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510(k) Data Aggregation

    K Number
    K113652
    Device Name
    LOQTEQ SMALL FRAGMENT SET LOQTEQ CORTICAL SCREW3.5, SMALL HEAD, T15, SELF TAPPING LOQTEQ CORTICAL SCREW 3.5, T15, SELF T
    Manufacturer
    AAP IMPLANTATE AG
    Date Cleared
    2012-08-30

    (262 days)

    Product Code
    HRS
    Regulation Number
    888.3030
    Type
    Traditional
    Panel
    Orthopedic
    Reference & Predicate Devices
    K000684,K011335,K082527
    Predicate For
    K141949,K161703,K161747,K173641,K202803
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    Fixation of fractures, osteotomies, and non-unions of the scapula, olecranon, humerus, radius, ulna, distal tibia, and fibula, particularly in osteopenic bone

    Device Description

    Bone plates and screws are used for fixation of bone fragments, 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. If the plates are used in conjunction with locking screws, a so called internal fixator will be realized (internal fixation).

    The LOQTEQ® Small Fragment Set consists of:

    • LOQTEQ® Straight Plate 3.5
    • LOQTEQ® Reconstruction Plate 3.5
    • LOQTEQ® 1/3 Tubular Plate 3.5
    • LOQTEQ® Cortical Screw 3.5, T15, self-tapping
    • LOQTEQ® Cortical Screw 3.5, small head T15, self-tapping
    • Cortical Screw 3.5, self-tapping
    • Cortical Screw 3.5, small head, self-tapping
    • Set of Instruments, Small Fragment Set
    AI/ML Overview

    The aap LOQTEQ Small Fragment Set is a medical device used for the internal fixation of bone fractures and other bone injuries. The acceptance criteria and the study proving the device meets these criteria are outlined below.

    1. Table of Acceptance Criteria and Reported Device Performance

    Acceptance Criteria (Defined by ASTM F382)Reported Device Performance
    Mechanical performance, specifically implant fatigue tests with progressive loadings (worst-case scenario for clinical use)Substantial equivalence to predicate devices (Small Fragment Locking Compression Plate (LCP®) System, Synthes (USA), and Zimmer® Small Fragment Universal Locking System) in mechanical performance.
    Static and dynamic 4-Point bending testsSubstantial equivalence to predicate devices in mechanical performance.
    Compliance with pre-defined requirements for safety and effectivenessThe device is safe and effective, and its performance meets the requirements of its pre-defined acceptance criteria and intended uses.

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

    The information provided does not specify a distinct "test set" in the context of typical AI/ML studies. Instead, the performance data discussed is based on non-clinical mechanical tests. Therefore, details like "sample size for the test set" and "data provenance" (country of origin, retrospective/prospective) are not applicable in the same way they would be for studies involving human subject data or AI model validation. The testing was conducted on the device components themselves, following established ASTM standards.

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

    This information is not applicable. The "ground truth" for this device's performance is established by mechanical testing according to industry standards (ASTM F382), not by expert human interpretation of data in the way an AI model's output would be validated.

    4. Adjudication Method for the Test Set

    This information is not applicable as the "test set" involves physical device testing against established mechanical standards, not human expert adjudication of results.

    5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

    No. This document describes the premarket notification (510(k)) for a medical device (bone plates and screws), not an AI/ML diagnostic or prognostic tool. Therefore, a multi-reader multi-case (MRMC) comparative effectiveness study comparing human readers with and without AI assistance was not performed or discussed.

    6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study Was Done

    No. This device is a physical implant, not a software algorithm. Therefore, "standalone (algorithm only without human-in-the-loop performance)" is not applicable. The performance evaluated is the mechanical integrity and functionality of the physical device components.

    7. The Type of Ground Truth Used

    The "ground truth" used for this device is based on established mechanical performance standards and material properties defined by ASTM (American Society for Testing and Materials) standards, specifically ASTM F382. The device's performance is compared against these standards and against the mechanical performance of legally marketed predicate devices.

    8. The Sample Size for the Training Set

    This information is not applicable. There is no mention of a "training set" in the context of AI/ML or statistical modeling. The document describes the mechanical testing of a physical medical device.

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

    This information is not applicable as there is no "training set" for this type of device submission. The "ground truth" for the device's performance is derived from compliance with specified mechanical testing protocols and comparison to predicate devices, as described in point 7.

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