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510(k) Data Aggregation

    K Number
    K233653
    Device Name
    Midfield Light Pipe, 23ga (3269.M06-00); Midfield Light Pipe, 25ga (3269.M05-00); Midfield Light Pipe, 27ga (3269.M04-00)
    Manufacturer
    Peregrine Surgical, LLC
    Date Cleared
    2024-08-05

    (265 days)

    Product Code
    MPA
    Regulation Number
    876.1500
    Type
    Traditional
    Panel
    Ophthalmic (OP)
    Reference & Predicate Devices
    K950529,K213467,K151604
    Why did this record match?
    Device Name :

    Midfield Light Pipe, 23ga (3269.M06-00); Midfield Light Pipe, 25ga (3269.M05-00); Midfield Light Pipe

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

    The Midfield Light Pipe is a disposable microsurgical instrument used to conduct a field of light to the posterior seqment of the eye in order to visualize the internal structures of the eyes during ophthalmic surgery.

    Device Description

    The Midfield Light Pipe will be offered in a 23 gauge (GA), 25GA and 27GA size. Each device consists of an ABS handpiece, 304 stainless steel illumination connector, LDPE EVA jacket material, PMMA illumination fiber, 304 stainless steel needle and a PMMA scleral depressor. The Midfield Light Pipe is an external communicating device, in contact with tissue/bone/dentin for a limited duration (

    AI/ML Overview

    I am sorry, but based on the provided text, there is no information about acceptance criteria and a study that proves a device meets these criteria in the context of AI/ML performance, human reader studies, or associated metrics like AUC, sensitivity, specificity, etc.

    The document discusses a 510(k) premarket notification for a medical device called "Midfield Light Pipe." The performance testing described is related to the physical characteristics and safety of the device, such as light output, needle strength, phototoxicity, sterilization, shelf-life, packaging, and biocompatibility.

    Therefore, I cannot provide the requested information.

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