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510(k) Data Aggregation

    K Number
    K103100
    Device Name
    MOUNTAINEER OCT SPINAL SYSTEM
    Manufacturer
    DEPUY SPINE, INC.
    Date Cleared
    2010-11-17

    (28 days)

    Product Code
    MNI,KWP,PRO
    Regulation Number
    888.3070
    Type
    Special
    Panel
    Orthopedic
    Reference & Predicate Devices
    K080828,K041203
    Predicate For
    K110963,K113593
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The indications for use for the modified devices described in this submission are the same as those for the MOUNTAINEER OCT Spinal System. The indications are as follows:

    When intended to promote fusion of the cervical spine and occipito-cervico-thoracic junction (occiput - T3), the MOUNTAINEER Occipito-Cervical-Thoracic (OCT) Spinal System is intended for:

    • ddd (neck pain of discogenic origin with degeneration of the disc as confirmed by patient history and radiographic studies)
    • spondylolisthesis
    • spinal stenosis
    • fracture/dislocation
    • atlanto/axial fracture with instability
    • occipitocervical dislocation
    • revision of previous cervical spine surgery
    • tumors

    The occipital bone screws are limited to occipital fixation only.

    The use of the monoaxial and 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 Songer Cable System, to be used with the MOUNTAINEER OCT Spinal System, allows for wire/cable attachment to the posterior cervical spine.

    The MOUNTAINEER OCT Spinal System can also be linked to the ISOLA®, TiMX®, MONARCH®, EXPEDIUM®, VIPER® and MOSS® MIAMI® Systems using the dual wedding band and axial connectors, and via dual diameter rods.

    Device Description

    Addition of the 3.5mm diameter monoaxial screw to the existing MOUNTAINEER® OCT Spinal System. This system also contains Class 1 manual surgical instruments and cases that are considered exempt from premarket notification.

    AI/ML Overview

    The KIO3100 submission describes the addition of a 3.5mm diameter monoaxial screw to the existing MOUNTAINEER® OCT Spinal System. The device's performance is demonstrated through non-clinical mechanical testing, comparing it to predicate devices. This is a medical device, not an AI/ML device, so many of the requested categories are not applicable.

    Here's the breakdown of the available information:

    1. A table of acceptance criteria and the reported device performance
    Acceptance Criteria (Test)Reported Device Performance
    Static cantilever beam in accordance with ASTM F1798Testing conducted and results supported substantial equivalence. The submission implies that the new components meet the same performance standards as the predicate devices under these conditions. Specific numerical results are not provided in the summary, but the conclusion states "Based on the predicate comparison and testing, the subject MOUNTAINEER® OCT Spinal System is device substantially equivalent to the predicate device."
    Static axial slip in accordance with ASTM F1798Testing conducted and results supported substantial equivalence. The submission implies that the new components meet the same performance standards as the predicate devices under these conditions.
    Dynamic cantilever beam in accordance with ASTM F1798Testing conducted and results supported substantial equivalence. The submission implies that the new components meet the same performance standards as the predicate devices under these conditions.
    Intended Use, Design Characteristics, Materials, Performance, and Packaging (comparison to predicate devices)The proposed components "have the same intended use, design characteristics, materials, performance, and packaging as the predicate devices."

    1. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)
      This information is not provided. The study involved non-clinical mechanical testing, not clinical human subject data.

    2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g., radiologist with 10 years of experience)
      Not applicable. This is a mechanical device, and "ground truth" as it applies to AI/ML or diagnostic studies is not relevant here. The ground truth for mechanical testing is established by the ASTM standards themselves and the physical measurements obtained.

    3. Adjudication method (e.g., 2+1, 3+1, none) for the test set
      Not applicable. This is a mechanical device.

    4. 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 applicable. This is a mechanical device.

    5. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
      Not applicable. This is a mechanical device.

    6. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
      For mechanical testing, the "ground truth" is defined by the physical properties measured under standardized ASTM test methods (ASTM F1798 in this case) and the established performance characteristics of the predicate devices.

    7. The sample size for the training set
      Not applicable. This is a mechanical device, not an AI/ML system requiring a training set.

    8. How the ground truth for the training set was established
      Not applicable.

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