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510(k) Data Aggregation

    K Number
    K013069
    Device Name
    BIOSPEED
    Manufacturer
    H.S. HOSPITAL SERVICES S.P.A.
    Date Cleared
    2001-12-12

    (90 days)

    Product Code
    FCG
    Regulation Number
    876.1075
    Type
    Traditional
    Panel
    Gastroenterology/Urology
    Reference & Predicate Devices
    K951598
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    This device is an automated, disposable biopsy needle and can be used in Fluoroscopic, CT and Mammographic procedures to obtain biopsies of various tissues including those from Prostate Kidney, Breast and Liver.

    Device Description

    This device is an automated, disposable biopsy needle

    AI/ML Overview

    This document is a 510(k) summary for the BIOSPEED™ Spring Loaded Biopsy Needle. It outlines the product, its intended use, and its substantial equivalence to a predicate device. However, it does not contain any information regarding clinical studies, acceptance criteria, or device performance data.

    Therefore, I cannot provide the requested information, including:

    1. A table of acceptance criteria and the reported device performance: This document does not present any performance data or acceptance criteria.
    2. Sample size used for the test set and the data provenance: Not mentioned.
    3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not mentioned.
    4. Adjudication method: Not mentioned.
    5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, and the effect size: Not mentioned. This type of study would not typically be applicable to a basic biopsy needle like this, which is a physical instrument rather than an AI-enabled diagnostic tool.
    6. If a standalone study was done: Not mentioned. Again, for a physical instrument, "standalone" performance (without human interaction) isn't a relevant concept in the same way it would be for an AI algorithm.
    7. The type of ground truth used: Not mentioned.
    8. The sample size for the training set: Not mentioned.
    9. How the ground truth for the training set was established: Not mentioned.

    Conclusion: The provided document is a regulatory submission summary primarily focused on establishing substantial equivalence for a medical device. It does not contain the detailed clinical study design, performance data, or ground truth establishment information required to answer your specific questions about acceptance criteria and device performance studies. Such information would typically be found in a separate, more comprehensive testing report or clinical study report, which is not part of this 510(k) summary.

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