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510(k) Data Aggregation

    K Number
    K063130
    Date Cleared
    2006-11-02

    (20 days)

    Product Code
    Regulation Number
    892.1550
    Reference & Predicate Devices
    Why did this record match?
    Device Name :

    APLIO XG DIAGNOSTIC ULTRASOUND SYSTEM, MODEL SSA-790A, VERSION 1.0

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

    The Aplio XG System is intended to be used for the following types of studies: feta, abdominal, intraoperative, pediatric, small organs, neonatal cephalic, adult cephalic, cardiac, transrectal, transvaginal, transesophageal, peripheral vascular and muscoloskeletal (both conventional and superficial.

    Device Description

    The Aplio XG Ultrasound System is a mobile system. It is a Track 3 device that employs a wide array of probes that include flat linear array, convex linear array, and sector array with a frequency range of 2 MHz to 12 MHz

    AI/ML Overview

    The provided text does not contain information about acceptance criteria or a study that proves the device meets those criteria. It is a 510(k) summary for an ultrasound imaging system, detailing its features, intended use, and substantial equivalence to a predicate device, along with a list of compatible transducers and their cleared indications.

    Therefore, I cannot extract the requested information, including:

    1. A table of acceptance criteria and reported device performance.
    2. Sample size for the test set and data provenance.
    3. Number of experts and their qualifications for establishing ground truth.
    4. Adjudication method.
    5. MRMC study details or effect size of AI assistance.
    6. Standalone algorithm performance.
    7. Type of ground truth used.
    8. Sample size for the training set.
    9. How ground truth for the training set was established.
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