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510(k) Data Aggregation

    K Number
    K983187
    Device Name
    MEDSOL GOLDENBERG BONE MARROW BIOPSY NEEDLE
    Manufacturer
    MEDSOL CORP.
    Date Cleared
    1998-12-10

    (90 days)

    Product Code
    KNW
    Regulation Number
    876.1075
    Type
    Traditional
    Panel
    Gastroenterology-Urology (GU)
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Device Name :

    MEDSOL GOLDENBERG BONE MARROW BIOPSY NEEDLE

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

    For procuring bone marrow core biopsies from patients with hematologic abnounalities

    Device Description

    Not Found

    AI/ML Overview

    The provided text is a 510(k) clearance letter from the FDA for a medical device called the "Medsol Goldenberg Bone Marrow Biopsy Needle." This document grants market clearance based on substantial equivalence to a predicate device, rather than providing detailed study results or acceptance criteria for a new device's performance.

    Therefore, the specific information requested about acceptance criteria and a study proving the device meets those criteria, as it relates to performance metrics (e.g., accuracy, sensitivity, specificity, or inter-reader agreement for an AI/CAD system), cannot be extracted from this document.

    This letter confirms that the device is substantially equivalent to a pre-amendments device and can be marketed subject to general controls. It does not contain data from performance studies in the way modern AI device submissions do.

    In summary, based on the provided text:

    1. Table of acceptance criteria and reported device performance: Not available. The document is a clearance letter, not a performance study report.
    2. Sample size for test set and data provenance: Not applicable. Performance study details are not provided.
    3. Number and qualifications of experts for ground truth: Not applicable. Performance study details are not provided.
    4. Adjudication method for test set: Not applicable. Performance study details are not provided.
    5. MRMC comparative effectiveness study and effect size: Not applicable. This device is a biopsy needle, not an AI/CAD system for which MRMC studies are typically conducted.
    6. Standalone performance study: Not applicable. Performance study details are not provided.
    7. Type of ground truth used: Not applicable. Performance study details are not provided.
    8. Sample size for training set: Not applicable. This device is a physical medical instrument, not an AI model that requires a training set.
    9. How ground truth for training set was established: Not applicable. This device is a physical medical instrument, not an AI model.
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