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The SofLens® daily disposable toric (hilafilcon B) Visibility Tinted Contact Lens is indicated for the daily wear correction of refractive ametropia (myopia, hyperopia, and astigmatism) in not-aphakic persons with non-diseased eyes, exhibiting astigmatism of 5.00 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 toric (hilafilcon B) Visibility Tinted Contact Lens is a soft hydrophilic contact lens which is available in a toric lens design for the correction of astigmatism. The lens is made from the hilafilcon B material, a hydrophilic 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.

The provided document describes the SofLens® daily disposable toric (hilafilcon B) Visibility Tinted Contact Lens, and its substantial equivalence to previously cleared predicate devices. The document explicitly states that preclinical and clinical studies were completed and previously submitted for the predicate devices. It does not provide new acceptance criteria or specific study results for the SofLens® daily disposable toric (hilafilcon B) Visibility Tinted Contact Lens itself, but rather leverages the data from its predicates.

Therefore, for aspects like acceptance criteria, device performance, sample sizes, expert qualifications, and ground truth establishment, the information presented below reflects what would have been applicable to the predicate devices, or what can be inferred from the nature of the device and regulatory process.

1. Table of Acceptance Criteria and Reported Device Performance

Since this submission relies on substantial equivalence and refers to previous studies, specific acceptance criteria and reported performance for the new device are not explicitly detailed. However, for contact lenses, acceptance criteria typically revolve around visual acuity, fitting characteristics, oxygen permeability, comfort, and safety endpoints (e.g., adverse events). The "reported device performance" for the new lens is broadly understood to be equivalent to its predicates.

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

The document states: "A series of preclinical and clinical studies were completed and previously submitted in Premarket Notifications K061157, K994125 and K941370."

• Test Set Sample Size: Not specified for the current device's assessment, as it leverages prior studies. For the predicate devices, sample sizes would have been determined based on statistical requirements for non-inferiority or equivalence trials for contact lenses.
• Data Provenance: The document does not explicitly state the country of origin or whether the data was retrospective or prospective for the predicate studies. However, clinical trials for medical devices like contact lenses are typically prospective multicenter studies conducted in various countries, with the US often being a primary location.

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

This information is not provided in the supplied text for the current device, as it relies on substantial equivalence to predicate devices. For the predicate clinical studies, the ground truth (e.g., visual acuity measurements, slit lamp examinations for ocular health, subjective comfort ratings) would have been established by:

• Optometrists and Ophthalmologists: Qualified eyecare professionals (often with several years of experience) who conducted clinical examinations, performed refractions, assessed lens fit, and evaluated adverse events. The specific number is not disclosed in this summary.

4. Adjudication Method for the Test Set

The document does not describe any specific adjudication method for the test set, as no new primary clinical study data is presented for this specific 510(k) submission. In multi-center clinical trials for the predicate devices, adjudication of adverse events or ambiguous findings would typically involve:

• Independent Clinical Monitors: To ensure protocol adherence and data accuracy.
• Clinical Endpoints Committee (CEC): A small group of clinicians who independently review and adjudicate key clinical endpoints, especially adverse events, often blinded to treatment assignment.
• Data Safety Monitoring Board (DSMB): For ongoing monitoring of patient safety in larger trials.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, what was the effect size of how much human readers improve with AI vs without AI assistance

N/A. This device is a contact lens and does not involve AI assistance or "human readers" in the context of diagnostic interpretation. Therefore, an MRMC comparative effectiveness study regarding improvement with AI assistance is not applicable.

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

N/A. This device is a contact lens and does not involve any algorithm that operates in a standalone manner without human intervention.

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

For the predicate clinical studies, the ground truth would have been established through a combination of:

• Clinical Examination Findings: Objective measurements by eye care professionals (e.g., visual acuity charts, slit lamp biomicroscopy for corneal health, keratometry for corneal shape, lens fit assessment).
• Patient Reported Outcomes (PROs): Subjective data regarding comfort, vision quality, and overall satisfaction.
• Refractive Measurements: Objective and subjective refraction to determine the lens's corrective power.
• Adverse Event Reporting: Detailed documentation and classification of any ocular or systemic adverse events.

8. The Sample Size for the Training Set

The document does not mention a "training set" in the context of the 510(k) submission, as it leverages previous clinical data on predicate devices rather than developing a new algorithm with a training/test split. For contact lenses, "training set" is not a standard term unless referring to material development or specific design optimization, which wouldn't typically be a detailed part of a 510(k) summary. The "training" for such devices is based on extensive research and development in materials science and optical design.

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

As explained in point 8, the concept of a "training set" with established ground truth is not directly applicable in the context of this 510(k) summary for a physical medical device like a contact lens. The "ground truth" for the development of contact lens materials (hilafilcon B) and designs (toric, daily disposable) would have been built upon decades of ophthalmological and optometric understanding, extensive material testing, and prior clinical trials for predecessors. This continuous feedback loop from clinical performance and patient outcomes informs the iterative design process in contact lens development.

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