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510(k) Data Aggregation

    K Number
    K113602
    Device Name
    AAP LOQTEQ PROXIMAL LATERAL TIBIA PLATE 4.5 SYSTEM
    Manufacturer
    AAP IMPLANTATE AG
    Date Cleared
    2012-10-31

    (331 days)

    Product Code
    HRS,HWC
    Regulation Number
    888.3030
    Type
    Traditional
    Panel
    Orthopedic
    Reference & Predicate Devices
    K023802
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The aap LOQTEQ® Proximal Lateral Tibia Plates 4.5 System is intended for treatment of nonunions, malunions, and fractures of the proximal tibia, including simple, comminuted, lateral wedge, depression medial wedge, bicondylar combination of lateral wedge and depression, and fractures with associated shaft fractures.

    Device Description

    Bone plates used for fixation, i.e., for treatment of bone fractures and other bone injuries. Bone plates are fixed with bone screws. Bone plates and bone screws are implants. The aap LOQTEQ® Proximal Lateral Tibia Plates 4.5 are anatomically shaped osteosynthesis plates, which met in combination with the use of special screws the function of a Internal Fixator. The following products are required for application: LOQTEQ® Proximal Lateral Tibia Plate 4.5, LOQTEQ® Cortical Screw 4.5, T25, self-tapping, LOQTEQ® Cortical Screw 4.5, small head, T25, self-tapping, Cortical Screw 4.5, self-tapping, Cortical Screw 4.5, small head, self-tapping, Instruments, Proximal Lateral Tibia Plate 4.5. Plates and Screws are made of titanium alloy according to ASTM F136 or ISO 5832-3.

    AI/ML Overview

    Acceptance Criteria and Study Details for LOQTEQ® Proximal Lateral Tibia Plate 4.5 System

    This document outlines the acceptance criteria and the study conducted to demonstrate that the aap LOQTEQ® Proximal Lateral Tibia Plate 4.5 System meets these criteria.

    1. Acceptance Criteria and Reported Device Performance

    The core acceptance criterion for the LOQTEQ® Proximal Lateral Tibia Plate 4.5 System was substantial equivalence to its predicate device, specifically regarding mechanical performance. This was assessed through non-clinical fatigue implant tests.

    Acceptance CriterionReported Device Performance
    Mechanical Performance:
    Substantial equivalence to the predicate device (4.5 mm Titanium LCP® Proximal Tibia Plating System, Synthes (USA), K023802) in terms of safety and effectiveness, specifically under worst-case clinical loading scenarios, as demonstrated by fatigue implant tests."Substantial equivalence with respect to the mechanical performance of the aap system could be stated due to the test results gained. The subject device is safe and effective, and whose performance meets the requirements of its pre-defined acceptance criteria and intended uses."

    The non-clinical fatigue implant tests were performed with progressive loadings, representing worst-case scenarios with respect to clinical use. The results supported the conclusion that the device is safe and effective and meets the specified acceptance criteria. |

    2. Sample Size and Data Provenance (Test Set)

    • Sample Size: The document does not specify a distinct "test set" sample size in terms of patient data. The study primarily relies on non-clinical fatigue implant tests of the device itself. Therefore, the "sample size" refers to the number of devices or constructs tested in the mechanical studies. This exact number is not specified in the provided text.
    • Data Provenance: The data is from non-clinical testing conducted by aap Implantate AG. The country of origin for the testing is not explicitly stated, but the company is located in Germany. These would be considered prospective tests performed on newly manufactured devices.

    3. Number and Qualifications of Experts (Ground Truth for Test Set)

    • This question is not applicable as the provided study is a non-clinical mechanical performance test, not a study involving human readers or expert radiologists to establish ground truth for a diagnostic or imaging device. The "ground truth" here is the established mechanical properties and performance standards for bone fixation plates.

    4. Adjudication Method (Test Set)

    • This question is not applicable as the provided study is a non-clinical mechanical performance test, and does not involve adjudication of expert assessments.

    5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

    • No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. The study described is a non-clinical mechanical equivalency study for a bone fixation plate, not a study involving human readers' performance with or without AI assistance.

    6. Standalone Performance (Algorithm Only)

    • This question is not applicable. The device is a physical medical implant (bone plate), not an algorithm or AI system. Therefore, standalone algorithm performance is not relevant.

    7. Type of Ground Truth Used

    • The "ground truth" used for this study was based on established mechanical performance standards and expectations for bone fixation plates, particularly as benchmarked against the predicate device. This "ground truth" is derived from engineering principles, material science, and regulatory requirements for medical device safety and effectiveness in the context of mechanical loads.

    8. Sample Size for the Training Set

    • This question is not applicable as the study did not involve a training set for an algorithm. The study described is a non-clinical mechanical performance test of a physical device.

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

    • This question is not applicable as there was no training set for an algorithm.
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