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510(k) Data Aggregation

    K Number
    K152558
    Device Name
    Leksell Stereotactic System, Injection/ Aspiration Needle Kit
    Manufacturer
    ELEKTA INSTRUMENT AB
    Date Cleared
    2016-03-02

    (175 days)

    Product Code
    HAW
    Regulation Number
    882.4560
    Type
    Special
    Panel
    Neurology
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Device Name :

    Leksell Stereotactic System, Injection/ Aspiration Needle Kit

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

    Leksell Stereotactic System is intended for localization and diagnosis of intracranial disorders and their surgical treatment including radiosurgery and stereotactic radiation therapy.

    Device Description

    Not Found

    AI/ML Overview

    I am sorry, but the provided text does not contain the information requested in your prompt regarding acceptance criteria, study details, sample sizes, ground truth establishment, or any AI-related effectiveness studies. The document is a 510(k) clearance letter from the FDA for a medical device called the "Leksell Stereotactic System," classifying it as substantially equivalent to a predicate device for specific indications for use.

    Therefore, I cannot generate a response that includes:

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