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Calaview (Etafilcon A) Soft (hydrophilic) Contact Lens is indicated for daily wear the correction of visual acuity in not-aphakic persons with non-diseased eyes that are myopic or hyperopic and may exhibit refractive astigmatism up to 2.00 diopters that does not interfere with visual acuity.

Eye care practitioners may prescribe the lenses for either single-use daily disposable wear or frequent/planned replacement wear with cleaning, rinsing , disinfection and scheduled replacement as prescribed by the eyecare professional.. When prescribed for frequent/planned replacement wear , The contact lens may be disinfected using chemical (not heat) disinfection system.

Calaview (Etafilcon A) Soft (hydrophilic) Contact Lens for Daily Wear is available as non-spherical lenses manufactured by spin-casting method. The model illuminated with high water content (58 %). The hydrogel lens' material is a random copolymer composed of 2-hydroxyethyl methacrylate (HEMA) and methacrylic acid (MAA), which was cross-linked with 1,1,1-trimethylolpropane trimethacrylate (TMPTMA) and Ethylene Glycol Dimethacrylate (EGDMA) via UV photo- polymerization. The Calaview (Etafilcon A) Soft (hydrophilic) Contact Lens for Daily Wear contains pigments around the non-optic area that will mask or enhance the color of the natural iris without blocking the light transmittance. The lens is colored with one or more of the FDA-approval color additives: iron oxides, titanium dioxide, phthalocyaninato copper, phtalocyanine green, vat orange 1. The Calaview (Etafilcon A) Soft (hydrophilic) Contact Lens for Daily Wear is available in the following opaque colors: Blue, green, violet, gray, hazel, white, yellow, gold, orange red and black. Lenses are supplied sterile in sealed blister packers containing sterile isotonic phosphate buffered saline solution.

This 510(k) submission (K073060) is a Special 510(k) for a labeling modification to an already cleared device, Calaview Colors (Etafilcon A) Soft (hydrophilic) Contact Lens for Daily Wear (K062541). The key takeaway is that no new clinical or non-clinical studies were conducted for this specific submission because the device itself (materials, manufacturing, parameters) is identical to the previously cleared predicate device. Therefore, the information requested below regarding new studies, sample sizes, and ground truth establishment is largely not applicable to this specific 510(k), as it relies on previous submissions.

However, I will extract the available information and clarify where it refers to prior studies.

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria are implicitly defined by the parameters and performance of the predicate devices. The "reported device performance" are the characteristics of the Calaview device that demonstrate equivalence to the predicate.

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

• For this specific 510(k) (K073060): No new clinical or non-clinical test sets were used. The submission explicitly states: "There is no change in lens material, the manufacturing process, nor the parameter and properties. therefore, the clinical data previously submitted in K062541 supports the clinical safety of the subject device." and "Therefore, the non-clinical data previously submitted in K062541 supports the clinical safety of the subject device."
• For the referenced predicate (K062541): This document does not provide details on the sample sizes or data provenance for the original clinical or non-clinical studies conducted for K062541. These details would be found within the K062541 submission itself.

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

• Not applicable to this 510(k). No new clinical studies were conducted that would require expert ground truth establishment.

4. Adjudication method for the test set

• Not applicable to this 510(k). No new clinical studies were conducted.

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 diagnostic tool. No MRMC studies were performed.

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 an algorithm.

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

• For this specific 510(k): No new ground truth was established. The safety and effectiveness are based on the established performance of the predicate device.
• For the referenced predicate (K062541): For contact lenses, "ground truth" for clinical safety and effectiveness typically involves ophthalmological examinations, visual acuity measurements, adverse event tracking (e.g., corneal staining, infiltrates, discomfort), and patient reported outcomes. Details would be in the K062541 submission. For non-clinical tests, ground truth is based on standard laboratory testing methodologies (e.g., ISO standards for biocompatibility, sterility testing).

8. The sample size for the training set

• Not applicable. This is a medical device (contact lens), not an AI model requiring a training set.

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

• Not applicable. This is a medical device (contact lens), not an AI model.

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