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510(k) Data Aggregation

    K Number
    K122503
    Device Name
    PARALLAX BALLOON INFLATABLE BONE TAMP-10 MM BALLOON PARALLAX BALLOON INFLATABLE BONE TAMP-15 MM BALLOON PARALLAX BALLOON
    Manufacturer
    NEURO THERM, INC.
    Date Cleared
    2013-06-25

    (313 days)

    Product Code
    NDN
    Regulation Number
    888.3027
    Type
    Traditional
    Panel
    Orthopedic (OR)
    Reference & Predicate Devices
    K101864,K010246,K041454
    Why did this record match?
    Reference Devices :

    K101864, K010246, K041454

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

    The NeuroTherm Parallax Balloon Inflatable Bone Tamp is intended to be used as a conventional bone tamp for the reduction and fixation of fractures and/or creation of a void in cancellous bone in the spine. This includes use during percutaneous vertebral augmentation. The Parallax Balloon Inflatable Bone Tamp is to be used with cleared spinal polymethylmethacrylate (PMMA) bone cement indicated for use during percutaneous vertebral augmentation, such as kyphoplasty.

    Device Description

    The NeuroTherm Parallax Balloon Inflatable Bone Tamp with an inflatable component at the distal end. The tamp is designed to compress cancellous bone and/or move cortical bone as it inflates. The catheter shaft contains an outer lumen for the tamp inflation and a central lumen for a stylet to facilitate catheter introduction. At full inflation volume, the balloon design allows for a uniform balloon that is concentric to the catheter shaft. The wire mandrel provides stiffness to the balloon catheter to facilitate insertion through the access cannula. The NeuroTherm Parallax Balloon Inflatable Bone Tamp may be used with FDA cleared balloon inflation syringes.

    AI/ML Overview

    The NeuroTherm Parallax Balloon Inflatable Bone Tamp's acceptance criteria and performance study details are as follows:

    1. Table of Acceptance Criteria and Reported Device Performance

    The device's acceptance criteria are primarily demonstrated through substantial equivalence to predicate devices, supported by bench testing and compliance with relevant standards. No specific quantitative performance metrics or thresholds are explicitly stated as acceptance criteria beyond those inherent in establishing substantial equivalence.

    Acceptance Criterion (Implicit)Reported Device Performance and Evidence
    Technology is similar or same as predicate devices.The device description details a double-lumen catheter shaft, side arm adapter, continuous straight arm port, and radiopaque markers, which are comparable to the characteristics of the predicate KyphX Xpander and Inflatable Bone Tamps.
    Intended use/Indication for Use in the spine is similar or same as predicate devices.The intended use for reduction and fixation of fractures and/or creation of a void in cancellous bone in the spine, including percutaneous vertebral augmentation with cleared PMMA bone cement, directly aligns with the indications of the predicate KyphX Xpander and Inflatable Bone Tamps for similar spinal applications.
    Technical specifications or range of technical specifications are similar or same as predicate devices.While specific ranges are not detailed, the comparison table shows similarities in general design and features. For instance, the presence of a balloon length indicator (printed band vs. color-coded band) and the use of an inflatable bone tamp design align with predicates.
    No new issues of safety or effectiveness are raised by differences.The 510(k) summary explicitly states: "Any differences between the NeuroTherm Parallax Balloon Inflatable Bone Tamp and the predicate devices do not raise new issues of safety or effectiveness." This implies that any variations were assessed and deemed acceptable.
    Device performs as expected."Bench - Bench testing supports that the NeuroTherm Parallax Balloon Inflatable Bone Tamp performs as expected." (No specific quantitative results are provided in the summary.)
    Compliance with relevant consensus standards.The device complies with a list of ASTM, ANSI/AAMI/ISO, and ISO standards related to implants, sterilization, biological evaluation, and luer fittings, ensuring fundamental safety and performance aspects are met.

    2. Sample Size Used for the Test Set and Data Provenance

    The provided 510(k) summary does not specify a test set involving human data or a specific number of samples for the bench testing beyond the general statement "Bench testing supports that the NeuroTherm Parallax Balloon Inflatable Bone Tamp performs as expected." There is no indication of country of origin or whether any data was retrospective or prospective in detail. It appears the primary "test set" for substantial equivalence was the comparison to existing predicate devices and the internal bench testing.

    3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications

    This information is not provided in the given 510(k) summary. The summary focuses on engineering and regulatory comparisons rather than clinical performance studies requiring expert ground truth in the context of diagnostic or treatment efficacy.

    4. Adjudication Method for the Test Set

    This information is not provided in the given 510(k) summary, as there is no mention of a formal adjudication process for a clinical test set.

    5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

    No MRMC comparative effectiveness study was done. The device is a physical medical instrument (an inflatable bone tamp), not an AI-powered diagnostic or decision support system that would typically warrant such a study.

    6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study

    Not applicable. This device is an instrument used directly by a surgeon; it's not an algorithm or software requiring a standalone performance evaluation in the context of AI.

    7. Type of Ground Truth Used

    The ground truth used for demonstrating substantial equivalence was primarily:

    • Predicate Device Characteristics: The established design, intended use, and specifications of the legally marketed Kyphon Xpander II, KyphX Xpander, and KyphX Inflatable Bone Tamps.
    • Bench Test Results: Internal engineering data demonstrating the device's functional performance against its design requirements (though specific metrics are not detailed).
    • Compliance with Standards: Meeting the requirements of various recognized national and international standards related to medical devices.

    8. Sample Size for the Training Set

    There is no mention of a "training set" as this device is a physical instrument and not a machine learning or AI algorithm.

    9. How the Ground Truth for the Training Set Was Established

    Not applicable, as there is no training set for this type of device.

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