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Sphere/Asphere: Innova Vision Sphere and Asphere (mifilcon A) Silicone Hydrogel Soft Contact lenses are indicated for the correction of ametropia (myopia and hyperopia) in aphakic and non-aphakic persons with non-diseased eyes in powers from -20.00 to +20.00 diopters. The lenses may be worn by persons who exhibit astigmatism of 2.00 diopters or less that does not interfere with visual acuity.

Toric: Innova Vision Toric (inifilcon A) Silicone Hydrogel Soft Contact lenses are indicated for the correction of ametropia (myopia or hyperopia with astigmatism) in aphakic and non-aphakic persons with non-diseased eyes in powers from -20.00 to +20.00 diopters and astigmatic corrections from -0.25 to -2.25 diopters.

Multifocal: Innova Vision Multifocal (inifilcon A) Silicone Hydrogel Soft Contact lenses are indicated for the correction of refractive ametropia (myopia and hyperopia) and emmetropia with presbyopia in aphakic and non-aphakic persons with non-diseased eyes in powers from -20.00 to +20.00 diopters and with add powers from +0.25 to +4.00 diopters. The lenses may be worn by persons who exhibit astigmatism of 2.00 diopters or less that does not interfere with visual acuty.

Multifocal Toric: Innova Vision Multifocal Toric (inifiloon A) Silicone Hydrogel Soft Contact lenses are indicated for the optic correction of distance and near vision in presbyopic phakic persons with non-diseased eyes in powers of -20.00 to +20.00 diopters with add powers from +0.25 to +4.00 diopters and astigmatism corrections from -0.25 to -2.25 diopters.

Eye Care Practitioners may prescribe the Innova Vision (inifilcon A) Silicone Hydrogel Soft (Hydrophilic) Contact lenses for frequent/planned replacement wear, with cleaning, disinfection and scheduled replacement or for single-use disposable wear.

When prescribed for frequent/planned replacement, the Inifilcon A) Silicone Hydrogel Soft (Hydrophilic) Contact Lens is to be cleaned, rinsed and disinfected each time the lens is removed. The contact lens is to be discarded after the recommended wearing period as prescribed by the Eye Care Professional. When prescribed for frequent/planned replacement wear, the lenses may be disinfected using a chemical disinfection only.

When prescribed for single-use disposable wear, Innova Vision (inifilcon A) Silicone Hydrogel Soft (Hydrophilic) Contact Lens is to be discarded after each removal.

The Innova Vision (inifilcon A) Silicone Hydrogel Soft (Hvdrophilic) Contact Lens is a hemispherical shell with a molded spherical base curve and a molded front surface. The hydrophilic characteristics allow aqueous solutions to enter the lenses are fabricated from inifilcon A, which is a random co-polymer of silicone containing monomers and hydrophilic monomers. The lens consists of 60.0% inifilcon A and 40.0% water by weight when immersed in saline solution. The inifilcon A name has been adopted by the United States Adopted Names Council (USAN).

The Innova Vision (inifilcon A) Silicone Hydrogel Soft (Hydrophilic) Contact Lens contains C.I. Reactive Blue No. 19 (21 CFR Part 73.3127) for visibility and handling. The Innova Vision (inifilcon A) Silicone Hydrogel Soft (Hydrophilic) Contact Lens incorporates a benzotriazole UV blocking monomer to help protect against transmission of harmful UV radiation. The lens blocks >95% in the UVB range (280nm - 315nm), and >50% in the UVA range (316nm - 380nm).

The Innova Vision (inifilcon A) Silicone Hydrogel Soft (Hydrophilic) Contact Lens is manufactured in sphere/asphere, toric, multifocal and multifocal-toric design configurations.

The provided text describes the 510(k) premarket notification for the Innova Vision (inifilcon A) Silicone Hydrogel Soft (Hydrophilic) Contact Lens. The document focuses on demonstrating the substantial equivalence of this new device to legally marketed predicate devices rather than providing acceptance criteria and a study proving a device meets specific performance criteria for an AI/ML-based medical device.

The information requested in the prompt, related to AI/ML device performance metrics such as sample sizes for training/test sets, expert adjudication methods, MRMC studies, standalone algorithm performance, and ground truth establishment for AI/ML models, is not present in the provided 510(k) summary for a contact lens.

This document discusses:

• Non-Clinical Performance Testing: Including toxicology (in-vitro cytotoxicity, systemic toxicity, acute ocular irritation, skin sensitization, 22-day ocular irritation), shelf life, solution compatibility, preservative uptake and release, and bench performance tests (refractive index, water content, Dk, % transmission, tensile strength, modulus, % elongation to break, specific gravity, quantification of polymerization residuals).
• Clinical Testing: A single-masked, bilateral, multi-center, randomized concurrent-control study comparing the Innova Vision lenses to Acuvue Vita lenses.

Therefore, I cannot fulfill the request to describe the acceptance criteria and the study that proves the device meets the acceptance criteria for an AI/ML device based on the provided text. The prompt's questions are tailored for AI/ML device evaluations, which are distinct from the premarket notification requirements and testing specified for contact lenses in this document.

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