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510(k) Data Aggregation

    K Number
    K213519
    Device Name
    Rune Labs Tremor Transducer System
    Manufacturer
    Rune Labs, Inc.
    Date Cleared
    2022-06-10

    (219 days)

    Product Code
    GYD,ISD,NXQ
    Regulation Number
    882.1950
    Type
    Traditional
    Panel
    Neurology
    Reference & Predicate Devices
    K161717,K140086
    Why did this record match?
    Applicant Name (Manufacturer) :

    Rune Labs, Inc.

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

    The Rune Labs Kinematic System is intended to quantify kinematics of movement disorder symptoms including tremor and dyskinesia, in adults (45 years of age or older) with mild to moderate Parkinson's disease.

    Device Description

    The Rune Labs Kinematic System collects derived tremor and dyskinesia probability scores using processes running on the Apple Watch, and then processes and uploads this data to Rune's cloud platform where it is available for display for clinicians.

    The Rune Labs Kinematic System uses software that runs on the Apple Watch to measure patient wrist movements. These movements are used to determine how likely dyskinesias or tremors are to have occurred. The times with symptoms are then sent to the Rune Labs Cloud Platform using the Apple Watch's internet connection, which is then displayed for clinician use.

    The Apple Watch contains accelerometers and gyroscopes which provide measurements of wrist movement. The Motor Fluctuations Monitor for Parkinson's Disease (MM4PD) is a toolkit developed by Apple for the Apple Watch that assesses the likely presence of tremor and dyskinesia as a function of time. Specifically, every minute, the Apple Watch calculates what percentage of the time that tremor and dyskinesia were likely to occur. The movement disorder data that is output from the Apple's MM4PD toolkit have been validated in a clinical study (Powers et al., 20211).

    The Rune Labs Kinematic System is software that receives, stores, and transfers the Apple Watch MM4PD classification data to the Rune Labs Cloud Platform where it is available for visualization by clinicians. The device consists of custom software that runs on the users' smart watch and web browsers.

    AI/ML Overview

    Here's a breakdown of the acceptance criteria and the study proving the device meets them, based on the provided text:

    Acceptance Criteria and Reported Device Performance

    The acceptance criteria are implicitly defined by the correlation and differentiation shown by the device's measurements against established clinical ratings and conditions. The study highlights the performance in terms of correlation coefficients and statistical significance.

    Acceptance Criteria (Implicit)Reported Device Performance
    Tremor Detection Correlation: Strong correlation between daily tremor detection rate and clinician's overall tremor rating (MDS-UPDRS tremor constancy score).Spearman's rank correlation coefficient of 0.72 in both the design set (n=95) and hold-out set (n=43) for mean daily tremor percentage vs. MDS-UPDRS tremor constancy score.
    Tremor False Positive Rate (Non-PD): Low false positive rate for tremor detection in elderly, non-PD controls.False positives occurred 0.25% of the time in 171 elderly, non-PD longitudinal control subjects (43,300+ hours of data).
    Dyskinesia Differentiation: Significant difference in detected dyskinesia between subjects with and without chorea.Dyskinesia detected significantly differed (p
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