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510(k) Data Aggregation

    K Number
    K223398
    Device Name
    Gastric Alimetry System
    Manufacturer
    Alimetry Ltd.
    Date Cleared
    2023-04-27

    (170 days)

    Product Code
    MYE
    Regulation Number
    876.1735
    Type
    Traditional
    Panel
    Gastroenterology/Urology
    Reference & Predicate Devices
    K014269
    Why did this record match?
    Reference Devices :

    K014269

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

    The Gastric Alimetry System is intended to record, store, view and process gastric myoelectrical activity as an aid in the diagnosis of various gastric disorders.

    Device Description

    The Gastric Alimetry System is an electrogastrography (EGG) device, used for non-invasively measuring the myoelectrical activity of the stomach at the surface of the abdomen. The Gastric Alimetry System is intended to record, store, view and process gastric myoelectrical activity as an aid in the diagnosis of various gastric disorders.

    The device is used to acquire and digitize gastric myoelectrical data and movement artifacts using an array with recording electrodes on an adhesive patch. which is used for recording the myoelectrical data from the skin surface. An App is used to set up the device and capture patient-reported symptom data. A report is provided to the clinicians at the test which includes myoelectrical signal data for manual analysis, together with computed data summaries and plots. A Supplementary Report is also routinely available to clinicians that includes signal data from all 64 channels on the array.

    In the modified Gastric Alimetry System, the following minor updates are introduced in order to provide additional data summaries within the Report:

    • Addition of four post-processing data summary metrics:
      • Principal Gastric Frequency showing the frequency of myoelectrical activity o occurring within the gastric range
      • 'BMI-Adjusted Amplitude' calculated amplitude for BMI up to the recommended O device limit (BMI
    AI/ML Overview

    Based on the provided text, the Gastric Alimetry System is an electrogastrography (EGG) device. The performance data section focuses on demonstrating the substantial equivalence of four newly added data summary metrics to equivalent metrics in a Reference Device (Medtronic Polygram NET EGG System), rather than establishing new acceptance criteria for the entire device.

    Here's an analysis of the acceptance criteria and the study that proves the device meets them, based on the provided text:

    Acceptance Criteria and Reported Device Performance

    The acceptance criteria here aren't typical performance thresholds (like achieving a certain sensitivity or specificity for a diagnostic claim). Instead, the "acceptance criteria" for the newly added metrics in the modified Gastric Alimetry System appear to be demonstrating high correlation with equivalent metrics from a legally marketed Reference Device. The aim is to prove substantial equivalence, meaning these minor updates do not raise new questions of safety or effectiveness.

    Acceptance Criteria CategorySpecific Criteria (Implicit from Study Design)Reported Device Performance and How it Meets Criteria
    New Metrics' EquivalenceThe four newly introduced data summary metrics (Principal Gastric Frequency, BMI-Adjusted Amplitude, Gastric Alimetry Rhythm Index, fed:fasted Amplitude Ratio) must show high correlation with their equivalent metrics in the Reference Device (Medtronic Polygram NET EGG System)."In all four comparisons, high correlations were demonstrated (r>0.91; p
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