LogoFDA 510(k) Search
Search Filters

Search Results

Found 1 results

510(k) Data Aggregation

    K Number
    K020901
    Device Name
    SERRALSILK
    Manufacturer
    SERRAL, S.A. DE C.V.
    Date Cleared
    2002-04-26

    (37 days)

    Product Code
    GAP
    Regulation Number
    878.5030
    Type
    Traditional
    Panel
    General & Plastic Surgery
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Device Name :

    SERRALSILK

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

    SERRALSILK™ sutures are indicated for use in general soft tissue approximation and/or ligation, including use in cardiovascular, ophthalmic and neurological procedures.

    Device Description

    Not Found

    AI/ML Overview

    This document is a 510(k) clearance letter from the FDA for surgical sutures, not a study report for an AI/ML device. Therefore, it does not contain the information requested in the prompt regarding acceptance criteria and a study proving device performance for an AI/ML product.

    Specifically, the document discusses:

    • Trade/Device Name: Serralsilk™, Non-absorbable Surgical Sutures
    • Regulation Number: 21 CFR 878.5030 (Natural nonabsorbable silk surgical suture)
    • Regulatory Class: II
    • Product Code: GAP
    • Indications for Use: General soft tissue approximation and/or ligation, including use in cardiovascular, ophthalmic and neurological procedures.

    There is no mention of AI/ML, algorithms, performance metrics like sensitivity/specificity, sample sizes for test/training sets, expert readers, ground truth establishment, or any other elements related to the evaluation of an AI-powered diagnostic or assistive device.

    Therefore, I cannot provide the requested table or information because this document is entirely unrelated to the study of an AI/ML device.

    Ask a Question

    Ask a specific question about this device

    Page 1 of 1