(261 days)
The NeuStim NN-01 is an electrical stimulation device indicated for the following uses:
Functional Electrical Stimulation (FES):
Improvement of hand function and active range of motion in patients with hemiplegia due to stroke or upper limb paralysis due to C5 spinal cord injury.
NeuroMuscular Electrical Stimulation (NMES):
- · Maintaining or increasing hand range of motion;
- · Prevention or retardation of disuse atrophy;
- · Increasing local blood circulation;
- · Relaxation of muscle spasms; and
- · Muscle re-education.
The NeuStim NN-01 is intended for use on the right arm/right hand only.
The NeuStim Model NN-01 (herein Device) consists of a voltage-controlled generating source that connects to disposable electrodes that are worn by the patient on the anterior and posterior forearm and around the thumb, these are named the Flexor, Extensor and Thumb Disposable Electrodes respectively. The disposable electrodes consist of multiple contacts that can stimulate the muscles in different areas of the forearm and thumb with 10kHz voltage pulses generated by the NeuStim voltage-controlled stimulator.
The Device is classified as a Functional Stimulation (FES) and NeuroMuscular Electrical Stimulation (NMES) device. The Device uses galvanic electrical energy to evoke muscle contractions.
The Device has 181 addressable electrode contacts enabling fine spatial resolution of stimulation to the patient. The Device allows manual electrode scanning to facilitate rapid mapping of effective stimulation points, which can be stored for use in future sessions. This rapid scanning capability is enabled through the use of solid-state relay technology embedded in the flexible patches that mate directly with the disposable electrodes. The motion of the user's (i.e. licensed healthcare professional) finger on the screen of the NeuStim" Tablet electronically steers the stimulation point through the use of a solid-state relay matrix in each patch and thumb dongle, while lighting LED indicators on the back of the patch/dongle under control. This allows immediate, dynamic visual indication of the stimulation location which facilitates rapid mapping (i.e. user can quickly find and return to useful stimulation points). When the user observes desired muscle activations and associated wrist, hand, or finger movements, the related stimulation locations can be stored as a pattern. Up to three of these stored patterns can then be combined into a compound move where the stimulator will continuously time multiplex between them to allow for compound motion. Finally, up to three compound moves or patterns can be combined into a sequence where each of the selected compound moves or patterns are applied for a user configurable number of seconds.
The Device uses a stimulation pulse repetition rate of 50 Hz. The stimulation pulse is comprised of a multiphasic (5 cycle) waveform with a total duration of 0.5 ms. The stimulation output (peak) voltage is less than 65V (500 Ohm load) and less than 120V (10,000 Ohm load). The stimulation output power will not exceed 0.25 W/cm^2 (averaged over one second) into a 500 Ohm Load.
Here's an analysis of the provided text regarding the acceptance criteria and study information for the Neuvotion NeuStim (NN-01) device:
1. Table of Acceptance Criteria and Reported Device Performance
The provided FDA 510(k) summary does not explicitly detail a table of acceptance criteria with specific quantitative thresholds. Instead, it references compliance with various national and international standards. The "Results" column consistently states "Passed" for each test, indicating that the device met the requirements of these standards.
| Purpose | Testing | Reported Device Performance (Results) |
|---|---|---|
| Verify compliance with ANSI/AAMI ES60601-1 and IEC 60601-1 requirements for basic safety and essential performance | Battery powered device, Type BF Applied Parts | Passed |
| Verify compliance with IEC 60601-1-2 requirements for basic safety and essential performance Electromagnetic Disturbances | Battery powered device; radiated emissions, radiated field immunity, proximity filed immunity, magnetic field immunity, electrostatic discharge immunity | Passed |
| Verify compliance with IEC 60601-2-10 requirements for the safety and essential performance of nerve and muscle stimulators | Battery powered muscle stimulator, Type BF Applied Parts, normal and single-fault, energy and power limits | Passed |
| Verify compliance with ISO 10993-1 Biologic Evaluation of Medical Devices | Part 5: Tests for in vitro cytotoxicity; Part 10: Tests for irritation and skin sensitization | Passed |
| Verify compliance with IEC 62133-2 Secondary cells and batteries containing alkaline or other non-acid electrolytes - Safety requirements for portable sealed secondary cells, and for batteries made from them, for use in portable applications - Part 2: Lithium systems | Battery individual cells and packs certified via third party testing | Passed |
| Verify software meets requirements | Software Verification and Validation | Passed |
| Verify user needs are met | System Design Validation | Passed |
| Verify device meets requirements | Design Verification | Passed |
| Verify device meets IEEE/ANSI C63.27 Coexistence Testing | Tier 2 | Passed |
| Verify device meets labeled Shelf-Life. | Shelf-Life Validation Study | Passed |
| Verify device meets Adhesive Performance Criteria | Adhesive Performance Validation Study | Passed |
| Verify device meets Current Distribution (Dispersion) and Electrode Impedance Criteria | Power and Current Density Validation Study | Passed |
2. Sample Size Used for the Test Set and Data Provenance
The provided text does not include information about the sample size used for a test set, nor does it specify the data provenance (e.g., country of origin, retrospective or prospective). The studies listed are primarily non-clinical, focusing on device safety, performance, and compliance with standards. There is a "Summary of Clinical Testing: Not Applicable" statement, which further confirms the absence of a test set derived from human subjects.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications
Since "clinical testing is not applicable" and no human test set is described, there is no information provided regarding experts used to establish ground truth or their qualifications. The ground truth for the non-clinical tests is established by meeting the requirements of the specific engineering and safety standards referenced.
4. Adjudication Method for the Test Set
As there is no described test set involving human subjects and clinical outcomes, an adjudication method is not applicable and not mentioned.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No MRMC comparative effectiveness study is mentioned. The submission explicitly states "Summary of Clinical Testing: Not Applicable," indicating that no clinical studies (which would include MRMC studies) were performed for this 510(k). The comparison provided is between the subject device's technical specifications and the predicate device's general characteristics, not a clinical effectiveness study.
6. Standalone (Algorithm Only Without Human-in-the-Loop) Performance
The Neuvotion NeuStim (NN-01) is an external functional neuromuscular stimulator, a physical device that delivers electrical stimulation. It leverages software/firmware control for its operation but is not an AI algorithm that makes diagnostic or treatment decisions in a standalone manner without human interaction. Therefore, the concept of "standalone (algorithm only without human-in-the-loop performance)" as typically applied to AI/ML devices is not directly applicable here. The software verification and validation are part of the overall device performance, which is intrinsically human-controlled (by a licensed healthcare professional).
7. Type of Ground Truth Used
The ground truth used for the reported studies is primarily compliance with established regulatory standards and engineering specifications. For example:
- Safety and Essential Performance: Defined by standards like ANSI/AAMI ES60601-1, IEC 60601-1, IEC 60601-1-2, IEC 60601-2-10.
- Biocompatibility: Defined by ISO 10993-1 (specifically Parts 5 and 10).
- Battery Safety: Defined by IEC 62133-2.
- Software Requirements: Defined by the software verification and validation process against predefined requirements.
- User Needs, Device Requirements, Coexistence, Shelf-Life, Adhesive Performance, Current Distribution/Electrode Impedance: These are validated against internal design specifications, user requirements, and relevant standards (e.g., IEEE/ANSI C63.27 for coexistence).
8. Sample Size for the Training Set
There is no mention of a training set sample size. Training sets are typically associated with machine learning or AI models. The NeuStim NN-01, while having software, is not described as an AI/ML device that requires a data training set in the context of this 510(k) submission. Its functionality relies on pre-programmed parameters and user-defined stimulation patterns.
9. How the Ground Truth for the Training Set Was Established
Since there is no training set mentioned, there is no information on how its ground truth was established.
§ 882.5810 External functional neuromuscular stimulator.
(a)
Identification. An external functional neuromuscular stimulator is an electrical stimulator that uses external electrodes for stimulating muscles in the leg and ankle of partially paralyzed patients (e.g., after stroke) to provide flexion of the foot and thus improve the patient's gait.(b)
Classification. Class II (performance standards).