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The ACUVUE® Brand Contact Lens (spherical) are indicated for daily wear to enhance or alter the apparent color of the eye for lenses with cosmetic tint and/or for the correction of refractive ametropia (myopia and hyperopia) in aphakic or not-aphakic persons with non-diseased eyes who may have 1.00 D or less of astigmatism.

The ACUVUE® Brand (etafilcon A) Soft (hydrophilic) BIFOCAL Contact Lenses are indicated for daily wear to enhance or alter the apparent color of the eye for lenses with cosmetic tint and for the correction of distance and near vision in presbyopic, aphakic or not-aphakic persons with non-diseased eyes who may have 0.75 D or less of astigmatism.

The ACUVUE® Brand (etafilcon A) Soft (hydrophilic) TORIC Contact Lenses are indicated for daily wear to enhance or alter the apparent color of the eye for lenses with cosmetic tint and for the correction of visual acuity in aphakic or not-aphakic persons with non-diseased eyes that are hyperopic or myopic and may have 10.00 D or less of astigmatism.

The ACUVUE® Brand (etafilcon A) Soft (hydrophilic) TORIC BIFOCAL Contact Lenses are indicated for daily wear to enhance or alter the apparent color of the eye for lenses with cosmetic tint and for the correction of distance and near vision in presbyopic aphakic or not-aphakic persons with non-diseased eyes who may have 10.00 D of astigmatism or less.

ACUVUE® Brand (etafilcon A) Soft (hydrophilic) UV Blocking Contact Lenses help protect against transmission of harmful UV radiation to the cornea and into the eye.

Eye Care Practitioners may prescribe the lens for single-use disposable wear (See "Wearing Schedule").

The device descriptions do not change from those cleared under K994324 and K010114.

1. Acceptance Criteria and Reported Device Performance:

2. Sample Size and Data Provenance:

The document does not explicitly state the sample size used for the additional clinical study supporting the labeling modification. However, it mentions that this study demonstrated improved comfort for "2 out of 3 patients." This implies a small, likely prospective clinical study. The country of origin for the data is not specified, but given the submitter's location (Jacksonville, Florida) and the FDA submission, it likely originates from the United States or a region following similar clinical guidelines.

3. Number of Experts and Qualifications:

Not applicable. This device is a contact lens, and the study focuses on patient-reported comfort, not diagnostic image interpretation. The "experts" would be the patients themselves reporting on their comfort levels.

4. Adjudication Method:

Not applicable. The study's focus is on patient-reported comfort, not on expert adjudication of diagnostic findings. Patient comfort is a subjective measure, and adjudication in the traditional sense (e.g., by multiple clinical experts) is not typically used for such outcomes.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:

No, an MRMC comparative effectiveness study was not done. This type of study is relevant for diagnostic imaging devices where human readers interpret results, and the AI's impact on their performance is being evaluated. This submission is for a contact lens and focuses on patient comfort.

6. Standalone Performance Study:

A standalone performance study was done in the sense that the clinical research directly assessed the comfort provided by the ACUVUE® Brand (etafilcon A) Soft (hydrophilic) Contact Lenses when worn on a daily disposable basis. This was an "algorithm only" equivalent as the device itself is the intervention being tested, without human-in-the-loop interpretation.

7. Type of Ground Truth Used:

The ground truth for this study was patient-reported outcomes (PROs), specifically patient comfort and the experience of itching and mild discomfort associated with allergies during contact lens wear.

8. Sample Size for the Training Set:

Not applicable. This is not an AI/ML device that requires a training set. The clinical study directly evaluated the performance of the physical contact lens.

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

Not applicable. As noted above, this is not an AI/ML device, so there is no training set in the context of machine learning. The "ground truth" (patient comfort) for the clinical study was established through patient self-reporting.

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