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510(k) Data Aggregation

    K Number
    K071552
    Date Cleared
    2008-04-25

    (324 days)

    Product Code
    Regulation Number
    N/A
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Device Name :

    PURACOL PLUS AG COLLAGEN MICROSCAFFOLD WOUND DRESSING

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

    Puracol® Plus Ag MicroScaffold™ Wound Dressing is indicated for the management of:

    • Full thickness and partial thickness wounds
    • Pressure ulcers
    • Venous ulcers
    • Ulcers caused by mixed vascular etiologies
    • Diabetic ulcers
    • First and second degree burns
    • Donor sites and other bleeding surface wounds
    • Abrasions
    • Trauma wounds healing by secondary intention
    • Dehisced wounds
    • Surgical wounds
    • Dehisced surgical wounds

    These dressings may be cut to size and may be layered for the management of deep wounds.

    Device Description

    Not Found

    AI/ML Overview

    I am sorry, but the provided text does not contain the information required to answer your request. The document is an FDA 510(k) clearance letter for a wound dressing, which grants market approval by deeming the device substantially equivalent to a predicate device. It specifies indications for use, precautions, and contraindications.

    However, it does not provide any details about:

    • Acceptance criteria and reported device performance (in terms of specific metrics like sensitivity, specificity, accuracy, etc.)
    • Details of a study proving the device meets acceptance criteria.
    • Sample sizes for test or training sets.
    • Data provenance, number or qualifications of experts, or adjudication methods for ground truth.
    • Whether MRMC or standalone comparative effectiveness studies were performed, or any associated effect sizes.
    • How ground truth was established for training or test sets.

    Essentially, this document is a regulatory approval notice, not a detailed scientific study report on device performance.

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