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NeuroMetrix ADVANCE is intended to perform nerve conduction studies and needle electromyography procedures. As such, NeuroMetrix ADVANCE is intended to measure neuromuscular signals that are useful as an aid in diagnosing and evaluating patients suspected of having focal or systemic neuropathies. If the elective needle EMG module is used, then the device is also intended to measure signals that are useful as an aid in evaluating disorders of muscles.

This device must be used in the context of other patient information. Its output must be reviewed and interpreted by a physician who will exercise professional judgment when using this information.

Device Description

The NeuroMetrix ADVANCE System consists of the following components:

5.1 A Device that features a high-resolution touch-screen display panel with a stylus. The Device has a cable that connects to disposable surface electrodes for performance of nerve conduction studies. The Device communicates via Bluetooth with an accessory EMG Module that connects to electromyography needles for performance of invasive needle electromyography studies. The Device amplifies, digitizes and stores nerve and muscle signals. It delivers electrical stimuli through the electrodes for nerve conduction studies. Nerve conduction and needle clectromyography waveforms are displayed in real time. The Device reports standard nerve conduction parameters based on operator or computer assigned waveform cursors. Nerve conduction parameters include motor and sensory latency, motor and sensory conduction velocity, F-wave response parameters, A-waves, motor and sensory amplitude and waveform configuration. The Device may optionally upload stored data to the Communications Hub. The Device is powered by a rechargeable battery pack or by three standard AA alkaline batteries.
The Device may be used with the Proximal Stimulation Adapter, which is an accessory used to extend the physical reach of the Device connector and thereby enables proximal nerve stimulation.
5.2 A Charger that also houses the Device. In addition to charging the Device, it features a spare battery pack charger along with three LED indicators and is powered by an AC adapter
5.4 A Communications Hub that receives optional data uploads from the Device via Bluetooth and transmits the data to the onCall Information System for data storage and direct transference of acquired waveforms and nerve conduction parameters to a remote printer without further post-processing or data analysis. The Communications Hub is powered by an AC adapter.
5.5 A Needle EMG Module that enables invasive needle electromyography The Needle EMG Module connects to standard concentric sterile recordings. EMG needles and a surface electrode. With the needle inserted into a muscle of interest, the Needle EMG Module amplifies myoelectrical signals and transmits them to the Device via Bluetooth where they are continuously displayed. The electromyographic signals are also concurrently played through an integrated loud-speaker.
5.6 A Cart that houses and charges the Device and its accessories to facilitate patient testing.

AI/ML Overview

Below is a summary of the acceptance criteria and study information for the NeuroMetrix ADVANCE, based on the provided text.

1. Acceptance Criteria and Reported Device Performance

The acceptance criteria for the NeuroMetrix ADVANCE are not explicitly stated as numerical targets in the provided document. Instead, the study aimed to demonstrate the device's reliability by comparing its performance to established benchmarks. The "reported device performance" is essentially the measured reliability of various nerve conduction parameters.

Parameter	Acceptance Criteria (Benchmark)	Reported Device Performance (Coefficient of Variation)
Motor Latencies	Comparable to Bril et al. 1998, Kohara et al. 2000, Bird et al. 2006	Comparable to benchmark studies
Sensory Latencies	Comparable to Bril et al. 1998, Kohara et al. 2000, Bird et al. 2006	Comparable to benchmark studies
Conduction Velocities	Comparable to Bril et al. 1998, Kohara et al. 2000, Bird et al. 2006	Comparable to benchmark studies
F-wave Latencies	Comparable to Bril et al. 1998, Kohara et al. 2000, Bird et al. 2006	Best performance among parameters, consistent with benchmarks
Motor Amplitudes	Comparable to Bril et al. 1998, Kohara et al. 2000, Bird et al. 2006	Worst performance among parameters, consistent with benchmarks
Sensory Amplitudes	Comparable to Bril et al. 1998, Kohara et al. 2000, Bird et al. 2006	Worst performance among parameters, consistent with benchmarks

2. Sample Size and Data Provenance

Sample Size for Test Set: 15 subjects (14 of whom had symptoms of potential neuropathies).
Data Provenance: Not explicitly stated (e.g., country of origin). The study involved "clinical neurophysiology specialists" and a "central review laboratory" in the benchmark studies, suggesting medical settings. It appears to be a prospective study as tests were performed at specific intervals (3-7 days apart, and within 10 minutes at each session).

3. Number of Experts and Qualifications for Ground Truth

The provided document does not indicate the number of experts used to establish ground truth specifically for the NeuroMetrix ADVANCE study. However, it mentions that the benchmark studies (Bril et al. 1998, Kohara et al. 2000, Bird et al. 2006) involved measurements performed by "clinical neurophysiology specialists with oversight by a central review laboratory." This implies experienced medical professionals.

4. Adjudication Method for the Test Set

The document does not describe an adjudication method for establishing ground truth for the ADVANCE test set. The study focused on the reproducibility of the device's measurements rather than comparing them to an independently established "ground truth" diagnosis.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

No, a multi-reader multi-case (MRMC) comparative effectiveness study was not done according to the provided text. The study focused on the reliability and reproducibility of the device's measurements, not on the improvement of human readers with AI assistance.

6. Standalone Performance

Yes, a standalone (algorithm only without human-in-the-loop performance) was done. The study specifically assessed the "reproducibility of nerve conduction parameters derived from computer based data acquisition and waveform cursor assignments." The "between test" reliability quantified variation attributable to the ADVANCE System "in the absence of operator intervention," indicating standalone algorithmic performance.

7. Type of Ground Truth Used

The concept of a traditional "ground truth" (e.g., pathology, outcomes data, expert consensus diagnosis) as it relates to diagnostic accuracy is not directly applied here. Instead, the study assessed the reliability and reproducibility of the device's measurements. The "truth" in this context is the consistency of the device's own measurements over repeated tests, benchmarked against established physiological variability reported in the literature for nerve conduction studies.

8. Sample Size for the Training Set

The document does not mention a separate training set. The study described appears to be a validation study for the device's performance, not a development or training exercise for an algorithm.

9. How Ground Truth for the Training Set Was Established

Not applicable, as no separate training set is described in the provided text.

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