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510(k) Data Aggregation

    K Number
    K192653
    Device Name
    Perseus
    Date Cleared
    2020-09-09

    (351 days)

    Product Code
    Regulation Number
    882.4560
    Reference & Predicate Devices
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    PERSEUS is a computer-controlled system, intended to assist in distal femoral resection and tibial resection during Total Knee Arthroplasty, determining reference alignment axes in relation to anatomical and instrumentation structures during stereotaxic orthopaedic surgical procedures.

    Device Description

    PERSEUS is a computer assisted system, that helps surgeon in the positioning of implant components, during total knee implant surgical procedure, according to the conventional reference axes in relation to anatomical landmarks. Perseus System is configured to detect, measure, and display angular and positional measurement changes in a triaxial format. The device assists the surgeon in: Establishing the mechanical axis of the femur, determining the varus/valgus angle and the flexion/extension angle of the cutting block relative to the femur. Establishing the mechanical axis of the tibia, determining the varus/valgus angle and the posterior slope angle of the cutting block relative to the tibia. Perseus system utilizes triaxial accelerometer and triaxial gyroscope to determine, through limb movement, reference axes of femur and tibia and relative orientation of distal femoral and tibial cutting guide with respect to frontal and sagittal planes of the limb.

    AI/ML Overview

    Here's a detailed breakdown of the acceptance criteria and the studies proving the device's performance, based on the provided text:

    Acceptance Criteria and Device Performance

    1. Table of Acceptance Criteria and Reported Device Performance

    MeasureAcceptance CriteriaReported Device Performance
    HKA (Hip-Knee-Ankle) angle deviationwithin 3° (for final leg alignment)Average post-operative HKA angle deviation: 0.3 ± 1.5°
    Average post-operative HKA alignment deviation: 0.7° (range 0-2°)
    Femoral distal resection deviationwithin 2° (for distal femoral resection, frontal and lateral planes)Femoral distal resection deviation:
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