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510(k) Data Aggregation

    K Number
    K170310
    Device Name
    Alians Clavicle range
    Manufacturer
    Newclip Technics
    Date Cleared
    2017-03-30

    (57 days)

    Product Code
    HRS,HWC
    Regulation Number
    888.3030
    Type
    Traditional
    Panel
    Orthopedic
    Reference & Predicate Devices
    K143061,K100944,K102998
    Predicate For
    K092819
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The implants of the Alians Clavicle range are dedicated to the fixation of fractures, mal-unions and osteotomies of the clavicle in adults.

    Device Description

    The Alians Clavicle range consists of plates and screws designed for fixation of fractures, mal-unions, non-unions and osteotomies of the clavicle in adults.

    The implants of the Alians Clavicle range will be provided non sterile for sterilization by health care professionals prior to use or provided sterile by gamma sterilization. The instruments of the Alians Clavicle range will be provided non sterile for sterilization by health care professionals prior to use. Single use kits (Initial C) contain implants and instruments provided sterile by gamma sterilization. The Initial C kits contain implants (1 plate + screws), and instrumentation.

    AI/ML Overview

    The provided document is a 510(k) summary for the "Alians Clavicle range" device. This type of regulatory submission is for medical devices that are substantially equivalent to legally marketed predicate devices, not for novel AI/software devices requiring the kind of extensive performance criteria and studies outlined in your request.

    Therefore, many of the requested categories (e.g., sample size for test set, number of experts for ground truth, MRMC studies, standalone algorithm performance, training set details) are not applicable to this submission. This document describes a traditional orthopaedic medical device (bone fixation plates and screws), not an AI/ML algorithm.

    However, I can extract the acceptance criteria and study information that is relevant to this type of device and present it in your requested format.

    Acceptance Criteria and Device Performance for Alians Clavicle Range

    Acceptance Criteria CategoryDescription & Performance
    Material EquivalenceThe device uses Titanium alloy Ti-6Al-4V, which conforms to ASTM F 136 and/or ISO 5832-3. This is considered substantially equivalent to the materials of the predicate devices.
    Mechanical PerformanceAcceptance Criteria: The device must demonstrate mechanical safety and performance equivalent to or better than the predicate device. Reported Performance: Engineering analyses (non-clinical testing) were conducted in comparison with the Clavicle Locking Plating System of Newclip Technics (K100944). The analyses showed that the Alians Clavicle range is as strong or stronger than the predicate.
    Biological Safety (LAL)Acceptance Criteria: The device must meet the endotoxin limit. Reported Performance: LAL testing was performed to demonstrate that the subject device meets the endotoxin limit of <20 EU/device.
    Indications for Use (IFU)Acceptance Criteria: The IFU must be substantially equivalent to the predicate devices. Reported Performance: The Alians Clavicle range is indicated for the fixation of fractures, mal-unions, non-unions and osteotomies of the clavicle in adults, which aligns with the IFU of the predicate devices.
    Design and Principles of OperationAcceptance Criteria: Design and operating principles must be substantially equivalent to the predicate devices. Reported Performance: The device consists of plates and screws for clavicle fixation, with principles of operation, technology, and design similar to the predicate devices.

    Study Information:

    1. Sample size used for the test set and the data provenance: Not applicable. Performance was demonstrated through non-clinical (engineering) testing, not clinical studies involving patient data or a "test set" in the context of an AI/ML algorithm.

    2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. No "ground truth" in this sense was established as it's not an AI/ML device.

    3. Adjudication method for the test set: Not applicable.

    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: No. This is a physical medical device, not an AI/ML diagnostic tool. "No clinical studies were performed."

    5. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: No. This is a physical medical device.

    6. The type of ground truth used: For the mechanical performance, the "ground truth" was established through engineering analyses comparing the new device against the known and accepted performance characteristics of legally marketed predicate devices, measured using standardized tests. For biological safety, industry-standard LAL testing was used.

    7. The sample size for the training set: Not applicable. This is not an AI/ML device.

    8. How the ground truth for the training set was established: Not applicable. This is not an AI/ML device.

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