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510(k) Data Aggregation

    K Number
    K982972
    Device Name
    SIGNA PROFILE SMALL HEAD COIL
    Manufacturer
    GE MEDICAL SYSTEMS
    Date Cleared
    1998-11-16

    (83 days)

    Product Code
    MOS
    Regulation Number
    892.1000
    Type
    Traditional
    Panel
    Radiology
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Device Name :

    SIGNA PROFILE SMALL HEAD COIL

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

    The Indications for Use for the Signa Profile Small Head coil expands the imaging capability of the Signa Profile System. The small head coil is intended for imaging of the head anatomy and extremities.

    Device Description

    The Signa Profile Small Head Coil is a receive only coil with a birdcage RF design. It is designed for use with a vertical magnetic field MR imaging system.

    AI/ML Overview

    The provided text describes a 510(k) premarket notification for the GE Signa Profile Small Head Coil, a medical device. This type of submission focuses on demonstrating substantial equivalence to a predicate device rather than conducting a full clinical study with specific acceptance criteria and performance metrics for a new AI algorithm.

    Therefore, many of the requested categories for AI algorithm evaluation are not applicable to this document. The document describes a hardware device, a new MRI coil, and its performance is assessed against established safety and NEMA standards rather than clinical endpoints related to diagnostic accuracy of an AI.

    Here's an analysis based on the provided text, highlighting what information is available and what is not:

    1. A table of acceptance criteria and the reported device performance:

    Acceptance Criteria (from text)Reported Device Performance (from text)
    Compliance with appropriate NEMA performance standards."The Profile Small Head Coil was evaluated to the appropriate NEMA performance standards."
    Compliance with International safety standards IEC 601-1 and IEC 601-2-33."The coil was evaluated to the International safety standards IEC 601-1 and IEC 601-2-33 and performed to stated specifications."
    Substantial equivalence to the currently marketed Signa Profile Head Coil."It is the opinion of GE that the Signa Profile System with the Small Head Coil is substantially equivalent to the presently marketed Signa Profile Head Coil."
    Does not result in any new potential hazards."This coil does not result in any new potential hazards."

    2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

    This information is not provided in the document. As this is a hardware device (MRI coil) and not an AI algorithm, a "test set" in the context of diagnostic accuracy is not applicable. The evaluation focused on physical and electrical performance standards.

    3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

    This information is not provided and is not applicable. Ground truth, in the AI diagnostic sense, is not relevant for the evaluation of an MRI coil's performance against NEMA and safety standards.

    4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

    This information is not provided and is not applicable.

    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

    This information is not provided and is not applicable. This study type is specific to evaluating AI's impact on human diagnostic performance, which is not relevant for an MRI coil.

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

    This information is not provided and is not applicable. This document describes a hardware device, not an algorithm.

    7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

    This information is not provided and is not applicable. The "ground truth" for this device would be its physical and electrical characteristics conforming to specified engineering and safety standards, rather than a clinical diagnostic truth.

    8. The sample size for the training set

    This information is not provided and is not applicable. There is no "training set" for a hardware device like an MRI coil.

    9. How the ground truth for the training set was established

    This information is not provided and is not applicable.

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