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510(k) Data Aggregation

    K Number
    K120165
    Device Name
    INTRAOSSEOUS FIXATION SYSTEM
    Manufacturer
    ORTHOHELIX SURGICAL DESIGNS, INC.
    Date Cleared
    2012-04-17

    (89 days)

    Product Code
    HTY
    Regulation Number
    888.3040
    Type
    Traditional
    Panel
    Orthopedic
    Reference & Predicate Devices
    K022599,K070598
    Predicate For
    K133636,K141004,K141857,K170326
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The Intraosseous Fixation System is intended to stabilize and aid in the fixation of fractures, fusions, and osteotomies of the phalanges.

    Device Description

    The Intraosseous Fixation System consists of various size implants to stabilize and aid in the fixation of fracture, fusions, and osteotomies of the phalanges. The implants are offered in different lengths and diameters. All implants are manufactured from implant grade titanium alloy.

    AI/ML Overview

    The provided text is related to a 510(k) summary for the OrthoHelix Surgical Designs, Inc. Intraosseous Fixation System. This document outlines the device description, intended use, and substantial equivalence to predicate devices based on mechanical testing. It does not describe a study involving a comparison of device performance against acceptance criteria using statistical measures on a test set, nor does it refer to human readers, experts, or ground truth as would be relevant for a medical imaging or diagnostic device.

    Therefore, many of the requested categories of information are not applicable to this submission.

    Here is the information that can be extracted from the provided text based on your prompt:

    1. A table of acceptance criteria and the reported device performance

    Acceptance CriteriaReported Device Performance
    Not explicitly stated as acceptance criteria in the format of statistical metrics.Mechanical 4-point bend testing was performed to establish substantial equivalence to predicate devices (New Deal K-wire (K022599) and Memometal Technologies Smart Toe (K070598)). The submission states: "No new issues of safety and effectiveness have been raised." This implies the device's mechanical performance in 4-point bend testing was comparable to predicates.

    Regarding the other points, the provided text does not contain the information needed to answer them as they pertain to studies typically performed on diagnostic or AI-enabled devices.

    • 2. Sample size used for the test set and the data provenance: Not applicable. The study was mechanical testing, not a diagnostic accuracy study.
    • 3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. No ground truth was established by experts for this type of mechanical testing.
    • 4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable.
    • 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: Not applicable. This is not an AI or diagnostic device.
    • 6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable.
    • 7. The type of ground truth used (expert consensus, pathology, outcomes data, etc): Not applicable.
    • 8. The sample size for the training set: Not applicable. No training set was involved in this type of mechanical testing.
    • 9. How the ground truth for the training set was established: Not applicable.
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