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510(k) Data Aggregation

    K Number
    K974025
    Device Name
    ANSPACH SHIELDED ATTACHMENT
    Manufacturer
    THE ANSPACH EFFORT, INC.
    Date Cleared
    1998-07-06

    (256 days)

    Product Code
    GFF
    Regulation Number
    878.4820
    Type
    Traditional
    Panel
    General & Plastic Surgery
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Device Name :

    ANSPACH SHIELDED ATTACHMENT

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

    Cutting and Shaping Bone.

    Device Description

    Not Found

    AI/ML Overview

    I am sorry, but the provided text is a 510(k) clearance letter from the FDA, not a study report. It states that the device, "Anspach Black Max Shielded Attachment," is substantially equivalent to a predicate device and can be marketed.

    Therefore, the document does not contain any information about acceptance criteria or a study proving the device meets those criteria. It lacks details on:

    • A table of acceptance criteria and reported device performance.
    • Sample sizes, data provenance, expert qualifications, or adjudication methods for a test set.
    • Whether MRMC or standalone studies were performed, or any associated effect sizes.
    • The type of ground truth used.
    • Sample size for a training set or how its ground truth was established.

    I cannot fulfill your request to describe the acceptance criteria and study based on this document.

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