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510(k) Data Aggregation

    K Number
    K062454
    Device Name
    MAGNETOM SYSTEMS - I-CLASS AND T-CLASS RELEASES
    Manufacturer
    SIEMENS MEDICAL SOLUTIONS, INC.
    Date Cleared
    2006-11-03

    (73 days)

    Product Code
    LNH
    Regulation Number
    892.1000
    Type
    Traditional
    Panel
    Radiology
    Reference & Predicate Devices
    K032428,K041112,K050199,K050200
    Why did this record match?
    Device Name :

    MAGNETOM SYSTEMS - I-CLASS AND T-CLASS RELEASES

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

    The MAGNETOM Systems -- I-class and T-class releases are indicated for use as magnetic resonance diagnostic devices (MRDD) that produce transverse, sagittal, coronal and oblique cross sectional images, spectroscopic images and/or spectra, and that display the internal structure and/or function of the head, body, or extremities. These images and/or spectra, when interpreted by a trained physician, yield information that may assist in diagnosis.

    They may also be used for imaging during interventional procedures performed with MR compatible devices such as, in room display and safe biopsy needles.

    Device Description

    The MAGNETOM Systems - I-class and T-class releases are based on the syngo MR B15 software upgrade will be available for the following MAGNETOM Family systems: MAGNETOM Avanto, MAGNETOM Espree, MAGNETOM Symphony a Tim System, MAGNETOM Trio a Tim System. Siemens Medical Solutions, Inc., intends to offer a software and hardware upgrade syngo MR B15.

    AI/ML Overview

    Here's a breakdown of the acceptance criteria and study information based on the provided text:

    1. Table of Acceptance Criteria and Reported Device Performance

    The provided text does not explicitly state specific acceptance criteria or report device performance in terms of metrics like sensitivity, specificity, accuracy, or any quantitative measures. Instead, it focuses on demonstrating substantial equivalence to previously cleared devices. The "performance" mentioned relates to the system's general function as a Magnetic Resonance Diagnostic Device.

    Given the information, the acceptance criteria are implicitly met by demonstrating that the new software/hardware upgrade (syngo MR B15) for MAGNETOM systems has no significant effect on MR safety and performance parameters compared to the predicate devices.

    Acceptance CriterionReported Device Performance
    Implicit Acceptance Criterion: No significant effect on MR safety and performance parameters compared to predicate devices.The document states: "The introduction of the MAGNETOM systems - I-class and T-class releases with syngo MR B15 has no significant effect on the MR safety and performance parameters."
    Conformance to FDA recognized NEMA Standards for measurement of performance and safety parameters.The document states: "The MAGNETOM Systems will conform to the FDA recognized NEMA Standards for the measurement of performance and safety parameters..."
    Conformance to international IEC standard for safety issues with Magnetic Resonance Imaging Devices.The document states: "...and the international IEC standard for safety issues with Magnetic Resonance Imaging Devices."
    Continued safe and effective use.The document states: "This will assure that the performance of this device can be considered safe and effective with respect to the currently available MAGNETOM systems."

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

    This information is not provided in the given text. The document describes a software and hardware upgrade for existing MR systems and focuses on substantial equivalence rather than a new device requiring a clinical efficacy study with a specific test set.

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

    This information is not provided in the given text. As no explicit test set or clinical study for establishing ground truth is mentioned, this detail is absent.

    4. Adjudication Method for the Test Set

    This information is not provided in the given text.

    5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, and its effect size.

    No MRMC comparative effectiveness study is described in the provided text. The submission is for a software/hardware upgrade and focuses on maintaining substantial equivalence, not on improving human reader performance with AI assistance.

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

    The provided device, "MAGNETOM Systems - I-class and T-class releases," refers to Magnetic Resonance Diagnostic Devices (MRDD). These are imaging systems that produce images for interpretation by a trained physician. The text does not describe an AI algorithm or a standalone algorithm-only performance study. The focus is on the safety and performance of the MR system itself.

    7. The Type of Ground Truth Used

    This information is not explicitly stated or detailed in the provided text. Since the submission is for an upgrade to an existing MR system, the ground truth would inherently be related to the established medical understanding and diagnostic capabilities that the MR system generates images for. However, there's no mention of specific ground truth for a new diagnostic claim or algorithm.

    8. The Sample Size for the Training Set

    This information is not provided in the given text. As no AI algorithm is detailed, a training set is not applicable to the information given.

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

    This information is not provided in the given text, as no AI algorithm or training set is discussed.

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