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E-Shield Multi-paired Subdermal Needle Electrodes are intended for use with recording and monitoring equipment for the purpose of recording of biopotential signals. Examples include: Electromyography (EMG), Electroencephagraph (EEG) and Nerve potential signals. The electrodes are sterile and for single patient use only.

E-Shield Multi-paired Subdermal Needle Electrodes are single use, disposable, monopolar, non-pyrogenic and sterilized stainless steel subdermal needle electrodes. Electrodes are applied in the study of biopotentials such as electroencephalograph (EEG), electromyography (EMG). Electrodes are invasive as they are placed subcutaneously or in contact with nerve or muscle tissue. The subdermal needle electrodes can be used to record variety of types of neurological and neurophysiological evoked potentials, including but not limited to electroencephalogram (EEG), electromyogram (EMG) in hospital and clinical setting. It is highly recommended to be used of intra-operative neuromonitoring (IOM). The electrodes consist of a stainless steel needle with a lead wire attached and the lead wires terminate in a safety connector. The electrodes are used under the supervision of a physician. Each sterilized PET box contains 2 sets of 5-paired subdermal needle electrodes and a safety shield attached to each set. The safety shield is used to cover the needle sharps and the multi-paired lead wires are designed in group for easy organizing. Grouped wire cable can be separated into 5 paired lead wires to reach different recording sites of a patient over desired length. For instance, it can be used for the recording in one limb muscle groups.

The manufacturer, NeuroInvent Inc., established acceptance criteria and conducted non-clinical testing to demonstrate that "E-Shield Multi-paired Subdermal Needle Electrodes" meet these criteria.

1. Table of Acceptance Criteria and Reported Device Performance:

2. Sample size used for the test set and the data provenance:

The document does not specify the exact sample sizes for each non-clinical test (e.g., how many electrodes were tested for biocompatibility, sterility, etc.). It only lists the standards to which the tests were conducted.

The data provenance is from non-clinical testing performed by NeuroInvent Inc. There is no mention of patient data or specific geographic origin for the test materials beyond the product being manufactured by a company based in Mountain View, CA, with contact information in Taiwan.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

This information is not applicable as the study involved non-clinical, bench testing rather than studies requiring expert interpretation of patient data to establish ground truth. The acceptance criteria were based on recognized international and national standards for medical devices.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:

This information is not applicable as the study involved non-clinical, bench testing. Adjudication methods are typically employed in clinical studies or studies involving human readers to resolve discrepancies in interpretations.

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:

No MRMC comparative effectiveness study was done. The document explicitly states: "No clinical test data was used to support the decision of safety and effectiveness." The device is a physical medical electrode, not an AI-assisted diagnostic tool.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:

This information is not applicable. The device is a physical medical electrode, not a standalone algorithm. The non-clinical testing evaluated the physical and material properties of the electrodes.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):

The "ground truth" for the non-clinical testing was established by adherence to established international and national standards and regulations for medical devices (e.g., ISO, ASTM, USP, IEC, GB/T). The tests performed according to these standards (e.g., cytotoxicity tests, pyrogen tests, seal strength tests, electrical resistivity tests) provide the "ground truth" for the device's physical and material properties.

8. The sample size for the training set:

This information is not applicable. There was no training set, as the study involved non-clinical, bench testing of the physical device to meet predefined standards, not machine learning model training.

9. How the ground truth for the training set was established:

This information is not applicable as there was no training set.

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