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DAILIES® AquaComfort Plus® (nelfilcon A) One-Day Contact Lenses are indicated for daily wear for the optical correction of refractive ametropia (myopia and hyperopia) in not-aphakic persons with non-diseased eyes with up to approximately 1.50 diopters (D) of astigmatism that does not interfere with visual acuity.

DAILIES® AquaComfort Plus® Toric (nelfileon A) One-Day Contact Lenses are indicated for daily wear for the optical correction of refractive ametropia (myopia, hyperopia and asigmatism) in not-aphakic persons with non-diseased eyes with 6.0 diopters (D) or less of astigmatism.

DAILIES® AquaComfort Plus® Multifocal (nelfilcon A) Ore-Day 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 nondiseased 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.

DAILIES® (nelfilcon A) One-Day Contact 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 single use.

The lens material is 69% water and 31% nelfilcon A polymer (polyviny) 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.

Nelfilcon A lens designs include spherical, toric and multifocal lenses in the following parameter ranges:
Power Range: -20.00 D to +20.00 D
Center Thickness varies with design and power (0.10 mm for -3.00 D spherical)

Lenses have the following properties:
Refractive index: 1.38
Light transmittance: 92% (@ 610 nm)
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 Alcon marketed lens products and packaged lenses are effectively steam sterilized in a validated autoclave. Blister-pack 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).

The provided text is a 510(k) premarket notification for Alcon's DAILIES® AquaComfort Plus® contact lenses. It addresses the substantial equivalence of a modified device to a previously cleared predicate device.

Crucially, this document is for a medical device (contact lenses) and not an AI/ML powered medical device. Therefore, the standard questions regarding AI/ML device performance, such as acceptance criteria based on metrics like sensitivity/specificity, sample sizes for test/training sets, expert ground truth establishment, MRMC studies, or standalone algorithm performance, do not apply and are not addressed in this document.

The primary focus of this 510(k) is to demonstrate that a manufacturing modification (specifically, using a new print technology for the lenses) does not adversely affect the safety and effectiveness of the device, making it substantially equivalent to the predicate device.

Here's an analysis based on the information provided, explaining why certain requested points are not applicable:

1. A table of acceptance criteria and the reported device performance:

• Acceptance Criteria: For this device modification, the core acceptance criterion was demonstrating that the manufacturing process change (new print technology) did not alter the fundamental characteristics or safety/effectiveness of the contact lens. The document states: "A successful process validation was performed on the modified device to verify equivalence of the device to the predicate device. This resulted in the acceptance criteria being met."
• Reported Device Performance: The "performance" here refers to maintaining the inherent properties and safety profile of the contact lenses. The comparison table (Table 1: Substantial Equivalence Comparison) on pages 5-6 effectively serves as the "reported device performance" against the predicate. It shows that key attributes like intended use, material, water content, power range, visibility tint, manufacturing method, sterilization, packaging, and storage saline solution are either identical or considered equivalent after the modification.
  • Modified Device: DAILIES® AquaComfort Plus® Family (nelfilcon A)
  • Predicate Device: DAILIES® AquaComfort Plus® Family (nelfilcon A) (K123994)

2. Sample sizes used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective):

• This document refers to "process validation" and "non-clinical testing" rather than clinical test sets in the context of an AI/ML device. The "test set" here would refer to the samples used in the non-clinical process validation, which are not specified in terms of number or provenance. There are no descriptions of patient data, as this is a physical medical device.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g., radiologist with 10 years of experience):

• Not applicable. There is no "ground truth" to establish in the context of an AI/ML output. Performance is demonstrated through manufacturing controls and the comparison to the existing predicate.

4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:

• Not applicable. There is no human interpretation or adjudication of AI output.

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 is not an AI-assisted device.

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

• Not applicable. This is not an algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):

• Not applicable. The "ground truth" for this submission is the established safety and effectiveness of the predicate device, against which the modified device's characteristics are compared through non-clinical validation.

8. The sample size for the training set:

• Not applicable. There is no training set as this is not an AI/ML device.

9. How the ground truth for the training set was established:

• Not applicable. There is no training set.

Summary of the Study Proving Acceptance Criteria:

The study proving the device meets the acceptance criteria is described as "Non-clinical Testing: A successful process validation was performed on the modified device to verify equivalence of the device to the predicate device. This resulted in the acceptance criteria being met."

This indicates that the manufacturer conducted internal testing and validation of their manufacturing process for the modified contact lenses. The acceptance criteria were met because these non-clinical tests confirmed that the modified lenses, despite the change in print technology, maintained all the critical physical and chemical properties as well as safety aspects of the predicate device. The detailed comparison table serves as the evidence for this equivalence. The FDA letter confirms that "FDA's issuance of a substantial equivalence determination" means they have reviewed the submission and find the device substantially equivalent based on the provided information, thus accepting the manufacturer's evidence.

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DAILIES® AquaComfort Plus® (nelfilcon A) One-Day Contact Lenses are indicated for daily wear for the optical correction of refractive ametropia (myopia and hyperopia) in not-aphakic persons with non-diseased eyes with up to approximately 1.50 diopters (D) of astigmatism that does not interfere with visual acuity.

DAILIES® AquaComfort Plus® Toric (nelfilcon A) One-Day Contact Lenses are indicated for daily wear for the optical correction of refractive ametropia (myopia and hyperopia) in notaphakic persons with non-diseased eyes with 6.00 diopters (D) or less of astigmatism.

DAILIES® AquaComfort Plus® Multifocal (nelfilcon A) One-Day 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 may 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.

DAILIES® (nelfilcon A) One-Day Contact 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% nelficon 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.

Nelfilcon A lens designs include spherical, toric, and multifocal lenses in the following parameter ranges: Power Range: -20.00D to +20.00D, Center Thickness: varies with design and power (0.10 mm for -3.00D spherical).

Lenses have the following properties: Refractive index: 1.38, Light transmittance: ≥ 92% (@ 610 nm), 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 provided document, a 510(k) Summary for Nelfilcon A Soft Contact Lenses (K123994), primarily focuses on demonstrating substantial equivalence to predicate devices rather than proving a device meets specific acceptance criteria through a clinical study with detailed performance metrics.

Here's an analysis based on the provided text, addressing your questions to the extent possible:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state acceptance criteria in terms of numerical performance thresholds for safety or effectiveness for the modified device. Instead, it relies on demonstrating that the modified device's characteristics are substantially equivalent to established predicate devices. The "performance" reported is therefore a comparative one against these predicates.

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 (no clinical test set used for the modified device).
• Data provenance: Not applicable (no clinical data for the modified device). The documentation relies on the established safety and effectiveness of the predicate devices and non-clinical bench testing.

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

Not applicable, as no clinical testing was performed for the modified device. The "ground truth" for demonstrating substantial equivalence was derived from the established safety and performance of the predicate devices and the results of non-clinical, bench-top testing.

4. Adjudication Method for the Test Set

Not applicable, as no clinical testing was performed for the modified device.

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. The concept of "human readers" and "AI assistance" is not relevant to this medical device.

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

Not applicable. This device is a contact lens.

7. The Type of Ground Truth Used

The "ground truth" for this 510(k) submission stemmed from:

• Substantial Equivalence to Predicate Devices: The primary "ground truth" is the established safety and effectiveness of the legally marketed predicate devices (DAILIES® AquaComfort Plus® - K072777, and FOCUS® DAILIES® - K083216). The modified device is considered safe and effective because it is fundamentally the same as these already cleared devices, with a minor modification (integrated print step from one predicate applied to the other family) that is not deemed to adversely affect safety or effectiveness.
• Non-clinical Bench Testing: Physicochemical characteristics, biocompatibility (non-toxicity, non-irritation), and stability testing were performed to confirm that the modified device's properties were substantially equivalent to the predicate and supported the labeled expiration date.

8. The Sample Size for the Training Set

Not applicable, as this is a contact lens and not an algorithm requiring a training set.

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

Not applicable, as this is a contact lens and not an algorithm requiring a training set.

Summary of the Study that Proves the Device Meets the Acceptance Criteria:

The "study" presented is a demonstration of substantial equivalence through comparative analysis and non-clinical testing, rather than a clinical trial with acceptance criteria for a novel device.

• Rationale: The modification (applying an existing print technology from one predicate contact lens family to another closely related contact lens family) was considered minor enough that new clinical data was not required.
• Evidence:
  • Comparative Table (Table 1): Detail-by-detail comparison of the modified device's characteristics against two predicate devices, showing that most parameters are identical or have differences (like the specific manufacturing step for integrated print or minor saline solution variations) that are justified as not impacting safety or effectiveness.
  • Non-clinical Testing: Biocompatibility testing (in accordance with GLP regulation 21 CFR Part 58) confirmed the material was non-toxic and non-irritating. Physicochemical characteristics were verified as substantially equivalent. Stability testing supported the labeled expiration date.

The conclusion is that the DAILIES® AquaComfort Plus® family of lenses (with the integrated print step) is substantially equivalent to its predicate lenses and other similar daily wear soft contact lenses, and any existing differences "do not adversely affect the safety and effectiveness of the device."

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