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510(k) Data Aggregation

    K Number
    K974741
    Device Name
    MANAN ACCURA NEEDLE
    Manufacturer
    MEDICAL DEVICE TECHNOLOGIES, INC.
    Date Cleared
    1998-01-08

    (20 days)

    Product Code
    GAA
    Regulation Number
    878.4800
    Type
    Traditional
    Panel
    General & Plastic Surgery
    Reference & Predicate Devices
    K863848
    Why did this record match?
    Device Name :

    MANAN ACCURA NEEDLE

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

    The Manan™ Accura needle is intended for use as a needle localization of breast lesions.

    Device Description

    This needle is made in various gauges from 20 to 21 ga, and in various lengths from 3 to 15 cm. It is composed of an outer cannula essentially identical to the standard hypodermic needle and an inner stylet spring wire with an overbent tip.

    AI/ML Overview

    The provided document is a 510(k) summary for the Manan™ Accura Needle, a spring hook localization needle. It primarily focuses on demonstrating substantial equivalence to a predicate device and does not contain information about studies related to device performance or acceptance criteria in the context of a diagnostic AI device.

    Therefore, I cannot provide the requested information, such as acceptance criteria, reported device performance, details of a study with sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, ground truth establishment, or training set size. This document describes a physical medical device (a needle) and not an AI or diagnostic software.

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