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510(k) Data Aggregation

    K Number
    K011608
    Device Name
    MODEL 235GE-64; MULTI PURPOSE FLEX ARRAY COIL
    Manufacturer
    MEDICAL ADVANCES, INC.
    Date Cleared
    2001-08-14

    (81 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

    Magnetic resonance imaging (MRI) and magnetic resonance angiography (MRA) of the Head: Magical lobes (hippocampus), internal auditory canals, orbits and anterior optic pathways, I chiporal loocs (inppooaliffalo), interesonance angiography (MRA). Upper Neck: Skull base, Cranio-cervical junction, cervical carotid artery. Upper Extremities: Shoulder, Craino-cavicular (AC) joint, elbow, peripheral nerves. Lower Extremities: Knee, ankle and Achilles tendon, foot. Pediatric applications.

    Device Description

    Model 235GE-64: Multi Purpose Flex Array Coil. Compatible with GE Signa 1.5T MRI systems with Phased Array option.

    AI/ML Overview

    The provided documentation details a 510(k) summary for the Model 235GE-64: Multi Purpose Flex Array Coil, a magnetic resonance specialty coil. This submission aims to demonstrate substantial equivalence to legally marketed predicate devices, primarily focusing on safety and imaging performance.

    Here's an analysis of the acceptance criteria and the study characteristics:

    1. Table of Acceptance Criteria and Reported Device Performance

    The acceptance criteria for the Model 235GE-64 coil are based on demonstrating "no change" compared to the predicate device when used in conjunction with the GE 1.5T Signa MRI system. This implies that the device's performance should be equivalent to that of the predicate, and not degrade the existing system's capabilities.

    ParameterAcceptance Criteria (Expected Performance)Reported Device Performance (with Model 235GE-64 Coil)
    Safety Parameters
    Maximum Static Magnetic FieldNo change from predicateNo change
    Rate of Magnetic Field ChangeNo change from predicateNo change
    RF Power DepositionNo change from predicateNo change
    Acoustic Noise LevelsNo change from predicateNo change
    BiocompatibilityNo change from predicateNo change
    Imaging Performance Parameters
    Specification VolumeNo change from predicateNo change
    Signal-to-Noise RatioNo change from predicateNo change
    Image UniformityNo change from predicateNo change
    Geometric DistortionNo change from predicateNo change
    Slice Thickness and GapNo change from predicateNo change
    High Contrast Spatial ResolutionNo change from predicateNo change

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

    The document does not specify the sample size used for any test set (e.g., number of patients, number of images). It also does not provide information on data provenance (e.g., country of origin, retrospective or prospective nature). The evaluation appears to be based on engineering and performance testing against established MRI system specifications rather than clinical data from a specific test set.

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

    The document does not mention the involvement of experts to establish a ground truth for a test set. This type of FDA submission (510(k) for a coil) typically relies on technical specifications and comparisons rather than expert-derived ground truth from a clinical study.

    4. Adjudication Method for the Test Set

    As no specific test set requiring expert ground truth is described, there is no mention of an adjudication method.

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

    A Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not performed or described in this 510(k) summary. The study focuses on the coil's technical performance and safety equivalence, not on comparing human reader performance with and without AI assistance.

    6. Standalone (Algorithm Only) Performance Study

    This device is a magnetic resonance imaging coil, not an AI algorithm. Therefore, a standalone (algorithm only) performance study was not performed.

    7. Type of Ground Truth Used

    The "ground truth" for this submission is implicitly the performance specifications and safety limits of the predicate MRI system and its existing coils. The goal is to demonstrate that the new coil does not degrade these established parameters. There is no mention of pathology, outcome data, or expert consensus used as ground truth in a clinical sense.

    8. Sample Size for the Training Set

    Since this is a physical medical device (an MRI coil) and not an AI algorithm, there is no concept of a "training set" in the context of machine learning.

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

    As there is no training set, this question is not applicable.

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