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510(k) Data Aggregation
(396 days)
The VISCO Soft (Hydrophilic) Contact Lenses is indicated for the correction of refractive ametropia (myopia and hyperopia) in phakic or aphakic persons with non-diseased eyes who exhibit refractive astigmatism of 2.00D or less where the astigmatism does not interfere with visual acuity. Eyecare practitioners may prescribe the lens for either single-use disposable wear, or for frequent/planned replacement wear, with cleaning, disinfection, and scheduled replacement. When prescribed for frequent replacement, the lens may be disinfected using a chemical disinfection system only. The VISCO Soft (Hydrophilic) Contact Lenses help protect against transmission of harmful UV radiation to the cornea and into the eye.
The VISCO Soft Contact Lens is a spherical lens with UV blocker. The VISCO Soft Contact Lens is available in hemispherical shell. The lens material is a silicon combination hydrogel. It is a copolymer of 1-vinyl-2-pyrrolidinone (NVP) and Siloxane macromer. The water content is 47%. The VISCO Soft Contact Lens is light blue tinted with "reactive Blue19" for handling visibility purpose. A benzotriazole UV absorbing monomer is used to block UV radiation. The transmittance characteristics are less than 5% (1.1%) in the UVB range of 280-315nm and less than 50% (9.4%) in the UVA range of 316-380nm. The lens is supplied in a sterile state, packaged in a buffered saline solution.
The provided document describes the Visco Soft Contact Lens and its substantial equivalence to a predicate device. However, it does not contain a detailed study report with acceptance criteria for device performance in the context of an AI/ML algorithm. Instead, it focuses on the physicochemical and mechanical properties of the contact lens.
Therefore, many of the requested details regarding AI/ML study design, such as sample size for test/training sets, data provenance, expert ground truth, adjudication methods, and MRMC studies, are not applicable to this document.
Here's an analysis based on the information available:
1. A table of acceptance criteria and the reported device performance
The document does not specify formal "acceptance criteria" in the context of an AI/ML device performance study with specific metrics like sensitivity, specificity, or AUC. Instead, it presents a comparison of the physical and mechanical properties of the Visco Soft Contact Lens to a predicate device. The performance is assessed by showing that these properties are comparable.
| Characteristic | Visco Soft Contact Lens Performance | Predicate Device (BIOFINITY) Performance | Comment |
|---|---|---|---|
| Physicochemical: | |||
| Water Content | 47% | 48% | Similar |
| Oxygen Permeability (Dk) | 150 (Fatt method) | 128 (Fatt method) | Higher Dk for Visco (indicating potentially better oxygen transmission) |
| Refractive Index | 1.410 | 1.40 | Similar |
| Light Transmittance | 94% | >97% | Slightly lower, but still high. The document states it is for handling visibility and UV blocking, which has stricter criteria as below. The UV transmittance values are 1.1% in UVB and 9.4% in UVA, which are below the 5% and 50% benchmarks. |
| Mechanical Strength: | |||
| Tensile strength (Mpa) | $0.55 \pm 0.06$ | $0.50 \pm 0.07$ | Comparable |
| Modulus (Mpa) | $0.59 \pm 0.05$ | $0.8 \pm 0.1$ | Visco has a lower modulus, implying it is softer than the predicate. This feature is a subjective measure, and not a criteria as such. |
| Elongation at break (%) | $106 \pm 5$ | $130 \pm 2$ | Lower elongation at break than the predicate. This feature is a subjective measure, and not a criteria as such. |
| Toughness (J/m³) | $0.26 \pm 0.02$ | Not reported | Compare to Frequency 55: 0.38. Visco is less tough than Frequency 55. This feature is a subjective measure, and not a criteria as such. |
| UV Blocking: | Not explicitly detailed | < 5% (1.1%) in UVB (280-315nm)< 50% (9.4%) in UVA (316-380nm) |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
The document mentions "Clinical Studies" were performed but does not provide details on sample size, data provenance, or study type (retrospective/prospective). It only states: "The clinical performance result proves that the safety and effectiveness of the VISCO soft contact lens is non-inferior to the BIOFINITY (comfilcon A) Soft Contact Lens currently marketed by Cooper Vision Inc."
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. This is a contact lens, not an AI/ML diagnostic device requiring expert interpretation for ground truth.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable.
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 a contact lens, not an AI-assisted diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
For the physicochemical and mechanical properties, the "ground truth" would be established by standardized laboratory testing methods (e.g., ISO 18369-Ophthalmic optics - Contact lenses) as mentioned in section 5.11.1. For the clinical performance, the ground truth would typically come from clinical endpoints and outcomes observed in human subjects, although details are not provided here.
8. The sample size for the training set
Not applicable.
9. How the ground truth for the training set was established
Not applicable.
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