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510(k) Data Aggregation

    K Number
    K964779
    Device Name
    MODEL I 100 RF PASSIVE ATTENUATOR/SPLITTER AND MODEL QL 10 LOOP ELECTRODE
    Manufacturer
    QUANTUM LOOP, INC.
    Date Cleared
    1997-08-27

    (273 days)

    Product Code
    GEI
    Regulation Number
    878.4400
    Type
    Traditional
    Panel
    General & Plastic Surgery
    Reference & Predicate Devices
    N/A
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The RF Passive Attenuator/Splitter Model I 100 I 200 and Cutting/Coagulating Electrode Model R 10 is indicated for the cutting and coagulation of the tissue. This device is intended for use by qualified medical personnel in the use of electrosurgery.

    Device Description

    RF Passive Attenuator/Splitter Model I 100, I 200 and Cutting/Coagulating Electrode Model R 10.

    AI/ML Overview

    1. Table of Acceptance Criteria and Reported Device Performance:

    The provided document does not contain any specific acceptance criteria or reported device performance metrics for the RF Passive Attenuator/Splitter (PAS) and Loop Electrode. The letter is a 510(k) clearance stating substantial equivalence to a predicate device, which focuses on device type, indications for use, and regulatory compliance rather than detailed performance specifications.

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

    No information regarding a test set sample size or data provenance is available in this document.

    3. Number of Experts Used to Establish Ground Truth and Qualifications:

    No information about experts or ground truth establishment is provided.

    4. Adjudication Method for the Test Set:

    No information regarding an adjudication method is provided.

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

    No information about a MRMC study or its effect size is present in this document.

    6. Standalone (Algorithm Only) Performance:

    This device is a hardware component (RF Passive Attenuator/Splitter and Loop Electrode), not an algorithm or AI system. Therefore, standalone algorithm performance is not applicable and not discussed.

    7. Type of Ground Truth Used:

    No information regarding the type of ground truth used is provided. As this is a hardware device clearance, the "ground truth" would likely relate to electrical safety, performance specifications, and clinical effectiveness demonstrated in predicate devices, rather than a diagnostic ground truth.

    8. Sample Size for the Training Set:

    This device is a hardware component. The concept of a "training set" is not applicable here as it refers to data used to train AI models.

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

    Not applicable, as this is a hardware device.

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