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    K Number
    K191597
    Device Name
    Stealth Autoguide System, Midas Rex Legend Depth Stop System
    Manufacturer
    Medtronic Navigation, Inc.
    Date Cleared
    2019-11-01

    (137 days)

    Product Code
    HAW,HBB,HBC,HBE
    Regulation Number
    882.4560
    Type
    Traditional
    Panel
    Neurology (NE)
    Reference & Predicate Devices
    K131433,K162309,K162604,K151359,K170312,K163182
    Why did this record match?
    Reference Devices :

    K131433, K162309, K162604

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

    The Stealth Autoguide™ System is a positioning and guidance system intended for the spatial positioning and orientation of instrument holders or tool guides to be used by neurosurgeons to guide standard neurosurgical instruments, based on a pre-operative plan and feedback from an image-guided navigation system with three-dimensional imaging software.
    The Stealth Autoguide™ System is a remotely-operated positioning and guidance system, indicated for any neurological condition in which the use of stereotactic surgery may be appropriate (for example, stereotactic EEG, laser tissue ablation, etc.).
    The Midas Rex™ Legend™ depth stop attachment and tools are incision, cutting, removing, and drilling of soft and hard tissue during cranial surgical procedures with the intent to create a hole through the cranium to allow surgeons access to desired surgical locations and/or to facilitate insertion, placement of other surgical devices during such procedures.

    Device Description

    Stealth Autoguide™ System: The Stealth Autoguide System is a robotic positioning and guidance system intended to interpret navigation tracker coordinates and surgical plan coordinates from the StealthStation to robotically position and orient instrument holders or tool guides to be used by neurosurgeons to guide standard neurosurgical instruments to pre-defined plans.
    Midas Rex™ Legend™ Depth Stop System: The Midas Rex™ Legend™ Depth Stop System consists of a Depth Stop Attachment and specific surgical dissecting tools that will be used in conjunction with the Stealth Autoguide System to create cranial access holes for neurosurgical procedures.

    AI/ML Overview

    The provided text describes the Medtronic Stealth Autoguide System and Midas Rex Legend Depth Stop System. It includes information on performance testing for the Stealth Autoguide System, but lacks specific details on acceptance criteria and a study to prove the device meets all acceptance criteria in a comprehensive format. It also doesn't contain the requested information about training sets, expert ground truth development, MRMC studies, or standalone performance.

    However, based on the provided text, I can extract the following information concerning the performance testing for the Stealth Autoguide System's accuracy:

    Acceptance Criteria and Reported Device Performance for Stealth Autoguide™ System

    Acceptance CriterionReported Device Performance (Mean)Standard Deviation99% CI* Upper
    3D Positional Accuracy: Mean error ≤ 2.0 mm
    Biopsy Needle Accuracy Validation - StealthStation S70.92 mm0.47 mm3.03 mm
    Biopsy Needle Accuracy Validation - StealthStation S80.97 mm0.26 mm1.70 mm
    sEEG bolts/Visualase Accuracy Validation - StealthStation S71.50 mm0.68 mm3.08 mm
    sEEG bolts/Visualase Accuracy Validation - StealthStation S81.48 mm0.48 mm2.60 mm
    Trajectory Angle Accuracy: Mean error ≤ 2.0 degrees
    Biopsy Needle Accuracy Validation - StealthStation S71.22 degrees0.51 degrees2.41 degrees
    Biopsy Needle Accuracy Validation - StealthStation S80.59 degrees0.23 degrees1.11 degrees
    sEEG bolts/Visualase Accuracy Validation - StealthStation S71.04 degrees0.76 degrees2.81 degrees
    sEEG bolts/Visualase Accuracy Validation - StealthStation S80.42 degrees0.17 degrees0.82 degrees

    Details of the Accuracy Study:

    1. Sample size used for the test set and the data provenance: The document states that performance was determined using "overall end-to-end worst-case system level accuracy testing which incorporated clinically relevant anatomical phantoms." Further specifics about the sample size (e.g., number of phantoms, number of measurement points per phantom) and data provenance (e.g., country of origin, retrospective or prospective) are not provided in this document.

    2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: This information is not provided in the document. The accuracy testing seems to be based on direct physical measurements against defined targets on phantoms rather than expert interpretation of images.

    3. Adjudication method for the test set: This information is not provided. Given the nature of the accuracy testing (physical measurements), traditional adjudication methods for image interpretation would likely not apply.

    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: This information is not provided. The assessment described is a technical accuracy validation of the device's navigation and positioning capabilities, not a study involving human readers or AI assistance.

    5. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: The "Stealth Autoguide™ System" is described as a "robotic positioning and guidance system" and the accuracy validation focuses on its "performance in 3D positional accuracy" and "trajectory angle accuracy." This implies standalone technical performance testing of the system's ability to achieve planned trajectories, before a human surgeon uses it to guide instruments. The system is designed to "robotically position and orient instrument holders or tool guides," suggesting its core function is algorithm-driven positioning. However, the evaluation here focuses on the accuracy of the guidance provided, which would then be utilized by a surgeon.

    6. The type of ground truth used: The ground truth for the accuracy study was established by defining "clinically relevant anatomical phantoms" and measuring the device's "performance in 3D positional accuracy" and "trajectory angle accuracy" against the known positions and trajectories on these phantoms. This is a phantom-based measurement ground truth.

    7. The sample size for the training set: This information is not provided. The document describes an accuracy validation study, not the development or training of an AI algorithm.

    8. How the ground truth for the training set was established: This information is not provided, as details about a training set are not included in the document.

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