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510(k) Data Aggregation

    K Number
    K960361
    Device Name
    PERMAMESH-D HYDROXYLAPATITE MATRIX
    Manufacturer
    CERAMED CORP.
    Date Cleared
    1996-04-15

    (81 days)

    Product Code
    LYC
    Regulation Number
    872.3930
    Type
    Traditional
    Panel
    Dental
    Reference & Predicate Devices
    K023249,K072782
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    Bone filling and/or augmentation of the alveolar ridge.

    Device Description

    PermaMesh-D is a synthetic form of hydroxylapatite, the major mineral component of tooth enamel and bone, produced in the form of a woven sheet. It is manufactured as high purity, radiopaque, rounded particles sized at 1000 microns diameter and organized into a flat, flexible clothlike form by means of absorbable suture.

    AI/ML Overview

    I am sorry, but the provided text is a 510(k) summary for a medical device (PermaMesh-D Hydroxylapatite Matrix) and does not contain any information about acceptance criteria, device performance studies, or efficacy data as it relates to software or AI algorithms.

    The document describes the device's characteristics, intended use, and comparison to predicate devices, focusing on its material composition and physical form. It does not touch upon any computational, diagnostic, or interpretive performance.

    Therefore, I cannot fulfill your request to describe the acceptance criteria and the study that proves the device meets the acceptance criteria, as the necessary information is not present in the provided input.

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    K Number
    K960354
    Device Name
    PERMAMESH-D HYDROXYLAPATITE MATRIX
    Manufacturer
    CERAMED CORP.
    Date Cleared
    1996-03-20

    (55 days)

    Product Code
    LZK
    Regulation Number
    878.3550
    Type
    Traditional
    Panel
    General & Plastic Surgery
    Reference & Predicate Devices
    N/A
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    Facial (malar) restoration and augmentation

    Device Description

    PermaMesh-D is a synthetic form of hydroxylapatite, the major mineral component of tooth enamel and bone, produced in the form of a woven sheet. It is manufactured as high purity, radiopaque, rounded particles sized at 1000 microns diameter and organized into a flat, flexible clothlike form by means of absorbable suture.

    AI/ML Overview

    The provided text describes a medical device (PermaMesh-D Hydroxylapatite Matrix) and its intended use, but it does not contain information about acceptance criteria, device performance studies, or AI/software components.

    Therefore, I cannot fulfill the request to describe the acceptance criteria and the study that proves the device meets them, as the necessary information is absent from the input.

    The document is a 510(k) summary from 1996 for a physical implant, not a software or AI-powered diagnostic/analysis device. The questions in your prompt are geared towards evaluating AI/machine learning medical devices.

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