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510(k) Data Aggregation

    K Number
    K092801
    Device Name
    ABS BLOWER, ABS NOZZLE, MODEL 1001
    Manufacturer
    NIMBIC SYSTEMS, LLC
    Date Cleared
    2011-05-20

    (616 days)

    Product Code
    ORC
    Regulation Number
    878.5070
    Type
    Traditional
    Panel
    General Hospital
    Reference & Predicate Devices
    K831531
    Predicate For
    K123006
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The Air Barrier System is a portable device for use in a surgical operating room that produces a directed, non-turbulent flow of air to the surgical site. The air flow from the device is HEPA-filtered to reduce the presence of particulate matter and microorganisms at the surgical site during hip arthroplasty. The ABS Nozzle is intended to be used only where: (1) it can be placed on anatomical surface with no gap between the bottom of the nozzle and the surface, (2) the incision plane is parallel to the direction of airflow, and (3) the incision dimensions are within: 6″ (15.2 cm) in width and 20" (50.8 cm) in length. Device effectiveness may not be reliably detectable at a distance of 20 inches from the Nozzle, and effectiveness depreciates beyond this specified area.

    Device Description

    The Air Barrier System (ABS) is used in the surgical operating room. The Air Barrier System (ABS) has two components: a Filter/Blower and an Air Delivery System. The Filter/Blower is nonsterile and reusable. The Air Delivery System is sterile, single-use. The ABS Filter/Blower captures and filters ambient air found in a typical surgical operating room through a High Efficiency Particle Arresting (HEPA) filter. The HEPA filtered air leaves the Filter/Blower via the exit port where it is connected to the Hose portion of the sterile, single-use Air Delivery System. The Hose ends in the Nozzle portion of the Air Delivery System; the Nozzle is gently applied to the incision drape adjacent to a surgical incision. The Nozzle delivers HEPA filtered air directly to the surgical site area to reduce the presence of airborne particulate and microorganisms.

    AI/ML Overview

    Here's a breakdown of the acceptance criteria and the study that proves the device meets them, based on the provided text:

    1. Table of Acceptance Criteria and Reported Device Performance

    Acceptance Criteria (Performance Goal/Endpoint)Reported Device Performance (Experiment Group vs. Control/Sham)
    Microorganism Density Reduction at the surgical siteMean microorganism density: 1.60 CFU/m³ (experiment group) vs. 10.73 CFU/m³ (outside ABS area of effect, likely representative of control/sham levels) - Significantly lower (P<0.001)
    Particulate Reduction (5µm) at the surgical siteMean 5µm particulate count: 524 particles/ft³ (experiment group) vs. 3853 particles/ft³ (sham) and 4092 particles/ft³ (control) - Significantly lower (P<0.001)

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

    • Sample Size: 29 patients
    • Data Provenance: The study was a "clinical study at a single investigator." The text does not specify the country of origin but implies it was conducted in a clinical setting in the same jurisdiction as the submission (US). It was a prospective study, as patients were randomized into groups for the purpose of the study.

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

    The document does not mention the use of experts to establish a "ground truth" for the test set in the traditional sense of diagnostic accuracy. The ground truth for this device (an Air Barrier System) is established by directly measuring physical quantities (microorganism density and particulate counts) in the surgical environment, rather than expert interpretation of images or patient outcomes. Therefore, this section is not applicable in the context of this device and study design.

    4. Adjudication Method for the Test Set

    Not applicable. This was a study measuring physical parameters rather than subjective interpretations requiring adjudication.

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

    • Was it done? No. This study is focused on the device's ability to reduce contaminants, not on improving human reader performance.
    • Effect size of human readers improve with AI vs. without AI assistance: Not applicable.

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

    • Was it done? Yes, in essence. The study's experiment group used the device "active" without human intervention beyond its installation and operation. The performance metrics (microorganism and particulate reduction) were measured directly as a result of the device's operation. This can be considered a standalone performance evaluation of the device's effect on the environment.

    7. Type of Ground Truth Used

    The ground truth used was direct measurements of environmental parameters:

    • Colony-forming units per cubic meter (CFU/m³) for microorganisms.
    • Particles per cubic foot (particles/ft³) for particulate matter.

    8. Sample Size for the Training Set

    The document does not mention a "training set" in the context of machine learning, as this is a medical device for physical intervention, not an AI/ML algorithm.

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

    Not applicable, as there was no training set in the AI/ML context.

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