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The SofLens® daily disposable (hilafilcon B) Visibility Tinted Contact Lens is indicated for the daily wear correction of refractive ametropia (myopia, hyperopia and astigmatism) in aphakic and/or not-aphakic persons with nondiseased eyes, that exhibit refractive astigmatism up to 2.00 diopters or less, that does not interfere with visual acuity. The lens may be prescribed in spherical powers ranging from +20.00D to -20.00D.

The lens is to be prescribed for single-use disposable wear, and is to be discarded after each removal.

The SofLens® daily disposable (hilafilcon B) Visibility Tinted Contact Lens is a hemispherical flexible shell which covers the cornea and may cover a portion of the adjacent sclera. It consists of a copolymer of 2-hydroxyethyl methacrylate and N-vinyl pyrrolidone, and is 59% water by weight when immersed in a sterile saline solution. This lens is tinted blue with Reactive Blue Dye 246 ((1,4-Bis[4-(2-methacryloxyethyl) phenylamino] anthraquinone). The color additive conforms with 21 CFR Part 73.3106. The lens may also be supplied clear (no tint).

The physical / optical properties of the lens are:
Specific Gravity: 1.119
Refractive Index: 1.4036
Light Transmittance: C.I.E. Y value - at least 97%
Water Content: 59%
Oxygen Permeability (Dk): 22 x10-11[cm³O₂(STP) x cm]/(sec x cm² x mmHg)@35°C(Polarographic Method)

The SofLens® daily disposable (hilafilcon B) Visibility Tinted Contact Lens is a hemispherical shell of the following dimensions:
• Diameter: 13.5mm to 15.0mm
• Center Thickness: 0.05mm to 0.75mm
• Base Curve: 7.8mm to 9.5mm
• Powers (Spherical): +20.00D to -20.00D

Each SofLens® daily disposable (hilafilcon B) Visibility Tinted Contact Lens is supplied in a plastic blister container with a saline solution. The container is marked with the manufacturing lot number of the diameter, sphere power, base curve and expiration date.

The provided text is a 510(k) summary for the SofLens® daily disposable (hilafilcon B) Visibility Tinted Contact Lens. It primarily focuses on demonstrating substantial equivalence to predicate devices and does not detail a study specifically designed to establish acceptance criteria and then demonstrate the device meets those criteria through clinical performance testing for the new device. Instead, it relies on previously conducted studies for its predicate devices.

Here's an analysis of the requested information based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state "acceptance criteria" in the traditional sense of a study's primary endpoints and statistical thresholds for a new clinical trial. Instead, it aims to demonstrate that the new device has "no change in the lens material, the manufacturing process, nor the parameters and properties" compared to its predicates, and therefore, the prior clinical data supports its safety and effectiveness.

However, we can infer some "performance" metrics from the device description which are inherent characteristics, rather than results of a specific performance study against defined criteria for this 510(k).

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

The document states: "A series of preclinical and clinical studies have been completed and were previously submitted under submissions K994125 and K974780." And, "There is no change in the lens material, the manufacturing process, nor the parameters and properties, therefore, the clinical data previously submitted in K994125 and K974780 supports the clinical safety and effectiveness of the subject device."

Therefore, for the current 510(k), no new clinical "test set" was used. The data provenance would be from the studies associated with the predicate devices (K994125 for SofLens®59 (hilafilcon B) and K974780 for SofLens® one day disposable (hilafilcon A)). The specifics of those previous studies (sample size, country of origin, retrospective/prospective nature) are not detailed in this 510(k) summary.

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

As no new clinical "test set" was conducted for this 510(k), this information is not applicable to this submission. The ground truth would have been established in the predicate device studies, the details of which are not provided here.

4. Adjudication method for the test set

Again, since no new clinical "test set" was conducted for this 510(k), this information is not applicable to 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

This is not applicable. The device is a contact lens, not an AI or imaging device that uses human readers or AI assistance.

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

This is not applicable. The device is a contact lens, not an algorithm or AI.

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

For the predicate clinical studies, the "ground truth" for contact lenses typically refers to parameters like visual acuity, comfort ratings, adverse event rates, and fitting characteristics assessed by ophthalmic professionals (optometrists, ophthalmologists). This would be based on clinical observation, patient feedback, and objective measurements (e.g., visual acuity, slit lamp examination), which falls under "outcomes data" and expert clinical assessment. The exact details for the predicate devices are not in this document.

8. The sample size for the training set

This is not applicable in the context of this 510(k). The device is a physical product (contact lens), not an AI algorithm that requires a training set. The "training" in this context would refer to the historical clinical data from the predicate devices that demonstrated the safety and effectiveness of the material and manufacturing process. The sample size for those predicate studies is not provided here.

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

This is not applicable as outlined in point 8. The "ground truth" for the predicate clinical studies (which serve as the basis for this submission) would have been established through standard clinical trial methodologies for contact lenses, involving:

• Investigator assessments: Eye care professionals evaluating lens fit, ocular health, and measuring visual acuity.
• Patient subjective feedback: Questionnaires or interviews regarding comfort, vision quality, and handling.
• Adverse event reporting: Documentation of any issues observed or reported during the study.

This information would have been collected and analyzed to support the safety and effectiveness claims of the predicate devices.

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