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510(k) Data Aggregation

    K Number
    K100243
    Device Name
    QUINTEX CERVICAL PLATING SYSTEM
    Manufacturer
    AESCULAP IMPLANT SYSTEMS, LLC
    Date Cleared
    2010-09-02

    (218 days)

    Product Code
    KWQ
    Regulation Number
    888.3060
    Type
    Traditional
    Panel
    Orthopedic (OR)
    Reference & Predicate Devices
    K050813,K040017,K000486,K974706,K953720,K936269,K913730,K022997,K050804
    Why did this record match?
    Reference Devices :

    K050813,K040017,K000486,K974706,K953720,K936269,K913730,K022997,K050804

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

    The Quintex Cervical Plating System is intended for the immobilization and stabilization of the spine as an adjunct to fusion in patients with:

    • . Degenerative disc disease (DDD) (defined as neck pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies),
    • Spondylolisthesis,
    • Trauma (i.e. fracture or dislocation), ●
    • Spinal Stenosis,
    • . Deformity (i.e., scoliosis, kyphosis, and/or lordosis),
    • . Tumors.
    • Pseudoarthrosis as a result of failed spine surgery,
    • Failed previous fusions, .
    • Symptomatic cervical spondylosis
    • . Instability following surgery for the above indications.
      Levels of anterior cervical intervertebral body screw fixation for this indication are from C2-T1.
      Warning: This device is not approved or intended for screw attachment or fixation to the posterior elements (pedicles) of the cervical, thoracic, or lumbar spine.
    Device Description

    The Aesculap Implant Systems (AIS) Quintex Cervical Plating System consists of dynamic and semi-constrained plate, screws and associated instruments. Fixation is provided by bone screws inserted into the vertebral body of the cervical spine using an anterior approach. The AIS 3G Cervical Plating System is manufactured from Titanium/ Titanium Alloy and will be provided non-sterile.

    AI/ML Overview

    The provided text describes the Quintex Cervical Plating System, its indications for use, and its substantial equivalence to predicate devices based on biomechanical testing. However, it does not contain the specific information required to complete the table and answer the questions related to acceptance criteria and a study proving a device meets those criteria, particularly in the context of AI/software performance or detailed clinical trials.

    The document discusses performance data in a general sense, stating: "Biomechanical testing of the subject device was found to be similar in performance to previously cleared spinal systems with similar indications. All required testing per 'Draft Guidance for the Preparation of Premarket Notifications (510(k)s) Applications for Orthopedic Devices-The Basic Elements' were done where applicable. In addition, testing per the 'Spinal System 510(k)s' was completed where relevant. Testing results demonstrate the AIS Quintex Cervical Plating System is safe and effective comparable to other predicate systems currently on the market."

    This indicates that mechanical and possibly other non-clinical performance benchmarks were met, but it lacks the detail to fulfill the prompt's request for specific acceptance criteria and study designs relevant to clinical performance, expert adjudication, or AI performance.

    Therefore, many of the requested fields cannot be filled based on the provided text.

    Here's a breakdown of what can and cannot be answered:

    1. Table of Acceptance Criteria and Reported Device Performance:

    Acceptance CriteriaReported Device Performance
    Mechanical/Biomechanical performance comparable to predicate devices."Biomechanical testing of the subject device was found to be similar in performance to previously cleared spinal systems with similar indications." "Testing results demonstrate the AIS Quintex Cervical Plating System is safe and effective comparable to other predicate systems currently on the market."
    Compliance with "Draft Guidance for the Preparation of Premarket Notifications (510(k)s) Applications for Orthopedic Devices-The Basic Elements""All required testing per... were done where applicable."
    Compliance with "Spinal System 510(k)s" guidance"Testing per the 'Spinal System 510(k)s' was completed where relevant."

    2. Sample size used for the test set and the data provenance: Not specified in the document. The testing mentioned appears to be mechanical/biomechanical, not a clinical test set with patient data.

    3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not specified, as the "ground truth" seems to relate to engineering and biomechanical properties rather than clinical diagnoses.

    4. Adjudication method for the test set: Not applicable and not specified.

    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 device is a mechanical implant, not an AI or imaging diagnostic tool.

    6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done: Not applicable.

    7. The type of ground truth used: For biomechanical testing, the "ground truth" would likely be established mechanical properties, failure limits, and performance under various loads, as defined by engineering standards and predicate device performance. Specifics are not provided.

    8. The sample size for the training set: Not applicable, as this is not an AI/ML device.

    9. How the ground truth for the training set was established: Not applicable.

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