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510(k) Data Aggregation

    K Number
    K032481
    Device Name
    THERATEARS CONTACT LENS COMFORT DROPS
    Manufacturer
    ADVANCED VISION RESEARCH, INC.
    Date Cleared
    2003-11-04

    (84 days)

    Product Code
    LPN
    Regulation Number
    886.5928
    Type
    Traditional
    Panel
    Ophthalmic
    Reference & Predicate Devices
    K992928,K013204
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    TheraTears Contact Lens Comfort Drops is indicated

    • to lubricate and rewet soft (hydrophilic) and RGP* (rigid gas permeable) contact lenses.
    • to help relieve dryness, discomfort and irritation that may be associated with lens wear and,
    • to cushion lenses and ease insertion.
    • RGP lenses include silicone acrylate and fluoro silicone acrylate rigid gas permeable lenses. Consult with your eye care practitioner to identify your RGP material.
    Device Description

    TheraTears® brand Contact Lens Comfort Drops contains carmellose sodium in purified water as a lubricant. It is a sterile, hypotonic, borate buffered solution containing the following essential electrolytes found in natural tears: sodium chloride, potassium chloride, sodium chloride, sodium bicarbonate, calcium chloride, magnesium chloride, and sodium phosphate. The gentle patented preservative system consists of sodium perborate stabilized with phosphonic acid. This solution contains no chlorhexidine, no thimerosal and no other mercury-containing ingredients, and it contains no detergents.

    AI/ML Overview

    The provided text describes the 510(k) summary for TheraTears Contact Lens Comfort Drops, focusing on its safety and effectiveness. It outlines non-clinical and clinical testing performed to demonstrate substantial equivalence to predicate devices.

    1. Table of Acceptance Criteria and Reported Device Performance

    The document does not explicitly state quantitative "acceptance criteria" in terms of specific numerical thresholds for performance metrics. Instead, it describes demonstrating "equivalence in performance, safety and efficacy" to a predicate device based on several qualitative and semi-quantitative metrics.

    Acceptance Criteria (Implied)Reported Device Performance (Summary)
    Relative frequency and severity of positive slit lamp findingsEquivalent to Bausch & Lomb ReNu MultiPlus® Lubricating and Wetting Drops
    Stability of contact lens visual acuitiesEquivalent to Bausch & Lomb ReNu MultiPlus® Lubricating and Wetting Drops
    Stability of best spectacle-corrected visual acuitiesEquivalent to Bausch & Lomb ReNu MultiPlus® Lubricating and Wetting Drops
    Relative incidence and severity of symptoms, problems, and complaintsEquivalent to Bausch & Lomb ReNu MultiPlus® Lubricating and Wetting Drops
    Lack of solution-associated complicationsEquivalent to Bausch & Lomb ReNu MultiPlus® Lubricating and Wetting Drops

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

    • Sample Size: The document states "A one month clinical study was conducted," but it does not specify the sample size (i.e., number of participants) used in this clinical study.
    • Data Provenance: The document does not explicitly state the country of origin. Given the 510(k) submission to the US FDA, it is highly probable the data was collected in the United States. The study was a prospective clinical study conducted by the applicant.

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

    The document does not provide information regarding the number of experts, if any, used to establish ground truth or their specific qualifications for this clinical study. The assessment of parameters like slit lamp findings, visual acuities, and patient-reported symptoms would typically involve trained ophthalmologists or optometrists, but details are not provided.

    4. Adjudication Method for the Test Set

    The document does not specify any adjudication method used for the test set data.

    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

    No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. This device is a contact lens comfort drop, not an AI-powered diagnostic or assistive tool.

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

    No, a standalone (algorithm-only) performance study was not done. This device is a physical product (contact lens drops), not an algorithm.

    7. The Type of Ground Truth Used

    The "ground truth" for the clinical study was established by clinical assessment and comparison to a legally marketed predicate device (Bausch & Lomb ReNu MultiPlus® Lubricating and Wetting Drops). This involved:

    • Objective clinical observations (e.g., slit lamp findings, visual acuity measurements).
    • Subjective patient-reported outcomes (e.g., symptoms, problems, complaints).
    • Assessment of complications.

    The aim was to show "equivalence in performance, safety and efficacy."

    8. The Sample Size for the Training Set

    The document does not mention a training set because this is a clinical trial for a medical device (eye drops), not an AI model.

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

    Not applicable, as there was no AI model or training set in the context of this device submission.

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