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510(k) Data Aggregation

    K Number
    K023703
    Device Name
    BI-OSTETIC
    Manufacturer
    BERKELEY ADVANCED BIOMATERIALS, INC.
    Date Cleared
    2003-01-30

    (87 days)

    Product Code
    MQV,MOV
    Regulation Number
    888.3045
    Type
    Traditional
    Panel
    Orthopedic
    Reference & Predicate Devices
    K020986,K990131
    Predicate For
    K042636,K050666,K050789,K062691
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    Bi-Ostetic™ is an osteoconductive bone substitute shaped as granules or blocks (cancellous, cortical or cortico-cancellous) that are intended to be used to fill voids and gaps that are not intrinsic to the stability of the bone structure. These gaps or voids may be located in the extremities, spine, pelvis, or cranium.

    The granules or blocks may be pressed into the void or into the surgical site by hand. The Bi-Ostetic™ granules or blocks provide void filling material that acts as a temporary support medium. The granules or blocks are not intended to provide structural support during the healing process. The implant is radio-opaque. Bi-Ostetic™ is biocompatible and resorbs in the body as bone ingrowth occurs.

    Device Description

    Bi-Ostetic™ is a sterile osteoconductive bone void filler. It consists of a formulation of calcium based compounds. This synthetic bone graft comes in the shape of granules or blocks. Bi-Ostetic™ is supplied sterile for single patient use only. Bi-Ostetic™ is biocompatible and resorbs in the human body as bone ingrowth occurs when applied according to its indications for use. The implant is bioresorbable and radio-opaque.

    AI/ML Overview

    The provided text does not contain information about acceptance criteria or a study proving that the Bi-OsteticTM device meets those criteria. The document is a 510(k) summary statement and subsequent FDA clearance letter, which focuses on the device's substantial equivalence to previously marketed devices.

    Therefore, I cannot fulfill your request for:

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

    The document states that the safety and effectiveness of Bi-Ostetic™ are "adequately supported by the substantial equivalence information, materials data, and test results provided in the full document submitted within the scope of this Premarket Notification." However, these "test results" are not detailed in the provided excerpt.

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