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510(k) Data Aggregation

    K Number
    K051785
    Manufacturer
    Date Cleared
    2005-08-23

    (53 days)

    Product Code
    Regulation Number
    876.5010
    Reference & Predicate Devices
    Predicate For
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The Cook® Formula™ 418™ Biliary Stent is indicated for use in palliation of malignant neoplasms in the biliary tree.

    Device Description

    The Formula 418 Biliary Stent is a balloon-expandable, stainless steel stent which is premounted on the delivery system. The stent will be available in diameters of 3, 4, 5, 6, 7, and 8 mm and lengths of 12, 16, 20, 24 and 30 mm. This device will be supplied sterile and is intended for one-time use.

    AI/ML Overview

    The provided text describes the 510(k) submission for the Cook® Formula 418™ Biliary Stent System. While it details various tests performed, it does not explicitly define acceptance criteria with numerical thresholds for each test, nor does it present the "reported device performance" in a manner suitable for a comparative table against such criteria. The document states that the tests provide "reasonable assurance that the device has been designed and tested to assure conformance to the requirements for its use as a biliary stent," implying that the device met some internal or industry-standard acceptance criteria, but these are not explicitly listed or quantified.

    Therefore, many of the requested sections regarding the study that proves the device meets acceptance criteria cannot be extracted directly from the provided text.

    Here is the information that can be extracted, with notes on what is missing:

    1. Table of Acceptance Criteria and Reported Device Performance:

    TestAcceptance Criteria (Not Explicitly Stated)Reported Device Performance (Not Explicitly Stated)
    Deployment TestingImplied successful deploymentImplied successful deployment
    Compression Force TestingImplied resistance to compressionImplied resistance to compression
    Expansion Force TestingImplied adequate expansionImplied adequate expansion
    Dimensional TestingImplied within specified dimensionsImplied within specified dimensions
    Corrosion TestingImplied negligible corrosionImplied negligible corrosion
    Balloon Performance TestingImplied suitable balloon functionImplied suitable balloon function
    Stent Deformation TestingImplied maintains structural integrityImplied maintains structural integrity
    Tensile Strength TestingImplied adequate tensile strengthImplied adequate tensile strength
    Magnetic Resonance Imaging (MRI) TestingImplied MRI compatibility/safetyImplied MRI compatibility/safety
    Shelf Life TestingImplied stable over specified shelf lifeImplied stable over specified shelf life
    Biocompatibility TestingImplied biocompatibleImplied biocompatible

    Missing Information: The document states that "The results of these tests provide reasonable assurance that the device has been designed and tested to assure conformance to the requirements for its use as a biliary stent." However, it does not provide specific numerical acceptance criteria or the quantitative results of these tests.

    2. Sample size used for the test set and the data provenance:

    • Sample size for test set: Not specified in the provided text. The tests are listed, but no number of samples per test is given.
    • Data provenance: Not specified (e.g., country of origin, retrospective or prospective). The text only mentions "Test Data" without details on its origin.

    3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

    • Not applicable. The tests listed (e.g., mechanical, material, imaging compatibility) are physical/engineering tests, not clinical evaluations requiring expert interpretation of medical images or patient outcomes to establish ground truth in the context of diagnostic accuracy.

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

    • Not applicable. This concept typically applies to clinical studies involving expert review of medical data. The tests described are laboratory/bench tests.

    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. This is a premarket notification for a medical device (stent), not an AI-assisted diagnostic tool. Therefore, an MRMC study related to AI assistance is not applicable.

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

    • No. This is a physical medical device (stent), not an algorithm.

    7. The type of ground truth used:

    • For the listed tests (Deployment, Compression, Expansion, Dimensional, Corrosion, Balloon Performance, Stent Deformation, Tensile Strength, MRI, Shelf Life, Biocompatibility), the "ground truth" would be established by engineering specifications, material standards, and validated testing protocols. For example, for dimensional testing, the ground truth would be the specified dimensions of the stent according to its design. For biocompatibility, it would be compliance with ISO standards for biological evaluation of medical devices.

    8. The sample size for the training set:

    • Not applicable. This device is a physical stent, not an AI model that requires a training set.

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

    • Not applicable. (See point 8).
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