LogoFDA 510(k) Search
Search Filters

Search Results

Found 1 results

510(k) Data Aggregation

    K Number
    K040338
    Device Name
    ARTHROCARE CONTROLLER, CABLE, FOOT CONTROL, POWER CORD, WANDS, MODELS H0970-02, H2000-04, H2000-05, H0970-06
    Manufacturer
    ARTHROCARE CORP.
    Date Cleared
    2004-03-01

    (19 days)

    Product Code
    GEI
    Regulation Number
    878.4400
    Type
    Special
    Panel
    General & Plastic Surgery
    Reference & Predicate Devices
    K020832,K030954
    Predicate For
    K070351,K071963
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The ArthroCare System is indicated for resection, ablation, and coagulation of soft tissue and hemostasis of blood vessels in orthopedic, arthroscopic, spinal, and neurological procedures. The ArthroCare System is indicated for ablation, coagulation, and decompression of disc material to treat symptomatic patients with contained herniated discs.

    Device Description

    The ArthroCare System is a bipolar, high frequency electrosurgical system consisting of three components: an electrosurgical generator called the Controller; a family of disposable, bipolar, single use Wands; and a reusable Patient Cable.

    AI/ML Overview

    I am sorry, but based on the provided text, there is no information about acceptance criteria or a study proving the device meets acceptance criteria. The document is a 510(k) summary for a medical device (ArthroCare System), focusing on its substantial equivalence to previously cleared predicate devices due to a modification in performance specifications and labeling.

    The document discusses:

    • General information about the submitter and device.
    • The device's description (electrosurgical system with generator, wands, and cable).
    • Intended uses.
    • A statement of substantial equivalence to predicate devices (K020832 and K030954).
    • A summary statement affirming the modifications do not significantly affect safety or efficacy.
    • An FDA letter confirming the 510(k) clearance based on substantial equivalence.
    • The Indications for Use statement.

    There are no details about:

    1. Acceptance criteria
    2. Reported device performance values against acceptance criteria
    3. Sample sizes for test sets or their data provenance
    4. Number or qualifications of experts for ground truth
    5. Adjudication methods
    6. MRMC comparative effectiveness studies (or effect sizes)
    7. Standalone algorithm performance studies
    8. Type of ground truth used
    9. Training set sample size
    10. How ground truth for the training set was established

    The document is a regulatory submission focused on demonstrating substantial equivalence rather than a detailed report of a performance study with specific acceptance criteria.

    Ask a Question

    Ask a specific question about this device

    Page 1 of 1