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510(k) Data Aggregation

    K Number
    K082460
    Device Name
    CENEFOM PVA SURGICAL SPEAR
    Manufacturer
    LONGTEK SCIENTIFIC CO., LTD.
    Date Cleared
    2008-12-15

    (111 days)

    Product Code
    HOZ
    Regulation Number
    886.4790
    Type
    Traditional
    Panel
    Ophthalmic
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Applicant Name (Manufacturer) :

    LONGTEK SCIENTIFIC CO., LTD.

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

    The Cenefom PVA Surgical Spear is indicated for short-term transient use in ophthalmic surgical procedures for absorbing excess fluids from the operative field.

    Device Description

    Not Found

    AI/ML Overview

    The provided FDA document (K082460) is a 510(k) clearance letter for the Longtek Cenefom PVA Surgical Spear and does not contain any information about acceptance criteria, device performance studies, or AI/algorithm-related details.

    This document solely focuses on:

    • The FDA's determination of substantial equivalence to a predicate device.
    • The device's regulation number, name, and regulatory class.
    • General controls and other regulations that apply to the device.
    • The indications for use for the device.

    Therefore, I cannot provide the requested information regarding acceptance criteria, study details, sample sizes, ground truth establishment, expert qualifications, or AI performance, as this document does not pertain to those aspects.

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