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510(k) Data Aggregation

    K Number
    K231577
    Device Name
    MOBILETT Impact
    Manufacturer
    Siemens Medical Solutions
    Date Cleared
    2023-07-25

    (55 days)

    Product Code
    IZL,SYS
    Regulation Number
    892.1720
    Type
    Traditional
    Panel
    Radiology (RA)
    Reference & Predicate Devices
    K213700,K222951
    Why did this record match?
    Device Name :

    MOBILETT Impact

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

    MOBILETT Impact is a mobile device intended to visualize anatomical structures of human beings by converting an Xray pattern into a visible image. MOBILETT Impact is not intended for mammography examinations.

    Device Description

    MOBILETT Impact is a complete X-ray imaging system on wheels. It contains a single tank high voltage generator with an X-ray tube and collimator attached to the end of a telescopic support arm connected to a swiveling column. The system is a manually driven system, with no motor support for movement. The system includes a digital image acquisition system with an image display and graphical user interface. The digital detector, Max wi-D can be stored in the built-in docking station in the system. In addition, the system can be used with detectors Max mini and Core-L. All three detectors are equipped with rechargeable batteries, which can be charged by external battery chargers. The system can perform X-Ray when it is connected to mains. Exposure can be released by a hand switch or remote control. The included system batteries only power the imaging system if it is not connected to the mains. Besides the detectors and image system, the hardware of the same as for the predicate device SEDECAL SM-V, which was cleared on 11/21/2022 with K222951.

    AI/ML Overview

    The provided text describes the Siemens MOBILETT Impact, a mobile X-ray system. However, it does not detail acceptance criteria or a study proving the device meets specific performance metrics for image quality or diagnostic accuracy in the way an AI/CADe device would.

    Instead, the document focuses on demonstrating substantial equivalence to a predicate device (SEDECAL SM-V, K222951) and a reference device (MULTIX Impact, K213700) based on regulatory compliance, technological characteristics, and safety.

    The summary highlights:

    • Regulatory Compliance: Adherence to various IEC, ANSI AAMI, ISO, NEMA, and FDA standards for medical electrical equipment, radiation protection, usability, risk management, software life cycle, and digital imaging.
    • Technological Equivalence: Comparison of features like regulation description, product code, indications for use (similar), high voltage generator, X-ray tube, tube voltage/current, collimator, touch screen control, movement (non-motorized), US Performance Standard, and power source (all same as predicate or similar).
    • Safety and Effectiveness Concerns: General statements about IFU, safety features (visual/audible warnings), error monitoring, and adherence to recognized industry practices to minimize electrical, mechanical, and radiation hazards.

    Regarding the specific information requested in your prompt for an AI/CADe device:

    1. Table of acceptance criteria and reported device performance: This information is not provided in the document. The document confirms regulatory compliance with various standards, but it doesn't state specific device performance metrics like sensitivity, specificity, or AUC for diagnostic tasks, as would be expected for an AI device.

    2. Sample size used for the test set and data provenance: This information is not provided. A "Customer Use Test (CUT)" was performed, but no details on sample size, data type, or provenance are given.

    3. Number of experts used to establish the ground truth for the test set and qualifications: This information is not provided. The CUT involved "gathering feedback on the device's usability in the clinical environment," but it doesn't describe a ground truth establishment process by experts for a diagnostic task.

    4. Adjudication method for the test set: This information is not provided.

    5. Multi-reader multi-case (MRMC) comparative effectiveness study: This information is not provided. The device is a mobile X-ray system, not an AI/CADe system designed to improve human reader performance.

    6. Standalone performance (algorithm only without human-in-the-loop performance): This information is not provided. The device is a hardware system for X-ray imaging, not a standalone algorithm.

    7. Type of ground truth used: For the "Customer Use Test (CUT)," the "ground truth" implicitly involved qualitative feedback on "system function and performance-related clinical workflow, image quality, ease of use, and overall performance and stability." This is not a quantitative ground truth for a diagnostic task like pathology or outcomes data.

    8. Sample size for the training set: This information is not provided. There is no mention of a training set as this is a hardware device.

    9. How the ground truth for the training set was established: This information is not provided.

    In summary, the provided FDA 510(k) clearance letter and its associated summary are for a conventional mobile X-ray imaging system, not an AI/CADe product. Therefore, the detailed performance metrics and study design elements typically associated with AI/CADe device validation (e.g., sensitivity, specificity, reader studies, ground truth establishment by experts) are not present in this document. The "study" mentioned is a "Customer Use Test (CUT)" focused on usability and overall system performance in a clinical workflow, rather than a diagnostic performance study.

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