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Axon Systems' Pre-gelled Surface Electrodes are intended for use with electrodiagnostic or neurological monitoring equipment for the recording of electrophysiological activity and for peripheral nerve electrical stimulation. The electrodes are non-sterile and for single patient use only.

Electrodes are the interface medium between neurodiagnostic or neuromonitoring equipment and the patient. Electrodes are used in electro-diagnostic clinical studies or during intraoperative monitoring for electroencephalography (EEG), electromyography (EMG) or evoked potentials recording and electrical stimulation. The electrodes used to detect electro-physiological signals or provide electrical stimulation cutaneously. The electrodes are non-sterile and are designed to be disposable, for single use only. Pre-gelled Surface Electrodes are noninvasive as they are placed cutaneously or in contact with the skin or muscle surface and are used under the supervision of a licensed physician. Axon Systems' Pre-gelled Surface Electrodes (PGSE) are supplied with leads or with snap connector. The leaded electrodes are comprised of a laminated, flexible structure composed of polyester fabric or polyethylene foam and use conductive carbon coated with Aq/AqCl and activated carbon mesh material and conductive hydrogel on one side as the coupling medium to the skin. No other adhesive is used. The active conductor is electrically connected to flexible, copper or carbon fiber lead wire and an industry standard DIN 42802 "touch proof" safety connector on the other end. The safety connector is connected to the recording input or electrical stimulator output of the neurodiagnostic or neuromonitoring equipment. The snap connector electrode is comprised of a polyethylene foam substrate with medical grade adhesive and uses Ag/AgCl pellet(s) as the conductive element. The active surface of the pellet is coated with conductive hydrogel to form the coupling medium to the skin. The pellet is attached to a male snap which is used to connect the electrode directly to the recording amplifier.

1. Table of Acceptance Criteria and Reported Device Performance:

   The submission primarily focuses on establishing substantial equivalence to predicate devices through functional testing rather than defining specific numerical acceptance criteria. The acceptance criteria can be inferred as meeting the functional performance of the identified predicate devices, as no novel technology or basic materials were used, and "Pre-gelled Surface Electrodes were tested functionally using accepted laboratory test procedures."

   Performance Metric	Acceptance Criteria (Implied)	Reported Device Performance
   Functional Performance	Equivalent to predicate devices (Nicolet Biomedical Pre-gelled Surface Electrodes, Medicotest, Inc. Surface Electrodes, Tyco Health Kendall ECG Pellet Electrodes) based on "accepted laboratory test procedures."	"The Pre-gelled Surface Electrodes were tested functionally using accepted laboratory test procedures. Based on the technical information provided and the safety and effectiveness criteria of the design and development process, we claim the Pre-gelled Surface Electrodes to be safe, effective and substantially equivalent to the predicate device(s) noted." (This indicates the device met the functional performance, though no specific numerical results are provided in the summary.)
   Materials	Identical or substantially equivalent to predicate devices.	"No new technology or basic materials are used in these designs."
   Intended Use	Same as predicate devices.	"Axon Systems' Pre-gelled Surface Electrodes are intended for use with electrodiagnostic or neurological monitoring equipment for the recording of electrophysiological activity and for peripheral nerve electrical stimulation. The electrodes are non-sterile and for single patient use only." (This matches the general intended use of surface electrodes.)
   Physical Dimensions	May vary from predicate devices.	"The exceptions are in physical dimensions only."

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

   The document does not specify a distinct "test set" in the context of a clinical study or a dataset for evaluating an AI algorithm. Instead, it refers to "functional testing using accepted laboratory test procedures." It's likely that a sample of the manufactured electrodes was subjected to these functional tests.

   The data provenance is not specified beyond "accepted laboratory test procedures." There is no mention of country of origin or whether the testing was retrospective or prospective in a clinical sense.

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

   This information is not applicable. The submission is for a medical device (surface electrodes) and does not involve AI or ground truth established by experts in the context of diagnostic interpretation. The "ground truth" for this device would be its physical and electrical properties meeting specifications through engineering and quality control testing.

4. Adjudication Method:

   This is not applicable as there is no diagnostic test or AI algorithm requiring adjudication of results.

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

   This is not applicable. The submission is for a physical medical device (surface electrodes), not an AI algorithm. Therefore, there's no comparison of human readers with vs. without AI assistance.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance):

   This is not applicable. The device is a physical surface electrode, not an algorithm.

7. The Type of Ground Truth Used:

   For a physical medical device like a surface electrode, the "ground truth" is established through engineering specifications, material properties, and functional performance tests (e.g., impedance, adhesion, signal integrity). The document states "Pre-gelled Surface Electrodes were tested functionally using accepted laboratory test procedures." This implies that the 'ground truth' was based on meeting the established performance characteristics for surface electrodes.

8. Sample Size for the Training Set:

   This is not applicable. The submission is for a physical medical device, not an AI algorithm requiring a training set.

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

   This is not applicable for the reasons stated above.

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