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510(k) Data Aggregation

    K Number
    K021357
    Device Name
    MEDPOR PLUS ORBITAL VOLUME REPLACEMENT IMPANT
    Manufacturer
    POREX SURGICAL, INC.
    Date Cleared
    2002-08-05

    (98 days)

    Product Code
    HPZ
    Regulation Number
    886.3320
    Type
    Traditional
    Panel
    Ophthalmic (OP)
    Reference & Predicate Devices
    K993077,K983279
    Why did this record match?
    Device Name :

    MEDPOR PLUS ORBITAL VOLUME REPLACEMENT IMPANT

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

    MEDPOR Surgical Implants in block, sheet and preformed shapes are intended for augmentation or restoration in the craniofacial region.

    Device Description

    The devices of this submission are orbital volume replacement implants formed by blending Bioglass® Synthetic Bone Graft Particulate with the polyethylene used to produce MEDPOR Surqical Implant Material.

    AI/ML Overview

    This document is a 510(k) summary for a medical device (MEDPOR® Plus Orbital Volume Replacement Implants) and, as such, it does not contain the type of detailed information about acceptance criteria, study design, and performance metrics typically found in clinical trial reports or validation studies for AI/ML devices.

    The information provided describes the device, its intended use, and its substantial equivalence to previously cleared devices. It confirms that the device is cleared for marketing but does not include any performance data or clinical study results in the manner requested by your prompt (e.g., acceptance criteria tables, sample sizes for test/training sets, expert qualifications, effect sizes of AI assistance, etc.).

    Therefore, I cannot extract the requested information from this document. The prompt asks for details that are not present in this 510(k) summary.

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