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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.

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

• Sample Size for Test Set: The document states that "A clinical study was conducted." However, it does not provide the specific sample size (number of subjects/eyes) used in this human clinical study.
• Data Provenance: The document does not explicitly state the country of origin. It mentions Sauflon Pharmaceuticals Ltd's address in Twickenham, Middlesex, England, implying the study might have been conducted in the UK or under their oversight. The study appears to be prospective, as it involved subjects using the lenses and a predicate device under specific daily wear conditions.

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

This type of information is generally found in detailed clinical study protocols and reports, which are not fully provided in this 510(k) summary. The summary does not specify the number of experts or their qualifications involved in establishing "ground truth" for the clinical safety and efficacy evaluation. Clinical studies for contact lenses typically involve ophthalmologists or optometrists for examinations and evaluations.

4. Adjudication Method for the Test Set

The document does not describe any specific adjudication method (e.g., 2+1, 3+1) for the clinical study's results. The statement "The results of this study showed the safety, acceptability and substantial equivalence..." implies a comprehensive evaluation of the collected data, but the method of resolving discrepancies or forming consensus is not detailed.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size

No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. This type of study typically assesses diagnostic performance of an imaging device interpreted by multiple readers. The device in question is a contact lens, and the study was a clinical trial evaluating safety and efficacy, not diagnostic interpretation. Therefore, there's no mention of effect size related to human readers improving with or without AI assistance, as AI is not a component of this device.

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

No, a standalone (algorithm only) performance study was not done. This device is a medical device (contact lens) and does not involve an AI algorithm or software that operates independently. Its performance is evaluated through its physical and optical properties and its interaction with the human eye in a clinical setting.

7. The Type of Ground Truth Used

For the physicochemical studies, the "ground truth" is established through standardized laboratory test methods (e.g., Fatt Method for oxygen permeability, spectrophotometry for light transmittance).

For the human clinical study, the "ground truth" for safety and efficacy is based on clinical observation, patient feedback, and examinations by eye care professionals. This would typically involve assessments of visual acuity, lens fit, comfort, adverse events, integrity of ocular tissues, and comparison to the predicate device's performance in the same subjects. The conclusion states "safety, acceptability and substantial equivalence," indicating these clinical observations served as the ground truth.

8. The Sample Size for the Training Set

This information is not applicable as the device is a contact lens and does not involve a "training set" in the context of machine learning or AI algorithms. The clinical study performed functions as a validation study.

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

This information is not applicable for the same reason as point 8.

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