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The Qualis (linofilcon A) Soft (Hydrophilic) Daily Wear Contact Lens is indicated for the correction of ametropia (myopia and hyperopia) in aphakic and non-aphakic persons with non-diseased eyes and 1.00 diopter (D) or less of astigmatism.

Eye Care Professionals may prescribe the lenses either for single-use disposable wear or frequent/planned replacement wear with cleaning, disinfection and scheduled replacement. When prescribed for daily disposable wear, the lens is to be discarded after each removal. When prescribed for frequent/planned replacement wear, the lens may be cleaned and disinfected using a chemical disinfection system only.

The Qualis (linofilcon A) Soft (Hydrophilic) Daily Wear Contact Lens is a hemispherical shell with a molded spherical base curve and a molded front surface. The hydrophilic characteristics allow aqueous solutions to enter the lens. The lenses are fabricated from linofilcon A, which is a random co-polymer of silicone containing monomers and hydrophilic monomers. The lens consists of 62.0% linofilcon A and 38.0% water by weight when immersed in saline solution. The linofilcon A name has been adopted by the United States Adopted Names Council (USAN).

The Qualis (linofilcon A) Soft (Hydrophilic) Daily Wear Contact Lens contains C.I. Reactive Blue No. 19 (21 CFR Part 73.3127) for visibility and handling. The Qualis (linofilcon A) Soft (Hydrophilic) Daily Wear Contact Lens incorporates a benzotriazole UV blocking monomer to help protect against transmission of harmful UV radiation. The lens blocks >95% in the UVB range (280mm -315nm), and >70% in the UVA range (316nm - 380nm).

The Oualis (linofilcon A) Soft (Hydrophilic) Daily Wear Contact Lens is manufactured in a spherical design configuration.

This document is a 510(k) Premarket Notification for a medical device, specifically a soft contact lens. It aims to demonstrate substantial equivalence to a predicate device, not necessarily to prove a new level of performance or an AI's diagnostic capabilities. Therefore, many of the requested elements for an AI-based diagnostic device evaluation (like MRMC studies, expert consensus for ground truth establishment, training set details) are not relevant or present in this type of submission.

However, I can extract the relevant acceptance criteria and performance data provided for this specific type of device (a contact lens) which are typically focused on non-clinical and clinical safety and basic effectiveness parameters.

Here's the breakdown based on the provided document:

Acceptance Criteria and Reported Device Performance

Note: The acceptance criteria for many non-clinical tests are qualitative (e.g., "non-toxic," "no irritation") and are met by complying with relevant ISO standards. For quantitative metrics like Dk, water content, and refractive index, the device's measured values are compared to the predicate's known values to establish substantial equivalence.

2. Sample Size and Data Provenance

• Test Set Sample Size: 75 subjects were enrolled in the clinical study. 50 subjects wore the test lenses (Qualis) and 25 subjects wore the control lenses (Acuvue Vita). 73 of the 75 enrolled subjects completed the study.
• Data Provenance: Not explicitly stated regarding country of origin, but typical for FDA submissions, the clinical study would be conducted in a manner compliant with Good Clinical Practice (GCP) guidelines, often with a global reach or in the US. The study was "open-label, multi-center, randomized concurrent-control." It was a prospective study.

3. Number of Experts and Qualifications for Ground Truth

• This submission is for a contact lens, not an AI diagnostic device. Therefore, the concept of "ground truth" derived from expert consensus on diagnostic images is not applicable here. The "ground truth" for the clinical study would refer to the observed clinical outcomes (biomicroscopy findings, symptoms, vision safety measures) as assessed by the participating clinicians. The qualifications of these clinicians are not specified in the summary but would typically be licensed optometrists or ophthalmologists experienced in fitting and evaluating contact lenses.

4. Adjudication Method for the Test Set

• Not applicable in the context of a contact lens clinical trial, which primarily gathers objective and subjective clinical measurements directly, rather than judgments that require adjudication for a "ground truth."

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 AI-powered diagnostic imaging devices to assess the impact of AI assistance on human reader performance. This submission is for a contact lens.

6. Standalone (Algorithm only) Performance

• No, standalone performance (i.e., algorithm only without human-in-the-loop performance) was not done. This is not an AI device.

7. Type of Ground Truth Used

• The "ground truth" for the clinical study in this context is based on clinical observations, measurements, and patient-reported symptoms as assessed by Eye Care Professionals during the 91-day follow-up. This includes biomicroscopy findings, assessment of symptoms, and vision safety measures. Non-clinical "ground truth" is based on bench testing and laboratory analyses against established scientific methods and standards (e.g., ISO standards for biocompatibility).

8. Sample Size for the Training Set

• Not applicable. This is not an AI device that requires a training set in the machine learning sense. The "training" for such a device is its manufacturing process and quality control.

9. How Ground Truth for the Training Set Was Established

• Not applicable as this is not an AI device.

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