LogoFDA 510(k) Search
Search Filters

Search Results

Found 1 results

510(k) Data Aggregation

    K Number
    K983622
    Device Name
    BODYFORM THORACO-LUMBAR FIXATION SYSTEM
    Manufacturer
    THEKEN SURGICAL,LLC
    Date Cleared
    1998-12-30

    (76 days)

    Product Code
    KWQ
    Regulation Number
    888.3060
    Type
    Traditional
    Panel
    Orthopedic
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Device Name :

    BODYFORM THORACO-LUMBAR FIXATION SYSTEM

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

    The BodyForm Thoraco-Lumbar Fixation System is intended for treatment of anterior thoraco-lumbar spinal instability caused by:

    1. Trauma.
    2. Tumor.
    3. Degenerative Disc Disease (DDD). DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies.
    4. Anterior fusion following multiple failed posterior fusion operations, including pseudoarthrosis.
      The instrumentation is designed for levels of fixation from T10 to L4.
    Device Description

    The BodyForm™ Thoraco-Lumbar Fixation System is a construct which consists of one plate, contoured to match the lateral profile of the thoraco-lumbar vertebral bodies, four Morse taper headed screws, and two locking set screws. Plates are designed specifically to particular graft heights, with anatomic limitations in mind.

    AI/ML Overview

    The provided text describes the "BodyForm™ Thoraco-Lumbar Fixation System," a medical device for spinal instability. However, it does not contain any information about acceptance criteria, device performance metrics, or any specific studies related to clinical or AI/algorithm performance.

    The document is a 510(k) summary for regulatory clearance, which primarily focuses on substantial equivalence to predicate devices and describes non-clinical testing for mechanical properties.

    Therefore, I cannot provide the requested information. The following points would be "Not Applicable" or "Not Provided in the text":

    1. A table of acceptance criteria and the reported device performance: Not provided. The text mentions "Properties of stiffness, strength, and fatigue life were characterized" according to ASTM F-1717-96, but no specific criteria or reported values are given.
    2. Sample size used for the test set and the data provenance: Not provided. This typically refers to clinical or algorithmic test sets, which are not detailed.
    3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not provided.
    4. Adjudication method for the test set: Not provided.
    5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance: Not provided. This is a mechanical device, not an AI diagnostic tool.
    6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not provided. This is a mechanical device, not an AI diagnostic tool.
    7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not provided.
    8. The sample size for the training set: Not provided.
    9. How the ground truth for the training set was established: Not provided.
    Ask a Question

    Ask a specific question about this device

    Page 1 of 1