LogoFDA 510(k) Search
Search Filters

Search Results

Found 1 results

510(k) Data Aggregation

    K Number
    K090841
    Device Name
    ADDPLUS
    Manufacturer
    ULRICH GMBH & CO. KG
    Date Cleared
    2009-10-05

    (192 days)

    Product Code
    MQP,MOP
    Regulation Number
    888.3060
    Type
    Traditional
    Panel
    Orthopedic
    Reference & Predicate Devices
    K012254
    Why did this record match?
    Device Name :

    ADDPLUS

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

    The AddPlus™ 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 AddPlus™ is intended to be used with supplemental internal fixation systems that are cleared by FDA for use in the thoracic and lumbar spine. Such systems include posterior pedical screw and rod systems, anterior plate systems, and anterior screw and rod systems.

    The use of bone grafting material with the AddPlus™ is optional.

    Device Description

    The AddPlus™ is a modification of the 12 mm diameter VBR™ device cleared under K012254. It is an adjustable (distractable) cylindrical cage with attached fixation plates that add supplemental bilateral spinal fixation to the design of the marketed VBR™ device. The device remains constructed from medical grade titanium alloy. In the case of resected vertebral bodies of the human spine, the AddPlus™ is used for bridging the intervertebral space and serves to lengthen the anterior column, realigning the spinal profile, to stabilize the anterior column, and to support the consolidation of inserted bone material.

    The attached fixation plates serve to provide further fixation and stabilization and to prevent migration as well as possible sinking in of the implant. The device is available in one diameter (i.e., 12 mm), four expansion ranges (i.e., 13 - 18 mm, 17 - 26 mm, 25 - 41 mm, and 40 - 65 mm), and four angles (i.e., 0°, 6°, 12°, and 18°).

    Available components to be used with the AddPlus™ include a locking screw, osmium™ screw. and cancellous bone screw. The locking screw is used to fix the height of the adjusted AddPlus™4. The osmium™ screw is used for monocortical fixation. It is available in lengths of 14, 16, and 18 mm, with a diameter of 5 mm. The cancellous bone screw is used for bicortical fixation. It is available in lengths of 12, 14, 16, 18, 20, 24, and 26 mm, with a diameter of 4 mm. In addition to these device components, a number of surgical instruments are available for use during implantation of the device.

    AI/ML Overview

    The provided document describes a medical device called AddPlus™, Anterior Distraction Device Plus, and its 510(k) summary for FDA clearance. The information focuses on its mechanical characteristics and intended use, rather than a clinical study evaluating diagnostic or prognostic performance. Therefore, many of the requested criteria cannot be directly addressed.

    Here's the breakdown of what can be extracted and what cannot:

    1. Table of Acceptance Criteria and Reported Device Performance

    Acceptance CriteriaReported Device Performance
    Equivalence to predicate devices in mechanical characteristics (withstanding anticipated in vivo loads)Mechanical testing, in accordance with applicable recommendations of FDA guidance titled "Guidance for Industry and FDA Staff, Guidance for Spinal Systems 510(k)s," dated May 2004, was conducted to demonstrate equivalence to the predicate devices and demonstrated the subject device's capability to withstand anticipated in vivo loads.

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

    • Not Applicable. The document describes mechanical (bench) testing, not a clinical test set with human or animal subjects. The "test set" in this context refers to the physical devices subjected to mechanical stress.

    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 this context, would typically refer to clinical diagnosis or outcomes. For mechanical testing, the "ground truth" is defined by established engineering standards and guidelines for spinal implants. The document does not specify human experts for establishing the "ground truth" of mechanical performance, as it relies on standardized testing methods.

    4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

    • Not Applicable. As this is mechanical testing, there is no human adjudication process described. Performance is measured against engineering specifications.

    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. The device is a physical spinal implant, not an AI-based diagnostic tool. Therefore, an MRMC study and AI assistance are not relevant.

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

    • Not Applicable. The device is a physical spinal implant, not an algorithm.

    7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

    • The ground truth for the mechanical performance is implicitly defined by accepted scientific methods and FDA guidance for spinal systems 510(k)s, which specify the types of loads and conditions the device must withstand. This is a form of engineering standard ground truth.

    8. The sample size for the training set

    • Not Applicable. This is not an AI/machine learning device, so there is no concept of a "training set" in the traditional sense.

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

    • Not Applicable. As there is no training set mentioned, this question is not applicable.
    Ask a Question

    Ask a specific question about this device

    Page 1 of 1