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510(k) Data Aggregation

    K Number
    K123194
    Device Name
    JUNCTIONAL EMERGENCY TREATMENT TOOL MODEL 30-0088
    Manufacturer
    NORTH AMERICAN RESCUE PRODUCTS, INC.
    Date Cleared
    2013-01-03

    (84 days)

    Product Code
    DXC
    Regulation Number
    870.4450
    Type
    Traditional
    Panel
    Cardiovascular
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Reference Devices :

    Combat Ready Clamp K102025

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

    The North American Rescue Junctional Emergency Treatment Tool is indicated for emergent purposes to control difficult bleeds in the inguinal area.

    Device Description

    The Junctional Emergency Treatment Tool is designed to be used by first responders for emergent purposes. The device is designed to control bleeding in the inguinal area where standard tourniquets cannot be used. The device can be used instead of manual pressure, allowing the healthcare provider to attend to other casualties. The Junctional Emergency Treatment Tool is used to control a difficult bilateral or unilateral bleeding for up to 4 hours until the casualty can be transferred for treatment. The Junctional Emergency Treatment Tool consists of a belt assembly, with two trapezoidal pressure pads and Threaded T-Handles. The two pressure pads allow the provider to treat a casualty with either unilateral or bilateral injuries.

    AI/ML Overview

    The Junctional Emergency Treatment Tool (JETT) is designed to control bleeding in the inguinal area. The device was tested in a cadaveric model and non-clinical bench top testing.

    Here's a breakdown of the information requested:

    1. Table of Acceptance Criteria and Reported Device Performance:

    Acceptance CriteriaReported Device Performance
    Consistently capable of stopping simulated vessel blood flow in unilateral hemorrhage control.The Junctional Emergency Treatment Tool was tested with a cadaveric model to demonstrate it was consistently capable of stopping simulated vessel blood flow, both in unilateral and bilateral hemorrhage control.
    Consistently capable of stopping simulated vessel blood flow in bilateral hemorrhage control.The Junctional Emergency Treatment Tool was tested with a cadaveric model to demonstrate it was consistently capable of stopping simulated vessel blood flow, both in unilateral and bilateral hemorrhage control.
    Consistently capable of applying forces equivalent to the predicate device (Combat Ready Clamp).The Junctional Emergency Treatment Tool was tested in Non-Clinical Bench Top Testing to demonstrate it was consistently capable of applying forces equivalent to the predicate device.

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

    • Sample Size: The document does not specify the exact number of cadavers used in the cadaveric model testing. It also doesn't specify the number of tests performed in the non-clinical bench top testing.
    • Data Provenance: The cadaveric model testing and non-clinical bench top testing were likely conducted in a controlled laboratory setting, implying a prospective study design for these specific tests. There is no information provided regarding the country of origin of the data.

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

    This information is not provided in the given document. The document describes the testing conducted on the device itself, not on a dataset requiring expert interpretation for ground truth.

    4. Adjudication Method for the Test Set:

    This information is not provided in the given document. The testing described (stopping blood flow, force application) does not involve a process that would typically require an adjudication method among experts.

    5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size:

    No, an MRMC comparative effectiveness study was not done. The study described focused on the device's technical performance (stopping blood flow, applying force) and comparison to a predicate device, not on human reader performance with or without AI assistance.

    6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done:

    This question is not applicable as the device is a physical medical tool (Junctional Emergency Treatment Tool), not an algorithm or AI system. Therefore, standalone algorithm performance is not relevant.

    7. The Type of Ground Truth Used:

    For the cadaveric model testing, the ground truth was direct observation of whether simulated vessel blood flow was stopped. For the non-clinical bench top testing, the ground truth was measurement of applied forces and comparison to the predicate device's force application.

    8. The Sample Size for the Training Set:

    This information is not applicable. The JETT is a physical medical device, not an AI or machine learning model that requires a training set.

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

    This information is not applicable for the same reason as above (not an AI/ML model).

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