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510(k) Data Aggregation

    K Number
    K101678
    Device Name
    ROMEO POSTERIOR OSTEOSYNTHESIS SYSTEM
    Manufacturer
    SPINEART
    Date Cleared
    2010-07-28

    (43 days)

    Product Code
    MNH,KWP,MNI
    Regulation Number
    888.3070
    Type
    Special
    Panel
    Orthopedic
    Reference & Predicate Devices
    K081165,K093170
    Predicate For
    K111127,K112108,K130267,K140948,K141835,K172101
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    ROMEO posterior osteosynthesis system is intended to provide immobilization and stabilization of spinal segments in skeletally mature patients as an adjunct to fusion in the treatment of the following acute and chronic instabilities or deformities of the thoracic, lumbar, and sacral spine: severe spondylolisthesis (grades 3 and 4) of the L5-S1 vertebra; degenerative spondylolisthesis with objective evidence of neurologic impairment; fracture; dislocation; scoliosis; kyphosis; spinal tumor; and failed previous fusion (pseudarthrosis).

    Device Description

    The modifications to ROMEO posterior osteosynthesis system (K081165 & K093170) manufactured by SPINEART consist of addition of 4.0 and 8.0 mm in diameter polyaxial screws made of titanium alloy, addition of Cobalt Chrome alloy rods, and extension of length range for other screw diameter and rods.

    AI/ML Overview

    The provided text is a 510(k) summary for a medical device called the "ROMEO posterior osteosynthesis system." This document focuses on demonstrating substantial equivalence to a predicate device through mechanical testing, rather than clinical performance based on diagnostic accuracy. Therefore, many of the requested categories related to diagnostic studies and expert-driven ground truth are not applicable.

    Here's an analysis based on the information provided:

    1. Table of Acceptance Criteria and Reported Device Performance

    Acceptance CriteriaReported Device Performance
    Conforms to special control established for Pedicle screw spinal system.Additional components conform to special control established for Pedicle screw spinal system.
    Conforms to "Spinal System 510(k)s - Guidance for Industry and FDA Staff Document" issued on: May 3, 2004.Additional components conform to "Spinal System 510(k)s - Guidance for Industry and FDA Staff Document" issued on: May 3, 2004.
    Performs as safely and effectively as their predicate devices based on mechanical testing (static axial compression, static torsion, dynamic axial compression) conducted according to ASTM F1717-09.Results of mechanical testing (static axial compression, static torsion, dynamic axial compression tests performed according to ASTM F1717-09) demonstrate that additional components perform as safely and effectively as their predicate devices.
    Substantially equivalent to predicate device in terms of intended use, material, design, mechanical properties, and function.ROMEO posterior osteosynthesis system additional components are substantially equivalent to their predicate device in terms of intended use, material, design, mechanical properties and function.

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

    • Sample Size for Test Set: Not applicable. This study involves mechanical testing of device components, not a test set of patient data.
    • Data Provenance: Not applicable. The data comes from mechanical test reports on the device components, not from patient populations or countries of origin.

    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 refers to engineering specifications and performance standards (ASTM F1717-09, FDA guidance), not expert interpretation of diagnostic images or patient outcomes.

    4. Adjudication method for the test set

    • Not applicable. There was no need for adjudication as the study did not involve interpretation of test results by multiple human readers.

    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 not an AI-assisted diagnostic device; it is a spinal implant system.

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

    • Not applicable. This is not an algorithmic device. The "standalone" performance refers to the mechanical integrity of the device components themselves.

    7. The type of ground truth used

    • The ground truth in this submission is the mechanical performance standards defined by ASTM F1717-09 and the FDA's "Spinal System 510(k)s - Guidance for Industry and FDA Staff Document." The device effectively measures up against these established engineering and regulatory benchmarks.

    8. The sample size for the training set

    • Not applicable. There is no training set of data for this type of device.

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

    • Not applicable. There is no training set for this type of device.
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