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The Bausch + Lomb Naturelle Daily Disposable (hilafilcon B) Cosmetically Tinted Contact Lens is indicated for the daily wear correction of refractive ametropia (myopia and hyperopia) in aphakic and not-aphakic persons with non-diseased eyes, exhibiting astigmatism of 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 Bausch + Lomb Naturelle Cosmetically Tinted daily disposable (hilafilcon B) Contact Lens is a hemispherical flexible shell which covers the cornea and may cover a portion of the adjacent sclera. The printed ink pattern consists of a copolymer of 2-hydroxyethyl methacrylate and N-vinyl pyrrolidone, and the lens is 59% water by weight when immersed in a sterile saline solution. The lens monomer may be tinted blue with Reactive Blue Dye 246 (1,4-Bis[4-(2methacryloxyethyl) phenylamino] anthraquinone, CFR Part 73.3106).

The provided document describes a 510(k) submission for the Bausch & Lomb Naturelle Daily Disposable (hilafilcon B) Cosmetically Tinted Contact Lens. The submission claims substantial equivalence to a predicate device, Bausch & Lomb SofLens® Daily Disposable (hilafilcon B) Visibility Tinted Contact Lens (K061157).

This submission is for a cosmetic contact lens, which is typically evaluated for safety and effectiveness through non-clinical testing rather than complex clinical studies involving AI. Therefore, many of the requested categories related to AI performance, multi-reader studies, and ground truth establishment will not be applicable.

Here's the information extracted from the document, with "N/A" (Not Applicable) for categories that don't fit this type of device submission:

Acceptance Criteria and Device Performance for Bausch & Lomb Naturelle Daily Disposable (hilafilcon B) Cosmetically Tinted Contact Lens

1. Table of Acceptance Criteria and the Reported Device Performance:

The document states that "conformity to predetermined specifications" was part of the performance testing. However, it does not explicitly list quantitative acceptance criteria with corresponding performance results in a table format. Instead, it relies on demonstrating that the device's functional characteristics are equivalent to the predicate device and that non-clinical testing ensures safety and effectiveness. The table below presents the comparative technological characteristics provided, which serve as the basis for demonstrating equivalence to the predicate. The "Acceptance Criteria" here are implied to be "same as predicate" or within acceptable ranges for cosmetic differences.

Study Proving Device Meets Acceptance Criteria:

The device's conformity is established through non-clinical testing, which includes:

• Toxicology / Biocompatibility:
  • ISO Ocular Irritation Study
  • ISO Systemic Toxicity
  • In-Vitro Cytotoxicity
• Chemistry / Leachables:
  • Leachable Monomer and Additives
• Physical and Mechanical Properties

The document states: "The testing performed on the Bausch + Lomb Naturelle Daily Disposable (hilafilcon B) Cosmetically Tinted Contact Lens demonstrated that the device continues to function in a safe and effective manner. Performance testing included conformance to predetermined specifications, functional test results verify that the device performs as expected and is equivalent to the predicate without creating additional risk to the user."

2. Sample Size Used for the Test Set and Data Provenance:

• Sample Size: Not specified in the provided document. For non-clinical tests like toxicity and physical property measurements, standard laboratory sample sizes are typically used (e.g., number of animals for in-vivo tests, number of lenses for physical property tests), but these are not detailed here.
• Data Provenance: Not specified, but generally, such tests are conducted in controlled laboratory environments, often in the country of manufacture or certified testing facilities. The tests are prospective in nature, meaning they are performed specifically for this device evaluation.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of those Experts:

• N/A. This device does not involve a "ground truth" established by human experts in the way AI algorithms do. Safety and performance are assessed through objective laboratory tests and comparison to established standards and the predicate device.

4. Adjudication Method for the Test Set:

• N/A. Adjudication methods like 2+1 or 3+1 are used for human expert review of imaging or clinical cases, which is not relevant to the non-clinical testing of a contact lens.

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:

• N/A. This is not an AI-assisted device. No MRMC study was conducted.

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

• N/A. This is not an AI algorithm.

7. The Type of Ground Truth Used:

• For the non-clinical tests, the "ground truth" is defined by established scientific principles, validated testing methodologies (e.g., ISO standards), and the performance characteristics of the legally marketed predicate device. For example, for biocompatibility, the ground truth is "no significant ocular irritation" or "no significant systemic toxicity," as determined by the specific ISO tests.

8. The Sample Size for the Training Set:

• N/A. This device does not involve a training set as it is not an AI algorithm or a device requiring machine learning.

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

• N/A. This device does not involve a training set.

Summary of Equivalence Claim and Lack of Clinical Studies:

The submission relies heavily on the claim of "substantial equivalence" to the predicate device (K061157). The key statement is: "The technological characteristics, formulation, manufacturing and sterilization processes are the same as the predicate device, therefore, no clinical studies were required to demonstrate the safety or effectiveness of the subject device." The addition of the cosmetic tint was specifically addressed through "appropriate testing... to demonstrate that the differences do not impact the safety or efficacy of the device." This indicates that the non-clinical tests were crucial for validating that the cosmetic feature did not introduce new risks or alter the lens's fundamental performance characteristics.

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