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510(k) Data Aggregation

    K Number
    K061151
    Device Name
    PIONEER VERTEBRAL SPACER (VERTEBRAL SPACER)
    Manufacturer
    PIONEER SURGICAL TECHNOLOGY
    Date Cleared
    2006-07-24

    (90 days)

    Product Code
    MQP
    Regulation Number
    888.3060
    Type
    Traditional
    Panel
    Orthopedic (OR)
    Reference & Predicate Devices
    K043206
    Why did this record match?
    Device Name :

    PIONEER VERTEBRAL SPACER (VERTEBRAL SPACER)

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

    The Pioneer Vertebral Spacer is intended for use in the thoracolumbar spine (T1-L5) for partial replacement (i.e., partial vertebrectomy) of a diseased vertebral body resected or excised for the treatment of tumors in order to achieve anterior decompression of the spinal cord and neural tissues, and to restore the height of a collapsed vertebral body. The Pioneer Vertebral Spacer is also indicated for treating fractures of the thoracic and lumbar spine. The Pioneer Vertebral Spacer is designed to restore the biomechanical integrity of the anterior, middle and posterior spinal column, even in the absence of fusion for a prolonged period of time. The system must be used with the Pioneer Quantum Pedicle Screw System or supplemental internal fixation systems cleared for the conditions listed above (i.e., tumor or trauma of T1-L5). Additionally, the Pioneer Vertebral Spacer implant is intended to be used with bone graft.

    Device Description

    The Pioneer Vertebral Spacer is a radiolucent vertebral body replacement device of various heights and footprints used in conjunction with supplemental internal fixation to provide structural stability in skeletally mature individuals following partial replacement of a diseased vertebral body.

    AI/ML Overview

    The Pioneer Vertebral Spacer is a medical device and its predicate device is K043206.

    Here's the breakdown of the acceptance criteria and study information:

    1. Table of Acceptance Criteria and Reported Device Performance:

    Acceptance CriteriaReported Device Performance
    Mechanical Performance: The device must demonstrate structural integrity and long-term stability suitable for supporting the spinal column after partial vertebrectomy."Mechanical and Chemical information were presented." The submission states the device's substantial equivalence is based on "similar materials, performance, and indications for use" compared to the predicate device.
    Chemical Performance: The device materials must be biocompatible and conform to relevant standards."Mechanical and Chemical information were presented." The device uses "Radiolucent polymer and titanium alloy materials in conformance with ASTM Standard Specifications."
    Material Conformance: Materials used must adhere to specified ASTM standards."Radiolucent polymer and titanium alloy materials in conformance with ASTM Standard Specifications."
    Indication for Use Match: The device's intended use must be substantially equivalent to the predicate device.The device's indications for use are detailed (thoracolumbar spine (T1-L5) for partial replacement of diseased vertebral bodies due to tumors or fractures, to restore height and biomechanical integrity). Substantial equivalence assertion is based on "similar materials, performance, and indications for use demonstrated."
    Radiolucency: The device must be radiolucent."The Pioneer Vertebral Spacer is a radiolucent vertebral body replacement device."

    2. Sample size used for the test set and the data provenance:

    • This 510(k) submission primarily relies on bench testing (mechanical and chemical information) and demonstrated substantial equivalence to a predicate device (K043206).
    • The document does not mention a "test set" in the context of clinical data, human subjects, or image-based evaluations. Therefore, there is no sample size for a test set and no data provenance in terms of country of origin or retrospective/prospective human data.

    3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

    • Not applicable. There is no mention of a test set involving expert review of clinical cases.

    4. Adjudication method for the test set:

    • Not applicable. There is no mention of a test set involving adjudication.

    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:

    • No MRMC study was done. This device is a passive vertebral spacer, not an AI-powered diagnostic or assistive tool.

    6. If a standalone (i.e., algorithm only without human-in-the loop performance) was done:

    • No standalone algorithm performance study was done. This device is a physical implant, not an algorithm.

    7. The type of ground truth used:

    • The "ground truth" for this device's performance is established through engineering principles, material science testing (mechanical and chemical data), and comparison to the characteristics and performance of a legally marketed predicate device. There is no biological or diagnostic ground truth (like pathology or outcomes data) directly mentioned as part of the submission for this type of device.

    8. The sample size for the training set:

    • Not applicable. This device is not an AI/ML algorithm that requires a "training set."

    9. How the ground truth for the training set was established:

    • Not applicable, as there is no training set for an AI/ML algorithm.
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