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510(k) Data Aggregation

    K Number
    K190598
    Device Name
    CROSSWAY Spinal Access System
    Manufacturer
    Globus Medical Inc.
    Date Cleared
    2019-04-05

    (29 days)

    Product Code
    HRX
    Regulation Number
    888.1100
    Type
    Special
    Panel
    Orthopedic (OR)
    Reference & Predicate Devices
    K171413,K161591,K113352
    Why did this record match?
    Reference Devices :

    K171413, K161591

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

    The CROSSWAY™ Spinal Access System is indicated for minimally invasive visualization and access to the anterior spine for assisting in various surgical procedures such as herniated disc repair, biopsy, or harvesting autogenous bone.

    Device Description

    The CROSSWAY™ Spinal Access System consists of instruments used for minimally invasive visualization and access to the anterior spine. The system includes various guides, sleeves, temporary fixation screws, drills, and general surgical instruments.

    AI/ML Overview

    Here's an analysis of the provided text regarding the CROSSWAY™ Spinal Access System, focusing on acceptance criteria and study details.

    1. Table of Acceptance Criteria and Reported Device Performance

    Based on the provided text, the submission focuses on demonstrating substantial equivalence to predicate devices rather than establishing novel safety and effectiveness through extensive clinical trials with specific acceptance criteria. The performance data presented is primarily related to design verification and material testing.

    Acceptance Criteria CategoryReported Device Performance
    Design/Dimensional AnalysisSpecification review and dimensional analysis demonstrate that the CROSSWAY™ instruments can be used in accordance with their indications.
    Bacterial Endotoxin Testing (BET)Bacterial endotoxin testing (BET) was conducted in accordance with ANSI/AAMI ST-72:2011. (Implied to have met the standard)
    BiocompatibilityBiocompatibility of patient-contacting materials was demonstrated by using materials that meet applicable standards or are used in 510(k) cleared devices. (Implied to be acceptable)
    Technological Characteristics (Comparison to Predicate)Subject CROSSWAY™ instruments have similar technological characteristics with minor modifications compared to predicate CROSSWAY™ instruments including design, intended use, material composition, function, and range of sizes. (Implied to be substantially equivalent)

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

    The provided document does not mention a traditional "test set" in the context of clinical performance or algorithm evaluation. The studies mentioned are primarily engineering and material testing.

    • Design/Dimensional Analysis: The "sample size" would refer to the specific instruments and components of the CROSSWAY™ system that underwent review and analysis. The document does not specify this number.
    • Bacterial Endotoxin Testing: The sample size would be the number of devices or material samples tested for endotoxin. This is not specified.
    • Biocompatibility: The sample size would relate to the materials tested. This is not specified.

    Data Provenance: Not applicable as there are no clinical test sets or patient data mentioned. The data provenance is from internal testing and material certification.

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

    This information is not applicable as the provided document does not describe a study involving human expert evaluation of a test set (e.g., for image interpretation or diagnosis). The studies are engineering and materials-based.

    4. Adjudication Method for the Test Set

    This information is not applicable as there is no traditional "test set" requiring expert adjudication for ground truth.

    5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

    No, an MRMC comparative effectiveness study was not done or mentioned in this document. This submission is for a medical instrument system, not a diagnostic or AI-assisted interpretation device. Therefore, there's no mention of human readers improving with or without AI assistance.

    6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study

    No, a standalone algorithm performance study was not done or mentioned. The CROSSWAY™ Spinal Access System is a set of physical surgical instruments, not an algorithm or AI system.

    7. Type of Ground Truth Used

    The concept of "ground truth" as typically applied to diagnostic or AI studies is not directly relevant here. For the studies mentioned:

    • Design/Dimensional Analysis: The "ground truth" is adherence to engineering specifications and design tolerances.
    • Bacterial Endotoxin Testing: The "ground truth" is compliance with the specified standard (ANSI/AAMI ST-72:2011) and its biological limits.
    • Biocompatibility: The "ground truth" is that the materials either meet applicable standards or have been previously cleared for patient contact in other 510(k) devices.

    8. Sample Size for the Training Set

    This information is not applicable as the CROSSWAY™ Spinal Access System is a set of surgical instruments, not an AI or machine learning device that requires a training set.

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

    This information is not applicable for the same reasons as point 8.

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