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510(k) Data Aggregation

    K Number
    K182810
    Device Name
    Distal Radius Plating System
    Manufacturer
    Miami Device Solutions, LLC
    Date Cleared
    2018-12-10

    (68 days)

    Product Code
    HRS,HWC
    Regulation Number
    888.3030
    Type
    Special
    Panel
    Orthopedic
    Reference & Predicate Devices
    K041461,K151418,K161292,K162635,K071092,K133246
    Why did this record match?
    Reference Devices :

    K041461, K151418

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

    The MDS Distal Radius Plating System is internal fixation of fractures of the distal radius.

    Device Description

    This special 510(k) submission is intended to add new plate designs, screw diameter options and lengths, pegs, and accompanying instrumentation to the Miami Device Solutions Distal Radius Plating System cleared through K161292/K162635.

    The Distal Radius Plating System is an internal fixation system to be used for the treatment of distal radius fractures. The system consists of plates, screws, pegs, and locking caps. The Distal Radius Plates are available in bilateral and side-specific designs to accommodate different anatomies and fracture patterns. The addition of new devices through this special 510(k) provides the user with more options for fixation.

    Materials: Ti-6Al-4V ELI alloy conforming to ASTM F136.

    AI/ML Overview

    The provided text is an FDA 510(k) clearance letter and summary for a medical device: the Distal Radius Plating System. This document is related to orthopedic surgical implants, not to an AI/ML-driven diagnostic device.

    Therefore, the document does not contain any information about:

    • Acceptance criteria for an AI/ML model's performance.
    • A study proving a device meets acceptance criteria for an AI/ML model.
    • Sample sizes for test sets or data provenance for an AI/ML model.
    • Number of experts or their qualifications for establishing ground truth for an AI/ML model.
    • Adjudication methods for an AI/ML model.
    • Multi-reader multi-case (MRMC) comparative effectiveness studies for AI.
    • Stand-alone (algorithm-only) performance of an AI.
    • Type of ground truth used for AI/ML.
    • Sample size for training sets for AI/ML.
    • How ground truth for training sets was established for AI/ML.

    The "Performance Data" section explicitly states:

    • Non-Clinical Performance and Conclusions: "The results of non-clinical (laboratory/performance) testing as well as engineering analysis for subject devices demonstrate that the device is as safe and as effective as the predicates. Substantial equivalence is demonstrated in the performance testing section of the submission by comparing subject and predicate designs, as well as testing according to ASTM F543-07, Standard Specification and Test Method for Metallic Bone Screws."
    • Clinical Performance and Conclusions: "Clinical data and conclusions were not needed for this device."

    This indicates that the clearance was based on bench testing (mechanical properties, material specification, comparison to predicates), not on the performance of a diagnostic algorithm or AI.

    In summary, none of the requested information regarding acceptance criteria and performance studies for an AI/ML device can be extracted from this document, as it pertains to a different type of medical device.

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