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510(k) Data Aggregation

    K Number
    K990561
    Device Name
    OPTICAL FORCEPS
    Date Cleared
    1999-05-14

    (81 days)

    Product Code
    Regulation Number
    874.4680
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Device Name :

    OPTICAL FORCEPS

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

    To be used for Tracheobronchial or Esophageal foreign body removal or biopsy procedures. To be used through rigid scopes: Bronchoscopes, Esophagoscopic, Laryngoscopes and Mediastinoscopes

    Device Description

    The Optical Forcep consists of two components - a. Telescope - b. Biopsy Forcep

    AI/ML Overview

    The provided text does not contain information about acceptance criteria or a study proving the device meets said criteria. The document is a 510(k) summary for the Pilling Weck Surgical Optical Forcep, focusing on its substantial equivalence to a predicate device, its intended use, and its classification. It explicitly states that the technological characteristics are "the same as, or equivalent to, predicate devices."

    Therefore, I cannot provide details for the following requested information as it is not present in the given text:

    • A table of acceptance criteria and the reported device performance
    • Sample size used for the test set and the data provenance
    • Number of experts used to establish the ground truth for the test set and their qualifications
    • Adjudication method for the test set
    • If a multi-reader multi-case (MRMC) comparative effectiveness study was done, and its effect size
    • If a standalone performance study was done
    • The type of ground truth used
    • The sample size for the training set
    • How the ground truth for the training set was established

    The 510(k) summary is primarily concerned with demonstrating substantial equivalence to a legally marketed predicate device, rather than presenting a performance study with specific acceptance criteria.

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