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510(k) Data Aggregation

    K Number
    K021767
    Device Name
    ASSUFIL
    Manufacturer
    ASSUT EUROPE S.P.A.
    Date Cleared
    2002-11-19

    (174 days)

    Product Code
    GAM
    Regulation Number
    878.4493
    Type
    Traditional
    Panel
    General & Plastic Surgery
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Device Name :

    ASSUFIL

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

    Assufil It is advised when an absorbable suture is needed for use in General Soft Tissue Approximation and Ligation

    Device Description

    absorbable surgical suture

    AI/ML Overview

    This document is a 510(k) premarket notification for a medical device, specifically an absorbable surgical suture called Assufil™. It does not present a study with acceptance criteria and device performance data in the way typically seen for AI/ML-based diagnostic devices.

    Instead, this is a regulatory submission for a traditional medical device (suture) seeking substantial equivalence to a predicate device. The information provided is for regulatory clearance, not a performance study evaluating metrics like sensitivity, specificity, or accuracy against a ground truth for a diagnostic algorithm.

    Therefore, I cannot extract the requested information regarding acceptance criteria, study details, sample sizes, expert qualifications, or ground truth methods from the provided text, as this type of information is not contained within this particular 510(k) submission for a surgical suture.

    The content focuses on:

    • Device Identification: Assufil™ absorbable surgical suture.
    • Intended Use: General Soft Tissue Approximation and Ligation.
    • Regulatory Classification: Class II, Absorbable poly(glycolide/L-lactide) surgical suture.
    • Substantial Equivalence: The FDA's determination that the device is substantially equivalent to a legally marketed predicate device.

    To answer your questions, I would need a 510(k) summary or a scientific publication detailing a performance study for a diagnostic or AI-driven device, which would include specific metrics, study design, and ground truth methodology.

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