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510(k) Data Aggregation

    K Number
    K162972
    Device Name
    ExactVu High Resolution Micro-Ultrasound System
    Manufacturer
    Exact Imaging
    Date Cleared
    2016-12-02

    (38 days)

    Product Code
    IYO,ITX,OIJ
    Regulation Number
    892.1560
    Type
    Traditional
    Panel
    Radiology
    Reference & Predicate Devices
    K160674,K081154
    Predicate For
    K180636
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The ExactVu High Resolution Micro-Ultrasound System is intended for use by qualified medical professionals for diagnostic ultrasound imaging or fluid flow analysis of the human body; the intended uses are:

    Small Organ (prostate) Transrectal

    The system may be used with patients of all ages, but is not designed for pediatric or fetal use.

    Device Description

    The ExactVu high resolution micro-ultrasound system is intended for use by qualified medical professionals for diagnostic ultrasound imaging, data processing and quidance of puncture and biopsy. The ExactVu System is comprised of transducers responsible for ultrasound signal generation and recording, a needle guide and a main unit that controls the transducers, processes the acoustic data, and processes and displays images.

    AI/ML Overview

    The provided FDA 510(k) summary for the ExactVu High Resolution Micro-Ultrasound System does not contain any information regarding acceptance criteria or a study proving the device meets acceptance criteria related to its diagnostic performance.

    The document primarily focuses on demonstrating substantial equivalence to predicate devices based on technological characteristics and compliance with safety standards rather than clinical performance metrics.

    Specifically, the "Summary of Clinical Tests" section on page 10 explicitly states: "The ExactVu System, transducers and needle guide, subject of this submission, did not require clinical studies to support the determination of substantial equivalence."

    Therefore, I cannot fulfill your request for the following information based on the provided text:

    1. A table of acceptance criteria and the reported device performance
    2. Sample size used for the test set and the data provenance
    3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
    4. Adjudication method for the test set
    5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done
    6. If a standalone performance (algorithm only) was done
    7. The type of ground truth used
    8. The sample size for the training set
    9. How the ground truth for the training set was established
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