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The VISCO (olifilcon A) Toric Soft Contact lenses are indicated as daily wear for the correction of ametropia (myopia and hyperopia) with astigmatism in aphakic and non-aphakic persons with non-diseased eyes and whose powers are from -20.00 to +20.00 diopters and astigmatic corrections are from -0.75 to -2.25 diopters.

The VISCO (olifilcon A) Multifocal Soft Contact lenses are indicated as daily wear for the correction of ametropia (myopia and hyperopia) and emmetropia with presbyopia in aphakic and non-aphakic persons with non-diseased eyes and whose powers are from -20.00 to +20.00 diopters with add powers from +0.75 to +2.75 diopters. The lenses may be worn by persons who exhibit astigmatism of 1.00 diopters or less where the astigmatism does not interfere with visual acuity.

Eye care practitioners may prescribe the lens for either single-use daily 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 (olifilcon A) toric/multifocal soft contact lenses are manufactured in toric or multifocal configurations with UV blocker. The lens material, olifilcon A, is a silicon hydrogel with water content 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% in the UVB range of 280-315nm and less than 50% in the UVA range of 316-380mm. The lens is supplied in a sterile state, packaged in a buffered saline solution containing Sodium Hyaluronate and Sodium Alginate

The provided document is a 510(k) Premarket Notification for a soft contact lens (VISCO (olifilcon A) Soft Contact Lens). It explicitly states that clinical studies were NOT required for this submission. Therefore, the document does not contain the information requested regarding acceptance criteria, study details, sample sizes, expert ground truth establishment, adjudication methods, MRMC studies, or standalone algorithm performance.

The basis for the substantial equivalence claim relies on physicochemical studies and the equivalence of the technical characteristics, formulation, manufacturing, and sterilization processes to previously cleared predicate devices.

Specifically, the document states:

• "1.10 Clinical Studies: The technical characteristic, formulation, manufacturing, and sterilization processes of the subject device are equivalent to the VISCO (olifilcon A) soft contact lens currently available (K141348). Therefore, the clinical data is not required." (Page 9)
• "1.9 Nonclinical Tests Performed: Physiochemical studies were conducted according to ISO 18369 First edition 2006-08-15, Ophthalmic optics - Contact lenses (Ophthalmic). The physical, optical and chemical properties of the lens are within established specifications for the lenses. Toxicology studies show that the lenses are non-toxic and biocompatibility result is acceptable in ocular environment." (Page 9)

In summary, as this is a 510(k) submission for a contact lens cleared based on substantial equivalence to existing devices through non-clinical testing and manufacturing data, the detailed information about an AI/algorithm performance study (which would typically involve ground truth, expert adjudication, MRMC, etc.) is not applicable and not present in this document.

Therefore, I cannot provide the requested table and study details.

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