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The NeuroMetrix UNIVERSAL Electrodes are intended for use with electrodiagnostic equipment for the recording of electrophysiological activity from peripheral nerves and muscles, and for peripheral nerve electrical stimulation. UNIVERSAL Electrodes are non-sterile and are for single patient use only.

Surface electrodes are the interface medium between neurodiagnostic equipment and the patient. When used for recording, they transduce bioelectric signals into electronic signals for measurement of bioelectrical phenomena in the body, such as peripheral nerve or muscle responses. When used in conjunction with stimulation circuitry in neurodiagnostic devices, they provide the interface necessary to stimulate peripheral nerves. Surface electrodes are used in the performance of nerve conduction studies (NCS). They are provided non-sterile and are designed and intended to be for single patient use only and are disposable.

• l UNIVERSAL Stimulator Bar Electrode (UE-001)
• UNIVERSAL Tab Electrode Set (UE-002) 트
• 트 UNIVERSAL Ring Electrode Set (UE-003)
  These individually placed electrodes are not configured for specific nerves, limbs, or clinical applications. The Stimulator Bar Electrode (UE-001) is for stimulation of peripheral nerves and consists of two electrodes in a bar configuration. The Tab Electrode Set (UE-002) and the Ring Electrode Set (UE-003) each consist of three distinct electrodes that are individually placed by the user.

This 510(k) summary for NeuroMetrix UNIVERSAL Electrodes does not contain the detailed information necessary to answer all aspects of your request regarding acceptance criteria and a study proving device performance.

This document primarily focuses on establishing substantial equivalence to predicate devices based on shared intended use, clinical applications, and technological characteristics, rather than presenting a performance study with specific acceptance criteria and detailed results.

Here's an analysis of what can be extracted from the provided text, and what is missing:

1. Table of Acceptance Criteria and Reported Device Performance

This information is not provided in the given 510(k) summary. The summary states that "testing data presented, support a finding of substantial equivalence," but it does not detail what specific tests were performed, what the acceptance criteria for those tests were, or what the reported device performance metrics were against those criteria.

2. Sample Size Used for the Test Set and Data Provenance

This information is not provided in the given 510(k) summary. There is no mention of any specific test set, its sample size, or the provenance of any data.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications

This information is not provided in the given 510(k) summary. Given the absence of a described test set, there's no mention of experts establishing ground truth.

4. Adjudication Method for the Test Set

This information is not provided in the given 510(k) summary.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size

This information is not provided in the given 510(k) summary. MRMC studies are typically for evaluating the impact of an AI algorithm on human reader performance, which doesn't appear to be the focus of this submission for surface electrodes.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

This information is not applicable/not provided in the context of this device. The NeuroMetrix UNIVERSAL Electrodes are physical surface electrodes, not an AI algorithm. Therefore, "standalone" performance in the sense of an algorithm is not relevant. The document implies performance testing of the physical electrodes (e.g., electrical properties, skin compatibility, durability), but details are absent.

7. The Type of Ground Truth Used

This information is not provided in the given 510(k) summary. For physical electrodes, ground truth would likely relate to objective physical and electrical measurements (e.g., impedance, signal-to-noise ratio, material biocompatibility), rather than expert consensus on diagnostic interpretations.

8. The Sample Size for the Training Set

This information is not provided in the given 510(k) summary. As these are physical electrodes, the concept of a "training set" in the machine learning sense is not directly applicable. If "training set" refers to data used to design or optimize the electrode, those details are not present.

9. How the Ground Truth for the Training Set Was Established

This information is not provided in the given 510(k) summary for the reasons mentioned above.

Summary of Missing Information:

This 510(k) summary largely relies on demonstrating substantial equivalence to existing predicate devices (Axon Systems Pre-gelled Surface Electrodes and NeuroMetrix Biosensors) rather than providing a detailed performance study with explicit acceptance criteria and results. The text states:

• "A comparison of the UNIVERSAL Electrodes to the predicate Axon Systems Pre-gelled Surface Electrodes (K062198), along with testing data presented, support a finding of substantial equivalence."
• "The UNIVERSAL Electrodes and these predicate electrodes share similar intended use, clinical applications, and technological characteristics."

This indicates that any "testing data" was likely used to confirm that the new electrodes perform similarly to the predicates, thereby not raising new questions of safety or effectiveness. The specific details of that testing, including numerical acceptance criteria, sample sizes, and empirical results, are not included in this publicly available portion of the submission. For a device like surface electrodes, performance "acceptance criteria" generally relate to electrical characteristics (e.g., impedance, noise levels), biocompatibility, adhesion, and durability, but these are not quantified or presented here.

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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.

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.

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.

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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