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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 detection, they transduce broelectric 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 perspheral nerves Surface electrodes are used in the performance of nerve conduction studies (NCS) They are provided non-stertle and are designed and intended to be for single patient use only and are disposable

• 트 UNIVERSAL Multi-Electrode Set A (UE-004)
• 0 UNIVERSAL Multi-Electrode Set B (UE-005)

These individually placed electrodes are not configured for specific nerves. limbs, or clinical applications They may be repositioned on the same patient up to four times Both of the Multi-Electrode Sets include two surface electrodes in a bar configuration for perspheral nerve stumulation, two pars of recording electrodes for measurement of broelectrical potentials, and a reference electrode The par of recording surface electrodes in Multi-Electrode set A (UE-004) are distinct with one arranged as ring electrodes In Multi-Electrode Set B (UE-005), three surface electrodes are used to create two recording pars by sharing of one of the electrodes All of the surface electrodes in the Multi-Electrode Sets are individually placed by The UNIVERSAL Electrodes include an embedded digital thermometer for the user measurement of skin-surface temperature, and a ruler (as part of the graphics layers) for the measurement of inter-electrode distances that are used for calculating conduction velocities

The provided document is a 510(k) summary for the NeuroMetrix UNIVERSAL Electrodes, which focuses on demonstrating substantial equivalence to predicate devices rather than presenting a standalone study proving the device meets specific acceptance criteria based on performance data. Therefore, many of the requested details about acceptance criteria, study design, and performance metrics are not explicitly stated in this type of regulatory submission.

However, based on the information provided, here's what can be extracted and inferred:

1. Table of Acceptance Criteria and Reported Device Performance

This information is not provided in the 510(k) summary. A 510(k) submission for electrodes typically focuses on demonstrating that the new device is as safe and effective as a legally marketed predicate device, often through material comparisons, intended use alignment, and technological characteristics, rather than through detailed performance metrics against specific quantitative acceptance criteria.

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

This information is not provided. The submission does not detail any specific clinical or performance test sets used to generate data for this 510(k). The focus is on substantial equivalence to existing devices rather than a new performance study.

3. Number of Experts Used to Establish Ground Truth and Their Qualifications

This information is not provided. As no specific performance study with a test set is described, there's no mention of ground truth establishment by experts.

4. Adjudication Method for the Test Set

This information is not provided. No test set or adjudication process is mentioned.

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

This information is not provided. An MRMC study is not mentioned. The 510(k) focuses on the device itself (electrodes), not a diagnostic algorithm that would typically be evaluated in an MRMC study.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop) Performance Study Was Done

This information is not provided. The device is an electrode, not an algorithm. Therefore, a standalone algorithm performance study would not be applicable.

7. The Type of Ground Truth Used

This information is not provided. No ground truth is described as there's no performance study detailed.

8. The Sample Size for the Training Set

This information is not provided. The document describes an electrode, not a machine learning algorithm that requires a training set.

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

This information is not provided. (See reason for #8).

Summary of the 510(k) Document's Approach to Meeting Regulatory Requirements:

The NeuroMetrix UNIVERSAL Electrodes 510(k) relies on demonstrating substantial equivalence to predicate devices. This means that instead of conducting a new study to prove specific performance metrics, the manufacturer asserts that the new electrodes are as safe and effective as previously cleared devices because they share the same:

• Intended Use: For use with electrodiagnostic equipment for recording electrophysiological activity from peripheral nerves and muscles, and for peripheral nerve electrical stimulation.
• Clinical Applications.
• Technological Characteristics:
  • Surface electrodes that transduce bioelectric signals or provide an interface for stimulation.
  • Non-sterile, single-patient use, and disposable.
  • Inclusion of multi-electrode sets with various configurations (bar, ring) for stimulation and recording.
  • Embedded digital thermometer and ruler for inter-electrode distance measurement.
• Materials, Manufacturing Process, and Packaging: Stated to be the same as NeuroMetrix Biosensors (K060584).

The predicate devices mentioned are:

• NeuroMetrix UNIVERSAL Electrodes (K081871)
• NeuroMetrix Biosensors (K060584)

The FDA's letter confirms that they reviewed the submission and determined that the device is substantially equivalent to the legally marketed predicate devices. This determination allows the device to be marketed without requiring a new Pre-Market Approval (PMA) application.

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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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