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FreshLook Spherical (phemfilcon A) soft (hydrophilic) contact lenses are indicated for the correction of visual acuity in persons with nondiseased eves that are myopic (nearsighted) or hyperopic (farsighted) and may exhibit refractive astigmatism of up to 2.0 diopters that does not interfere with visual acuity.

The FreshLook Spherical Colors, ColorBlends, and Dimensions lenses act to enhance or alter the apparent color of the eye.

The eye care professional may prescribe the lens for frequent with daily removal for cleaning and disinfection. The lens may be disinfected using a chemical disinfection system.

FreshLook (phemfilcon A) are a family of soft contact lenses, intended for the optical correction of refractive error. The lenses are available in spherical designs and in the following lens models: FreshLook Handling Tint, FreshLook Colors, FreshLook ColorBlends and FreshLook Dimensions.

FreshLook contact lenses are made of phemfilcon A lens material, a hydrophilic copolymer of 2-hydroxyethyl methacrylate (HEMA) and 2-ethoxyethyl methacrylate (EOEMA). The lenses have a water content of 55% by weight.

FreshLook Colors and FreshLook ColorBlends lenses are made of clear lens material, FreshLook Handling Tint and FreshLook Dimensions are made of tinted (green handling tint) lens material polymer to facilitate lens visibility for handling.

FreshLook Colors, FreshLook ColorBlends and FreshLook Dimensions lenses are printed with an intermittent coating containing color additives listed in the color additive provisions of 21 CFR. FreshLook Colors are available in the colors Blue, Green, Hazel, Misty Gray, Sapphire Blue and Violet. FreshLook ColorBlends are available in the colors Amethyst, Blue, Brown, Gray, Green, Honey, Pure Hazel, True Sapphire, Turquoise, Gemstone Green, Brilliant Blue and Sterling Gray. FreshLook Dimensions are available in the colors Caribbean Aqua, Pacific Blue and Sea Green.

FreshLook soft contact lenses are supplied sterile. The lenses immersed in 2.5 ml isotonic borate buffered saline solution are packaged in individual foil-blister packs and are terminally sterilized in a validated autoclave (moist heat, steam under pressure). The packaging saline contains 0.005% Poloxamer.

The foil-blister pack system consists of a thermo-formed array bottom made from polypropylene resin, sealed with an aluminum-based foil lidding. The blister packs are packaged into carton boxes available in different pack sizes.

This document describes the 510(k) submission for FreshLook contact lenses, which are a modification of already cleared devices. The modification involves adding an alternate foil lidding material grade for the primary packaging. As such, the study focuses on demonstrating that this packaging change does not negatively impact the device's performance, safety, or effectiveness.

Here's a breakdown of the requested information based on the provided text:

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

The document states that "all acceptance criteria [were] met" for the non-clinical testing. However, it does not explicitly list what those acceptance criteria were for each specific test, nor does it provide detailed quantitative performance results for the modified device beyond stating they are "Same" as the predicate for most performance specifications. The table below summarizes the listed performance specifications from the comparison table (Table 1), indicating that the modified device is expected to meet these same specifications.

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

The document does not explicitly state the sample sizes used for the non-clinical tests (stability, biocompatibility, process validation). It primarily focuses on comparing the modified device's characteristics to the predicate. The data provenance is not specified, but the submission is from Alcon Laboratories, Inc. in the USA, with the contact person in Germany, which implies the testing may have been conducted internationally. The testing appears to be prospective, as it was conducted for the modified device to verify equivalence.

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)

This information is not applicable to this submission. The device is a soft contact lens, and the study is a non-clinical evaluation of a packaging change. It does not involve diagnostic image analysis or clinical expert review in the manner described by this question. The "ground truth" here is the physical and chemical properties and performance of the lens with the new packaging, compared to the established performance of the predicate device.

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

This information is not applicable. Adjudication methods like "2+1" or "3+1" are typically used in clinical trials or studies where human expert review disagreement needs to be resolved for ground truth establishment, often in diagnostic AI studies. This submission involves non-clinical laboratory testing.

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

No, a multi-reader, multi-case (MRMC) comparative effectiveness study was not done. This type of study is relevant for AI-assisted diagnostic tools. The current submission is for a medical device (contact lens) where the modification is a packaging material change, and the evaluation is non-clinical.

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

This question is not applicable to the device described. The device is a contact lens, not an algorithm or AI system.

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

The "ground truth" in this context refers to the established performance characteristics and safety profile of the predicate device. The modified device's performance was compared against these established specifications through non-clinical laboratory testing (stability, biocompatibility, process validation). Therefore, the "ground truth" is essentially the physical, chemical, and biological performance characteristics and safety data of the legally marketed predicate device, as determined by prior validated testing.

8. The sample size for the training set

This information is not applicable. The submission is for a physical medical device (contact lens) and involves non-clinical testing of a packaging change, not the development or training of an algorithm or AI model.

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

This information is not applicable for the reasons stated in point 8.

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