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DAILIES TOTAL1 (delefilcon A) and DAILIES TOTAL1 Asphere (delefilcon A) soft contact lenses are indicated for the optical correction of refractive ametropia (myopia and hyperopia) in phakic or aphakic persons with non-diseased eyes with up to approximately 1.50 diopters (D) of astigmatism that does not interfere with visual acuity.

DAILIES TOTAL1 for ASTIGMATISM (delefilcon A) soft contact lenses are indicated for the optical correction of refractive ametropia (myopia and hyperopia) in phakic or aphakic persons with non-diseased eyes with up to 6.00 diopters (D) of astigmatism.

DAILIES TOTAL1 Multifocal (delefilcon A) soft contact lenses are indicated for the optical correction of presbyopia, with or without refractive ametropia (myopia and hyperopia) in phakic or aphakic persons with non-diseased eyes who may require a reading addition of +3.00 diopters (D) or less and who may have up to approximately 1.50 diopters (D) of astigmatism that does not interfere with visual acuity.

DAILIES TOTAL1 Multifocal Toric (delefilcon A) soft contact lenses are indicated for the optical correction of presbyopia with or without refractive ametropia (myopia, hyperopia) in phakic or aphakic persons with non-diseased eyes who may require a reading addition of +3.00 diopters (D) or less and who may have up to 6.00 diopters (D) of astigmatism.

The lenses are to be used for single use, daily disposable wear (less than 24 hours while awake) only. The lenses are not intended to be cleaned or disinfected and should be discarded after a single use.

The DAILIES TOTAL 1® family of daily disposable soft contact lenses are made from delefilcon A, a silicone hydrogel with a water content of approximately 33% and a water gradient surface treatment. The delefilcon A silicone hydrogel material is considered a Group 5C material according to ISO 18369-1:2017 (defined as: "enhanced oxygen permeable material", water content less than 50%, no ionic monomer or oligomer at pH 6 to pH 8).

Modified DAILIES TOTAL1® lenses contain a combination of light absorbing chromophores. Specifically, benzotriazole UV absorbing monomers are used to block UV radiation and, additionally, reduce transmittance in the range from 380 nm. The color additive [phthalocyaninato (2-)] copper (synonym: copper phthalocyanine) provides a light blue-green handling tint.

Lens designs for the modified DAILIES TOTALI® (delefilcon A) lenses include spherical, asphere, toric, multifocal, and multifocal toric lenses in the following parameter range:

• Diameter Range: 13.0 to 15.0 mm
• Base Curve Range: 8.0 to 9.2 mm
• Power Range: -20.00D to +20.00D
• Center Thickness: varies with design and power (0.09 mm for -3.00D spherical)

Lenses have the following properties:

• Refractive index: 1.42 (hydrated)
• Water content: 33% by weight in normal saline
• Oxygen permeability 140 barrer units measured at 35 °C (intrinsic Dk - Coulometric method)
• % Light transmittance, visible: 90 ± 5% (average over 380 to 780 nm)
• % UV transmittance UVA (315-380 nm): < 10.0%
• UVB (280-315 nm): < 1.0%

Lenses are supplied sterile in sealed blister packs containing isotonic phosphate buffered saline solution (PBS) with polymeric wetting agents that form the water gradient surface. The compatibility and package integrity of the blister pack packaging system has been demonstrated and successfully used for other 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). Shelf-life studies are ongoing to further extend the labeled expiration date.

The provided text describes modifications to already cleared contact lenses (DAILIES TOTAL1®). The submission (K182782) focuses on showing that the modified device remains substantially equivalent to the predicate device. Therefore, the information required for a study proving device meets acceptance criteria, particularly for a new device with specific performance metrics, is not directly applicable or comprehensively provided as it would be for a novel AI/software medical device.

Based on the document, here's a breakdown of the relevant information:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not present a formal "acceptance criteria" table with corresponding "reported device performance" in the way one would expect for an AI/software device with quantitative metrics like sensitivity, specificity, etc.
Instead, it focuses on demonstrating substantial equivalence to a predicate device. The "performance" is assessed by showing that the modified device's characteristics are the "same as" the predicate device in key areas, and that non-clinical testing confirms its safety and effectiveness.

Here's a table derived from the "Comparison to Technological Characteristics with the Predicate Device" and "Performance Data" sections:

2. Sample size used for the test set and the data provenance

• Non-clinical Testing: The document states, "A series of non-clinical testing was performed to characterize the lens material properties..." and "Light transmittance properties (incl. UV and UV-Vis) are supported by testing in accordance with ISO 18369-3:2017." However, specific sample sizes (e.g., number of lenses tested for physicochemical properties, UV transmittance) are not provided.
• Clinical Testing: "The scope of the device modification did not require clinical testing to establish safety and effectiveness of the modified device." Therefore, there was no test set for clinical performance, and thus no data provenance or sample size for such. The substantial equivalence was based on non-clinical data and the similarity to the predicate device.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

Not applicable, as there was no clinical test set requiring expert ground truth for performance evaluation in this 510(k) submission. The evaluation was based on material characterization and comparison to a predicate device.

4. Adjudication method for the test set

Not applicable, as there was no clinical test set requiring adjudication in this submission.

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/software medical device that assists human readers (e.g., radiologists).

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

Not applicable. This device is a contact lens, not a standalone algorithm.

7. The type of ground truth used

For the non-clinical testing, the "ground truth" was established by established scientific methods and international standards (e.g., ISO 18369-3:2017 for light transmittance, ISO 10993 series for biocompatibility, and GLP regulation for biocompatibility studies' conduct). The comparison was primarily against the known characteristics of the predicate device and relevant standards.

8. The sample size for the training set

Not applicable. This is a contact lens product, not an AI/machine learning device that requires a training set.

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

Not applicable, as there is no training set for this type of device.

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