(165 days)
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.
| Acceptance Criteria (Implied) | Reported Device Performance (SAUFLON CLARITI 1 DAY) |
|---|---|
| Material Composition | Somofilcon A (hydrophilic co-polymer) |
| Water Content | 56% |
| Oxygen Permeability (Dk) | 60 x 10^-11 (cm^2/sec) (ml O2/ml x mmHg at 35°C) |
| UVB Transmittance (280-315nm) | 0.71% (less than 5% required for UV blocker) |
| UVA Transmittance (316-380nm) | 20.62% (less than 30% required for UV blocker) |
| Refractive Index | 1.4003 |
| % Transmittance @ 590nm | 98.13% |
| Modulus (MPa) | 0.55 |
| Tensile Strength (MPa) | 1.05 |
| Elongation at Break % | 163 |
| Safety (Cytotoxicity, Sensitization, Ocular Irritation, Systemic Toxicity) | Passed (no evidence of adverse clinical effects) |
| Efficacy (Clinical Study) | Demonstrated safety, acceptability, and substantial equivalence to predicate. |
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.
§ 886.5925 Soft (hydrophilic) contact lens.
(a)
Identification. A soft (hydrophilic) contact lens is a device intended to be worn directly against the cornea and adjacent limbal and scleral areas of the eye to correct vision conditions or act as a therapeutic bandage. The device is made of various polymer materials the main polymer molecules of which absorb or attract a certain volume (percentage) of water.(b)
Classification. (1) Class II if the device is intended for daily wear only.(2) Class III if the device is intended for extended wear.
(c)
Date PMA or notice of completion of a PDP is required. As of May 28, 1976, an approval under section 515 of the act is required before a device described in paragraph (b)(2) of this section may be commercially distributed. See § 886.3.