Search Filters

Search Results

Found 1 results

510(k) Data Aggregation

    K Number
    K954848
    Date Cleared
    1996-02-01

    (101 days)

    Product Code
    Regulation Number
    870.3450
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Device Name :

    HEMASHIELD MICROVEL VELOUR KNITTED VASCULAR GRAFT

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

    For use in the replacement or repair of arteries affected with aneurysmal or occlusive disease. which is substantially equivalent to the currently marketed devices.

    Device Description

    The HEMASHIELD® CARDIOVASCULAR GRAFTS are knitted and woven polyester grafts. impregnated with bovine collagen.

    AI/ML Overview

    Here's an analysis of the provided text regarding the acceptance criteria and study for the device, organized according to your requested information.

    Please note that this document is a 510(k) summary for a medical device and not a detailed clinical study report for an AI/ML device. Therefore, some of the requested information (especially points 2, 3, 4, 5, 8, and 9) is not applicable or cannot be extracted from this type of regulatory submission. The device described is a traditional medical device (vascular grafts) and not an AI/ML powered device.


    Acceptance Criteria and Device Performance

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

    The document states that the proposed devices ("HEMASHIELD® MICROVEL® Double Velour Knitted" and "HEMASHIELD® Woven Double Velour Vascular Grafts" with modified collagen manufacturing) were tested for various characteristics to demonstrate substantial equivalence to their currently marketed PMA approved predicate devices. The acceptance criterion for each test was effectively "equivalent to marketed product."

    Test ParameterAcceptance Criteria (Stated or Implied)Reported Device Performance
    Burst StrengthEquivalent to marketed productequivalent to marketed product
    Tensile StrengthEquivalent to marketed productequivalent to marketed product
    Suture Pull OutEquivalent to marketed productequivalent to marketed product
    Wall ThicknessEquivalent to marketed productequivalent to marketed product
    Longitudinal StretchEquivalent to marketed productequivalent to marketed product
    Needle PenetrationEquivalent to marketed productequivalent to marketed product
    Crush ResistanceEquivalent to marketed productequivalent to marketed product
    Flexural RigidityEquivalent to marketed productequivalent to marketed product
    Integral Water PermeabilityEquivalent to marketed productequivalent to marketed product
    Integral Water Permeability under loadEquivalent to marketed productequivalent to marketed product
    Strength of Collagen BondingEquivalent to marketed productequivalent to marketed product
    Shrinkage TemperatureEquivalent to marketed productequivalent to marketed product
    Glycerol ContentEquivalent to marketed productequivalent to marketed product
    Collagen ContentEquivalent to marketed productequivalent to marketed product
    Scanning Electron MicrographsEquivalent to marketed productequivalent to marketed product

    Additionally, "Biocompatibility Testing" was performed to demonstrate safety for intended use and substantial equivalence in biocompatibility to the currently marketed PMA approved devices.

    2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

    The document does not specify the sample sizes for the various mechanical and material tests conducted. There is no mention of data provenance (e.g., country of origin) or whether the data was retrospective or prospective. Given the nature of the tests, it's typically laboratory testing of manufactured devices.

    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)

    This information is not applicable to the type of device and testing described. The ground truth for mechanical/material properties is established through standardized laboratory testing methods, not by expert consensus in the clinical sense.

    4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

    This information is not applicable. Adjudication methods like 2+1 or 3+1 are typically used for clinical image interpretation or diagnostic performance studies involving human readers, which is not the case here.

    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

    No, an MRMC comparative effectiveness study was not done. This device is a vascular graft, not an AI-powered diagnostic tool, and involves no human readers in its functional assessment.

    6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

    Yes, a standalone performance assessment was done, as the testing described (Burst Strength, Tensile Strength, etc.) evaluates the device's physical and material properties directly, without human interaction with the device during the test itself. This is not an "algorithm only" standalone performance as in AI, but rather a direct characterization of the physical product.

    7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

    The ground truth for the test set was established by the characteristics and performance of the predicate devices (currently marketed PMA approved HEMASHIELD® devices). The studies aimed to show that the new devices were "equivalent to marketed product" across a range of physical, mechanical, and material properties. This is a "predicate comparison" ground truth rather than a clinical ground truth like pathology or outcomes data.

    8. The sample size for the training set

    This information is not applicable. There is no mention of a "training set" as this is not an AI/ML device. The "training" for such a device would be the manufacturing process development itself, not a data-driven model training.

    9. How the ground truth for the training set was established

    This information is not applicable, as there is no training set mentioned or implied for this type of medical device submission.

    Ask a Question

    Ask a specific question about this device

    Page 1 of 1