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510(k) Data Aggregation

    K Number
    K220337
    Device Name
    GaiaBone Bioabsorbable Bone Graft
    Manufacturer
    Corliber (Shenzhen) Medical Device Co., Ltd.
    Date Cleared
    2023-02-03

    (361 days)

    Product Code
    MQV,MOV
    Regulation Number
    888.3045
    Type
    Traditional
    Panel
    Orthopedic
    Reference & Predicate Devices
    K141725
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    GaiaBoneTM Bioabsorbable Bone Graft is an implant intended to fill bony voids or gaps of the skeletal system. i.e., the pelvis and extremities. These osseous defects may be surgically created of traumatic injury to the bone and are not intrinsic to the stability of the boneTM Bioabsorbable Bone Graft resorbs and is replaced with bone during the healing process.

    Device Description

    GaiaBone™ Bioabsorbable Bone Graft is a composite of synthetic hydroxyapatite [Ca10(PO4)6(OH)2] and lactide-caprolactone copolymer. The composite material is a shapable, absorbable, osteoconductive putty bone graft. It is available in cylinders. This bone graft material contains approximately 50% mineral by weight. GaiaBone™ Bioabsorbable Bone Graft is intended to be used as bone void filler for voids or gaps of the skeletal system that are not intrinsic to the stability of the bony structure (i.e., the pelvis, and/or extremities).

    GaiaBone™ is easy to be shaped and designed to retain its shape and physical integrity following implantation into a bony site. The product is sterile and for single use only.

    AI/ML Overview

    The provided document is a 510(k) summary for a medical device (GaiaBone™ Bioabsorbable Bone Graft) and does not describe software or AI. Therefore, it does not contain the information requested about acceptance criteria and studies for an AI-powered device.

    The document discusses:

    • Device Name: GaiaBone™ Bioabsorbable Bone Graft
    • Intended Use: To fill bony voids or gaps of the skeletal system (pelvis and extremities).
    • Composition: Synthetic hydroxyapatite and lactide-caprolactone copolymer.
    • Non-Clinical Testing: Includes anti-collapse property, in vitro degradation, sterilization, product shelf-life, biocompatibility (ISO 10993-1:2018), and a rabbit femoral critical defect study.
    • Rabbit Study Results: After 12 weeks, GaiaBone™ showed a 5.8% difference in new bone formation compared to the empty defect group, while the autograft control showed a 14.5% difference.
    • Clinical Testing: Not applicable; substantial equivalence was not based on clinical performance data.

    Since the request is specifically for information related to AI device acceptance criteria and studies, and this document pertains to a bioabsorbable bone graft, I cannot extract the requested information from the provided text.

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