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510(k) Data Aggregation

    K Number
    K073131
    Device Name
    MICROMRI WRIST COIL
    Manufacturer
    MICROMRI, INC.
    Date Cleared
    2008-01-18

    (73 days)

    Product Code
    MOS
    Regulation Number
    892.1000
    Type
    Traditional
    Panel
    Radiology
    Reference & Predicate Devices
    N/A
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The MicroMRI Wrist Coll is a transmitting and receiving device to be used in conjunction with GE Healthcare and Siemens 1.5T MRI systems to image the wrist. The images acquired using the MicroMRI Wrist Coil along multiple axes (axial, coronal, sagittal, and oblique) are a measure of the spatial distribution of protons (hydrogen nuclei) exhibiting magnetic resonance. The NMR properties that determine the spatial image are proton density, spin-lattice (TI) and spin-spin (T2) relaxation times, flow velocity and chemical shift. These wrist MRU images when interpreted by a trained physician can be useful in determining a diagnosis. The MicroMRI Wrist Coil cannot be used with an MRI system that supports the use of only receive coils.

    Device Description

    The MicroMRI Wrist Coil uses an elliptical birdcage design to provide the highest possible signal-to-noise ratio (SNR) for imaging a human wrist. The two piece structure facilitates the use of the coil for a wide range of wrist sizes. The elliptical design and ability to conform to the subject's wrist makes the coil unique and efficient in transmitting and receiving the RF signal to the anatomy (i.e., the wrist).

    The accompanying immobilization system provides a means to stabilize the patient's arm during the scan. The immobilization system provides a means for positioning the patient's arm consistently in the same position and orientation.

    AI/ML Overview

    Here's an analysis of the provided text regarding the MicroMRI Wrist Coil, focusing on acceptance criteria and study details:

    Device: MicroMRI Wrist Coil

    1. Table of Acceptance Criteria and Reported Device Performance

    Acceptance CriteriaReported Device Performance
    SafetyPerformance testing was conducted in accordance with IEC/UL/CSA/EN 60601-1 standards.
    PerformancePerformance testing was conducted in accordance with NEMA standards. The performance test results indicate that the MicroMRI Wrist Coil is comparable to the predicate devices (Mayo Clinic BC-10 1.5T wrist coil and Invivo HRW Array Coil).
    Equivalence (Primary differences from predicates)Vs. BC-10 1.5T Wrist Coil: MicroMRI Wrist Coil scans only the wrist, while BC-10 can scan hand and wrist. Vs. HRW Array Coil: MicroMRI Wrist Coil is a transmit and receive coil (quadrature birdcage design, requiring less power), while HRW Array Coil is a receive-only coil. Despite these differences, the device is considered substantially equivalent.
    Intended UseThe device is a transmitting and receiving device for imaging the wrist with GE Healthcare and Siemens 1.5T MRI systems. Images are used by trained physicians for diagnosis. (Device performance meets this intended use implicitly through equivalence to predicate devices for similar wrist imaging).
    No New IndicationsThe device does not include any new indications for use.
    No New Safety/Efficacy IssuesThe device does not present any new safety or efficacy issues.

    2. Sample Size Used for the Test Set and Data Provenance

    The provided text does not specify a sample size for a test set. This submission is for a medical device (an MRI coil), and the performance evaluation focused on adherence to engineering and safety standards (NEMA, IEC/UL/CSA/EN 60601-1) and comparison to predicate devices, rather than a clinical study with a patient test set in the traditional sense for an AI/algorithm.

    3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of Those Experts

    This information is not applicable to this submission. The device is hardware (an MRI coil), not an AI algorithm that would require expert-established ground truth on a test set of medical images. The "ground truth" related to this device's performance would be derived from physical measurements according to engineering standards.

    4. Adjudication Method for the Test Set

    This information is not applicable for the reasons stated in point 3.

    5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

    No, an MRMC comparative effectiveness study was not done. This device is an MRI coil, not an AI algorithm designed to assist human readers or for standalone diagnosis.

    6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done

    No, a standalone performance study was not done. This device is a hardware component (an MRI coil), not an algorithm.

    7. The Type of Ground Truth Used

    The "ground truth" for this device's performance relies on:

    • Engineering Standards: Adherence to NEMA and IEC/UL/CSA/EN 60601-1 standards for safety and performance (e.g., signal-to-noise ratio, power requirements, electrical safety).
    • Comparison to Predicate Devices: Demonstrating comparable performance characteristics to existing, legally marketed MRI wrist coils. This implicit ground truth is that if it performs like a legally marketed predicate device, it is acceptable.

    8. The Sample Size for the Training Set

    This information is not applicable. This device is a hardware component and does not utilize a "training set" in the context of machine learning or AI.

    9. How the Ground Truth for the Training Set was Established

    This information is not applicable for the reasons stated in point 8.

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