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510(k) Data Aggregation

    K Number
    K020069
    Device Name
    MEDTRONIC MIDA REX LEGEND SYSTEM, MIDAS REX LEGEND PNEUMATIC HIGH SPEED SYSTEM OR LEGEND SYSTEM
    Manufacturer
    MEDTRONIC MIDAS REX
    Date Cleared
    2002-03-18

    (68 days)

    Product Code
    HBB
    Regulation Number
    882.4370
    Type
    Traditional
    Panel
    Neurology
    Reference & Predicate Devices
    K882672,K974637,K981146
    Why did this record match?
    Device Name :

    MEDTRONIC MIDA REX LEGEND SYSTEM, MIDAS REX LEGEND PNEUMATIC HIGH SPEED SYSTEM OR LEGEND SYSTEM

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

    The Medtronic Midas Rex Legend System is a pneumatically operated surgical instrument system. The pneumatic motor provides power to operate removable rotating surgical cutting tools and their accessories intended for use in neurosurgery, including craniotomy and spinal surgery; as well as Ear Nose and Throat (ENT), orthopedic, and general surgical applications including maxillofacial, craniofacial and sternotomy surgeries.

    Device Description

    The Medtronic Midas Rex Legend System is a modular, pneumatic, highspeed instrument system consisting of a motor (handpiece) and accessories/attachments, including but not limited to adapters, spindles, burrs, drills, cutters, and other dissecting tools.

    AI/ML Overview

    The provided 510(k) summary for the Medtronic Midas Rex Legend System does not contain the detailed information required to describe acceptance criteria and a study proving the device meets those criteria in the way typically expected for AI/ML-driven medical devices.

    Instead, this document is a summary for a traditional medical device (a surgical drill system) and focuses on demonstrating substantial equivalence to existing predicate devices, rather than a performance study against specific acceptance criteria for diagnostic or AI-driven tasks.

    Therefore, many of your requested points cannot be answered from the provided text. I will address the points as best as possible based on the information given, highlighting where information is missing due to the nature of the device and the document.

    Acceptance Criteria and Study for Medtronic Midas Rex Legend System (Surgical Drill System)

    1. Table of acceptance criteria and the reported device performance

    Acceptance Criteria (Implied)Reported Device Performance
    Operate as intended (e.g., provide power, cut effectively)"Confirms that the device operates as intended"
    Substantially equivalent to predicate devices (Midas Rex Classic, Midas Rex III, Mednext 1000 Instrumentation Systems)"Is substantially equivalent to the Midas Rex Classic, Midas Rex III, and Mednext 1000 Instrumentation Systems"
    No new safety or effectiveness issues"Raises no new safety or effectiveness issues"
    Same technological characteristics as predicates"Have the same technological characteristics"
    Same operating principles as predicates"Use the same operating principles"
    Use same patient contacting materials as predicates"Use the same patient contacting materials"
    Similar performance characteristics as predicates"Have similar performance characteristics"

    Explanation: In a 510(k) submission for a non-AI/ML device, the primary "acceptance criteria" revolve around demonstrating that the new device is as safe and effective as a legally marketed predicate device. The performance data is therefore framed around "substantial equivalence." Specific quantitative performance metrics (like sensitivity, specificity, accuracy for an AI system) are not typically presented in this type of submission for a surgical drill system.

    2. Sample size used for the test set and the data provenance

    • Sample Size: Not specified. The document states "Performance testing on the Medtronic Midas Rex Legend System confirms that the device operates as intended." This likely refers to engineering and bench testing, rather than a "test set" in the context of data for an AI/ML device. There is no mention of patient data.
    • Data Provenance: Not applicable in the context of data for AI/ML. The testing would be performed on the physical device itself.

    3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

    • Not applicable. This device is a surgical instrument, not a diagnostic tool requiring expert interpretation of results to establish ground truth.

    4. Adjudication method for the test set

    • Not applicable. There is no "test set" in the AI/ML sense, nor a need for expert adjudication.

    5. 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

    • No. This is a surgical tool, not an AI-assisted diagnostic or interpretive device. Therefore, MRMC studies are not relevant.

    6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

    • No. This is a human-operated surgical tool, not an algorithm.

    7. The type of ground truth used

    • The "ground truth" for this device would be its functional performance (e.g., speed, torque, cutting ability, durability, temperature generation) validated against engineering specifications and comparison to the predicate devices. It would likely involve bench testing, mechanical stress tests, and potentially animal or cadaver studies, though these details are not provided in the summary.

    8. The sample size for the training set

    • Not applicable. There is no "training set" for an AI/ML algorithm for this type of device.

    9. How the ground truth for the training set was established

    • Not applicable. There is no "training set" for an AI/ML algorithm for this type of device.
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