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510(k) Data Aggregation

    K Number
    K220820
    Device Name
    Parky App
    Manufacturer
    H2O Bilisim Yazilim
    Date Cleared
    2022-11-17

    (241 days)

    Product Code
    GYD,ISD,NXQ
    Regulation Number
    882.1950
    Type
    Traditional
    Panel
    Neurology
    Reference & Predicate Devices
    K213519
    Why did this record match?
    Applicant Name (Manufacturer) :

    H2O Bilisim Yazilim

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

    The Parky App 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

    Parky App is a symptom tracker mobile app for Parkinson's Disease patients. It collects motion data through Apple Watch continuously and quantifies tremor and dyskinesia episodes based on clinically validated MM4PD algorithm. Tracked symptoms are reported as daily, weekly and monthly. Each report is shared with the prescribing healthcare professional through email. The mobile app has a medication reminder module which the patients can manually enter their medication schedule, receive on-time reminder notifications on Apple Watch and iPhone and can respond to them as "taken" or "not yet taken". Parky also reports daily step counts provided by Apple Services - HealthKit.

    AI/ML Overview

    Acceptance Criteria and Device Performance Study for Parky App

    The Parky App utilizes the MM4PD (Mobile Movement for Parkinson's Disease) algorithm to quantify movement disorder symptoms in adults with mild to moderate Parkinson's disease. The following details outline the acceptance criteria and the study proving the device meets them, based on the provided FDA 510(k) summary.

    1. Table of Acceptance Criteria and Reported Device Performance

    Acceptance Criteria / Performance MetricReported Device Performance
    Correlation with clinical evaluations of tremor severity (MDS-UPDRS tremor constancy)Rank Correlation Coefficient (ρ) = 0.72
    Differentiation of dyskinesia presence (from no dyskinesia)Statistically significant difference (P = 0.027) with Wilcoxon rank sum test between "No DK" and "Chorea" groups
    Smartwatch captured symptom changes matching clinician expectations94% of cases with full patient history (blinded: 87.5% correct classifications by 3 experts)
    Likelihood of dyskinesia mapped to expert ratingsP
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