(94 days)
The Neu Platform is intended to quantify the kinematics of movement disorder symptoms, including tremor in adults (45 years and older) with mild to moderate Parkinson's disease.
The Neu Platform is a platform designed to capture digital motor and patient-reported data in patients with mild to moderate Parkinson's Disease. The platform has two key components:
- A smartphone application for the remote capture of symptoms - Patients utilise the smartphone application to perform the motor tremor measurement activities. The app is also used for the patient to self-reported data, including onboarding information and subjective symptom information,
- A dashboard for the clinical team to view the captured data - The clinician dashboard presents the data to clinical staff responsible for managing the patient's condition for review.
The Platform is comprised of a patient app, supporting backend infrastructure, and a clinician web-based dashboard. The Neu Platform is related to the components of the platform specifically for data capture from patients with Parkinson's disease.
Here's a breakdown of the acceptance criteria and study details for the Neu Platform, based on the provided FDA 510(k) clearance letter:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criterion (Implicit) | Reported Device Performance |
|---|---|
| Correlation with Clinical Standard (Rest Tremor) | 0.92 (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).