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510(k) Data Aggregation

    K Number
    K110049
    Device Name
    REUSABLE LINEAR STAPLER HANDLE
    Manufacturer
    ETHICON ENDO-SURGERY, LLC
    Date Cleared
    2011-02-10

    (34 days)

    Product Code
    GDW
    Regulation Number
    878.4750
    Type
    Traditional
    Panel
    General & Plastic Surgery
    Reference & Predicate Devices
    K020779
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The Reusable Linear Stapler and Disposable Reload has application throughout the alimentary tract and in thoracic surgery for transection and resection of internal tissues.
    The Reusable Linear Stapler and Disposable Reload has application throughout the alimentary tract and in thoracic surgery for transection of internal tissues.

    Device Description

    The Reusable Linear Stapler and Disposable Reload is a surgical stapling device used throughout the alimentary tract an in thoracic surgery for transection and resection of internal tissues. The device delivers two staggered rows of titanium alloy staples in a 40 mm staple line to approximate internal tissues. Staple height is adjustable to compensate for tissue thicknesses from 1.5 mm to 2.5 mm. The device consists of two components: the Reusable Linear Stapler Handle (ADLH) and the disposable Linear Stapler Rcload (ADL40R).
    The Reusable Linear Stapler and Disposable Reload consists of two components: the reusable handle and the disposable reload. The handle can be used for 200 applications. The reload, which is designed for a single use, is made up of two staggered rows of staples with a length of 40 mm. The staple height can be adjusted to accommodate a compressed tissue thickness of 1.5 mm to 2.5 mm. A spent reload indicator warns when the reload must be discarded.

    AI/ML Overview

    Here's a breakdown of the acceptance criteria and study information for the Reusable Linear Stapler and Disposable Reload, based on the provided text:

    1. Table of Acceptance Criteria and Reported Device Performance:

    Acceptance CriteriaReported Device Performance
    Bench Testing: Performance of the disposable reload and reusable handle after 200 simulated uses."Test results demonstrated the bench testing acceptance criteria were met."
    Animal (tissue) Testing: Leak pressure tolerance of an anastomotic stoma created in porcine colon."Testing results demonstrated that staple lines created by the linear stapler device met the leak pressure acceptance criteria."

    No further specifics on the exact quantitative acceptance criteria (e.g., specific pressure thresholds, performance metrics for bench testing) are provided in the text.

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

    • Sample Size for Test Set: Not explicitly stated. For bench testing, it mentions "after 200 simulated uses" for the reusable handle, implying the handle was tested through 200 cycles, but the number of disposable reloads tested is not specified. For animal testing, it mentions "porcine colon" but does not give the number of animals or anastomotic stomas.
    • Data Provenance: Not explicitly stated. However, animal testing was conducted on "porcine colon," indicating animal data. The text doesn't specify the country of origin for the data, nor whether it was retrospective or prospective. Given the nature of a 510(k) submission, it would almost certainly be prospective testing conducted for regulatory purposes.

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

    This information is not provided in the given text. For a stapling device, ground truth is typically based on objective measurements and observations rather than expert consensus on subjective interpretations.

    4. Adjudication Method for the Test Set:

    This information is not provided in the given text. Adjudication methods are typically relevant for studies involving human interpretation (e.g., image reading), which is not explicitly the case for this type of device testing.

    5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study Was Done:

    No, an MRMC comparative effectiveness study was not done. This type of study typically involves human readers evaluating cases and is common for diagnostic imaging AI. The Reusable Linear Stapler is a surgical device, and its performance is evaluated through bench and animal testing.

    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 surgical stapler, not an AI algorithm. Its performance is inherently "standalone" in the sense that it operates as designed without requiring human-in-the-loop assistance for its mechanical function.

    7. The Type of Ground Truth Used:

    • Bench Testing: The ground truth for bench testing would be defined by engineering specifications and performance metrics for the device's mechanical operation (e.g., staple formation, firing force, integrity after repeated uses). These are objective measurements.
    • Animal (Tissue) Testing: The ground truth for animal testing would be based on objective physiological measurements, specifically the "leak pressure acceptance criteria" for the anastomotic stoma. This indicates a measurable outcome related to the biological function and integrity of the staple line.

    8. The Sample Size for the Training Set:

    This information is not applicable as the device is a mechanical surgical stapler, not an AI algorithm 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 point 8.

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