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FLOSI (willofocon A) Rigid Gas Permeable Spherical, Aspherical, Toric, and Bifocal Contact Lenses are indicated for dally wear correction of refractive ametropla (myopla, hyperopla, astigmatism and presbyopla) In aphakic and non-aphakic persons with non-diseased eyes. The lens may be disinfected using a chemical disinfection system only.

The FLOSI (wilofocon A) Rigid Gas Permeable Contact Lons Is available as a spherical, aspherical, and astigmatic (toric) lens. The lens material, willofocon A, is sphencer, asphonour, and assigment which contains D & C Green No: 6 as a color additive. The FLOS (willofocon A) Contact Lens is a hemispherical shell.

Here's an analysis of the provided text to fulfill your request, focusing on the acceptance criteria and the study proving the device meets them:

Device: Flosi (wilofocon A) Rigid Gas Permeable Contact Lens (Spherical, Aspheric, Toric, and Bifocal)

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria are not explicitly stated as quantitative targets in the provided document. Instead, the study's findings are presented as being "within expecteds" or demonstrating "no significant issues," implying that the performance met acceptable clinical standards for this type of device. Based on the clinical study summary, the implied acceptance criteria revolve around the safety and efficacy of the contact lens, specifically related to potential adverse reactions, visual acuity, slit-lamp findings, and refractive changes.

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

• Sample Size for Test Set:
  • Clinical Study: 122 eyes enrolled, with 110 eyes completing a minimum of three months of contact lens wear. 12 eyes were discontinued.
  • Preclinical Studies:
    • Systemic Injection Test: Animals (number not specified, but typically small groups)
    • Eye Irritation Test: Rabbits (number not specified, but typically small groups)
    • Tissue Culture-Agar Overlay Cytotoxicity Assay: In vitro (not applicable for animal count)
• Data Provenance: The document does not specify the country of origin for the clinical study data. Given the submission to the FDA (United States), it is highly probable the study was conducted in the USA or a region with comparable clinical standards. The study appears to be prospective, as it describes enrolling patients and following them over a three-month period of contact lens wear.

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

The document does not specify the number of experts used to establish the ground truth for the clinical test set or their specific qualifications (e.g., "radiologist with 10 years of experience"). However, clinical studies for medical devices like contact lenses are typically overseen and evaluated by ophthalmologists or optometrists who are experienced in contact lens fitting and management. The observations (slit-lamp findings, keratometry, refraction, visual acuity) would have been performed and recorded by these clinical professionals.

4. Adjudication Method for the Test Set

The document does not describe a specific adjudication method (e.g., 2+1, 3+1) for the clinical test set. The clinical findings collected (SLFs, SPCs, keratometry, refraction, visual acuity) are typically direct observations or measurements made by the treating clinician during the study visits. It is implied that the clinical investigators made these assessments and their findings were recorded and aggregated for analysis. There is no mention of a separate panel or process for resolving discrepancies.

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

• No, an MRMC comparative effectiveness study was not explicitly done. The clinical study described focuses on the performance of the Flosi contact lens on its own, not in comparison to human readers or with AI assistance. It evaluates the device's safety and efficacy in a standalone clinical setting.

6. Standalone (i.e., algorithm only without human-in-the-loop performance) Study

• Yes, a standalone study was done, if we interpret "standalone" as the device performing its intended function without human intervention beyond fitting and wear. The clinical study specifically evaluates the Flosi contact lens as the standalone device. The lens is placed in the eye, and its performance (visual acuity correction, impact on eye health) is assessed. There is no AI component or algorithm described in this submission; the "device" is the physical contact lens itself.

7. Type of Ground Truth Used

For the clinical study, the "ground truth" was established through direct clinical observations and measurements by eye care professionals. This includes:

• Clinical Examination Findings: Slit-lamp examinations for corneal and conjunctival health.
• Patient-Reported Outcomes (PROs): Symptoms, problems, and complaints (SPCs).
• Objective Measurements: Keratometry (corneal curvature), Refraction (visual correction needed), Visual Acuity (measured using standard charts like Snellen).
• Adverse Event Monitoring: Tracking any adverse reactions or significant clinical issues.

For the preclinical studies, the ground truth was based on established laboratory assays and animal model observations (e.g., signs of toxicity, ocular irritation).

8. Sample Size for the Training Set

• Not applicable / Not explicitly stated. This device is a physical contact lens, not an AI/ML algorithm that requires a "training set" in the computational sense. The "training" for such a device would reside in the historical data and scientific principles used during its design and material formulation, but this is not a data set in the sense of AI.

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

• Not applicable. As mentioned above, there is no AI/ML training set defined for this physical device. The "ground truth" for the development of any medical device comes from scientific understanding, clinical experience with similar devices, regulatory standards, and extensive pre-clinical and clinical testing, which includes the safety and efficacy data presented in this submission.

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