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510(k) Data Aggregation

    K Number
    K241961
    Device Name
    Vent Creativity Knee v1.0 (Hermes)
    Manufacturer
    Date Cleared
    2025-03-20

    (260 days)

    Product Code
    Regulation Number
    892.2050
    Why did this record match?
    Applicant Name (Manufacturer) :

    Vent Creativity

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    Hermes is intended for use as a software interface and image segmentation system for the transfer of medical imaging information to an output file. It is also intended as preoperative software for diagnostic and surgical planning. For these purposes, output files can also be used for the fabrication of physical replicas using traditional or additive manufacturing methods. The physical replicas can be used for diagnostic purposes in the field of orthopedic applications. The software is intended to be used in conjunction with other diagnostic tools and expert clinical judgment.
    Device Description
    Vent Hermes takes DICOM based CT scans from the scanning machine and plots the data generated by the machine in the form of slices of data, similar to all commercially available predicates. The intensity data (Hounsfield Unit data) inside these is displayed to ensure that all intensity data is visible to the users. The point clouds from these data points are used to find landmarks in discrete locations, unlike the predicates that use bone outlines from automatic or semi automatic or manual sources to generate points for landmarks. This approach allows for more accurate predictions, as validated in previous studies by radiology experts. Published literature is used to define the 3 cut planes where proximal tibia and distal and posterior femoral cuts are calculated. The product does not currently make any claims of individual implant fits but planes shared by all surgeon and implant manufacturers as the first step. The python code has been history file with design terations recorded on all major changes to the system. The segmentation aspect is a Convolutional Networks model trained with arthritic CT scans from 120 de-identified patients with varying arthritic states, demographics, and centers partnering with surgeon champions. The seqmentation and landmarking system was validated aqainst manual, Materialize Mimics 24 autosegmentaiton, and Synopsys Simpleware knee auto segmentation models, and results were reviewed with the Chief of Radiology of Hospital for Special Surgery in New York, NY. The results were published in the International Society for Technology in Arthroplasty 2022 annual conference. Vent Hermes is a cloud-based python code that allows users to upload the de-identified DICOM files to their encrypted Google Cloud Platform folder (a business agreement certified partner with HIPAA and 21 CFR 11 certifications available). Once the files are uploaded, the cloud server de-identifies the folder again for redundant safety, then passes it to Vent Creativity's internal server for the system to automatically run the scripts to generate the bone models, landmarks, and the final cut planes and returns these files to the user file same file number. Once the point clouds, meshes, and landmarks are calculated, any number of CAD or visualization tools can be used to review the data. The system uses a custom Ul qenerated on the OHF medical imaging platform with system version controls and validation documents on file. This portion is considered to be software outside of the medical device as no calculation is allowed outside the python code. The visualizations are final and are for user review and approval only.
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