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510(k) Data Aggregation

    K Number
    K203192

    Validate with FDA (Live)

    Device Name
    NaviCam Xpress Stomach System
    Manufacturer
    AnX Robotica Corp
    Date Cleared
    2021-05-04

    (188 days)

    Product Code
    QKZ
    Regulation Number
    876.1310
    Type
    Traditional
    Panel
    Gastroenterology/Urology
    Age Range
    All
    Reference & Predicate Devices
    DEN190037
    Predicate For
    K221608,K230694
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticPediatricDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The NaviCam Xpress Stomach System is intended for visualization of the stomach of adults (≥22 years) with BMI <38. The system can be used in clinics and hospitals, including ER settings.

    Device Description

    The NaviCam Xpress Stomach System is a endoscopic capsule imaging system intended to obtain images of the stomach. It differs from passive capsule endoscopy systems in that it uses magnetic fields to allow the position of the capsule within the stomach to be controlled by an operator. The NaviCam Xpress Stomach System includes the following key components: Ingestible capsule (AKEM-11SW) for obtaining images, Data recorder (AKR-1) for logging image data, Locator (AKS-1) for turning on the capsule and for determining if the capsule is still in the body, Controller (NaviEC-2000) with the NaviCtrl software that allows the navigation of the capsule within the stomach, ESView software for review of the images obtained by the capsule and generating reports.

    AI/ML Overview

    The provided text is a 510(k) summary for the NaviCam Xpress Stomach Capsule Endoscope System. It describes the device, its intended use, and its substantial equivalence to a predicate device. However, it does not contain the acceptance criteria or a study proving the device meets those criteria, especially in terms of diagnostic performance or clinical accuracy. The "Performance Data" section solely discusses bench/in-vitro testing related to the controller's functionality and compliance with electrical safety standards, not the diagnostic performance of the capsule endoscope system itself.

    Therefore, most of the requested information regarding acceptance criteria, performance, sample sizes, expert involvement, and ground truth for a diagnostic study cannot be extracted from this document.

    Here's what can be inferred or explicitly stated based on the provided text, alongside what is missing:

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

    Acceptance CriteriaReported Device Performance
    Diagnostic Performance: (e.g., Sensitivity, Specificity, Accuracy for detecting gastric abnormalities)NOT PROVIDED IN THIS DOCUMENT. The document focuses on the controller's performance and system compliance, not the diagnostic capabilities of the capsule endoscope.
    NaviCam Xpress Controller meets performance requirements in specifications and implements software functions.Passed: Verified that the NaviCam Xpress Controller meets its specifications and implements software functions as stated in its User Manual.
    Magnetic field intensity range meets specifications with various examination beds.Passed: Verified that the magnetic field intensity range meets specifications when used with examination beds/tables provided by users.
    Mechanical motion range meets specifications.Passed: Verified that the mechanical motion range meets specifications.
    Titanium clips do not affect data communication, and clips do not move during magnetic head rotation.Passed: Data communication not affected, and clip position does not change.
    Compliance with IEC 60601-1, ANSI/AAMI ES60601-1, CAN/CSAC22.2 No. 60601-1:14, EN 60601-1:2006, AAMIIEC 60601-1-2:2014, EN 60601-1-2:2015.Passed: The system was found to comply with all applicable requirements of these standards.

    The following information cannot be extracted from the provided text:

    • 2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
    • 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)
    • 4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
    • 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
    • 6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
    • 7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
    • 8. The sample size for the training set
    • 9. How the ground truth for the training set was established

    Reasoning for Missing Information:

    This 510(k) summary focuses on demonstrating substantial equivalence for a modification to an already cleared device (the NaviCam Stomach System). The "Performance Data" section details bench/in-vitro testing and compliance with electrical safety and EMC standards. It explicitly states, "The NaviCam Xpress Stomach System successfully passed the following test," and then lists functional and safety-related tests for the controller. It does not discuss any clinical diagnostic performance studies comparing the NaviCam Xpress Stomach System's ability to detect stomach abnormalities against a ground truth, which would involve patient data, expert review, and metrics like sensitivity or specificity.

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