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510(k) Data Aggregation

    K Number
    K024185
    Device Name
    BIODHOC
    Manufacturer
    FUTURE MEDICAL SYSTEMS, SA
    Date Cleared
    2004-01-15

    (392 days)

    Product Code
    HTY
    Regulation Number
    888.3040
    Type
    Traditional
    Panel
    Orthopedic
    Reference & Predicate Devices
    K991009,K023963
    Why did this record match?
    Device Name :

    BIODHOC

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

    The BIODHOC is an implant used for rotator cuff repair in shoulder surgery.

    Device Description

    The BIODHOC is an implant used for rotator cuff repair in shoulder surgery. The BIODHOC is made of poly DL- lactic acid (PLLA) a bio absorbable polymer.

    AI/ML Overview

    This 510(k) submission does not contain the information requested regarding acceptance criteria and a study proving the device meets those criteria for software or an AI/ML device.

    The provided document is a 510(k) summary for a "Soft Tissue Fixator" named BIODHOC, which is an implant used for rotator cuff repair. It describes a physical medical device, not a software or AI/ML product. The content focuses on:

    • Manufacturer and contact information.
    • Device name, common name, classification, and predicate devices.
    • Intended use and description of the physical implant (made of poly DL-lactic acid).
    • A statement of substantial equivalence to predicate physical devices.
    • The FDA's letter granting 510(k) clearance, confirming substantial equivalence for a physical device.
    • Indications for use for the physical implant.

    Therefore, I cannot extract the requested information (performance characteristics, sample sizes, ground truth details, expert qualifications, MRMC studies, standalone performance, training set details) because these concepts are specific to software, AI, or diagnostic imaging devices, and are not present in this submission for a surgical implant.

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