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510(k) Data Aggregation

    K Number
    K043434
    Device Name
    OSTEOMED PEDIATRIC INTRAORAL MANDIBULAR DISTRACTION SYSTEM
    Manufacturer
    OSTEOMED L.P.
    Date Cleared
    2005-02-10

    (59 days)

    Product Code
    MQN
    Regulation Number
    872.4760
    Type
    Traditional
    Panel
    Dental
    Reference & Predicate Devices
    K010139,K013618
    Predicate For
    K062851,K121502
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    Intended as a bone stabilizer and lengthening (and/or transport) device when correction of congenital deficiencies or post traumatic defects of the mandible (including ramus, body, symphisis), require gradual distraction. This system is intended for use in pediatric population for children under 4 years of age including infants and neonates. The OsteoMed Pediatric Intraoral Mandibular Distraction System is intended for single patient use only.

    Device Description

    The OsteoMed Pediatric Intraoral Mandibular Distraction System is a subcutaneous bone distractor. It features various curved and straight bars. activated with a threaded wire, that have plates that are fixed to bone via 1.2mm bone screws. The distractor is available in right and left versions. The threaded wire is activated by a hex driver and is capable of distraction lengths of up to 35mm.

    AI/ML Overview

    The provided text describes the OsteoMed Pediatric Intraoral Mandibular Distraction System (K043434), a medical device. However, it does not contain any information regarding acceptance criteria, study details, performance metrics, sample sizes, ground truth establishment, or expert involvement for a study proving the device meets acceptance criteria.

    The document is a 510(k) summary for a medical device submitted to the FDA. Such summaries primarily focus on demonstrating substantial equivalence to a legally marketed predicate device rather than presenting detailed study results against specific acceptance criteria.

    Therefore, I cannot fulfill your request for the detailed table and study information because the provided input lacks the necessary data.

    To answer your request, the input document would need to include sections detailing:

    1. Specific performance metrics the device was designed to achieve (acceptance criteria).
    2. A study design that evaluated these metrics.
    3. Results from that study, comparing them to the acceptance criteria.
    4. Information on the data used (sample size, provenance), ground truth establishment (experts, adjudication), and training set details (if applicable for an AI device, which this is not).
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