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510(k) Data Aggregation

    K Number
    K230679
    Device Name
    WellsForm Tricuspid Annuloplasty Band (WF)
    Manufacturer
    Genesee Biomedical Inc
    Date Cleared
    2023-05-26

    (74 days)

    Product Code
    KRH,DTI
    Regulation Number
    870.3800
    Type
    Traditional
    Panel
    Cardiovascular
    Reference & Predicate Devices
    K093903
    Why did this record match?
    Reference Devices :

    K093903

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

    WellsForm Tricuspid Annuloplasty Band is indicated for the surgical reconstruction or remodeling of diseased or damaged tricuspid valves. The band provides support for and restricts expansion of the tricuspid annulus.

    Device Description

    The WellsForm™ Tricuspid Annuloplasty Band is an implantable ring intended for surgical repair of the tricuspid heart valve. WellsForm Tricuspid Annuloplasty Band is indicated for the surgical reconstruction or remodeling of diseased or damaged tricuspid valves. The band provides support for and restricts expansion of the tricuspid annulus.

    The WellsForm™ Tricuspid Annuloplasty Band consists of a braided textile polyester body with a semi-rigid (stiflened) portion at the septal and aortic segments. The flexible section runs from the aortic segment, about half of the posteroseptal commissure to help remodel and stabilize the enlarged portion of the tricuspid annulus found in patients with functional tricuspid requrgitation.

    The size range of the WellsForm Tricuspid Annuloplasty Band is from 26mm in 2mm increments (sizes: 26, 28, 30, 34, and 36).

    AI/ML Overview

    I'm sorry, but the provided text describes a medical device submission (510(k)) for a Tricuspid Annuloplasty Band. This document focuses on demonstrating substantial equivalence to a predicate device, primarily through non-clinical testing (e.g., computational structural analysis, tensile strength, sterilization validation, biocompatibility tests like cytotoxicity, pyrogenicity).

    The document does not contain information about:

    • Acceptance criteria in the context of an AI/ML algorithm's performance.
    • Clinical study design involving a test set, training set, or ground truth establishment by experts.
    • Multi-reader multi-case (MRMC) comparative effectiveness studies.
    • Stand-alone algorithm performance.
    • Any form of artificial intelligence (AI) or machine learning (ML).

    Therefore, I cannot extract the information required to answer your questions about acceptance criteria for an AI/ML device and the study proving it meets those criteria. The provided text is relevant to traditional medical device clearance, not AI/ML performance evaluation.

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