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The Soft K (xylofilcon A) Soft (hydrophilic) Keratoconus Contact Lens for Daily Wear is indicated for daily wear for persons requiring Keratoconia management and for the correction of myopia and hyperopia in aphakic and nonaphakic persons that may exhibit refractive and/or corneal irregularity such as irregular astigmatism up to 2.00 D that does not interfere with irregular astigmatism and may be disinfected with a chemical or heat disinfection system.

The Soft K Toric (xylofilcon A) Soft (hydrophilic) Keratoconus Contact Lens for Daily Wear is indicated for daily wear for persons requiring Keratoconia management and for the correction of myopia, hyperopia and astigmatism in aphakic and non-aphakic persons that exhibit refractive and/or post-refractive surgery corneal irregularity corneal astigmatism. The lens may be disinfected with a chemical or heat disinfection system.

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This is a 510(k) premarket notification for a medical device (contact lenses). These types of documents do not typically include detailed studies with acceptance criteria, sample sizes, expert qualifications, or ground truth methodologies as might be found for AI/ML device submissions.

Instead, the FDA determines "substantial equivalence" to legally marketed predicate devices based on similarities in intended use, technological characteristics, and safety/effectiveness data. The document confirms that the device has been found substantially equivalent.

Therefore, the specific information requested in your prompt for acceptance criteria and a study proving device performance (as would be applicable for AI/ML or novel devices) is not present in this document. The "performance" in this context refers to the device meeting the same standards as existing, legally marketed contact lenses through non-clinical or clinical data that demonstrates similar design and performance characteristics.

The document does include:

• Trade/Device Name: Soflex Soft K (xylofilcon A) Soft (hydrophilic) Keratoconus Contact Lens for Daily Wear and Soflex Soft K Toric (xylofilcon A) Soft (hydrophilic) Keratoconus Contact Lens for Daily Wear
• Indications for Use: Detailed in the "Page 1 of 1" section (document {2}).
• Regulatory Class: Class II
• Product Code: LPL

To answer your specific questions in the context of this document:

1. A table of acceptance criteria and the reported device performance: This document does not contain such a table. The "acceptance criteria" for a 510(k) are typically met by demonstrating substantial equivalence to a predicate device, which would involve showing that the new device is as safe and effective as the predicate.
2. Sample size used for the test set and the data provenance: Not applicable/not provided in this document. Information on clinical or non-clinical testing would have been submitted in the 510(k) application, but the summary letter does not detail these aspects.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable/not provided. This type of information is more relevant for diagnostic devices requiring expert interpretation of results.
4. Adjudication method for the test set: Not applicable/not provided.
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 device is a contact lens, not an AI-powered diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This device is a physical contact lens.
7. The type of ground truth used: Not applicable/not provided. Performance data would relate to lens fit, vision correction, comfort, and safety, typically compared to predicate lenses.
8. The sample size for the training set: Not applicable/not provided. Training sets are relevant for AI/ML models, not for physical medical devices like contact lenses.
9. How the ground truth for the training set was established: Not applicable/not provided.

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

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This document is a 510(k) premarket notification decision letter from the FDA regarding several Soflex contact lens products. It states that the FDA has determined the devices are substantially equivalent to legally marketed predicate devices.

Therefore, this document does not contain information about acceptance criteria or a study that proves a device meets acceptance criteria. It is a regulatory approval notice, not a study report. The typical information requested in the prompt (sample sizes, ground truth, expert qualifications, etc.) would be found in a clinical study report or a 510(k) submission summary, neither of which is present in the provided text.

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The Soft K. (xylofilcon A) Soft (hydrophilic) Keratoconus 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 notaphakic persons with non-diseased eyes that may exhibit refractive and/or corneal astigmatism up to 2.00 diopters. The lens may be disinfected with a chemical or heat disinfection system.

The Soft K. Toric (xylofilcon A) Soft (hydrophilic) Keratoconus Contact Lens for Daily Wear is indicated for daily wear for persons requiring keratoconus management and for the correction of refractive ametropia (myopia, hyperopia and astigmatism) in aphakic and not-aphakic persons with non-diseased eyes that may exhibit refractive and/or corneal astigmatism up to 2.00 diopters. The lens may be disinfected with a chemical or heat disinfection system.

Not Found

This document is a 510(k) premarket notification decision letter from the FDA for contact lenses. It does not contain any information about acceptance criteria for a device, nor does it describe a study to prove a device meets acceptance criteria.

The letter primarily:

• Confirms the substantial equivalence of the Soflex Soft K. and Soft K. Toric contact lenses to legally marketed predicate devices.
• States the regulation number, name, and class for the device.
• Outlines general controls provisions and other compliance requirements.
• Provides contact information for further advice.
• Includes the intended Indications for Use for both contact lens types.

Therefore, I cannot provide the requested table and study details based on the input text.

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The Eye-Q (Xylofilcon 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 not-aphakic persons with non-diseased eyes that may exhibit refractive an/or corneal astigmatism up to 2.00 diopters. The lens may be disinfected using a chemical disinfection system.

Soflex Eye-Q (Xylofilcon A) Soft (hydrophilic) Multifocal Contact Lens for Daily Wear

I am sorry, but the provided text is a 510(k) clearance letter from the FDA for a contact lens. It does not contain information about a study that proves the device meets acceptance criteria, nor does it include details such as sample sizes, ground truth establishment, or expert qualifications. Therefore, I cannot generate the requested table and information about the study.

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The Toric Eye-Q (Xylofilcon A) Soft (hydrophilic) Toric Multifocal Contact Lens for Daily Wear is indicated for daily wear for the correction of refractive ametropia (myopia, hyperopia and astigmatism) and presbyopia in aphakic and not-aphakic persons with non-diseased eyes that may exhibit refractive an/or corneal astigmatism up to 5.00 diopters. The lens may be disinfected using a chemical disinfection system.

Toric Eye-Q (xylofilcon A) Soft (hydrophilic) Toric Multifocal Contact Lens for Daily Wear

This document is an FDA 510(k) clearance letter for a contact lens. It does not contain information about acceptance criteria or a study proving the device meets acceptance criteria. It primarily focuses on the substantial equivalence determination. Therefore, I cannot provide the requested information based on the given text.

Ask a specific question about this device

Ask a specific question about this device