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    K Number
    K033639
    Device Name
    ACUMED LOWER EXTREMITY CONGRUENT PLATE SYSTEM
    Manufacturer
    ACUMED LLC
    Date Cleared
    2004-01-15

    (56 days)

    Product Code
    HWC
    Regulation Number
    888.3040
    Type
    Traditional
    Panel
    Orthopedic
    Reference & Predicate Devices
    K012655,K001941,K974537,K982347,K020401,K981775
    Why did this record match?
    Device Name :

    ACUMED LOWER EXTREMITY CONGRUENT PLATE SYSTEM

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

    The Acumed Lower Extremity Congruent Plate System provides fixation during fractures, fusions, and osteotomies for the phalanges, metatarsals, tibia and fibula.

    Device Description

    The Acumed Lower Extremity Congruent Plate System consists of bone plates and screws for fractures, fusions, and osteotomes: The bone plates are pre-bent to minimize bending which is done intraoperatively. Instruments are supplied with the implants to aid in the insertion of the plates and screws. All plates and screws are manufactured from titanium in conformance with ASTM F136. Plates and screws are provided non-sterile.

    AI/ML Overview

    This document describes a 510(k) submission for the Acumed Lower Extremity Congruent Plate System. The submission aims to demonstrate substantial equivalence to previously marketed predicate devices.

    1. Table of Acceptance Criteria and Reported Device Performance

    As per the 510(k) summary, "An assessment of performance data is not applicable. A discussion of clinical and non-clinical tests is not applicable." Therefore, there are no specific performance acceptance criteria or reported device performance metrics provided in this submission in the way one might expect for a software or diagnostic device.

    The "acceptance criteria" in this context are implicitly that the technological characteristics of the new device are substantially equivalent to those of the predicate devices such that it raises no new issues of safety or effectiveness.

    Acceptance Criteria (Implicit)Reported Device Performance (Implicit)
    Material Composition: Device is manufactured from a biocompatible surgical-grade material.Acumed Lower Extremity Congruent Plate System is made out of Titanium as per ASTM F136. Predicate devices use either 316L stainless steel or Titanium as per ASTM F136, demonstrating material equivalence for their stated purpose.
    Intended Use: Device performs its intended function (fixation during fractures, fusions, osteotomies) in a similar manner to predicate devices.The Acumed Lower Extremity Congruent Plate System is indicated for use in providing fixation during fractures, fusions, and osteotomies for specific lower extremity bones (phalanges, metatarsals, tarsals, tibia, and fibula). This is stated as "similar to intended use of predicate devices and do not raise new issues of safety and effectiveness."
    Technological Characteristics: Device design and function are sufficiently similar to predicate devices.The bone plates are pre-bent to minimize-intraoperative bending, a design feature. No specific performance tests are reported, but the overall design is considered sufficiently similar to predicates to avoid new safety/effectiveness concerns.

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

    This is a submission for a medical device (bone plates and screws), not a diagnostic or AI device that relies on a "test set" of data in the traditional sense. Therefore, there is no test set sample size or data provenance provided. The safety and effectiveness are established through demonstrating substantial equivalence to predicate devices, not through a separate performance study with a test set.

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

    There is no test set or ground truth established by experts in this type of submission. The safety and effectiveness are primarily based on material safety standards (ASTM F136), manufacturing processes, and the long-standing safe use of similar predicate devices in the market.

    4. Adjudication Method for the Test Set

    As there is no test set, there is no adjudication method described.

    5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

    No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. This type of study is typically associated with diagnostic imaging devices or AI algorithms where human readers' performance is being evaluated with and without AI assistance. This submission is for a surgical implant (bone plates and screws).

    6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

    No, a standalone performance study was not done. This submission is for a physical medical device, not an algorithm.

    7. The Type of Ground Truth Used

    The "ground truth" for this type of device is established through:

    • Material standards: Conformance to ASTM F136 for titanium, ensuring biocompatibility and mechanical properties.
    • Clinical history of predicate devices: The safe and effective use of the legally marketed equivalent devices serves as the primary "ground truth" for the new device as their designs, materials, and intended uses are analogous.
    • General understanding of orthopedic fixation principles: The scientific and clinical consensus on the effectiveness of bone plates and screws for fracture fixation, fusions, and osteotomies.

    8. The Sample Size for the Training Set

    There is no "training set" in the context of this traditional medical device submission.

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

    As there is no "training set", there is no ground truth established for a training set.

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