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510(k) Data Aggregation

    K Number
    K191932
    Device Name
    Momentum™ Posterior Spinal Fixation System
    Manufacturer
    Ulrich Medical USA
    Date Cleared
    2019-10-02

    (75 days)

    Product Code
    NKB
    Regulation Number
    888.3070
    Type
    Traditional
    Panel
    Orthopedic (OR)
    Reference & Predicate Devices
    K123717,K133369,K102853,K161032,K151704
    Why did this record match?
    Device Name :

    Momentum™ Posterior Spinal Fixation System

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

    The Momentum™ Posterior Spinal Fixation System is intended to provide immobilization of spinal segments in skeletally mature patients as an adjunct to fusion of the thoracolumbar and sacroiliac spine. When used as a posterior spine system, Momentum is intended for the following indications: degenerative disc disease, spinal stenosis, spondylolisthesis, spinal deformities (i.e., scoliosis, and/ or lordosis), trauma (i.e., fracture or dislocation), tumor, pseudoarthrosis and failed previous fusion.

    In order to achieve additional levels of fixation, the Momentum Posterior System can also be connected to the neon3® universal OCT spinal stabilization system via transition rods or connectors. Please refer to the neon3 Instructions for Use for a list of indications for use.

    Device Description

    The Momentum™ Posterior Spinal Fixation System consists of longitudinal members (rods), anchors (screws), connectors (rod/rod and rod/anchor) and fasteners in a variety of sizes to accommodate differing anatomic requirements.

    AI/ML Overview

    This document is a 510(k) summary for the Momentum™ Posterior Spinal Fixation System. It describes the device, its intended use, and its substantial equivalence to predicate devices, primarily based on mechanical testing. It does not describe an AI/ML-based medical device. Therefore, the questions related to acceptance criteria and studies proving the device meets those criteria, specifically concerning AI/ML performance metrics, ground truth, expert involvement, and sample sizes for AI model training/testing, are not applicable to the provided document.

    The document focuses on the mechanical performance of a spinal fixation system. Below is the relevant information from the document related to its performance as a physical medical device, structured as closely as possible to the request, while noting the non-applicability of AI/ML specific criteria.

    1. A table of acceptance criteria and the reported device performance

    Acceptance Criteria (What was tested)Reported Device Performance (How the device performed)
    Static and Dynamic Compression Bending according to ASTM F1717The mechanical test results demonstrate that the Momentum™ Posterior Spinal Fixation System performance is substantially equivalent to the predicate devices.
    Static Torsion according to ASTM F1717The mechanical test results demonstrate that the Momentum™ Posterior Spinal Fixation System performance is substantially equivalent to the predicate devices.
    Tulip/Shank Pull-Off TestingPerformed, and results demonstrate substantial equivalence to predicate devices.

    2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

    • The document mentions "Mechanical testing of worst case Momentum™ System constructs." However, it does not specify the sample size (number of constructs tested) used for these mechanical tests.
    • Data Provenance: Not specified, but generally, mechanical testing for medical devices is conducted in a laboratory setting, not typically described by country of origin or retrospective/prospective data.

    3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

    • This question is not applicable as the device is a mechanical spinal fixation system, not an AI/ML diagnostic or prognostic tool. "Ground truth" in this context would refer to the physical and mechanical properties measured in a lab, not expert interpretations of medical images or data.

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

    • This question is not applicable. Mechanical testing typically involves predefined test methods and measurements, not adjudication by human experts.

    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

    • This question is not applicable as the device is a mechanical spinal fixation system and does not involve human readers or AI assistance.

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

    • This question is not applicable as the device is a mechanical spinal fixation system and does not involve algorithms or AI.

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

    • The "ground truth" for this device would be its measured mechanical properties (e.g., strength, stiffness, resistance to pull-off) determined experimentally and compared against established industry standards (ASTM F1717) and the performance of predicate devices. This is not "expert consensus," "pathology," or "outcomes data" in the medical sense.

    8. The sample size for the training set

    • This question is not applicable as the device is a mechanical spinal fixation system and does not involve AI/ML models with training sets.

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

    • This question is not applicable for the same reason mentioned in point 8.
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