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510(k) Data Aggregation

    K Number
    K071335
    Device Name
    MEDPOR ATTRACTOR IMPLANT
    Manufacturer
    POREX SURGICAL, INC.
    Date Cleared
    2007-08-08

    (89 days)

    Product Code
    HPZ,MQU
    Regulation Number
    886.3320
    Type
    Traditional
    Panel
    Ophthalmic
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Device Name :

    MEDPOR ATTRACTOR IMPLANT

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

    The MEDPOR ATTRACTOR Implant is intended for patients who require replacement of volume of an enucleated or eviscerated orbit and who wish to gain improved prosthetic eye motility by coupling the MEDPOR ATTRACTOR Implant to the prosthetic eye.

    Device Description

    MEDPOR Orbital Implant made of porous polyethylene with a titanium nitride coated stainless steel screw or insert. The screw or insert acts as an attractor to a magnet that is embedded into the posterior of a prosthetic eye. The magnets are gold plated and designed small enough to remain entirely within the prosthesis material of the prosthetic eye, and powerful enough to provide a coupling force between the implant and the prosthesis.

    AI/ML Overview

    Due to the nature of the provided document, which is a 510(k) summary for a medical implant and not a study report, it does not contain the detailed information requested regarding acceptance criteria and a study proving the device meets those criteria in the context of the requested AI/algorithm-related metrics.

    This document describes a physical medical device (an orbital implant with a magnetic component), not a software algorithm or AI device. Therefore, the concepts of "test set," "ground truth," "training set," "experts," "adjudication," "MRMC study," and "stand-alone algorithm performance" as typically applied to AI/ML device evaluations are not applicable to the information provided.

    The document primarily focuses on:

    • Device Description: What the device is and how it works (a magnetic orbital implant to improve prosthetic eye motility).
    • Indications for Use: For whom the device is intended and its purpose.
    • Substantial Equivalence: A comparison to legally marketed predicate devices to establish that the new device is as safe and effective.

    Therefore, I cannot extract the requested information in the format of the provided table and subsequent bullet points because the source material does not contain it.

    If you have a document describing an AI/ML medical device study, I would be happy to analyze it for the requested criteria.

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