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    K Number
    K142655
    Device Name
    CB PROT II Posterior Spinal System
    Manufacturer
    CHIN BONE TECHNIQUE CORP
    Date Cleared
    2015-01-26

    (130 days)

    Product Code
    MNH,MNI
    Regulation Number
    888.3070
    Type
    Traditional
    Panel
    Orthopedic
    Reference & Predicate Devices
    K111883
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The CB PROT II Posterior Spinal System is intended to provide immobilization and stabilization for posterior, noncervical, pedicle fixation of the thoracic, lumbar and sacral spinal elements (T1-S1) as an adjunct to fusion for the following indications:

    • Trauma (i.e. fracture or dislocation).
    • Spinal stenosis.
    • Vertebral tumors.
    • Pseudoarthrosis and failed previous fusion in skeletally mature patients.
    • Scoliosis, kyphosis and lordosis, and severe spondylolisthesis (grade 3 or 4) of the T1-S1 vertebra.
      The system is intended to be used with autograft or allograft to facilitate fusion.
    Device Description

    The CB PROT II Posterior Spinal System consists of non-sterile rods, monoaxial and polyaxial pedicle screws. The thoraco-lumbar rods are available in a variety of lengths (one diameter). Screws are available in various lengths and diameters according to practical requirements.

    AI/ML Overview

    This document is a 510(k) premarket notification for a medical device called the "CB PROT II Posterior Spinal System." It is a regulatory submission to the FDA to demonstrate that the new device is substantially equivalent to legally marketed predicate devices.

    The document does not describe an acceptance criteria or study for an AI/CADe/CADx device that relies on diagnostic performance metrics like sensitivity, specificity, or AUC, nor does it involve human readers, expert ground truth, or training sets in the typical sense of AI device evaluation.

    Instead, this document describes the acceptance criteria and a study for a spinal implant system, which is a physical device subject to mechanical and material performance standards. Therefore, the questions in the prompt, which are tailored for AI/diagnostic devices, do not directly apply to this submission.

    However, I can extract the information relevant to the device's "performance" and "acceptance criteria" in the context of this specific regulatory submission for a spinal system:

    1. Table of Acceptance Criteria and Reported Device Performance

    Acceptance CriteriaReported Device Performance
    Material: Components manufactured from medical grade titanium alloy (Ti6Al4V) meeting ASTM F136 & ISO 5832-3 standards.Components are manufactured from medical grade titanium alloy (Ti6Al4V) that meets ASTM F136 & ISO 5832-3.
    Mechanical Performance: Performance as well as or better than the predicate device (SmartLocTM spinal fixation system) in:Static axial compression bending testDynamic axial compression bending testStatic torsion test (All referring to ASTM F1717 standards).The results represented that the CB PROT II Posterior Spinal System performs as well as or better than the predicate device in static/dynamic axial compression bending tests and static torsion tests, conducted referring to ASTM F1717.
    Substantial Equivalence: Demonstrated substantial equivalence to predicate system with respect to technical characteristics, performance, and intended use.The information provided within this premarket notification supports substantial equivalence of the subject device to the predicate device.

    2. Sample size used for the test set and the data provenance
    The document does not specify a "sample size" in the context of a test set of images or patient data. For mechanical testing, the "test set" would refer to the number of physical device units tested. This specific number is not provided in the summary, but such tests typically involve multiple units to ensure statistical significance for mechanical properties. The provenance is implied to be from the manufacturer's internal testing.

    3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
    Not applicable. This is not an AI/diagnostic device that requires expert review for ground truth in clinical data. The "ground truth" for this device relates to engineering specifications and mechanical performance standards.

    4. Adjudication method for the test set
    Not applicable. There is no adjudication method described as this is not a diagnostic performance study involving human reviewers.

    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 applicable. This is not an AI-assisted diagnostic device, so no MRMC study or assessment of human reader improvement with AI assistance was performed.

    6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
    Not applicable. This is not an algorithm-based device. "Standalone performance" in this context refers to the device's ability to meet mechanical standards independently, which was indeed what the mechanical tests evaluated.

    7. The type of ground truth used
    The "ground truth" for this device's performance evaluation is based on established engineering and material science standards (ASTM F136, ISO 5832-3, ASTM F1717) and comparative performance against a legally marketed predicate device.

    8. The sample size for the training set
    Not applicable. This is not an AI device that requires a training set.

    9. How the ground truth for the training set was established
    Not applicable. This is not an AI device that requires a training set.

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