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510(k) Data Aggregation

    K Number
    K081684

    Validate with FDA (Live)

    Device Name
    BLACKSTONE PEDICLE SCREW SYSTEM
    Manufacturer
    BLACKSTONE MEDICAL, INC.
    Date Cleared
    2008-09-15

    (90 days)

    Product Code
    NKB,MNH,MNI
    Regulation Number
    888.3070
    Type
    Traditional
    Panel
    Orthopedic
    Reference & Predicate Devices
    K994217,K020674,K013558,K003735,K023498,K030581,K030862,K080407,K052123,K052151
    Predicate For
    K082797,K092624,K093926,K100044,K102204,K111448,K122901,K130932
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The Blackstone Pedicle Screw System is intended for posterior, non-cervical pedicle fixation. Pedicle screw fixation is limited to skeletally mature patients and is intended to be used as an adjunct to fusion using autograft or allograft. The device is indicated for all of the following indications regardless of the intended use:

    1. degenerative disc disease (defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies)
    2. spondylolisthesis,
    3. trauma (i.e., fracture or dislocation),
    4. spinal stenosis,
    5. deformities or curvatures (i.e., scoliosis, kyphosis, and/or lordosis),
    6. tumor,
    7. pseudoarthrosis, and
    8. failed previous fusion
      The Blackstone Pedicle Screw System components are used with certain components of the Blackstone SFS system, including rods, rod connectors and cross-connectors.
    Device Description

    The Blackstone Pedicle Screw System consists of an assortment of multiaxial and monoaxial pedicle screws, set screws, and screw bodies.

    AI/ML Overview

    Here's an analysis of the provided text regarding the acceptance criteria and the study that proves the device meets those criteria:

    Device: Blackstone Pedicle Screw System

    1. Table of Acceptance Criteria and Reported Device Performance

    Criteria CategoryAcceptance Criteria (Implicit)Reported Device Performance (Blackstone Pedicle Screw System)
    Substantial EquivalenceDemonstrate substantial equivalence to legally marketed predicate devices in intended use, indications, technological characteristics, and principles of operation. Differences should not raise new safety or effectiveness issues.- Same intended use as predicate devices. - Similar indications as predicate devices. - Similar technological characteristics and principles of operation as predicate devices. - Mechanical testing addressed technical differences, showing no new safety or effectiveness issues.
    Mechanical PerformanceMechanical performance (e.g., strength, durability) must be comparable to predicate devices to ensure safety and effectiveness.Mechanical testing was conducted which demonstrates that the system is substantially equivalent to predicate devices.

    Explanation of Implicit Criteria: The document is a 510(k) summary, which focuses on demonstrating "substantial equivalence" to a legally marketed predicate device. Therefore, the explicit acceptance criteria are not stated in terms of specific performance metrics for the device itself but rather its ability to perform at least as well as and be as safe and effective as the predicate devices. The "performance data" section states that mechanical testing was conducted to prove this equivalence.

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

    The provided summary does not specify a sample size for a "test set" in the context of clinical data or human evaluation. The performance data section refers to "mechanical testing," which implies laboratory-based tests on device components or finished products.

    • Sample Size for Test Set: Not applicable/Not specified in the provided document, as the study described is mechanical testing, not a user-based or clinical study.
    • Data Provenance: Not applicable/Not specified. The tests are laboratory-based mechanical tests.

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

    Not applicable. This information would be relevant for studies involving human interpretation or clinical outcomes. The document discusses mechanical testing.

    4. Adjudication Method for the Test Set

    Not applicable. Adjudication methods are used to resolve discrepancies in human assessments, which is not relevant to mechanical testing.

    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, an MRMC comparative effectiveness study was not done. The document describes mechanical testing for a medical device (pedicle screw system), not an AI-assisted diagnostic or interpretative system that would involve human readers.

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

    Not applicable. This is not an AI/algorithm-based device. The "standalone" performance here refers to the mechanical integrity and functionality of the physical pedicle screw system itself, which was assessed through mechanical testing.

    7. The Type of Ground Truth Used

    The "ground truth" for the mechanical testing would be the performance characteristics of the predicate devices. The Blackstone Pedicle Screw System was deemed acceptable if its mechanical performance was "substantially equivalent" to these known and previously approved devices.

    8. The Sample Size for the Training Set

    Not applicable. This is not an AI/machine learning device that would require a "training set."

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

    Not applicable. As there is no training set mentioned for this device, there is no ground truth established for it.

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