(112 days)
The Sauflon Clariti 1 Day (somofilcon A) Soft (hydrophilic) Daily Disposable Contact Lens with UV blocker and Handling Tint 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 and Handling Tint is indicated for daily wear single use only 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 1 DAY MULTIFOCAL (somofilcon A) Soft (hydrophilic) Daily Disposable Contact Lens with UV blocker and Handling Tint 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 +4.00 Diopers 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 and Handling Tint 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 +4.00 Diopters or less.
Sauflon Clariti 1 Day (somolilcon A) Soft (hydrophilic) Daily Disposable Contact lens. with UV blocker and Handling Tim help protect against transmission of harmful UV radiation to the cornea and into the eye.
The Sauflon Clariti 1 Day (somofilcon A) Soft (hydrophilic) Daily Disposable Contact Lens with UV Blocker and Handling Tint is available as a single vision, toric, multifocal and multifocal toric lens. The lens muterial (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% somofileon 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 handling tint is added to the composition of the lens to make the lens visible for handling.
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 1 Day (somofileon A) Soft (hydrophilic) Daily Disposable Contact Lens with UV Blocker and Handling Tint is a hemispherical flexible shell, which covers the cornea and a portion of the adjacent schera, with the following dimensions:
Chord Diameter: 13.0mm to 18.0mm
Centre Thickness: 0.03mm to 0.70mm
Base Curve: 7.5mm to 9.50mm
Powers: -30.00 DS to +30.00 DS
Toric Cylinder options: -0.75 to -9.75
Toric Axis options: 10° to 180° (5° steps).
Multifocal Add: Add power 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%
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 510(k) summary for the SAUFLON CLARITI I DAY TINTED CONTACT LENS primarily focuses on demonstrating substantial equivalence to predicate devices through comparisons of physical, optical, and chemical properties, as well as toxicology and human clinical studies. However, it does not explicitly define "acceptance criteria" in the traditional sense of specific performance metrics with binary outcomes for the device itself. Instead, the "acceptance criteria" can be inferred as demonstration of safety, efficacy, and substantial equivalence to existing legally marketed devices.
The study that "proves the device meets the acceptance criteria" is described as a "clinical study" which evaluated "the safety and efficacy" and "substantial equivalence" of the Sauflon Clariti (somofilcon A) Soft (hydrophilic) Contact Lens with UV Blocker and Handling Tint.
Here's a breakdown of the requested information based on the provided text:
1. A table of acceptance criteria and the reported device performance
Since explicit "acceptance criteria" with numerical targets are not stated, the table below infers them based on the substantial equivalence claims and the type of information presented. The reported performance is the conclusion of the studies.
| Acceptance Criteria (Inferred) | Reported Device Performance |
|---|---|
| Physical/Optical/Chemical Properties: | Substantially equivalent to predicate devices. Specific properties are listed with values that are either identical or comparable to predicate devices (e.g., Water Content 56%, Refractive Index 1.40, Light Transmittance ≥96%, Dk @35°C 60). |
| - Water Content | 56% |
| - Refractive Index | 1.40 |
| - Light Transmittance | ≥96% |
| - Oxygen Permeability (Dk) | 60 x 10^-11 (cm²/sec) (ml O2/ml x mmHg) at 35°C |
| - Leachable substances levels | Low or below measurable levels. |
| Biocompatibility/Toxicology: | Passed ISO 10993 standards. No evidence of adverse clinical effects caused by the lens across cytotoxicity, ocular irritation, and systemic toxicity assessments. |
| - Cytotoxicity (ISO 10993) | Passed |
| - Ocular Irritation (ISO 10993) | Passed |
| - Systemic Toxicity (ISO 10993) | Passed |
| Clinical Safety and Efficacy: | Demonstrated safety, acceptability, and substantial equivalence to the predicate device (Air Optix Aqua) for its intended use through a human clinical study. The study showed "no evidence of adverse clinical effects." |
| - Acceptable safety profile (no adverse clinical effects) | Achieved ("no evidence of adverse clinical effects caused by the lens" and "the safety, acceptability and substantial equivalence... to the predicate device for its intended use") |
| - Efficacy for intended use (refractive correction, UV blockage) | Achieved (Inferred from "substantial equivalence... to the predicate device for its intended use" and the specific UV transmittance characteristics that are stated for the device (less than 5% in UVB, less than 50% in UVA), which meet typical Class 2 UV blocker requirements for contact lenses, although not an explicit acceptance criterion). |
| - Substantial Equivalence to Predicate Devices (Air Optix Aqua, Acuvue Trueye, Sauflon Clariti 1 Day) | Concluded by the sponsor and FDA (via 510(k) clearance) based on the comprehensive evaluation, including physical/optical properties, toxicology, and clinical study findings. |
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 the human clinical study: Not explicitly stated. The text only mentions "Subjects" were used.
- Data provenance: Not explicitly stated (e.g., country of origin, retrospective or prospective). However, clinical studies conducted for 510(k) submissions are typically prospective and often involve participants from various regions, though this document doesn't specify.
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)
- The document does not mention the number or qualifications of experts used to establish ground truth for the clinical study. Such detail is typically found within the full clinical study report, not necessarily in a 510(k) summary. Given the nature of a contact lens study, the "ground truth" would likely be derived from direct clinical observations, objective measurements (e.g., visual acuity, fits assessment), and reported symptoms by the subjects, assessed by optometrists or ophthalmologists.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- The document does not describe any specific adjudication method for the clinical study data.
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 MRMC comparative effectiveness study was done. This type of study is not relevant for a contact lens approval, as it's for evaluating diagnostic aids or imaging interpretation, not the physical performance of a medical device like a 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 contact lens, meaning it is a physical product designed for human wear, not an algorithm. Therefore, "standalone algorithm performance" is not a relevant concept here.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- For the human clinical study, the "ground truth" would be clinical observations and measurements related to safety (e.g., ocular health, adverse events) and efficacy/acceptability (e.g., visual acuity, comfort, fit, patient preference, manifest refraction/prescription as a baseline). This is effectively outcomes data from the subjects themselves, assessed by clinicians.
- For the physicochemical studies, the "ground truth" is established by standard laboratory test methods (e.g., Fatt Method for oxygen permeability measurement).
8. The sample size for the training set
- This question is not applicable as this is a physical medical device (contact lens) and not an AI/ML algorithm that requires a "training set."
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.
§ 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.