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    K Number
    K121929
    Device Name
    ZEPHYR 'X-SERIES PATIENT TRANSFER SLED
    Manufacturer
    DIACOR, INC.
    Date Cleared
    2013-01-17

    (199 days)

    Product Code
    FRZ,IYE,LHN,LNH
    Regulation Number
    880.6775
    Type
    Traditional
    Panel
    Radiology
    Reference & Predicate Devices
    K111340
    Why did this record match?
    Device Name :

    ZEPHYR 'X-SERIES PATIENT TRANSFER SLED

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

    The Zephyr "x-series" Patient Positioning and Transfer System is indicated to aid in the support, positioning, and transfer of a patient for procedures involving imaging, including MRI, and external beam radiation therapy treatment with electrons, photons or protons, as well as other procedures requiring transfer of a patient.

    Device Description

    The Zephyr "x-series" Patient Positioning and Transfer System functions as an accessory to support a patient and positioning devices during imaging and radiation therapy procedures, and other procedures requiring the transfer of a patient. The Zephyr "x-series" Patient Positioning and Transfer System utilizes forced air as a low-friction bearing to transfer patients from one flat surface to another, eliminating the need to manually lift the patient.

    AI/ML Overview

    The Diacor Zephyr "x-series" Patient Positioning and Transfer System is indicated to aid in the support, positioning, and transfer of a patient for procedures involving imaging, including MRI, and external beam radiation therapy treatment with electrons, photons or protons, as well as other procedures requiring transfer of a patient.

    Here's an analysis of the acceptance criteria and the study proving the device meets them:

    1. Table of Acceptance Criteria and Reported Device Performance

    Acceptance Criteria (from Bench Testing)Reported Device Performance
    Attenuation: In line with patient positioning devices readily found on the market. Measurements taken at 6MV and 10MV clinical photon energies.Average attenuation factor measured: 3.33
    Median attenuation factor measured: 2.65
    Build-up: In line with patient positioning devices readily found on the market. Measurements taken at various depths in solid water.Produced a dose buildup effect with an approximate equivalence to 6mm of tissue.
    MR Safety: No detectable pull by the magnet when positioned on the MR patient table and slid into the MR bore. Blower hose should show minimal attraction.Board showed no detectable pull by the magnet. Blower hose showed a slight attraction when directly next to the magnet, but was easily removed from the bore. All components, excluding the air blower, tested MR Safe.

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

    • Test Set: Not applicable as this submission details bench testing rather than a clinical study with a patient test set.
    • Data Provenance: The data is from bench testing conducted by Diacor Inc. The country of origin for this testing is not explicitly stated, but Diacor Inc. is based in West Valley City, UT, USA.

    3. Number of Experts Used to Establish Ground Truth and Qualifications

    • Not applicable. Ground truth in this context (bench testing) is established through physical measurements and scientific methodologies rather than expert consensus on medical images or diagnoses.

    4. Adjudication Method for the Test Set

    • None. Adjudication is not relevant for bench testing where objective physical measurements are performed.

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

    • No. An MRMC study was not conducted as this device is a patient positioning and transfer system, not an imaging or diagnostic AI device that would involve human readers interpreting cases.

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

    • Yes, in the context of device function. The "standalone" performance here refers to the device's physical and material properties (attenuation, build-up, MR safety) as measured during bench testing, independent of human interaction beyond operating the testing equipment. There is no algorithm involved in the "standalone" sense of an AI device.

    7. Type of Ground Truth Used

    • Physical Measurements and Scientific Standards:
      • Attenuation and Build-up: Measured using a Unidose-E electrometer with specific chambers (Farmer Chamber FC65-G, PTW Advanced Markus Plane Parallel Chamber) in solid water, based on established physics principles for radiation dosimetry.
      • MR Safety: Assessed by observing the physical interaction (attraction/pull) of the device components with a magnet and a hand-held metal detector, adhering to MR safety guidelines.

    8. Sample Size for the Training Set

    • Not applicable. This submission describes a physical medical device, not an AI/machine learning algorithm, so there is no "training set" in that context.

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

    • Not applicable. As there is no AI algorithm training set, this question is not relevant.
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