat) prior to reinsertion as recommended by the eye care professional.

Sauflon Clariti (somofilcon A) Soft (hydrophilic) Contact lens with UV blocker and handling tint helps protect against transmission of harmful UV radiation to the cornea and into the eye. The lens has a tint added to make the lens more visible for handling.

The Sauflon Clariti (somofilcon A) Soft (Silicone Hydrogel) Contact Lens with UV Blocker and handling tint is available as a single vision, toric and multifocal lens. The lens material (somofilcon A) is a hydrophilic co-polymer of silicone containing monomers and hydrophilic monomers which is cross-linked with Alkyl bis methacrylate. 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 to block UV radiation. A D&C Green 6 tint is also included in the composition of the lens for ease of handling and visibility.

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 Sauflon Clariti (somofilcon A) Soft (hydrophilic) Contact Lens with UV Blocker and Handling Tint is spherical flexible shell, which covers the cornea and a portion of the adjacent sclera, with the following dimensions:

• Chord Diameter: 13.0 to 18.0mm
• Centre Thickness: 0.03 to 0.70mm
• Base Curve: 7.5 to 9.5mm
• Powers: -30.00 DS to +30.00 DS
• Toric cylinder options: Between -0.75 and -9.75
• Toric Axis options: 10° to 180° (5° steps)
• Multifocal ADD: Add power of up to +4.00, labelled with indicative add strength to be read in conjunction with the fitting guide.

The physical/optical properties of the lenses are:

· Refractive Index: 1.4008
· %Transmittance @ 590nm: 98.30%
. %Transmittance @ 280-315nm: 0.71 .
. %Transmittance @ 316-380nm: 20.62
. Surface Character: Hydrophilic
Water Content: . 56%
60 x 10-11 (cm2/sec) (ml O2/ml x mmHg) Oxygen Permeability (DK): . at 35°C (Fatt Method for determination of oxygen permeability).
1.17 Specific Gravity:

The provided document is a 510(k) summary for a contact lens, which primarily focuses on demonstrating substantial equivalence to predicate devices rather than proving the device meets distinct acceptance criteria through a standalone study with a defined ground truth.

Here's an analysis based on the available information:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state "acceptance criteria" in the format of defined numerical thresholds that the new device must meet independently. Instead, it relies on demonstrating that the physical, optical, and chemical properties of the subject device are substantially equivalent to its predicate devices. The reported device performance is presented through a comparison table outlining these properties for the subject device and the predicates.

Summary of Device Performance against "Acceptance Criteria" (Substantial Equivalence): The document claims "substantial equivalence" based on these comparisons. For most properties, the subject device directly matches one of the predicate devices. Where differences exist (e.g., tint, water content, Dk, UV blocker, Modulus, Tensile Strength, Elongation at Break, packaging materials, packaging solution), the differences are argued to not raise new questions of safety or effectiveness.

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

The document mentions "A clinical study was conducted to evaluate the safety and efficacy of SAUFLON CLARITI (somofilcon A) Soft (hydrophilic) with UV Blocker and handling tint by comparison with Air Optix Aqua hydrophilic contact lenses (Ciba Vision Inc.)."

• Sample Size for Test Set: The specific number of subjects in this clinical study (test set) is not provided in the summary.
• Data Provenance: The study involved a comparison with Air Optix Aqua lenses. The summary does not explicitly state the country of origin for the data or whether it was retrospective or prospective, but clinical trials for regulatory submissions are typically prospective.

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

This type of information is usually relevant for studies involving human interpretation (e.g., image analysis). For a contact lens clinical study evaluating safety and efficacy, the "ground truth" is generally derived from direct clinical observations (e.g., visual acuity, adverse events, fit) performed by qualified clinicians (optometrists, ophthalmologists). The document does not specify the number or qualifications of experts involved in establishing ground truth for the clinical study.

4. Adjudication Method for the Test Set

The document does not specify an adjudication method (such as 2+1, 3+1, or none) for the clinical study. This is less common to report for contact lens clinical studies compared to, for example, studies involving subjective image interpretation where expert discrepancies need resolution.

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

No, an MRMC comparative effectiveness study was not conducted as described in the provided text. MRMC studies are typically used to assess the performance of diagnostic devices interpreted by multiple human readers, often with and without AI assistance, which is not applicable to a contact lens evaluation in this context. The clinical study was a direct comparison of the subject contact lens to a predicate contact lens.

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

This question is not applicable. The device is a physical contact lens, not an algorithm or AI system. The "standalone performance" of the contact lens is assessed through its physical, optical, chemical properties, and human clinical trials (with humans wearing the device, not interacting with an algorithm).

7. The Type of Ground Truth Used

For the clinical study:

• Derived from: Clinical observations (e.g., visual acuity, comfort, lens fit, adverse events) as measured during the study by clinical investigators. This is a form of outcomes data and expert clinical assessment.
• For the physicochemical studies: Laboratory measurements of defined properties (e.g., water content, Dk, transmittance, modulus, tensile strength).

8. The Sample Size for the Training Set

This question is not applicable. The document describes a physical medical device (contact lens), not an AI/algorithm-based device that requires a training set. The manufacturing process for contact lenses (cast moulding) does not involve a "training" phase in the context of machine learning.

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

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

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The SAUFLON CLARITI (somofilcon A) Soft (hydrophilic) Contact Lens with UV blocker is indicated for monthly disposable wear for the correction of refractive ametropia (myopia and hyperopia) in phakic or aphakic persons with non-diseased eyes that may exhibit astigmatism up to 2.00 Diopters that does not interfere with visual acuity.

The SAUFLON CLARITI TORIC (somofilcon A) Soft (hydrophilic) Contact Lens with UV blocker is indicated for monthly disposable wear for the optical correction of refractive ametropia (myopia and hyperopia) in phakic persons with nondiseased eyes that may exhibit astigmatism up to 10.00 Diopters.

The SAUFLON CLARITI MULTIFOCAL (somofilcon A) Soft (hydrophilic) ontact Lens with UV blocker is indicated for monthly disposable wear for the optical correction of refractive ametropia (myopia and hyperopia) and/or presbyopia in phakic or aphakic 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 SAUFLON CLARITI MULTIFOCAL TORIC (somofilcon A) Soft ydrophilic) Contact Lens with UV blocker is indicated for monthly disposable wear for the optical correction of refractive ametropia (myopia and hyperopia) and/or presbyopia in phakic or aphakic persons with non-diseased eyes that may exhibit astigmatism up to 10.00 Diopters and that may require a reading addition of +3.00 Diopters or less.

The lenses may be prescribed for daily wear with removal for cleaning and isinfection (chemical, not heat) prior to reinsertion as recommended by the eye care professional.

Sauflon Clariti (somofilcon A) Soft (hydrophilic) Contact lens with UV blocker help protect against transmission of harmful UV radiation to the cornea and into the eye.

The Sauflon Clariti (somofilcon A) Soft (Silicone Hydrogel) Contact Lens with UV Blocker is available as a single vision, toric, multifocal and multifocal toric lens. The lens material (somofilcon A) is a hydrophilic co-polymer of silicone containing monomers and hydrophilic monomers which is cross-linked with tetraethyleneglycol dimethacrylate. 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 to block UV radiation.

The average transmittance characteristics are less than 5% in the UVB range of 280 to 315nm and less than 50% in the UVA range of 316-380nm

The Sauflon Clariti (somofilcon A) Soft (hydrophilic) Contact Lens with UV Blocker is 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 . 7.5mm to 9.30mm Base Curve: . Powers: -20.00 DS to +20.00 DS . . Toric Cylinder options: -0.75, -1.25, -1.75 and -2.25
• Toric Axis options: .
• . Multifocal Add:

10° to 180° (10° steps).

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 the K130342 510(k) summary for the Sauflon Clariti (somofilcon A) Soft (hydrophilic) Contact Lens with UV Blocker. It focuses on demonstrating substantial equivalence to predicate devices, primarily through physicochemical and toxicological studies, and a human clinical study.

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

1. Table of Acceptance Criteria and Reported Device Performance

The document doesn't explicitly state "acceptance criteria" for the clinical study in a quantifiable manner (e.g., "minimum visual acuity improvement of X"). Instead, it focuses on demonstrating safety, acceptability, and substantial equivalence. However, we can infer some performance metrics from the physicochemical properties table and the overall conclusion.

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The SAUFLON 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 or aphakic persons with non-diseased eyes that may exhibit astigmatism up to 2.00 Diopters that does not interfere with visual acuity.

The SAUFLON 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 and hyperopia) and/or presbyopia in phakic or aphakic persons with non-diseased eyes that may exhibit astigmatism up to 10.00 Diopters.

The SAUFLON 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 or aphakic 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 SAUFLON 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 or aphakic 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 eye care professional should prescribe the lenses for daily wear single use only. The lenses are to be discarded upon removal; therefore, no cleaning or disinfecting is required. Sauflon Clariti 1-Day (somofilcon A) Soft (hydrophilic) Daily Disposable Contact Lenses with UV Blocker help protect against transmission of harmful UV radiation to the cornea and into the eye.

The Sauflon Clariti I Day (somofileon A) Soft (hydrophilic) Daily Disposable Contact Lens with UV Blocker is available as a single vision, toric and multifocal The lens material (somofileon A) is a hydrophilic co-polymer of silicone lens. containing monomers and hydrophilic monomers which is cross-linked with tetraethyleneglycol dimethacrylate. 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 to block UV radiation:

The average transmittance characteristics are less than 5% in the UVB range of 280 to 315nm and less than 30% in the UVA range of 316-380nm

The Sauffon Clariti 1 Day (somofileon A) Soft (hydrophilic) Daily Disposable Contact Lens with UV Blocker is a hemispherical flexible shell, which covers the cornea and a portion of the adjacent sciera, 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 is a 510(k) summary for the SAUFLON CLARITI 1 DAY Contact Lens, not an AI/ML device. Therefore, it does not contain the specific information requested about acceptance criteria for an AI device, a study proving device meeting acceptance criteria, sample sizes for test/training sets, data provenance, expert ground truth establishment, adjudication methods, MRMC studies, or standalone algorithm performance.

Instead, the document focuses on demonstrating substantial equivalence to existing predicate devices based on physicochemical properties, toxicology studies, and human clinical studies for a medical device (contact lens).

Here's an attempt to interpret the request's structure in the context of the provided document, but be aware that it won't directly answer for AI device specifics:

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

Since this is a contact lens, the "acceptance criteria" are implied by the properties matching or being superior to predicate devices, and demonstrating safety and efficacy in various tests.

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

• Sample Size for Test Set: The document states "A clinical study was conducted...", but the specific number of subjects (sample size) for this study is not provided in the summary.
• Data Provenance: The location of the clinical study is not explicitly stated in the provided abstract. It is a "clinical study" which implies prospective data collection, but no further details are given.

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)

This concept is not applicable to this type of medical device submission. "Ground truth" for a contact lens primarily comes from direct measurement of physical properties and clinical outcomes from patient use, not expert interpretation of outputs.

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

Not applicable for a contact lens clinical study. Adjudication methods like 2+1 are typically used for disagreements in expert readings for AI/ML performance evaluation.

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-assisted diagnostic device submitting an MRMC study. The clinical study was a comparison of contact lenses, not human readers.

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

Not applicable. This is not an algorithm.

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

For the clinical study, the "ground truth" would be related to clinical outcomes data (safety, comfort, visual acuity, acceptability, etc.) derived from direct patient observation and measurements during lens wear. For physicochemical properties, the ground truth is direct measurement of those properties using standardized testing methods.

8. The sample size for the training set

Not applicable. This is a manufactured product, not an AI/ML model that undergoes a "training" phase with data.

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

Not applicable. There is no training set mentioned or implied for this device.

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Sauflon Multipurpose Solution is indicated for use in the daily cleaning, rinsing, disinfection, removal of proteins, storage and conditioning of soft (hydrophilic) contact lenses including silicone hydrogel lenses, as recommended by the eye care practitioner.

Sauflon Multipurpose Solution is a sterile, isotonic solution that contains poloxamer, sodium phosphate buffer, sodium chloride, and disodium edetate; preserved with polyhexanide 0.0001%. Contains no chlorohexidine or thimerosal.

In the provided text, the device in question is "Sauflon Multipurpose Solution". The purpose of the 510(k) submission is to add the indication for use with Silicone Hydrogel Lenses, with the predicate device being Aquify Multi-Purpose Disinfecting Solution.

Here's an analysis of the acceptance criteria and study information:

Acceptance Criteria and Reported Device Performance

Study Details

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

   • Clinical Trial: Circa 250 subjects.
   • Data Provenance: Not explicitly stated, but the submission is from a UK company, making it plausible the study was conducted there or internationally. The text does not specify if it was retrospective or prospective, but clinical trials are generally prospective.
   • Silicone Hydrogel Lens Compatibility: Tested with "4 representative marketed silicone hydrogel lenses."

2. 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):

   • The document does not mention the use of experts to establish a "ground truth" in the traditional sense. The clinical study compares the new solution to a predicate device, focusing on safety and acceptability based on subject outcomes and observations, rather than expert interpretation of data points.

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

   • Not specified. The clinical trial focused on safety and acceptability, which typically involves collection of adverse events, comfort scores, and other objective measures, rather than subjective adjudication by multiple experts.

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:

   • No, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. This type of study is relevant for diagnostic devices involving human interpretation (e.g., radiology AI), which is not applicable to a contact lens solution.

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

   • Not applicable. This device is a contact lens solution, not an algorithm. The "standalone" performance would refer to the chemical properties and biological effects of the solution, which were tested in pre-clinical (toxicology, microbiology) and clinical studies.

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

   • For pre-clinical studies (toxicology, microbiology, lens compatibility): The "ground truth" was established by objective laboratory test results against predefined standards (e.g., cytotoxicity assays, microbial kill rates, material compatibility assessments).
   • For clinical studies: The "ground truth" for safety and acceptability was established through clinical observations, reported adverse events, comfort questionnaires, and other objective measures from the 250 subjects, compared against the predicate device. This falls under outcomes data or clinical endpoints.

7. The sample size for the training set:

   • Not applicable. This is a contact lens solution, not an AI/machine learning algorithm that requires a "training set."

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

   • Not applicable, as no training set was used.

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The Sauflon New Day® (methafilcon A) Soft (hydrophilic) Visibility tinted contact lens is a daily disposable lens indicated for the correction of the refractive ametropia (myopia and hyperopia) and astigmatism in aphakic and not-aphakic persons with non-diseased eyes that may exhibit astigmatism up to 2.00 Dioptres that does not interfere with visual acuity.

The SAUFLON New Day® (methafilcon A) Soft (Hydrophilic) Visibility Tinted Daily Disposable Contact Lenses are available in an aqua visibility tint. The lens material (methafilcon A) is a hydrophilic polymer of 2-hydroxyethyl methacrylate (HEMA) and methacrylic acid, which is cross-linked with ethyleneglycol dimethacrylate. When hydrated the lens consists of 45% HEMA and 55% water by weight of saline immersed in normal saline. The lens is visibility tinted aqua with weight of summe inimelod in his meller on the well and one UV absorbing monomer is used to block UV radiation. Sauflon New Day lenses are daily disposable lenses. The average transmittance characteristics are less than 10% in the UVB range of 280 to 315nm and less than 40% in the UVA range of 315-380nm. The SAUFLON New Day Daily Disposable Lens is a hemispherical flexible shell, which covers the cornea and a portion of the adjacent sclera.

This 510(k) summary describes a contact lens, the SAUFLON New Day® (methafilcon A) Soft (Hydrophilic) Visibility Tinted Daily Disposable Contact Lens, and aims to establish its substantial equivalence to a predicate device, the SAUFLON 55UV (methafilcon A) Soft (hydrophilic) Visibility Tinted Contact Lens for Daily Wear (K013649).

The acceptance criteria relate to demonstrating that the new device is as safe and effective as the predicate device. The study presented is a comparison of physical, optical, and chemical properties, as well as manufacturing processes and safety tests, between the two contact lenses. No clinical effectiveness study with human readers or AI assistance is mentioned as this is a medical device approval for a contact lens.

Here's the breakdown of the information requested:

1. Table of Acceptance Criteria and the Reported Device Performance

The acceptance criteria are implicitly that the new device (SAUFLON New Day) demonstrates properties, materials, and manufacturing processes that are identical or equivalent to the legally marketed predicate device (SAUFLON 55UV), and where differences exist (e.g., lens design or modality), these differences do not affect safety or efficacy.

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

• Sample Size for Test Set: Not explicitly stated as a number of tested units for each property. The "test set" here refers to the SAUFLON New Day lens, for which various properties were measured and compared. The data provenance is from Sauflon Pharmaceuticals Ltd., United Kingdom. The studies appear to be prospective in that new measurements were taken for the subject device to compare against the known predicate device. For some aspects (e.g., stability, leachability, toxicology), the data from the predicate device's prior approval (K013649) was deemed applicable due to identical materials and processes.

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

This type of information is not applicable for this submission. The "ground truth" for contact lens properties like water content, transmittance, Dk, etc., is established through standardized physical, optical, and chemical testing methods, not through expert consensus on interpretation. Toxicology and leachability tests also follow established laboratory protocols.

4. Adjudication method for the test set

Not Applicable. As mentioned above, the "ground truth" is derived from objective physical, optical, and chemical measurements and standard laboratory tests, not from subjective expert 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

No. This is a submission for a medical device (contact lens), not an AI-powered diagnostic or assistive technology. Therefore, an MRMC comparative effectiveness study involving human readers and AI is not applicable and was not performed.

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

No. This is not an AI algorithm. Therefore, a standalone algorithm performance study is not applicable and was not performed.

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

The "ground truth" for the comparison is based on:

• Standardized physical, optical, and chemical measurements: For properties like water content, transmittance, Dk, refractive index, tensile strength, etc.
• Laboratory test results: For toxicology (cytotoxicity, systemic toxicity, ocular irritation), residual monomers, and color leachability studies.
• Manufacturing process documentation: To confirm identical processes.
• Reference to prior FDA clearance (K013649): For established safety and efficacy of the predicate device's materials and processes.

8. The sample size for the training set

Not applicable. This is not an AI/machine learning device. There is no concept of a "training set" in this context.

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

Not applicable. As above, there is no training set for this type of device. The ground truth for the comparison was established through objective, standardized testing and the documented equivalence to a previously cleared device.

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Storage of soft (hydrophilic), hard and rigid gas permeable (RGP) contact lenses during chemical disinfection only. Not to be used for heat disinfection.

The SAUFLON Flat Coloured Lens Case are moulded plastic, flat style cases with screw top lids, similar in design to currently marketed products.

Here's an analysis of the provided 510(k) summary for the SAUFLON Flat Coloured Contact Lens Cases, focusing on the acceptance criteria and the study performed:

1. Table of Acceptance Criteria and Reported Device Performance

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

The 510(k) summary does not specify the sample sizes used for the cytotoxicity, systemic toxicity, or ocular irritation studies. The data provenance is not explicitly stated as retrospective or prospective, nor does it mention the country of origin of the data. However, given that Sauflon Pharmaceuticals Ltd. is based in the UK, it's reasonable to infer the studies likely involved testing done in the UK or under UK/European standards at the time, but this is not explicitly stated.

3. Number of Experts Used to Establish Ground Truth and Qualifications

The 510(k) summary does not mention the use of experts to establish ground truth for the test set. The reported performance is based on the laboratory study results (cytotoxicity, systemic toxicity, ocular irritation). These types of studies typically involve scientific methodologies and instrumentation rather than expert consensus on subjective interpretations.

4. Adjudication Method for the Test Set

No adjudication method is mentioned. The testing performed (cytotoxicity, systemic toxicity, ocular irritation) are laboratory-based studies that produce objective results, not requiring an adjudication process commonly used for subjective interpretation tasks (e.g., image reading).

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done

No, an MRMC comparative effectiveness study was not done. This type of study is relevant for devices involving human interpretation, often clinical imaging, to assess reader performance with and without AI assistance. The Sauflon contact lens case is a physical medical device, not an AI-powered diagnostic tool.

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

This question is not applicable. The Sauflon Flat Coloured Lens Case is a physical product for storing contact lenses during chemical disinfection. It does not involve an algorithm or AI functionality, so the concept of standalone performance (algorithm-only) does not apply. The "standalone" performance here relates to the inherent safety and effectiveness of the material and design as tested in the mentioned studies.

7. The Type of Ground Truth Used

For the studies mentioned:

• Cytotoxicity: The ground truth would be established through laboratory assays (e.g., cell viability, cell proliferation) comparing the device's extract/material exposure to control substances, with scientific criteria defining what constitutes cellular toxicity.
• Systemic Toxicity: The ground truth would be established through animal models (e.g., using extracts of the material) with predetermined endpoints and measurements to assess systemic adverse effects, using established toxicological protocols.
• Ocular Irritation: The ground truth would be established through in-vitro or in-vivo testing (e.g., using extracts applied directly to ocular tissues or cell lines, or in animal models) using established protocols to evaluate irritating effects on the eye.

The ground truth in all these cases is based on objective scientific/laboratory measurements and established biological assays/protocols, rather than expert consensus, pathology, or outcomes data in the context of clinical trials.

8. The Sample Size for the Training Set

This question is not applicable. The device is a physical contact lens case, not an AI/machine learning model that requires a training set. The safety and effectiveness were demonstrated through direct testing of the device's materials, not through a learning algorithm.

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

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

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Storage of soft (hydrophilic), hard and rigid gas permeable (RGP) contact lenses during chemical disinfection only. Not to be used for heat disinfection.

The SAUJFLON contact lens cases are moulded plastic, flat or barrel style cases with screw top leads, similar in design to currently marketed products. The barrel style include a lens basket used for holding the lens during storage.

This document describes a 510(k) submission for Sauflon Contact Lens Cases and focuses on their substantial equivalence to a predicate device rather than a study with acceptance criteria for a new device's performance. Therefore, most of the requested information regarding acceptance criteria, study details, and expert ground truth is not explicitly available in this type of submission.

However, I can extract the information relevant to the safety and effectiveness assessment conducted:

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

Since this is a 510(k) for a contact lens case, the "acceptance criteria" are not reported as specific numerical thresholds for performance metrics. Instead, "acceptance" is implicitly defined by demonstrating that the device is substantially equivalent to a predicate device, particularly regarding safety aspects. The reported "performance" is the successful completion of safety studies without adverse findings.

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

• Sample size for test set: Not explicitly stated in terms of number of units or biological samples used for the cytotoxicity, systemic toxicity, and ocular irritation studies.
• Data provenance: Not explicitly stated (e.g., country of origin, retrospective/prospective). This is typically detailed in the full study reports, not the 510(k) summary.

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

• Number of experts: Not applicable/not stated. The safety studies (cytotoxicity, systemic toxicity, ocular irritation) would be assessed by trained toxicologists and histopathologists, but a "ground truth" derived from expert consensus in the diagnostic sense is not relevant here.

4. Adjudication method for the test set:

• Adjudication method: Not applicable/not stated. The results of the toxicology studies would be interpreted by specific scientific methods rather than through an adjudication process among multiple experts as typically seen in clinical diagnostic studies.

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:

• MRMC study: No, this type of study is not relevant for a contact lens case. MRMC studies are typically for diagnostic AI systems that assist human readers in interpreting medical images or data.

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

• Standalone performance: No, this is not a diagnostic algorithm. The "device" is a physical product (contact lens case), not software or AI.

7. The type of ground truth used:

• Type of ground truth: For the safety studies (cytotoxicity, systemic toxicity, ocular irritation), the "ground truth" would be established by scientific methods and measurements (e.g., cell viability assays, histopathological examination, irritation scoring) against established toxicity standards and biological responses. It's objective scientific criteria rather than "expert consensus" or "pathology" in a diagnostic imaging context.

8. The sample size for the training set:

• Sample size for training set: Not applicable. This device is not an AI/ML product that requires a "training set."

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

• Ground truth for training set: Not applicable.

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The Sauflon Multipurpose Solution is indicated for use in the daily cleaning, rinsing, chemical (not heat) disinfection, removal of proteins and storage of soft (hydrophilic) contact lenses, as recommended by the eye care practitioner

Sauflon Multipurpose Solution is a sterile, isotonic solution that contains poloxamer, sodium phosphate buffer, sodium chloride, and disodium edetate; preserved with polyhexanide 0.0001%. Contains no chlorohexidine or thimerosal. Sauflon Multipurpose Solution remains unchanged from the previously approved product in K974485, except for the revised directions for use.

Here's a breakdown of the acceptance criteria and study information for the Sauflon Multipurpose Solution, based on the provided text:

Important Note: The provided document is a 510(k) summary for a multipurpose solution, which is a chemical product, not a medical device in the typical sense of AI-powered diagnostic or therapeutic tools. Therefore, many of the requested categories (like "Number of experts," "MRMC study," "AI assistance," "Standalone performance," "Training set sample size," etc.) are not applicable to this type of submission. The information provided focuses on the safety and efficacy of the solution itself and its comparison to a predicate device.

1. Table of Acceptance Criteria and Reported Device Performance

Study Details for Clinical Safety & Acceptability (as applicable for this product)

Since this is a solution, not a device with AI, the "test set" and "ground truth" concepts are interpreted differently. For the clinical study, the "test set" refers to the subjects using the product, and "ground truth" is established through clinical observations of safety and acceptability.

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

  • Test Set (Clinical Study): 50 subjects using Sauflon Multipurpose Solution.
  • Control Group: 21 control subjects using AMO Complete Brand Multi-Purpose Solution - No Rub.
  • Data Provenance: The document does not explicitly state the country of origin for the clinical study data beyond the submission being from "Twickenham, Middlesex TW1 3LP United Kingdom". The study is prospective, as it describes a 3-month usage period.

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

  • This is not explicitly stated. The "ground truth" for a contact lens solution clinical study would typically involve clinical assessments by eye care practitioners or other medical professionals monitoring the subjects for adverse events, comfort, and other relevant outcomes. The document indicates the product is for use "as recommended by the eye care practitioner," implying expert involvement in monitoring but doesn't specify how many or their qualifications for establishing study "ground truth."

• 4. Adjudication Method for the Test Set:

  • Not described in the provided text. For a clinical study of this nature, adjudication of adverse events or safety concerns would typically be part of the protocol, but the method is not detailed here.

• 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, this was not done. This type of study is relevant for diagnostic imaging AI devices, not for contact lens care solutions.

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

  • No, this was not done. This concept is only applicable to AI/algorithm-based devices. The "standalone" tests for this product were laboratory tests for sterility, preservative efficacy, and disinfection efficacy (as listed in section 7 of the 510(k) summary).

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

  • For the clinical study, the ground truth was based on clinical observations and subjective feedback from subjects regarding safety and acceptability over a 3-month period, likely assessed against outcomes data such as adverse event rates, comfort scores, and overall satisfaction, compared to the predicate device.
  • For the pre-clinical (laboratory) tests (sterility, efficacy, etc.), the "ground truth" was established by defined laboratory standards and measurement protocols (e.g., USP requirements, specific disinfection test standards).

• 8. The Sample Size for the Training Set:

  • Not applicable. This product is a chemical solution, not an AI model that requires a "training set."

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

  • Not applicable. As above, no training set for an AI model.

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The Sauflon 55 UV soft (hydrophilic) contact lens is indicated for daily wear for the correction of the refractive ametropia (myopia and hyperopia) and astigmatism in aphakic and not-aphakic persons with non-diseased eyes that may exhibit astigmatism up to 2.00 Dioptres that does not interfere with visual acuity.

Eyecare practitioners may prescribe the lens for daily wear in a Frequent Replacement Program. The lenses may be disinfected using chemical or hydrogen peroxide disinfection systems.

The SAUFLON 55UV (methafilcon A) Soft (Hydrophilic) Visibility Tinted Contact Lenses for Daily Wear is available as a single vision lens in an aquamarine visibility tint. The lens material (methafilcon A) is a hydrophilic polymer of 2-hydroxyethyl methacrylate (HEMA) and methacrylic acid, which is cross-linked with ethyleneglycol dimethacrylate. When hydrated the Inns consists of 45.0% HEMA and 55.0% water by weight of saline immersed in normal saline. The lens is visibility tinted aqua with: Reactive Blue No. 4 and Reactive Yellow Dye # 86. A benzophenone UV absorbing monomer is used to block UV radiation.

The average transmittance characteristics are less than 10% in the UVB range of 280 to 315nm and less than 40% in the UVA range of 315-380mm.

The SAUFLON 55 UV Contact Lens is a hemispherical flexible shell, which covers the cornea and a portion of the adjacent sclera.

The provided text describes specific information about a contact lens and its comparative testing. However, it does not include the details requested in your prompt regarding acceptance criteria for a device performance study, the study details (sample size, data provenance, expert ground truth, adjudication, MRMC, standalone performance), or training set information.

Instead, the document focuses on:

• Device Description: SAUFLON 55 UV (methafilcon A) Soft (Hydrophilic) Visibility Tinted Contact Lens for Daily Wear.
• Substantial Equivalence Claim: To FREQUENCY 55 (methafilcon A) Hydrophilic Contact Lenses, based on physical and optical properties.
• Preclinical Testing: Toxicology, residual monomer, and color leachability to demonstrate non-toxicity and non-irritation.
• Physical/Optical Property Comparison Table: Between the SAUFLON 55 UV and the predicate device, FREQUENCY 55. This table presents performance metrics but these are not explicitly framed as "acceptance criteria" for a study in the context of the prompt's request.
• Indications for Use: Correction of refractive ametropia (myopia and hyperopia) and astigmatism in aphakic and not-aphakic persons with non-diseased eyes; daily wear in a Frequent Replacement Program; disinfection compatibility.
• Transmittance Curves: Showing UV blocking characteristics compared to human cornea and crystalline lens.

Therefore, I cannot populate the table or provide the detailed study information as requested because the document does not contain that specific type of performance study data or acceptance criteria. It primarily relies on demonstrating substantial equivalence through material properties and basic preclinical safety tests.

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