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510(k) Data Aggregation

    K Number
    K202521
    Device Name
    PtoleMedic System
    Date Cleared
    2021-05-04

    (245 days)

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

    Lento Medical Innovation, Inc.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The PtoleMedic System is an on-line orthopedic surgical planning software system. MRI images supply data sufficient to allow accurate modeling of anatomy for on-line surgical planning before knee joint replacement surgery. The surgeon preoperatively plans, reviews, adjusts and orients images to select implant size and create an idealized surgical plan for the first bony cuts only.
    Device Description
    A medical image management and processing system is a device that provides one or more capabilities relating to the review and digital processing of medical images for the purposes of interpretation by a trained practitioner of disease detection, diagnosis, or patient management. The software components may provide advanced or complex image processing functions for image manipulation, enhancement, or quantification that are intended for use in the interpretation and analysis of medical images. Advanced image manipulation functions may include image segmentation, multimodality image registration, or 3D visualization. Complex quantitative functions may include semi-automated measurements or time-series measurements. The ProleMedic System software described here utilized an FDA Guidance Document for industry called "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices, May 11, 2005". This guidance helped determine submission content and provided a determination of a "MODERATE" level of safety concern for the software. Improper use of software planning or processing could result in harm requiring medical intervention to correct. The PtoleMedic System software access is only available via a web/cloud-based software interface. The program is a surgeon-directed surgical case Planning package primarily but not exclusively directed at total joint replacement and closely related orthopedic indications. After completing secure log-in, the user registers, enters case information, requests MRI images, specifies implant size and parameters, sets orientation requirements, reviews expected outcome positioning, and ultimately authorizes the desired surgical plan. Once the case is physician authorized, additional Lento Medical Innovation engineering review of the case requirements begin converting the physician recommended implant plan into personalized surgical instruments to reproduce the physician created plan. Only Lento Medical Innovation personnel may access engineering modules of the PtoleMedic System software. The engineering staff uses proprietary software to convert the plan parameters into manufacturing output. Manufacturing output means anatomically personalized models to help the surgeon visualize the bony cuts' physical orientation. Trained engineers then convert style/brand of implant, sizing requirements, component orientation, and limb alignments into output to make anatomically fitted models for exclusive use by the surgeon and the specifically named patient.
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