(159 days)
The NESS H200® Wireless Hand Rehabilitation System 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): - Maintenance and/or increase of range of motion -
- Prevention and/or retardation of disuse atrophy l
- Increase of local blood circulation -
- Reduction of muscle spasm —
- Muscle re-education |
The Intelli-Connect is an optional accessory device used exclusively with the H200 Wireless System. The Intelli-Connect is used to trigger the H200 Wireless Orthosis through simple jaw movements.
The NESS H200 System consists of the following components:
- Functional Stimulation (FS) Orthosis with a Radio Frequency (RF) Stim Unit .
- Control Unit .
- . Intelli-Connect triggering device optional accessory, consisting of an earpiece, a charger and connecting cable
The Intelli-Connect Earpiece triggering device is fitted over the ear and detects clicks of the teeth to wirelessly trigger the stimulation unit of the H200 Wireless orthosis. Software built into the Intelli-Connect earpiece is designed to register and work exclusively with the patient's orthosis. The Earpiece is rechargeable with a lithium-polymer battery. It is FCC identified and meets part 15 of the FCC regulations. Once the earpiece is turned on, Intelli-Connect will trigger stimulation when teeth are clicked together.
The provided document is a 510(k) Summary for the Bioness NESS H200 Wireless Hand Rehabilitation System with an optional Intelli-Connect Earpiece Triggering Device. It details various performance tests conducted to demonstrate the device's compliance and substantial equivalence to a predicate device.
Here's a breakdown of the requested information based on the provided text:
1. Table of Acceptance Criteria and the Reported Device Performance
| Purpose (Acceptance Criteria) | Testing (Method to meet criteria) | Reported Performance (Results) |
|---|---|---|
| Verify that the Intelli-Connect complies with 60601-1 general requirements for basic safety and essential performance | Power input, leakage current, dielectric strength, mechanical strength, physical stability, excessive temperature, humidity, ingress of liquids, cleaning, mechanical abuse, stress relief | Pass |
| Verify that Intelli-Connect system complies with EMC requirements of 60601-1-2 | Radiated emissions, AC mains, electrostatic discharge, immunity to surge, RF field immunity, magnetic field immunity, interruptions immunity | Pass |
| Verify that the battery satisfies IEC 62133:2202 | Vibration, temperature cycling, external short circuit, free fall, crash hazard | Pass |
| Verify conformance with FCC Part 15 Class B | Field strength, bandwidth, spurious emissions, AC mains emissions, antenna requirement, | Pass |
| Verify conformance to biocompatibility (ISO 10993) requirements | Sensitization, cytotoxicity, irritation | Pass |
| Verify software meets requirements | Hardware verification, module verification, internal peripherals, settings, accelerometers, initialization, watch dog timer, charging, battery capacity, registration, LED behavior, state machine, trigger commands | Pass |
| Verify user specifications are met | Weight, charge access, insertion, donning and doffing, handling, talking, with glasses, consistent detection, roll and pitch, fit, cleaning | Pass |
2. Sample size used for the test set and the data provenance
The document does not specify the sample size for the test sets used in any of the performance verification tests (e.g., how many units were tested for electrical safety, EMC, battery, software, or user specifications). The provenance of the data (country of origin, retrospective or prospective) is also not mentioned. These tests appear to be bench or engineering tests rather than clinical studies with human participants.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
This information is not provided in the document. The tests described are engineering and safety standard compliance tests, not clinical performance evaluations that would typically involve expert-established ground truth.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
The document does not describe any adjudication method for the test sets. Given the nature of the tests (compliance with standards), adjudication by multiple experts is not typically applicable.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
An MRMC comparative effectiveness study was not done. The device is a physical rehabilitation system accessory (a hands-free trigger), not an AI-assisted diagnostic or interpretive tool that would involve "human readers" or AI assistance in that sense.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This concept is not directly applicable to the Intelli-Connect earpiece. The Intelli-Connect is designed to work in conjunction with the H200 Wireless System to trigger functional stimulation based on jaw movements (teeth clicks). Its standalone performance relates to its ability to reliably detect these clicks and wirelessly transmit the trigger command, which is covered by the mentioned software and user specification verification tests. There isn't an "algorithm only" performance that would be separate from its intended human-in-the-loop use (as a trigger for a patient's rehabilitation).
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
For the engineering and safety tests, the "ground truth" is defined by the technical specifications and requirements of the referenced standards (e.g., IEC 60601-1, FCC Part 15, IEC 62133, ISO 10993) and the user specifications defined by the manufacturer. These are objective engineering criteria rather than clinical ground truth established by experts or pathology.
8. The sample size for the training set
The document does not mention any training set. This is a medical device accessory and its performance is validated through engineering, regulatory, and user specification testing, not typically through machine learning model training.
9. How the ground truth for the training set was established
Not applicable, as there is no mention of a training set.
§ 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).