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510(k) Data Aggregation

    K Number
    K973554
    Device Name
    VALLEY FORGE BIPOLAR BALL TIP ELECTRODE
    Manufacturer
    VALLEY FORGE SCIENTIFIC CORP.
    Date Cleared
    1997-12-19

    (91 days)

    Product Code
    JOS
    Regulation Number
    878.4400
    Type
    Traditional
    Panel
    General and Plastic Surgery (SU)
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Device Name :

    VALLEY FORGE BIPOLAR BALL TIP ELECTRODE

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The bipolar ball electrodes are designed for electrosurgical coagulation of soft tissue in a bloody, irrigated or wet surgical field.

    Device Description

    Bipolar Ball Electrodes

    AI/ML Overview

    The provided text describes the regulatory clearance of a medical device (Bipolar Ball Electrodes) not an AI device, and therefore does not contain information about acceptance criteria, study data, or performance metrics in the way one would typically describe for a software algorithm or AI model.

    The document is a 510(k) premarket notification summary, which focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than presenting detailed performance studies against pre-defined acceptance criteria, especially not in the context of an AI device.

    Therefore, I cannot provide a response filling the requested table and sections as the information is not present in the provided text.

    Specifically:

    • Acceptance Criteria and Reported Device Performance: Not mentioned. The document relies on the opinion of an expert and general descriptions of the technology's benefits compared to monopolar electrosurgery.
    • Sample Size (test set), Data Provenance: Not applicable/not mentioned. No specific test set data is presented.
    • Number of Experts, Qualifications, Adjudication Method: Not applicable/not mentioned.
    • MRMC Comparative Effectiveness Study: Not applicable/not mentioned.
    • Standalone Performance: Not applicable/not mentioned.
    • Type of Ground Truth: Not applicable/not mentioned for device performance. The "ground truth" for 510(k) historically is substantial equivalence to a predicate.
    • Sample Size (training set), Ground Truth (training set): Not applicable/not mentioned.

    The text primarily summarizes the safety and effectiveness features of the bipolar ball electrodes and the FDA's clearance decision.

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