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    K Number
    K092239
    Device Name
    ROSA SURGICAL DEVICE, MODEL ROSA 1.1
    Manufacturer
    MEDTECH S.A.
    Date Cleared
    2009-11-17

    (117 days)

    Product Code
    HAW
    Regulation Number
    882.4560
    Type
    Traditional
    Panel
    Neurology (NE)
    Reference & Predicate Devices
    K991081,K001801,K060556
    Why did this record match?
    Reference Devices :

    K991081, K001801, K060556

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

    ROSA Surgical Device is a computer-controlled electromechanical arm. It is intended to be used in the operating room for the spatial positioning and orientation of an instrument holder or tool guide. Guidance is based on a pre-operative plan developed with three-dimensional imaging software, and uses fiducial markers registration. The system is intended for use by neurosurgeons to guide standard neurosurgical instruments. It is indicated for any neurosurgical condition in which the use of stereotactic surgery may be appropriate.

    Device Description

    ROSA Surgical Device is a computer controlled electromechanical arm. It is intended to be used in the operating room for the spatial positioning and orientation of an instrument holder or tool guide. Guidance is based on a pre-operative plan developed with three-dimensional imaging software, and uses fiducial markers registration. The system is intended for use by neurosurgeons to guide standard neurosurgical instruments.

    AI/ML Overview

    The ROSA Surgical Device is a computer-controlled electromechanical arm intended for the spatial positioning and orientation of an instrument holder or tool guide in neurosurgery. Guidance is based on a pre-operative plan developed with three-dimensional imaging software and uses fiducial marker registration.

    Here's a breakdown of the acceptance criteria and study information:

    1. Acceptance Criteria and Reported Device Performance

    ParameterAcceptance CriteriaReported Device Performance
    AccuracyNot explicitly stated in quantitative terms in the provided text, but implied as sufficient for neurosurgical guidance."Device performance tests were performed to validate the accuracy and repeatability of the device."
    RepeatabilityNot explicitly stated in quantitative terms in the provided text, but implied as sufficient for neurosurgical guidance."Device performance tests were performed to validate the accuracy and repeatability of the device."
    Electrical SafetyCompliance with IEC 60601-1 standard for electrical safety."Testing was carried out to assure compliance with recognized electrical safety standards: IEC 60601-1 standard for electrical safety..."
    Electromagnetic CompatibilityCompliance with IEC 60601-1-2 standard for electromagnetic compatibility."...and IEC 60601-1-2 standard for electromagnetic compatibility."
    Software RegulationsCompliance with FDA Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices and IEC 62304 (Medical Device Software - Life Cycle Process)."Tests were also carried out to satisfy the requirements of the FDA Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices and IEC 62304 (Medical Device Software - Life Cycle Process)."

    2. Sample Size and Data Provenance

    The provided text does not explicitly state a sample size for the test set or the data provenance (e.g., country of origin, retrospective or prospective). It mentions "Device performance tests were performed," but no details on the specifics of these tests are given.

    3. Number of Experts and Qualifications for Ground Truth

    The provided text does not specify the number or qualifications of experts used to establish ground truth for any testing.

    4. Adjudication Method for the Test Set

    The provided text does not describe any adjudication method used for the test set.

    5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

    There is no mention of a multi-reader multi-case (MRMC) comparative effectiveness study in the provided text. The submission focuses on the performance of the device itself, not on human-in-the-loop performance or the effect size of AI assistance on human readers.

    6. Standalone Performance Study

    Yes, the information implies a standalone (algorithm only without human-in-the-loop performance) study was done. The "Device performance tests" focused on validating the "accuracy and repeatability of the device" itself, suggesting an evaluation of the system's inherent performance.

    7. Type of Ground Truth Used

    The type of ground truth used is not explicitly stated. However, given the nature of a computer-controlled electromechanical arm for spatial positioning and orientation, it is highly likely that the ground truth for "accuracy and repeatability" would be established through precision measurements and validated spatial references within a controlled environment, rather than expert consensus, pathology, or outcomes data in the traditional sense of diagnostic AI.

    8. Sample Size for the Training Set

    The provided text does not state the sample size for the training set. It refers to "pre-operative planning developed with three-dimensional imaging software," which would require data for algorithm training, but no details are given.

    9. How Ground Truth for the Training Set Was Established

    The provided text does not describe how ground truth for the training set was established. The device uses "fiducial markers registration" and "three-dimensional imaging software" for planning, which implies that the training data would be related to accurate spatial mapping and image processing, but the method of establishing their ground truth is not detailed.

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