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510(k) Data Aggregation

    K Number
    K221737
    Device Name
    InstaFill Graft Delivery System, SIGNIFY Bioactive
    Manufacturer
    Globus Medical Inc.
    Date Cleared
    2022-08-11

    (57 days)

    Product Code
    FMF
    Regulation Number
    880.5860
    Type
    Traditional
    Panel
    General & Plastic Surgery
    Reference & Predicate Devices
    K180937,K170675,K130977
    Why did this record match?
    Device Name :

    InstaFill Graft Delivery System, SIGNIFY Bioactive

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

    The InstaFill™ Graft Delivery System is intended to be used for the delivery of allograft, autograft, or synthetic bone graft material to an orthopedic surgical site.

    Device Description

    The InstaFill™ Graft Delivery System consists of a delivery device with an actuating handle, loading plunger, conical tip, and empty and pre-filled cartridges, designed to deliver graft material to an orthopedic surqical site. Cartidges are pre-filled with DBM or SIGNIFY® Gel. The delivery device and associated instruments are reusable, and the cartridges are provided sterile for single use. InstaFill™ components are manufactured from stainless steel, aluminum and PEEK, with polypropylene cartridges.

    AI/ML Overview

    The InstaFill™ Graft Delivery System is intended for the delivery of allograft, autograft, or synthetic bone graft material to an orthopedic surgical site.

    Here's an analysis of the acceptance criteria and the study performed:

    1. Acceptance Criteria and Reported Device Performance

    Acceptance CriteriaReported Device Performance
    Usability testing in a cadaverAll specified acceptance criteria were met.
    Axial pull-off testingAll specified acceptance criteria were met.
    Axial force testingAll specified acceptance criteria were met.
    Burst testingAll specified acceptance criteria were met.
    Bacterial Endotoxin Testing (BET)Conducted on prefilled cartridges in accordance with ANSI/AAMI ST-72:2011. (Implied: results met the acceptance criteria as part of "All specified acceptance criteria were met.")
    Biocompatibility of patient-contacting materialsDemonstrated by using materials that meet applicable standards or are used in 510(k)-cleared devices.

    2. Sample Size and Data Provenance

    The document does not explicitly state the sample sizes for the specific tests (e.g., number of cadavers for usability, number of devices for axial pull-off, axial force, and burst testing).
    The data provenance is not specified. However, the testing was conducted in-house by the manufacturer (Globus Medical Inc.) to confirm the device's performance.

    3. Number of Experts and Qualifications for Ground Truth

    Not applicable. This device is a delivery system for bone graft material and the testing described is primarily mechanical and functional verification, not an AI or diagnostic device that requires expert-established ground truth on medical images or patient outcomes.

    4. Adjudication Method for the Test Set

    Not applicable. The testing described focuses on mechanical and functional performance, not diagnostic classification requiring adjudication.

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

    Not applicable. This is not an AI or diagnostic device that would typically undergo an MRMC study.

    6. Standalone (Algorithm Only) Performance

    Not applicable. This is a physical medical device, not a software algorithm.

    7. Type of Ground Truth Used

    The "ground truth" for this device's performance is based on engineering specifications, material standards, and functional requirements inherent in its design and intended use. For example:

    • Usability: Successful delivery of graft material in a cadaveric setting.
    • Axial Pull-Off, Axial Force, Burst: Measurement against predefined mechanical thresholds.
    • BET: Compliance with the ANSI/AAMI ST-72:2011 standard for endotoxin levels.
    • Biocompatibility: Conformance to established standards for medical device materials or prior FDA clearance of the materials.

    8. Sample Size for the Training Set

    Not applicable. This is a physical medical device, not a machine learning model.

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

    Not applicable.

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