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510(k) Data Aggregation

    K Number
    K031089
    Device Name
    GORE-FLEX MP8 MULTIPURPOSE TORSO ARRAY
    Manufacturer
    W.L. GORE & ASSOCIATES,INC
    Date Cleared
    2003-05-08

    (31 days)

    Product Code
    MOS
    Regulation Number
    892.1000
    Type
    Special
    Panel
    Radiology
    Reference & Predicate Devices
    K013810
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The GORE-FLEX™ MP8, is intended for multiple imaging applications with GE Signa® 1.5T MRI Systems, using EXCITE™ Technology. Its large field of view will allow for images of the complete thorax, including the heart, and its associated vasculature, the abdomen, pelvis, and spine. A specialized sub-array will provide high resolution images of the thoracic region.

    Device Description

    The GORE-FLEX™ MP8, is a ten element phased array coil. It is for use on the upgraded GE Signa® 1.5T MRI System with EXCITE™ Technology. The applicant device, the GORE-FLEX™ MP8, has a modified Scanner Interface Connector. This modification allows the coil to take advantage of the 8 channel receiver system. Only the design of the connector box has been modified to allow up to 8 loops to be used as opposed to 4 loops. The antenna loops, patient interface, and MR safe cables remain unchanged. The GORE-FLEX™ MP8, the applicant device, is designed to maximize patient safety by using active decoupling, passive decoupling, and the MR safe cable, as does the predicate device.

    AI/ML Overview

    Here's an analysis of the provided text regarding the acceptance criteria and study for the GORE-FLEX™ MP8 Multipurpose Torso Array:

    1. Table of Acceptance Criteria and Reported Device Performance

    Acceptance CriteriaReported Device Performance
    Substantially equivalent field-of-view as predicate deviceThe GORE-FLEX™ MP8 has a substantially equivalent field-of-view as the Cardiovascular Array (predicate device).
    Substantially equivalent image clarity as predicate deviceThe GORE-FLEX™ MP8 has substantially equivalent image clarity as the Cardiovascular Array (predicate device).
    Substantially equivalent signal-to-noise ratio (SNR) as predicate deviceThe GORE-FLEX™ MP8 has a substantially equivalent signal-to-noise ratio as the Cardiovascular Array (predicate device).
    No patient safety concernsNo patient safety concerns are raised as a result of the clearance of the GORE-FLEX™ MP8.

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

    The document states, "Test data was acquired systematically on the GE Signa® 1.5T system with EXCITE™ Technology. The comparative images of the thorax and abdomen demonstrate that the GORE-FLEX™ MP8, the applicant device, has a substantially equivalent field-of-view, image clarity and signal-to-noise ratio as the Cardiovascular Array, the predicate device."

    • Sample Size: The exact sample size (number of images, patients, or scans) for the test set is not specified in the provided text. It only mentions "comparative images of the thorax and abdomen."
    • Data Provenance: The data was acquired on a "GE Signa® 1.5T system with EXCITE™ Technology." It does not specify the country of origin. The study appears to be prospective, comparing the new device against a predicate device under controlled conditions.

    3. Number of Experts Used to Establish Ground Truth and Qualifications

    The document does not mention the use of experts or their qualifications for establishing ground truth regarding image quality metrics (field-of-view, clarity, SNR). The assessment appears to be based on direct comparative image analysis rather than expert consensus on diagnostic interpretations.

    4. Adjudication Method for the Test Set

    No adjudication method is described. The comparison seems to be direct and quantitative or semi-quantitative, not relying on expert agreement or disagreement.

    5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

    No MRMC study is mentioned. The comparison focuses on the technical characteristics and image quality of the device itself, not on human reader performance with or without AI assistance.

    6. Standalone (Algorithm Only) Performance Study

    This device is an MRI surface coil, not an AI algorithm. Therefore, a standalone (algorithm only) performance study is not applicable and not mentioned.

    7. Type of Ground Truth Used

    The "ground truth" for the comparison relates to the technical image quality metrics:

    • Field-of-view: Likely determined by the physical dimensions of the images produced and the anatomical coverage.
    • Image clarity: Could be assessed using quantitative metrics (e.g., contrast, resolution) or qualitative visual comparison.
    • Signal-to-noise ratio: A quantitative metric directly measured from the images.
      The comparative nature of the study suggests the predicate device's performance served as the benchmark for "truth."

    8. Sample Size for the Training Set

    This device is an MRI hardware component (a coil), not a machine learning model. Therefore, there is no "training set" in the context of AI/ML, and no sample size for training data is applicable or mentioned.

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

    As explained above, there is no training set for this type of device.

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