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The Eni-Eye SH Soft K Semi Scleral (Efrofilcon A) Soft (hydrophilic) Keratoconus and Irregular Cornea Contact Lens for Daily Wear is indicated for keratoconus management and for the correction of refractive ametropia (myopia and hyperopia) in aphakic and non-aphakic persons that may exhibit refractive and/or corneal astigmatism, or post-refractive surgery corneal irregularity such as irregular astigmatism up to 2.00 D that does not interfere with visual acuity. The lens may be disinfected with a chemical disinfection system.

Eni-Eye SH Soft K Toric Semi Scleral (Efrofilcon A) Soft (hydrophilic) Keratoconus and Irregular Cornea Contact Lens for Daily Wear is indicated for keratoconus management and for the correction of refractive ametropia (myopia and hyperopia) in aphakic and non-aphakic persons that may exhibit refractive and/or corneal astigmatism, or post-refractive surgery corneal irregularity such as irreqular astigmatism up to 5.00 D that does not interfere with visual acuity. The lens may be disinfected with a chemical disinfection system.

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The provided document is a 510(k) premarket notification letter from the FDA regarding a contact lens. It does not contain information about acceptance criteria or a study proving device performance as typically understood for AI/ML devices. Therefore, I cannot extract the requested information from this document.

The document primarily focuses on:

• FDA's substantial equivalence determination for two contact lens types: Eni-Eye SH Soft K Semi Scleral (Efrofilcon A) and Eni-Eye SH Soft K Toric Semi Scleral (Efrofilcon A).
• The regulatory classification and product codes for these devices.
• A reminder of general controls provisions and other applicable regulations.
• The Indications for Use for both types of contact lenses.

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The Eni-Eye SH Sphere (Efrofilcon A) Soft (hydrophilic) Contact Lens for Daily Wear is indicated for daily wear for the correction of ametropia (myopia and hyperopia) in aphakic and non-aphakic persons.

Eni-Eye SH Sphere (Efrofilcon A) Soft (hydrophilic) Contact Lens for Daily Wear

This document is a 510(k) clearance letter from the FDA for a contact lens. It does not contain information about acceptance criteria or performance studies as typically requested for AI/ML device evaluations. Therefore, I cannot provide the requested information based on the given text.

The document states that the FDA reviewed a premarket notification for the "Eni-Eye SH Sphere (Efrofilcon A) Soft (hydrophilic) Contact Lens for Daily Wear" and determined it to be substantially equivalent to legally marketed predicate devices. It lists the indications for use as the correction of ametropia (myopia and hyperopia) in aphakic and non-aphakic persons for daily wear.

However, none of the specific details about acceptance criteria, study design, sample sizes, ground truth establishment, or expert involvement for AI/ML performance testing are present in this regulatory clearance letter.

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The Eni-Eye SH Toric (Efrofilcon A) Soft (hydrophilic) Contact Lens for Daily Wear is indicated for daily wear for the correction of refractive astigmatism with non-diseased eyes that may exhibit refractive and/or corneal astigmatism. The lens may be disinfected using a chemical disinfection system.

The Eni-Eye Q SH Multi (Efrofilcon A) Soft (hydrophilic) Multifocal Contact Lens for Daily Wear is indicated for daily wear for the correction of refractive ametropia (myopia and hyperopia) and presbyopia in aphakic and/or non aphakic persons with non-diseased eyes. The lenses may be disinfected using a chemical disinfection system.

The Eni-Eye Q SH Multi Toric (Efrofilcon A) Soft (hydrophilic) Multifocal Contact Lens for Daily Wear is designed to correct ametropia (myopia and hyperopia), presbiopia, and corneal astigmatism in aphakic and/or non aphakic persons with non-diseased eyes. The lenses may be disinfected using a chemical disinfection system.

The ENI-EYE SH Soft K (Efrofilcon A) Soft (hydrophilic) Keratoconus and irregular cornea Contact Lens for Daily Wear is indicated for daily wear for persons requiring keratoconus management and for the correction of refractive ametropia (myopia and hyperopia) in aphakic and non-aphakic persons that may exhibit refractive and/or corneal astigmatism, or post-refractive surgery corneal irregularity such as irreqular astigmatism up to 2.00 D that does not interfere with visual acuity. The lens may be disinfected with a chemical or heat disinfection system.

The Eni-Eye SH Soft K Toric (Efrofilcon A) Soft (hydrophilic) Keratoconus and irregular cornea Contact Lens for Daily Wear is indicated for daily wear for persons requiring keratoconus management and for the correction of refractive ametropia (myopia and hyperopia) in aphakic and non-aphakic persons that may exhibit refractive and/or corneal astigmatism, or post-refractive surgery corneal irregularity such as irregular astigmatism up to 2.00DS that does not interfere with visual acuity. The lens may be disinfected with a chemical or heat disinfection system.

Not Found

The provided document is a 510(k) premarket notification letter from the FDA for several contact lens products, including various "Eni-Eye SH" contact lenses. It confirms the substantial equivalence of these devices to legally marketed predicate devices.

However, the document does not contain information regarding acceptance criteria for device performance, or details of any specific study (such as clinical trials, AI studies, or comparative effectiveness studies) that would prove the device meets such criteria. It lists the device names, regulation numbers, regulatory class, and indications for use, but no performance data, test set details, ground truth establishment, or training set information.

Therefore, I cannot answer the requested questions based on the provided text. The document is primarily an administrative letter affirming substantial equivalence for market clearance, not a scientific report detailing device performance studies.

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