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510(k) Data Aggregation

    K Number
    K061155
    Device Name
    VISTA P VERTEBRAL BODY REPLACEMENT SYSTEM
    Manufacturer
    ZIMMER TRABECULAR
    Date Cleared
    2006-09-22

    (149 days)

    Product Code
    MQP
    Regulation Number
    888.3060
    Type
    Traditional
    Panel
    Orthopedic
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Device Name :

    VISTA P VERTEBRAL BODY REPLACEMENT SYSTEM

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

    The Vista® P Vertebral Body Replacement System is a vertebral body replacement device intended for use in the thoracolumbar spine (T1 – L5) to replace a collapsed, damaged or unstable vertebral body due to tumor or trauma (i.e., fracture). - The Vista® P Vertebral Body Replacement is intended for use with supplemental internal spinal fixation systems. The Vista® P Vertebral Body Replacement may be used with bone graft.

    Device Description

    The Vista" P Vertebral Body Replacement (VBR) System is comprised wholly of unfilled PEEK Optima material. This VBR system accommodates replacement of a vertebral body in the thoracic and lumbar region of the spine. The device is available in a variety of cross sections and heights to properly tension the spine. The device must be implanted in pairs and cannot be used singly. The superior and inferior surfaces of the device have a pattern of teeth to provide increased stability. Radiopaque markers are press fit into the device to identify the boundary of the device in intra and postoperative imaging.

    AI/ML Overview

    The provided text describes a 510(k) submission for the Zimmer Trabecular Metal Technology, Inc. Vista® P Vertebral Body Replacement System. However, it does not describe:

    • Acceptance criteria in the typical sense of a target performance metric (e.g., sensitivity, specificity, accuracy). Instead, "Performance Data" refers to mechanical testing.
    • A study proving the device meets acceptance criteria related to diagnostic performance or AI algorithm performance. This is a medical device, not an AI/imaging diagnostic device.

    Therefore, many of the requested items (e.g., sample size for test set, data provenance, number of experts for ground truth, adjudication method, MRMC study, standalone performance, training set details) are not applicable to this specific document as it pertains to a physical medical implant device and its mechanical performance, not a diagnostic algorithm.

    Here's an attempt to answer the questions based only on the provided text, highlighting the information that is missing or not applicable:

    1. Table of Acceptance Criteria and Reported Device Performance

    Acceptance Criteria (Type)Reported Device Performance
    Mechanical performance per established ASTM standards"The results of this performance testing demonstrated that the device will perform as intended and is equivalent to the cited predicate devices."
    Substantial equivalence to predicate devices for indications for use"The Vista P Vertebral Body Replacement System is substantially equivalent to the predicate devices identified in this premarket notification."

    Note: The document does not specify quantitative acceptance criteria (e.g., "must withstand X N of force," or specific fatigue life endpoints). It states performance against "established ASTM standards" and equivalence to predicates.

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

    • Not Applicable. This document reports on mechanical performance testing of an implantable device, not a diagnostic algorithm evaluated on a patient data test set. The "test set" would likely refer to a number of physical devices subjected to mechanical tests, but the sample size is not specified.
    • Data Provenance: Not applicable in the context of patient data. The mechanical testing would have been conducted in a controlled lab environment.

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

    • Not Applicable. Ground truth, in the context of diagnostic algorithms, typically refers to expert labels or pathology results. For mechanical testing, the "ground truth" is adherence to engineering standards and comparison to predicate devices, not expert consensus on patient data.

    4. Adjudication method for the test set

    • Not Applicable. This is relevant for studies involving human interpretation or labeling of data, not for mechanical device 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

    • Not Applicable. This is a physical medical device, not an AI-based diagnostic tool. No MRMC study was conducted or is relevant here.

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

    • Not Applicable. This is a physical medical device. There is no algorithm to be evaluated in a standalone manner.

    7. The type of ground truth used

    • For mechanical performance: Adherence to "established ASTM standards" and comparison to "cited predicate devices."
    • For regulatory conclusion: Substantial equivalence based on design, materials, and intended use compared to legally marketed predicate devices.

    8. The sample size for the training set

    • Not Applicable. This is a physical medical device. There is no concept of a "training set" in the context of this 510(k) submission.

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

    • Not Applicable. (See #8)
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