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510(k) Data Aggregation

    K Number
    K213215
    Device Name
    VSI HoloMedicine
    Manufacturer
    ApoQlar GmbH
    Date Cleared
    2022-11-25

    (422 days)

    Product Code
    LLZ
    Regulation Number
    892.2050
    Type
    Traditional
    Panel
    Radiology
    Reference & Predicate Devices
    K172418,K190764
    Why did this record match?
    Device Name :

    VSI HoloMedicine

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

    VSI HoloMedicine® is a software device for displaying digital medical images acquired from CT, Angio CT, MRI, CBCT, PET, and SPECT sources. It is intended to visualize 3D imaging holograms of the patient for pre-operative planning outside and/or inside the surgical room.

    When accessing VSI HoloMedicine® from a wireless head-mounted display (HMD) or PC monitor, images viewed are for informational purposes only and not intended for diagnostic use. VSI HoloMedicine® is indicated for use by qualified healthcare professionals including surgeons, radiologists, physicians, and technologists.

    Device Description

    VSI HoloMedicine is a software device for displaying digital medical images acquired from CT, Angio CT, MRI, CBCT, PET, and SPECT sources. It is intended to visualize 3D imaging holograms of the patient for pre-operative planning outside and/or inside the surgical room.

    When accessing VSI HoloMedicine from a wireless head-mounted display (HMD) or PC monitor, images viewed are for informational purposes only and not intended for diagnostic use. VSI HoloMedicine is indicated for use by qualified healthcare professionals including surgeons, radiologists, physicians, and technologists.

    AI/ML Overview

    The provided text does not contain detailed performance data or acceptance criteria for the VSI HoloMedicine® device beyond a general statement that "Visual quality testing on software using the Microsoft Hololens Headset has been performed." and that "software verification demonstrate that the VSI Holomedicine should perform as intended in the specified use conditions."

    The document focuses on establishing substantial equivalence to a predicate device (Medivis-SurgicalAR K190764) and a reference device (Novarad-OpenSight K172418) based on their design, indications for use, and technology. It lists applicable standards, but does not provide the results of specific performance tests against measurable acceptance criteria.

    Therefore, I cannot fulfill your request for:

    1. A table of acceptance criteria and the reported device performance: This information is not present in the provided text.
    2. Sample sizes used for the test set and the data provenance: This information is not present.
    3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: This information is not present.
    4. Adjudication method for the test set: This information is not present.
    5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, and its effect size: This information is not present.
    6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: This information is not present.
    7. The type of ground truth used: This information is not present.
    8. The sample size for the training set: This information is not present.
    9. How the ground truth for the training set was established: This information is not present.

    The document primarily provides regulatory information for a 510(k) submission, confirming the device's substantial equivalence and general safety/effectiveness, rather than detailed performance study results.

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