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510(k) Data Aggregation

    K Number
    K960849
    Device Name
    MAGNO ALARM
    Manufacturer
    CARDIAC ASSIST DEVICES, INC.
    Date Cleared
    1997-03-26

    (400 days)

    Product Code
    DTG
    Regulation Number
    870.3690
    Type
    Traditional
    Panel
    Cardiovascular
    Reference & Predicate Devices
    N/A
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    useful, safe and effective for forewarning presence of environmental magnetic fields that might be potentially harmful for certain individuals with implanable devices such as pacemakers or ICD's.

    Device Description

    a device that in presence of magnetic fields produce sound and light signals to be noticed by the hearing and sight senses of an individual who is using it.

    AI/ML Overview

    The provided text is a K960849 510(k) Summary for the "Magno Alarm" device. Based on this document, here's an analysis of the acceptance criteria and study described:

    1. Table of Acceptance Criteria and Reported Device Performance:

    The document doesn't explicitly state formal "acceptance criteria" in a quantitative, metrics-based format commonly seen in modern medical device submissions (e.g., sensitivity, specificity thresholds). Instead, the "acceptance criteria" are implied by the device's intended purpose and the qualitative claims made.

    Acceptance Criterion (Implied)Reported Device Performance
    1. Forewarning of Environmental Magnetic Fields: Device should detect and warn of potentially harmful environmental magnetic fields for individuals with implantable devices.The Magno Alarm has a "lower activation threshold from that of typical pacemakers and/or ICD's," providing a "safety factor of at least two (2) for the patient to get a warning." It produces "sound and light signals" in the presence of magnetic fields.
    2. Non-interference with Pacemakers/ICD's: Device should not disrupt the proper function of implantable cardiac devices."The Magno Alarm has been designed so that it does not interfere with the function of pacemakers/ICD's."
    3. Safety and Effectiveness: Device should be safe and effective for its stated purpose.The device is described as "useful, safe and effective for forewarning presence of environmental magnetic fields" and "a safe, effective and useful device."
    4. Substantial Equivalence to Predicate Device: Device performance should be comparable to a predicate device (test magnets).The Magno Alarm is "presented to be substantially equivalent to the test magnets employed as an external and noncontacting auxiliary tool for pacemakers/ICD's." The document then outlines three "bases of substantial equivalence" focusing on their respective interactions with magnetic fields and information they provide.
    5. Electromagnetic Compatibility (EMC): Device should operate without significant electromagnetic interference to or from other devices."The Magno Alarm has been tested for electromagnetic compatibility and the test results is included in the supplement to our 510(k) (K960849) of 08-12-96."

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

    The document does not provide any details regarding a specific "test set" for performance evaluation, nor does it mention sample sizes. It does not state the country of origin of data or whether it was retrospective or prospective.

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

    The document does not mention the use of experts to establish ground truth for a test set. The claims appear to be based on the device's design characteristics and a comparison to predicate devices, rather than a clinical study with expert-adjudicated outcomes.

    4. Adjudication Method for the Test Set:

    Since there is no mention of a test set or expert involvement, there is no adjudication method described.

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

    A MRMC comparative effectiveness study was not done or described. The device is a standalone alarm, not an interpretation aid for human readers. Therefore, the concept of "how much human readers improve with AI vs without AI assistance" is not applicable.

    6. Standalone (Algorithm Only) Performance:

    Yes, a form of standalone performance is described. The Magno Alarm itself is the "algorithm only" in this context. Its performance is characterized by its "lower activation threshold" compared to pacemakers/ICDs, providing a "safety factor of at least two (2)". It produces "sound and light signals" in the presence of magnetic fields. The EMC testing also falls under standalone performance.

    7. Type of Ground Truth Used:

    The "ground truth" implicitly used for the device's claim of effectiveness appears to be:

    • Physical Principles and Known Thresholds: The understanding of how pacemakers/ICDs respond to magnetic fields and the design intention of the Magno Alarm to have a lower activation threshold.
    • Predicate Device Functionality: The working principle of test magnets and how the Magno Alarm's function relates to or complements this.

    There is no mention of expert consensus, pathology, or outcomes data being used for ground truth.

    8. Sample Size for the Training Set:

    The document does not provide any information about a "training set" or its size. This type of submission predates the common use of AI/ML models that require distinct training and testing sets. The device's design appears to be based on engineering principles and existing knowledge of medical devices, rather than machine learning.

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

    As there is no mention of a training set, there is no description of how its ground truth was established.

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