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510(k) Data Aggregation

    K Number
    K082095
    Device Name
    ULTRASLIDE ACROMIOCLAVICULAR AND SYNDESMOTIC REPAIR DEVICE
    Manufacturer
    SMITH & NEPHEW ENDOSCOPY, INC.
    Date Cleared
    2008-10-21

    (89 days)

    Product Code
    HTN
    Regulation Number
    888.3030
    Type
    Traditional
    Panel
    Orthopedic
    Reference & Predicate Devices
    K052776,K043248
    Why did this record match?
    Device Name :

    ULTRASLIDE ACROMIOCLAVICULAR AND SYNDESMOTIC REPAIR DEVICE

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The Smith & Nephew Ultraslide Acromioclavicular and Syndesmotic Repair Device is intended as an adjunct in fracture repair providing fixation during the healing process following a syndesmotic trauma, such as fixation of acromioclavicular separations due to coracoclavicular ligament disruptions or fixation of ankle syndesmosis due to anterior inferior tibiofibular ligament and/or posterior inferior tibiofibular ligament disruptions.

    Device Description

    The Smith & Nephew Ultraslide Device allows for endoscopic fixation following a syndesmotic trauma as Coracoclavicular Separations or Ankle Syndesmotic Disruptions. The device consists of three components; two machined titanium ENDOBUTTON fixation devices on a continuous Polyester suture loop. It is prethreaded with a traction suture that is used for positioning of the fixation button. Although non-absorbable, the Ultraslide device does not require removal,

    AI/ML Overview

    Here's an analysis of the provided text regarding the Smith & Nephew Ultraslide Acromioclavicular and Syndesmotic Repair Device, focusing on acceptance criteria and supporting studies:

    1. Table of Acceptance Criteria and Reported Device Performance

    Acceptance Criteria (Implied)Reported Device Performance
    Substantial equivalence in design, indications, and fundamental scientific technology to predicate devices."The Smith & Nephew Ultraslide Device is substantially equivalent in design and function to the currently marketed Arthrex Tightrope™."
    No statistically significant differences in cyclical displacement values compared to predicate devices."Statistical comparison of the test data of the cyclical displacement values... demonstrates that there are no statistically significant differences between the Smith & Nephew Ultraslide Device and the predicate devices."
    No statistically significant differences in tensile strength compared to predicate devices."...tensile strength demonstrates that there are no statistically significant differences between the Smith & Nephew Ultraslide Device and the predicate devices."

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

    The document does not explicitly state the specific sample size used for the test set in terms of the number of devices or experimental replicates. It only refers to "test data."

    The data provenance is not specified in terms of country of origin or whether it was retrospective or prospective. Given the nature of a 510(k) submission for mechanical medical devices, it is highly likely that the "test data" refers to prospective in-vitro mechanical testing conducted under controlled laboratory conditions, rather than human subject data.

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

    This information is not applicable to this type of submission. The "ground truth" for the performance of a mechanical device like this is established through objective physical measurements (e.g., tensile strength, displacement) in a laboratory setting, not through expert consensus or interpretation of clinical images.

    4. Adjudication Method for the Test Set

    This information is not applicable. Adjudication methods are typically used in studies involving human interpretation or clinical outcomes, not in basic mechanical performance testing.

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

    A multi-reader multi-case (MRMC) comparative effectiveness study was not done. This type of study is relevant to diagnostic imaging devices or algorithms where human readers interpret results, and the AI's impact on their performance is being evaluated. The Ultraslide device is a surgical implant.

    6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study

    A standalone performance study was done, but it was a standalone device performance study (mechanical testing) rather than an algorithm-only standalone study. The performance of the Ultraslide device was evaluated independently, and then statistically compared to predicate devices. There is no "algorithm" in this context as it's a physical device.

    7. Type of Ground Truth Used

    The ground truth used was objective physical measurements (e.g., cyclical displacement values, tensile strength) obtained through standardized mechanical testing protocols in a laboratory setting. These measurements directly reflect the inherent physical properties and performance of the device.

    8. Sample Size for the Training Set

    This information is not applicable. The Ultraslide Device is a physical medical device, not an AI/ML algorithm that requires a "training set."

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

    This information is not applicable for the same reason as above. There is no training set for a mechanical medical device.

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