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510(k) Data Aggregation

    K Number
    K964196
    Date Cleared
    1996-12-23

    (63 days)

    Product Code
    Regulation Number
    876.1500
    Reference & Predicate Devices
    N/A
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The Nortech CFS-1 Pump system shall be used for supplying fluid for general endoscopic procedures.

    Device Description

    The CFS-1 Pump System incorporates a peristaltic pump, motor, controller, power supply, and associated sensors and tubing. The product allows continuous flow to an Endoscopic instrument by the constant re-filling of a fluid source container. The control of flow rates and source pressures remains in the physician's control by the conventional method of raising or lowering the fluid source container.

    AI/ML Overview

    I am sorry, but the provided text describes a medical device (CFS-1 Pump System) and its intended use, materials, and substantial equivalence to other devices. It does not contain any information about acceptance criteria, study designs, performance metrics, ground truth, or sample sizes.

    Therefore, I cannot fulfill your request for:

    1. A table of acceptance criteria and reported device performance.
    2. Sample size used for the test set and data provenance.
    3. Number of experts used to establish ground truth and their qualifications.
    4. Adjudication method for the test set.
    5. MRMC comparative effectiveness study results.
    6. Standalone performance results.
    7. Type of ground truth used.
    8. Sample size for the training set.
    9. How ground truth for the training set was established.

    The provided text is related to a 510(k) clearance document, which typically focuses on demonstrating substantial equivalence to a predicate device rather than comprehensive clinical performance studies with acceptance criteria as you've described.

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