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510(k) Data Aggregation

    K Number
    K980451
    Device Name
    BIODERM CALCIUM ALGINATE DRESSING
    Manufacturer
    BIODERM, INC.
    Date Cleared
    1998-04-09

    (63 days)

    Product Code
    KMF
    Regulation Number
    880.5090
    Type
    Traditional
    Panel
    General & Plastic Surgery
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Device Name :

    BIODERM CALCIUM ALGINATE DRESSING

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use
      1. Venous Stasis Ulcers
      1. Pressure Ulcers
      1. Diabetic Ulcers
      1. Surgical Wounds
    Device Description

    Bioderm Calcium Alginate Wound Dressing

    AI/ML Overview

    This document is a marketing clearance letter for a medical device (Bioderm Calcium Alginate Dressing) and does not contain the specific information required to complete your request. The letter confirms that the device is substantially equivalent to existing devices based on its stated indications for use but does not provide details of acceptance criteria, study methodologies, or performance data.

    Therefore, I cannot provide the requested information, including:

    1. A table of acceptance criteria and reported device performance.
    2. Sample sizes for test sets or data provenance.
    3. Number and qualifications of experts for ground truth.
    4. Adjudication method.
    5. MRMC comparative effectiveness study details.
    6. Standalone performance details.
    7. Type of ground truth used.
    8. Sample size for the training set.
    9. How ground truth for the training set was established.
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