(241 days)
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.
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.
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 Metric | Reported 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 expectations | 94% of cases with full patient history (blinded: 87.5% correct classifications by 3 experts) |
| Likelihood of dyskinesia mapped to expert ratings | P |
§ 882.1950 Tremor transducer.
(a)
Identification. A tremor transducer is a device used to measure the degree of tremor caused by certain diseases.(b)
Classification. Class II (performance standards).