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510(k) Data Aggregation

    K Number
    K183544
    Device Name
    Efficient Care 3D Planning
    Manufacturer
    Orthosoft, Inc. (d/b/a Zimmer CAS)
    Date Cleared
    2019-08-23

    (246 days)

    Product Code
    LLZ
    Regulation Number
    892.2050
    Type
    Traditional
    Panel
    Radiology
    Reference & Predicate Devices
    K161828
    Predicate For
    K202487
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    Efficient Care 3D Planning is software indicated for assisting orthopedic surgeons in preoperative planning of knee orthopedic surgeries. The software allows for the overlaying of 3D/2D implant models and for the visualization of the radiological images and 3D reconstruction of bones, and includes tools for performing measurements on the images or 3D model of bones, and for selecting and positioning the implant model. Clinical judgments and experience are required to properly use the software.

    Efficient Care 3D Planning is to be used with the following fixed bearing knee replacement systems in accordance with their indications and contraindications: NexGen CR, NexGen CR-Flex Gender, NexGen CR-Flex Gender, NexGen LPS, NexGen LPS-Flex, NexGen LPS-Flex Gender, Persona® CR, Persona PS, Vanguard® CR, and Vanguard PS.

    Device Description

    Efficient Care 3D Templating is software application that is intended to assist in the preoperative sizing of femoral and tibial implants. The software solution allows for the processing of multiple 2D X-rays to create 3D bone models that scales to patient bones and compensates for patient leg rotation in the X-rays images. The 3D bone models allow implant sizing to occur and output a template report, which includes overlays of prostheses, in respect to leg orientations on the X-ray images. Final implant sizing is based on intraoperative surgeon assessment.

    AI/ML Overview

    The provided text describes the regulatory clearance of a medical device called "Efficient Care 3D Planning" but does not contain detailed information about a comprehensive study that establishes specific acceptance criteria and rigorously proves the device meets those criteria with detailed performance metrics.

    However, based on the snippet provided under "Summary of Performance Data (Nonclinical and/or Clinical)", we can infer some information relevant to acceptance criteria and a study:

    Inferred Acceptance Criteria and Reported Device Performance

    Acceptance Criteria (Inferred)Reported Device Performance (From "Implant Predictability Tests")
    Accurate prediction of the correct implant size within ±2 sizes in 90% of cases, when the magnification sphere object is present."confirm that the Efficient Care device could accurately predict the correct implant size within ±2 sizes in 90% of cases when the magnification sphere object is present"

    Missing Information:

    The provided text lacks specific details for most of the requested points. Below is a breakdown of what is not present in the document for a complete description of the study and acceptance criteria:

    1. Sample sized used for the test set and the data provenance: Not specified.
    2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not specified.
    3. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not specified.
    4. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance: Not indicated beyond the statement that "Clinical judgments and experience are required to properly use the software." This implies human involvement, but no MRMC study details are given.
    5. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: The "Implant Predictability Tests" seem to describe an algorithm-only performance assessment against post-operative results. However, the exact methodology (standalone vs. assisted) isn't explicitly detailed.
    6. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): For the "Implant Predictability Tests," the ground truth was the "post-op implant size."
    7. The sample size for the training set: Not specified.
    8. How the ground truth for the training set was established: Not specified.

    Additional Information from the text regarding device validation:

    • Biocompatibility Testing: Conducted in accordance with ISO 10993. The device meets biocompatibility requirements.
    • Software Verification & Validation Testing: Conducted and documented as recommended by FDA guidance. The software was considered a "moderate level of concern" meaning a failure could lead to "Minor Injury."

    In summary, while the document mentions "Implant Predictability Tests" to confirm performance related to implant sizing accuracy, it does not provide the comprehensive study details, sample sizes, expert qualifications, or ground truth establishment methodologies that would typically be expected for a detailed description of device validation against acceptance criteria.

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