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The Unicon Hydrogel (Hioxifilcon A) Soft (Hydrophilic) Contact Lens is indicated for the correction of ametropia (myopia and hyperopia) in aphakic and non-aphakic persons with non-diseased eyes and 6.00 diopters (D) or less of astigmatism.

Eye Care Professionals may prescribe the lenses either for single-use disposable wear or frequent/planned replacement wear with cleaning, disinfection and scheduled replacement. When prescribed for daily disposable wear, the lens is to be discarded after each removal. When prescribed for frequent wear, the lens may be cleaned and disinfected using a chemical disinfection system only.

Unicon Hydrogel (Hioxifilcon A) Soft (Hydrophilic) Contact Lens is available as aspherical lenses manufactured by cast-molding method. The material is a high water content (59 % wt/wt) material. The hydrogel lens' material is a random copolymer composed of 2-hydroxyethyl methacrylate (HEMA) and 2,3-Dihydroxypropyl methacrylate (Glycerol methacrylate), which was cross-linked with Ethylene Glycol Dimethacrylate (EGDMA) via UV photo-polymerization. The Unicon Hydrogel (Hioxifilcon A) Soft (Hydrophilic) Contact Lens with visible tint is light tinted blue using C.I Reactive Blue 246 to make the lens more visible for handling. The lenses also contain a UV absorber {2-[3-(2H-Benzotriazol-2-yl)-4-hydroxypheny] ethyl methacrylate} which is included during the manufacturing process as an additive to block UV radiation. The average transmittance characteristics are less than 5% in the UVB range of 280 to 315 nm and less than 50% in the UVA range of 316 to 380 nm.

The provided text is related to a 510(k) premarket notification for a soft contact lens and focuses on demonstrating substantial equivalence to a predicate device. It does not describe a study involving an AI device, human readers, or the establishment of ground truth in the context of medical imaging or diagnostic aid. Therefore, I cannot extract the information requested as it is not present in the document.

Specifically, the document states:

• "No clinical test data was used to support the decision of substantial equivalence." (Page 6, Section 5.9 Clinical Testing)
• The studies conducted were non-clinical safety and performance studies for the contact lens, such as sterilization validation, shelf-life, biocompatibility, and material performance (e.g., water content, oxygen permeability). These are physical and chemical tests, not studies related to diagnostic accuracy or AI performance.

Therefore, I cannot provide:

1. A table of acceptance criteria and the reported device performance in the context of an AI device and diagnostic accuracy.
2. Sample size for a test set or its provenance for an AI device.
3. Number of experts or their qualifications for establishing ground truth for an AI device.
4. Adjudication method for an AI test set.
5. Information on a multi-reader multi-case (MRMC) comparative effectiveness study or effect size of human reader improvement with AI assistance.
6. Standalone performance of an algorithm (as there is no AI algorithm described).
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.) for AI evaluation.
8. Sample size for a training set for an AI device.
9. How ground truth for a training set was established for an AI device.

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