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510(k) Data Aggregation

    K Number
    K113346
    Device Name
    NEON SYSTEM
    Manufacturer
    ULRICH GMBH & CO. KG
    Date Cleared
    2012-02-28

    (106 days)

    Product Code
    KWP
    Regulation Number
    888.3050
    Type
    Traditional
    Panel
    Orthopedic
    Reference & Predicate Devices
    K033480,K073420,K031985,K052566,K062505,K090060,K030377,K011966
    Why did this record match?
    Device Name :

    NEON SYSTEM

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

    When intended to provide immobilization and stabilization as an adjunct to fusion of the cervical spine and the occipito-cervico-thoracic junction (occiput-T3), the plate/rod, rod, hook, screw, connector and crosslink components of neon™ are indicated for the treatment of:
    • DDD (neck pain of discogenic origin with degeneration of the disc as confirmed by patient history and radiographic studies),
    • spondylolisthesis,
    • spinal stenosis, fracture/dislocation, atlantoaxial fracture with instability, occipitocervical dislocation, revision of previous cervical spine surgery, and tumors
    The cortical (3.5mm) bone screws are limited to occipital fixation only.
    The hook, rod and crosslink component placement is indicated for the cervical/upper thoracic (C1-T3) spine.
    The use of neon screws (with easy fits), polyaxial connectors (with inlays and optional spacers) is limited to placement in the upper thoracic spine (T1-T3) for anchoring of the system. Screws are not intended to be placed in the cervical spine.

    Device Description

    neon™ is a modular, posterior system used for the surgical stabilization and fixation of the occipito-cervico-thoracic regions of the spine. If necessary, the occipito-cervical junction as well as the cervico-thoracic junction may be included. The system components include longitudinal members such as hybrid plate/rods and straight rods, anchors such as self-drilling and self-tapping screws and hooks, and interconnecting devices such as anchor-to-rod connectors and a rod-to-rod crosslink.

    AI/ML Overview

    The provided text describes the neon™ spinal fixation system, a medical device, and its 510(k) submission for FDA clearance. However, it does not contain information related to software or AI performance metrics, clinical studies with human readers, or expert adjudication specific to an AI device.

    The document details the device's intended use, materials, and technological characteristics compared to predicate devices. The study mentioned focuses solely on mechanical testing of the device itself (hardware), not on the performance of a software or AI component.

    Therefore, I cannot provide answers to most of your questions as they are designed for the evaluation of AI/software medical devices.

    Here's the relevant information based on the provided text, indicating where information is not available:

    1. Table of Acceptance Criteria and Reported Device Performance

    Acceptance Criteria (from predicate devices)Reported Device Performance
    Static and Dynamic Biocompatibility and Mechanical Testing (ASTM F1717 and ASTM F2076): Device must perform as well as or better than predicate devices.Mechanical test results demonstrate that neon™ performs as well as or better than the predicate devices. This implies the device met the safety and effectiveness benchmarks established by these predicate devices through mechanical performance testing.

    2. Sample Size Used for the Test Set and the Data Provenance

    This information is not applicable as the "test set" refers to the specific components of the neon™ system subjected to mechanical testing. The provenance of material for these tests is implicitly the manufacturer's production. There's no data provenance in the context of clinical images or patient data.

    3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts

    This information is not applicable. Ground truth establishment by experts relates to clinical data interpretation (e.g., radiologists labeling images). The "ground truth" for mechanical testing is defined by the ASTM standards applied and the physical properties and performance limits of the materials and constructs.

    4. Adjudication Method for the Test Set

    This information is not applicable. Adjudication methods are typically used for resolving discrepancies in expert interpretations of clinical data. For mechanical testing, the results are quantitative measurements against predefined standards.

    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

    No, an MRMC comparative effectiveness study was not done. This type of study is relevant for AI-assisted diagnostic or decision-support systems. The neon™ device is a physical spinal fixation system.

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

    No, a standalone performance study in the context of an algorithm or AI was not done. The neon™ device is a physical implant.

    7. The Type of Ground Truth Used

    The ground truth for the performance of the neon™ device was based on validated mechanical testing standards (ASTM F1717 and ASTM F2076), which define acceptable parameters for spinal fixation devices. The performance was then compared to that of legally marketed predicate devices.

    8. The Sample Size for the Training Set

    This information is not applicable. A "training set" refers to data used to train an AI model. The neon™ device is a physical implant and does not involve AI training data.

    9. How the Ground Truth for the Training Set was Established

    This information is not applicable for the same reasons as above.

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