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510(k) Data Aggregation

    K Number
    K061651
    Device Name
    FISCHER CONE BIOPSY EXCISOR, MODELS 900-150, 151, 152, 154, 155, 157 AND 158
    Manufacturer
    APPLE MEDICAL CORP.
    Date Cleared
    2006-10-20

    (129 days)

    Product Code
    HGI
    Regulation Number
    884.4120
    Type
    Traditional
    Panel
    Obstetrics/Gynecology
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Device Name :

    FISCHER CONE BIOPSY EXCISOR, MODELS 900-150, 151, 152, 154, 155, 157 AND 158

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

    The Fischer Cone Biopsy device is indicated for Large Loop Excision Of The Transformation Zone (LLETZ) in the diagnosis and treatment of some cervical intraepithelial neoplasias (CIN) and dysplasias.

    Device Description

    Not Found

    AI/ML Overview

    I apologize, but the provided text is a 510(k) clearance letter from the FDA for a medical device called the "Fischer Cone Biopsy Excisor." This type of document primarily confirms that the device is "substantially equivalent" to a legally marketed predicate device and grants permission to market it.

    The document does NOT contain the following information that you requested:

    • A table of acceptance criteria and reported device performance. The FDA clearance letter does not detail the specific performance metrics or acceptance criteria used in the substantial equivalence determination. It focuses on regulatory compliance rather than detailed device efficacy or safety study results in this letter.
    • Sample size used for the test set and data provenance. This information would typically be found in the device's 510(k) submission, not the clearance letter.
    • Number of experts used to establish the ground truth and their qualifications. Again, this level of detail about study design is not in this document.
    • Adjudication method.
    • If a multi-reader multi-case (MRMC) comparative effectiveness study was done, or the effect size of human readers improvement with AI vs. without AI assistance. This device is a surgical excisor, not an AI-assisted diagnostic tool, so such a study would not be applicable.
    • If a standalone performance (algorithm only) was done. Not applicable as it's not an algorithm.
    • The type of ground truth used.
    • The sample size for the training set.
    • How the ground truth for the training set was established.

    Therefore, I cannot fulfill your request for a description of the acceptance criteria and the study that proves the device meets them based on the provided text. The FDA letter only states that the device is "substantially equivalent" for its indicated uses to previously marketed devices.

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