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510(k) Data Aggregation

    K Number
    K142442
    Device Name
    MAGNA-FX AND MINI MAGNA-FX CANNULATED SCREW FIXATION SYSTEM
    Manufacturer
    ZIMMER, INC.
    Date Cleared
    2014-10-03

    (31 days)

    Product Code
    HWC
    Regulation Number
    888.3040
    Type
    Traditional
    Panel
    Orthopedic
    Reference & Predicate Devices
    K111994,K021932
    Predicate For
    K143702,K150693
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The Magna-FX Cannulated Bone Screws are indicated for fractures of: The intracapsular hip, femoral condyles, tibial condyles, ankle, acetabulum, pelvis, and other areas where accurate screw placement is required. The screw can also be applied to slipped capital femoral epiphysis if image intensification fluoroscopy is used to ascertain the proper position of the screw.

    The Mini Magna-FX Cannulated Bone Screws are indicated for: Fractures of the medial malleolus, distal tibia, distal radius, calcaneus, talus, patella, and pelvis. It can also be used in the reduction of small bone fragments and reduction and fixation with cerclage wire, and the fixation of bone prominences.

    Device Description

    The Magna-FX Cannulated Screw Fixation System consists of a line of cannulated bone screws that are self- reaming and self-tapping and an associated washer. Magna-FX screws are designed to provide rigid fixation for various fractures.

    AI/ML Overview

    This document describes a 510(k) premarket notification for the Magna-FX® Cannulated Screw Fixation System. It confirms that the device is substantially equivalent to legally marketed predicate devices.

    Here's an analysis of the acceptance criteria and the study as requested, based on the provided text:

    This document does not contain information about acceptance criteria or a study proving that a device meets acceptance criteria in the context of an AI/algorithm-based medical device. Instead, it is a traditional FDA 510(k) clearance letter and summary for a physical medical device (bone screws).

    Therefore, many of the requested categories for AI/algorithm performance studies cannot be answered from this provided text.

    However, I can extract the information relevant to non-clinical performance for this physical device:

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

    Based on the provided text, the "acceptance criteria" for a physical device like these screws are typically defined by recognized standards (e.g., ASTM) and demonstrated through testing. The "reported device performance" are the results of these tests.

    Acceptance Criteria / Test StandardReported Device Performance (as stated in the document)
    Non-Clinical Performance
    Shelf Life (Accelerated aging)10 years
    Biocompatibility (ISO 10993-1, 21 CFR 58)All testing passed
    Screw Torsional Properties (ASTM F543)Results demonstrate safety, effectiveness, and substantial equivalence to predicate devices.
    Axial Pull-out Strength (ASTM F543)Results demonstrate safety, effectiveness, and substantial equivalence to predicate devices.
    Clinical PerformanceNot needed for these devices to show substantial equivalence.

    Regarding the other requested points, the document states the following, or the information is not applicable/provided for this type of device submission:

    1. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective): Not applicable or not provided. The performance testing refers to physical tests on the screws (e.g., mechanical testing, biocompatibility), not a "test set" of patient data as would be used for an AI device.

    2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth in this context refers to the defined parameters of the mechanical or biocompatibility tests, not expert consensus on medical images or data.

    3. Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not applicable.

    4. 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 for a physical bone screw, not an AI device.

    5. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable.

    6. The type of ground truth used (expert consensus, pathology, outcomes data, etc): For the non-clinical tests, the "ground truth" would be the established scientific and engineering principles and the predefined pass/fail criteria according to standards like ASTM and ISO.

    7. The sample size for the training set: Not applicable. There is no concept of a "training set" for physical device testing in this context.

    8. How the ground truth for the training set was established: Not applicable.

    In summary: The provided document is a 510(k) clearance for a physical medical device (bone screws) and details non-clinical performance testing against recognized standards. It does not contain information related to AI or algorithm-based device studies, which would typically involve "acceptance criteria" and "studies" as described in your prompt for such technologies.

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