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510(k) Data Aggregation

    K Number
    K071435
    Device Name
    NUVASIVE OCT SYSTEM
    Manufacturer
    NUVASIVE, INC.
    Date Cleared
    2007-08-06

    (75 days)

    Product Code
    MNI
    Regulation Number
    888.3070
    Type
    Traditional
    Panel
    Orthopedic
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Device Name :

    NUVASIVE OCT SYSTEM

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

    When intended to promote fusion of the cervical spine and occipito-thoracic junction (Occiput-T3), the NuVasive OCT System is indicated for: (1) Degenerative disc disease (as defined by back pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies), (2) Degenerative spondylolisthesis with objective evidence of neurologic impairment, (3) Fracture/Dislocation, (4) Spinal Stenosis, (5) Atlantoaxial fracture with instability, (6) Occipitocervical dislocation, (7) Spinal turnor and/or (8) Revision of previous cervical spine surgery.

    The occipital bone screws are limited to occipital fixation only.

    The use of polyaxial screws is limited to placement in the upper thoracic spine (T1-T3) in treating thoracic conditions only. They are not intended to be placed in the cervical spine.

    The NuVasive OCT System can also be linked to the NuVasive SpheRx Spinal System via the rod to rod connectors.

    Device Description

    The NuVasive OCT System is a posterior system, which consists of a variety of shapes and sizes of screws, rods, hooks, offset connectors, set screws, and cross connectors which can be rigidly locked in a variety of configurations to accommodate patient anatomy.

    AI/ML Overview

    This document describes the NuVasive OCT System, a spinal fixation system, and its FDA 510(k) premarket notification. However, it does not contain information about acceptance criteria or a study proving the device meets specific performance criteria related to an AI/ML or diagnostic device.

    The document is a 510(k) summary for a traditional medical device (spinal fixation system), not a software or AI-based diagnostic tool. Therefore, the questions related to device performance in terms of AI/ML metrics (like AUC, sensitivity, specificity), sample sizes for test/training sets, expert adjudication, or MRMC studies are not applicable to the information provided.

    Specifically, the document states in section G and H:

    • "Summary of Non-Clinical Tests: Mechanical testing was presented." This indicates that the device's physical properties and structural integrity were evaluated.
    • "Summary of Clinical Tests: (Not Applicable)." This explicitly states that clinical tests (which would typically involve human subjects or data to assess diagnostic or prognostic performance) were not required or applicable for this submission. The device is a hardware implant, and its substantial equivalence was demonstrated through comparison to predicate devices and mechanical testing, not by evaluating its performance in interpreting medical data or providing diagnostic insights.

    Therefore, I cannot populate the requested table or answer the specific questions about acceptance criteria, study findings, sample sizes, ground truth establishment, or expert involvement, as this information is not present in the provided text for this type of device.

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