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510(k) Data Aggregation

    K Number
    K043263
    Device Name
    TRIMED OSTEOTOMY PLATE
    Manufacturer
    TRIMED, INC.
    Date Cleared
    2005-01-14

    (51 days)

    Product Code
    HRS
    Regulation Number
    888.3030
    Type
    Traditional
    Panel
    Orthopedic
    Reference & Predicate Devices
    K952766,K030310
    Why did this record match?
    Device Name :

    TRIMED OSTEOTOMY PLATE

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

    The TriMed Ulnar Osteotomy Plate is intended for use in osteotomy procedures of the ulna.

    Device Description

    Not Found

    AI/ML Overview

    The provided document is a 510(k) summary for a medical device called the "TriMed Ulnar Osteotomy Plate." This type of submission focuses on demonstrating substantial equivalence to a predicate device rather than conducting new clinical studies to prove effectiveness or meeting specific performance acceptance criteria.

    Therefore, the document does not contain the information requested regarding acceptance criteria, study details, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, or training set details.

    The 510(k) process for this device relies on demonstrating that the new device has the same intended use and technological characteristics as a legally marketed predicate device, or that any differences do not raise new questions of safety and effectiveness.

    Here's why the requested information is absent:

    • Acceptance Criteria & Device Performance: This document does not define specific performance metrics or acceptance criteria for the TriMed Ulnar Osteotomy Plate because its approval is based on substantial equivalence to existing devices (K952766 Rayhack Osteotomy System and K030310 Synthes 3.5/4.5 mm. LCP Metaphyseal Plates).
    • Study Details (Sample size, data provenance, experts, adjudication, MRMC, standalone): No clinical trials or performance studies are described in this 510(k) summary. The submission relies on a comparison of the new device's characteristics to those of the predicate devices.
    • Ground Truth: Since no performance study is detailed, there's no mention of how "ground truth" would be established.
    • Training Set Information: This is relevant for machine learning or AI-driven devices, which this medical plate is not.

    In summary, the provided K043263 document describes a traditional medical device submission through the 510(k) pathway, which primarily assesses substantial equivalence and does not typically include the detailed clinical or performance study data you've requested.

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