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Focus® DAILIES® and Focus® DAILIES® Toric (nelfilcon A) One-Day soft contact lenses are indicated for daily wear for the optical correction of refractive ametropia (myopia, hyperopia and astigmatism) in not-aphakic persons with non-diseased eyes.

Focus® DAILIES® Progressives (nelfilcon A) One-Day soft contact lenses are indicated for daily wear for the optical correction of refractive ametropia (myopia or hyperopia) and/or presbyopia in not-aphakic persons with non-diseased eyes who require a reading addition of +3.00 diopters (D) or less and who may have 2.00 diopters (D) or less of astigmatism that does not interfere with visual acuity.

The lenses are to be prescribed for single-use daily disposable wear. The lenses are not intended to be cleaned or disinfected and should be discarded after a single use.

The lens material is 69% water and 31% nelfilcon A polymer (polyvinyl alcohol partially acetalized with N-formylmethyl acrylamide). For VISITINT® lenses, the color additive phthalocyanine blue (also known as copper phthalocyanine) is added to the lens material to create a light blue edge to edge color to make them easier to see when handling. The lenses may be printed with inks containing one or more of the following color additives: phthalocyanine blue, phthalocyanine green.

Focus® DAILIES®, Focus® DAILIES® Toric, Focus® DAILIES® Progressives One-Day contact lenses include spherical, toric, and multifocal lens designs in the following parameter ranges:

• Power Range: -20.00D to +20.00D .
• 0.010 mm for -3.00D spherical (varies with power) Center Thickness: .

Lenses have the following properties:

• 1.38 Refractive index: .
• Light transmittance: approximately 96 %T .
• Water content : 69% by weight .
• Oxygen permeability 26 barrer
• measured at 35°C (single point Dk-Polarographic method)

Lenses are supplied sterile in sealed blister-packs containing buffered saline. The compatibility and package integrity of the blister-pack packaging system has been demonstrated and successfully used for other CIBA VISION marketed lens products, and packaged lenses are effectively steam sterilized in a validated autoclave. Blisterpack containers are labeled with the lens parameters, lot number and product expiration date. The expiration date has been established through stability studies that have assessed the chemical stability of the lens and package integrity (ability to maintain sterility). Shelf-life studies are ongoing to establish and extend the labeled expiration date.

Here's an analysis of the provided text regarding the acceptance criteria and supporting studies for the CIBA VISION Nelfilcon A Daily Wear Soft Contact Lenses:

1. Table of Acceptance Criteria and Reported Device Performance

This product is a contact lens seeking substantial equivalence through a 510(k) submission. For such devices, acceptance criteria are typically met by demonstrating that the device is as safe and effective as a legally marketed predicate device. The primary "performance" metric here is the demonstration of substantial equivalence.

2. Sample Size Used for the Test Set and Data Provenance

The document explicitly states: "The scope of the device modification did not require clinical testing to establish safety and effectiveness of the modified device."

Therefore:

• Sample Size for Test Set: Not applicable, as no new clinical testing was performed for this 510(k) submission.
• Data Provenance: Not applicable.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications

Not applicable, as no new clinical (test set) data was generated or evaluated for this 510(k) submission. The basis for substantial equivalence relies on the established safety and effectiveness of the predicate devices.

4. Adjudication Method for the Test Set

Not applicable, as no new clinical (test set) data requiring adjudication was generated.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, and effect size.

No. This is a medical device (contact lens) and not an AI/software device that would typically undergo MRMC studies. The approval pathway is 510(k) where "substantial equivalence" to a predicate is the primary criterion.

6. If a Standalone (i.e. algorithm only without human-in-the loop performance) was done

No. This is a contact lens, not an algorithm or AI.

7. The Type of Ground Truth Used

The "ground truth" in this context is the safety and effectiveness established for the predicate devices. This would have been determined through:

• Clinical Performance: Data from human clinical trials (implied to have been conducted for the original predicates).
• Physical and Chemical Properties: Bench testing data comparing material characteristics.
• Toxicological Testing: Data supporting biocompatibility.
• Stability Testing: Data demonstrating shelf life and sterility maintenance.

For the current submission, the ground truth is essentially the established regulatory status and performance of the predicate lenses.

8. The Sample Size for the Training Set

Not applicable, as no machine learning algorithm was involved. If "training set" refers to the data used to initially establish the safety and effectiveness of the predicate devices, that information is not provided in this 510(k) summary.

9. How the Ground Truth for the Training Set Was Established

Not applicable, as this is a contact lens and not an AI/software device with a "training set." The safety and effectiveness of the predicate devices were established through a combination of non-clinical (material properties, sterilization, packaging integrity, stability) and clinical testing, as is standard for contact lenses. The present submission leverages that established "ground truth" of the predicate devices to demonstrate substantial equivalence for the modified device.

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CIBA Vision® (nelfilcon A) Spherical and Toric One-Day soft contact lenses are indicated for daily wear for the optical correction of refractive ametropia (myopia, hyperopia and astigmatism) in not-aphakic persons with non-diseased eyes.

CIBA Vision® (nelfilcon A) Progressives One-Day soft contact lenses are indicated for daily wear for the optical correction of refractive ametropia (myopia or hyperopia) and/or presbyopia in not-aphakic persons with non-diseased eyes who require a reading addition of +3.00 diopters (D) or less and who may have 2.00 diopters (D) or less of astigmatism that does not interfere with visual acuity.

The lenses are to be prescribed for single-use daily disposable wear. The lenses are not intended to be cleaned or disinfected and should be discarded after a single use.

The nelfilcon A lens material is 69% water and 31% nelfilcon A polymer (polyviny) alcohol partially acetalized with N-formylmethyl acrylamide). The lenses are tinted from edge to edge for visibility purposes with the color additive copper phthalocyaninks (UD).

Nelfilcon A lens designs currently include spherical, toric, and multifocal in the following parameter ranges:
Power Range: -20.00D to +20.00D
Center Thickness: 0.010 mm for -3.00D spherical (varies with power)

Lenses have the following properties:
Refractive index: 1.38
Light transmittance: approximately 96 %T
Water content : 69% by weight
Oxygen permeability . 26 barrer measured at 35°C (single point Dk-Polarographic method)

Lenses are supplied sterile in sealed blister-packs containing buffered saline.

Here's a summary of the acceptance criteria and the study that proves the device meets them, based on the provided text:

Nelfilcon A Soft Contact Lenses for Daily Wear

1. Table of Acceptance Criteria and Reported Device Performance

The document describes "Substantial Equivalence" as the primary acceptance criterion, meaning the device must perform comparably to a predicate device. Specific quantitative acceptance criteria are not explicitly detailed in threshold values (e.g., "must achieve X% vision improvement"). Instead, the performance is described relative to the predicate device and established standards for contact lenses.

2. Sample Size Used for the Test Set and Data Provenance

• Sample Size: Not explicitly stated. The document mentions "a clinical study" and "an investigation" but does not provide the number of subjects or eyes included in the clinical test set.
• Data Provenance: Not explicitly stated regarding country of origin. The study was a "daily disposable wear investigation." The document implies that the study was prospective, as it "investigated" the lens and was performed to "demonstrate" substantial equivalence.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications

This information is not provided in the document. For contact lens studies demonstrating substantial equivalence, "ground truth" often refers to clinical assessments by ophthalmologists or optometrists, but the number and qualifications of such experts are not detailed here.

4. Adjudication Method for the Test Set

This information is not provided in the document.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

No, an MRMC comparative effectiveness study, as typically understood in AI/medical imaging, was not performed. The study compared the device's clinical performance to an "FDA cleared and commercially available contact lens" (the control/predicate), but this is a direct clinical comparison, not a study of human readers improving with AI assistance. The device itself is a contact lens, not an AI system.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done

N/A (Not Applicable). The device is a physical medical device (contact lens), not an algorithm or AI system. Therefore, standalone algorithm performance is not relevant. The "standalone" performance would be the lens's inherent physical and optical properties, which were part of the non-clinical testing.

7. The Type of Ground Truth Used

For the non-clinical tests, the "ground truth" would be established physical and material property measurements, and standard biocompatibility assays. For clinical testing, the "ground truth" was established through clinical assessments by medical professionals comparing the performance of the CIBA Vision® (nelfilcon A) lens to a control lens in terms of vision, health, comfort, and fit. This type of ground truth is based on expert clinical observation and evaluation, not pathology or outcomes data in the traditional sense for diagnostic devices.

8. The Sample Size for the Training Set

N/A (Not Applicable). The device is a physical contact lens, not an AI system or algorithm that requires a training set.

9. How the Ground Truth for the Training Set Was Established

N/A (Not Applicable), as there is no training set for a physical contact lens device.

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