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510(k) Data Aggregation

    K Number
    K170534
    Device Name
    PROLIXUS TOTAL KNEE SYSTEM
    Manufacturer
    OTIS Biotech Co., Ltd.
    Date Cleared
    2017-11-09

    (259 days)

    Product Code
    JWH
    Regulation Number
    888.3560
    Type
    Traditional
    Panel
    Orthopedic
    Reference & Predicate Devices
    K863668,K032163,K040267,K933785,K023211
    Predicate For
    K092819,K191192,K231975
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    This device is indicated in knee arthroplasty for reduction or relief of pain and/or improved knee function in skeletally mature patients with severe knee pain and disability due to rheumatoid arthritis, osteoarthritis, primary and secondary traumatic arthritis, polyarthritis,collagen disorders, avascular necrosis of the femoral condyle or pseudogout, posttraumatic loss of joint configuration, particularly when there is patellofemoral erosion, dysfunction or prior patellectomy, moderate valgus, varus, or flexion deformities. This device may also be indicated in the salvage of previously failed surgical attempts if the knee can be satisfactorily balanced and stabilized at the time of surgery. This device system is designed for cement use only.

    Device Description

    The Prolixus™ Cruciate Retaining (CR) Total Knee System consists of three primary components: Cruciate Retaining (CR) Femoral Component, Cruciate Retaining (CR) Tibial Insert, Patellar component and Tibial base plate.

    The Prolixus™ CR components are described below:

    PROLIXUSTMTotal Knee Cruciate Retaining (CR) Femoral Component

    Prolixus™ Total Knee Cruciate Retaining (CR) Femoral Component is fabricated from cast cobalt-chromium-molybdenum alloy, and is intended for cemented application to replace the articulating surface of the distal femur. This cruciate retaining femoral component is utilized when total knee replacement is indicated, and accommodates the posterior cruciate ligament if it is present.

    The Cruciate Retaining (CR) Femoral Component is available in right and left configurations, and six proportional sizes (sizes A to F) to accommodate differences in patient anatomy. The interior surface of the component is grit-blasted to increase surface roughness - this is intended to promote interdigitation of the polymethylmethacrylate (PMMA) bone cement with the surface texture and the apposing bone. This femoral component features cast-in pegs to help in femoral component placement, and to provide rotational stability.

    PROLIXUS™ Cruciate Retaining (CR) Tibial Insert

    The Cruciate Retaining (CR) Tibial Insert is neutral in configuration, and is available in six proportional sizes (sizes 1 to 6) and varying thicknesses (10mm, 12mm,14mm, 16mm, 18mm and 20 mm). The insert is fabricated from ultra high molecular weight polyethylene(medical grade PUR 1020 UHMPE) .The tibial insert is designed to accommodate the posterior cruciate ligament if it is present. There is a relief on the anterior aspect of the tibial insert to accommodate the patellar tendon and patellar fat pad.

    PROLIXUS™ Tibial base plate

    Stem tibial baseplate components (tibial baseplate) are made from Ti-The angled 6Al-4V titanium alloy. Tibial baseplates are available in 6 sizes (1 to 6).

    PROLIXUS™ | Patellar components

    patellar component is made from ultra high molecular weight The polyethylene(medical grade PUR 1020 UHMPE). The patella is available in five diameters, 26mm, 29mm, 32mm, 35mm and 38mm, which permit optimal bone coverage and surgical options.

    AI/ML Overview

    The provided text describes a 510(k) premarket notification for the "PROLIXUS™ TOTAL KNEE SYSTEM". This document focuses on demonstrating substantial equivalence to legally marketed predicate devices, primarily through bench testing comparing the new device's mechanical properties, materials, and design to established standards and predicate devices.

    Here's an analysis of the acceptance criteria and study information:

    1. Table of Acceptance Criteria and Reported Device Performance

    TestAcceptance Criteria (Implicit from ISO/Standard)Reported Device Performance
    Fatigue Test (Tibial Base Plate)ISO 21536 suggested minimum fatigue strength (10 million load cycles at 900 N without failure)Five tibial trays passed 10 million load cycles at 900 N without failure. Max run-out bending moment of 22.5 Nm.
    Knee Constraint Test (Anterior-Posterior)Implied to be comparable to predicate devices and within expected physiological ranges for stability.0° flexion: Mean anterior load -348 N (StdDev 9), posterior load 149 N (StdDev 4).15° flexion: Mean anterior load -348 N (StdDev 12), posterior load 147 N (StdDev 2).90° flexion: Mean anterior load -349 N (StdDev 3), posterior load 154 N (StdDev 4).135° flexion: Mean anterior load -331 N (StdDev 5), posterior load 152 N (StdDev 4).
    Knee Constraint Test (Medial-Lateral)Implied to be comparable to predicate devices and within expected physiological ranges for stability.0° flexion: Mean lateral load -396 N (StdDev 3), medial load 387 N (StdDev 6).15° flexion: Mean lateral load -385 N (StdDev 7), medial load 383 N (StdDev 3).90° flexion: Mean lateral load -415 N (StdDev 3), medial load 365 N (StdDev 3).135° flexion: Mean lateral load -370 N (StdDev 21), medial load 413 N (StdDev 5).
    Knee Constraint Test (Internal-External Rotation)Implied to be comparable to predicate devices and within expected physiological ranges for stability.0° flexion: Mean external torque -5.7 Nm (StdDev 0.4), internal torque 5.8 Nm (StdDev 0.2).15° flexion: Mean external torque -6.2 Nm (StdDev 0.3), internal torque 5.8 Nm (StdDev 0.1).90° flexion: Mean external torque -5.4 Nm (StdDev 0.1), internal torque 6.3 Nm (StdDev 0.1).135° flexion: Mean external torque -5.1 Nm (StdDev 0.4), internal torque 5.7 Nm (StdDev 0.1).
    Knee Tibia and Inserter Component Interlock Strength (Disassembly - AP Loading)Implied to be sufficient to prevent unintended disassembly during expected use.Mean assembly load 138 N (StdDev 22). Mean disassembly load 1,459 N (StdDev 31). Failure mode: plastic deformation of snap-in locking mechanism.
    Knee Tibia and Inserter Component Interlock Strength (Disassembly - ML Loading)Implied to be sufficient to prevent unintended disassembly during expected use.Withstood loads > 754 N (medial-lateral) and > 720 N (lateral-medial) with plastic deformation at load application point, no failure of interconnection mechanism.
    Knee Tibia and Inserter Component Interlock Strength (Disassembly - Pull-off Loading)Implied to be sufficient to prevent unintended disassembly during expected use.Mean ultimate load 2,015 N (StdDev 187) without tibia tilt.
    Knee Tibia and Inserter Component Interlock Strength (Assembly - AP Direction with tilt)Implied to be within acceptable range for surgical assembly.Mean assembly load of 132 N (StdDev 24) at 4.5 mm displacement.
    Knee Tibia and Inserter Component Interlock Strength (Disassembly - AP and Lateral Direction)Implied to be sufficient to prevent unintended disassembly during expected use.Mean ultimate disassembly load of 804 N (StdDev 70).
    Knee Femoral and Tibial Insert Contact Area/Pressure DistributionContact stresses and total contact areas fall within the common range of predicate devices (from EndoLab database of 19 test series).Contact stresses and total contact areas are within the common range of predicate devices.
    Knee Femoral and Patella Contact Area/Pressure DistributionImplied to be comparable to predicate devices and expected physiological performance.Smallest total contact area: 20.44 mm² (SD 0.29 mm²) at 15° flexion. Largest total contact area: 86.87 mm² (SD 0.92 mm²) at 135° flexion. Smallest contact area above 20 MPa: 11.61 mm² (SD 0.50 mm²) at 15° flexion. Highest contact area above 20 MPa: 66.07 mm² (SD 1.35 mm²) at 135° flexion.
    Femoral Component Surface FinishRa < 0.1 µm as per ISO 7207-2.Total mean Ra: 0.013 µm (Std. Dev. 0.001 µm). None exceeded 0.1 µm.
    Tibial Base Component Surface FinishNot explicitly stated but implied to be acceptable for comparison to predicate devices.Total mean Ra: 0.62 µm (Std. Dev. 0.078 µm).
    Tibia Insert Component Surface FinishRa < 2.0 µm as per ISO 7207-2.Overall mean Ra: 0.212 µm (Std. Dev. 0.079 µm). None exceeded 2.0 µm.
    Tibia Insert Component Minimum ThicknessMinimum thickness 6 mm in load-bearing area as per ISO 21536:2007.Total mean lateral thickness: 6.77 mm (Std. Dev. 0.05 mm). Total mean medial thickness: 6.77 mm (Std. Dev. 0.05 mm). None smaller than 6 mm.
    Patella Component Surface FinishRa < 2.0 µm as per ISO 7207-2.Overall mean Ra: 0.79 µm (Std. Dev. 0.20 µm). None exceeded 2.0 µm.
    Patella Component Minimum Thickness and WidthImplied to be appropriate for surgical use and comparison to predicate devices.Overall mean thickness: 8.01 mm (Std. Dev. 0.05 mm). Overall mean width: 25.98 mm (Std. Dev. 0.02 mm).
    Range of Motion CAD AnalysisMotions correspond to typical findings for fixed-type bearings; supports mixed sliding/rolling articulations theory.All motions observed correspond to typical findings. Sliding/rolling analysis supports common theory of mixed sliding/rolling articulations.
    Bacterial Endotoxins Test (BET/LAL)Product is suitable for endotoxin testing, meeting endotoxin standards and established criteria for testing.Test validation confirmed suitability of reagent (PTS cartridge) and laboratory environment. Inhibition/enhancement tests concluded product is suitable for endotoxin testing.

    2. Sample Size Used for the Test Set and the Data Provenance

    The "studies" described are primarily bench tests conducted on physical device components.

    • Fatigue Test (Tibial base plate): 5 tibial trays.
    • Knee Constraint Test: Specific number not explicitly stated for each measurement, but implied to be multiple units as "mean" and "StdDev" are reported.
    • Knee Tibia and Inserter Component Interlock Strength:
      • Disassembly Test by Anterior/Posterior Loading: 6 specimens for assembly, 6 specimens for disassembly.
      • Disassembly Test by Medial/Lateral Loading: 2 specimens (one for medial-lateral, one for lateral-medial).
      • Disassembly Test by Pull-off Loading: Not explicitly stated, but statistical data suggests multiple specimens.
      • Assembly Test in anteriorposterior direction: 5 specimens.
      • Disassembly Test in anteriorposterior direction and lateral direction: 5 specimens.
    • Knee Femoral and Tibial insert contact area/pressure distribution test: Not explicitly stated, but compared to an "EndoLab database (n=19 test series)."
    • Knee Geometry and Surfaces:
      • Femoral component: 5 components.
      • Tibia base component: 5 tibial trays.
      • Tibia insert component: Not explicitly stated, but discussed for "each insert" and statistical data provided.
      • Patella component: 6 patella components.
    • Bacterial Endotoxins Test (BET/LAL): Not explicitly stated, but validation testing was performed.

    Data Provenance: The studies were conducted by "EndoLab Mechanical Engineering GmbH" (likely Germany) and "Greenpia Technology, South Korea" (South Korea). The data is retrospective in the sense that it's laboratory bench testing of the manufactured device components, not data collected from patients. There is no mention of patient data or country of origin for such data.

    3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts

    Not applicable. These are bench tests against engineering standards and internal databases, not clinical studies requiring expert ground truth for interpretation of medical images or patient outcomes. The "ground truth" for these tests is the specified ISO standard (e.g., ISO 21536, ISO 7207-2) or established engineering principles.

    4. Adjudication Method for the Test Set

    Not applicable. This is not a clinical study requiring adjudication of expert readings. Test results are quantitative measurements against defined criteria.

    5. 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

    No. This document does not pertain to an AI or diagnostic imaging device. It describes a total knee replacement system, a physical medical device. MRMC studies are not relevant here.

    6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done

    No. This is not an algorithm or AI device.

    7. The Type of Ground Truth Used

    The ground truth used for these bench tests included:

    • International Standards: e.g., ISO 21536 for fatigue strength and minimum thickness, ISO 7207-2 for surface roughness, ISO 7207-1 for geometric dimensions.
    • Internal Databases/Predicate Device Data: For contact area/pressure distribution, the device performance was compared to an "EndoLab database (n=19 test series)" which contained data from predicate devices.
    • Engineering Specifications: Implied acceptable ranges for mechanical loads, torques, and material properties.

    8. The Sample Size for the Training Set

    Not applicable. This is a physical medical implant, not a machine learning model. There is no "training set." The design and manufacturing processes are likely informed by prior engineering knowledge and predicate device designs.

    9. How the Ground Truth for the Training Set Was Established

    Not applicable, as there is no training set for a machine learning model. The "ground truth" for the design and testing of a knee implant is based on established biomechanical principles, material science, clinical needs, and performance of existing devices (predicates).

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