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    K Number
    K123723
    Device Name
    SYNTHES MATRIXNEURO CRANIAL PLATING SYSTEM
    Manufacturer
    SYNTHES
    Date Cleared
    2013-09-05

    (275 days)

    Product Code
    GWO,GXR
    Regulation Number
    882.5320
    Type
    Traditional
    Panel
    Neurology
    Reference & Predicate Devices
    K042365,K033160,K031807,K022012
    Why did this record match?
    Device Name :

    SYNTHES MATRIXNEURO CRANIAL PLATING SYSTEM

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

    The Synthes MatrixNEURO Cranial Plating System is intended for use in fixation of the cranial bones in procedures such as reconstruction, fracture repair, craniotomies, and osteotomies.

    Device Description

    The Synthes MatrixNEURO Cranial Plating System consists of bone fixation implants offered in a variety of shapes and sizes to meet the anatomical needs of the patient. The reconstruction meshes are manufactured from titanium, are designed for use with Synthes MatrixNEURO Cranial Plating System screws, are offered sterile, and are intended for single use only. The screws are manufactured from titanium alloy, are designed for use with Synthes MatrixNEURO plates, burr hole covers, and meshes, may be offered sterile, and are intended for single use only.

    AI/ML Overview

    Here's a breakdown of the acceptance criteria and the study that demonstrates the Synthes MatrixNEURO Cranial Plating System meets them, based on the provided 510(k) summary:

    This device notification (K123723) is a 510(k) submission for a medical device (device name: Synthes MatrixNEURO Cranial Plating System). The intent of a 510(k) is to demonstrate that the new device is "substantially equivalent" to one or more legally marketed predicate devices, meaning it is as safe and effective as a legally marketed device. For such submissions, clinical efficacy studies are not typically required if substantial equivalence can be demonstrated through non-clinical data.

    Acceptance Criteria and Reported Device Performance

    The acceptance criteria for this device are not explicitly defined as specific numerical thresholds, but rather are based on demonstrating "comparability" to predicate devices in mechanical performance.

    Acceptance Criteria (Demonstrates Comparability to Predicates)Reported Device Performance
    Cross-sectional area comparable to predicates"The non-clinical performance data demonstrate that the mechanical performance of the proposed Synthes MatrixNEURO reconstruction meshes and screws is comparable to that of the predicates."
    Section modulus comparable to predicates"The non-clinical performance data demonstrate that the mechanical performance of the proposed Synthes MatrixNEURO reconstruction meshes and screws is comparable to that of the predicates."
    Peak load at 2 mm of displacement comparable to predicates"The non-clinical performance data demonstrate that the mechanical performance of the proposed Synthes MatrixNEURO reconstruction meshes and screws is comparable to that of the predicates."
    Stiffness at 2 mm of displacement comparable to predicates"The non-clinical performance data demonstrate that the mechanical performance of the proposed Synthes MatrixNEURO reconstruction meshes and screws is comparable to that of the predicates."
    Insertion torque comparable to predicates"The non-clinical performance data demonstrate that the mechanical performance of the proposed Synthes MatrixNEURO reconstruction meshes and screws is comparable to that of the predicates."
    Failure torque comparable to predicates"The non-clinical performance data demonstrate that the mechanical performance of the proposed Synthes MatrixNEURO reconstruction meshes and screws is comparable to that of the predicates."
    Insertion factor of safety comparable to predicates"The non-clinical performance data demonstrate that the mechanical performance of the proposed Synthes MatrixNEURO reconstruction meshes and screws is comparable to that of the predicates."
    Pullout load comparable to predicates"The non-clinical performance data demonstrate that the mechanical performance of the proposed Synthes MatrixNEURO reconstruction meshes and screws is comparable to that of the predicates."

    Study Information

    1. Sample size used for the test set and the data provenance:
      The document does not specify a "test set" in the context of clinical data for the proposed device, as no clinical studies were performed. The "test" in this context refers to non-clinical, mechanical performance testing. The sample sizes for these mechanical tests (e.g., number of meshes or screws tested for each parameter) are not provided in this summary.
      Data provenance: Non-clinical performance data, likely from laboratory testing. Country of origin for this testing is not specified, but the submitter is Synthes (USA).

    2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
      Not applicable. No "ground truth" was established by experts in the context of clinical data, as this was a non-clinical performance study. Mechanical performance metrics are typically measured by calibrated instruments and methods, not subjective expert assessment.

    3. Adjudication method for the test set:
      Not applicable. No expert adjudication was needed as the study involved non-clinical mechanical testing, not interpretation of clinical data.

    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 device is a cranial plating system, not an AI-powered diagnostic tool. Therefore, MRMC studies involving human readers and AI assistance are irrelevant to this submission.

    5. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
      Not applicable. This is a physical medical device, not an algorithm, so standalone algorithm performance is not relevant.

    6. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
      For non-clinical performance studies, the "ground truth" is typically the quantitative measurement obtained from standardized mechanical tests, as defined by relevant industry standards or internal validation protocols. No expert consensus, pathology, or outcomes data were used as "ground truth" for this non-clinical submission. The "ground truth" is the objective mechanical property being measured.

    7. The sample size for the training set:
      Not applicable. This is a physical medical device. The concept of a "training set" is relevant for machine learning algorithms, which are not involved here.

    8. How the ground truth for the training set was established:
      Not applicable, as no training set was used.

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