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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. There are three specifications for E-Shield Multi-paired Subdermal Needle Electrodes, 7mm, 13mm and 19mm. The sterilized PET box contains 2 sets of 5-paired, 2 sets of 4-paired or 1 set of single 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 multi-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 provided text describes the regulatory submission for the E-Shield Multi-paired Subdermal Needle Electrodes (K142470) and its substantial equivalence to a predicate device (K140200). It focuses heavily on non-clinical testing for safety and effectiveness rather than a clinical study evaluating diagnostic or prognostic performance.

Therefore, the requested information about acceptance criteria, device performance, sample sizes, ground truth establishment, expert involvement, and MRMC studies, especially in the context of efficacy for a diagnostic or prognostic medical AI device, is largely not applicable to this submission as it pertains to a needle electrode, not an AI device.

Let's break down what can be extracted based on the provided document:

1. Table of Acceptance Criteria and Reported Device Performance

The document describes non-clinical testing categories and the standards applied. The "performance" here refers to meeting these safety and manufacturing standards, not analytical or clinical performance in the sense of accuracy, sensitivity, or specificity commonly associated with AI/diagnostic devices.

The overall reported performance is: "All the test results demonstrate E-Shield Multi-paired Subdermal Needle Electrodes meet the requirements of its pre-defined acceptance criteria and intended uses."

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

This section is Not Applicable in the context of an "AI device" test set. The testing performed was non-clinical for safety, sterility, biocompatibility, and material properties. Sample sizes for these types of engineering and materials tests are typically determined by relevant ISO/ASTM standards and Good Manufacturing Practices (GMP) for device validation, not by patient data samples. The data provenance is from laboratory and manufacturing validation processes, not country of origin of patient data or retrospective/prospective studies.

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

This is Not Applicable. Ground truth, in the context of expert consensus, is relevant for diagnostic performance evaluation. The "ground truth" for this device's testing was established by adherence to the specified international and national standards by qualified testing facilities and personnel.

4. Adjudication method for the test set

Not Applicable. Adjudication methods (e.g., 2+1, 3+1) are used for resolving disagreements among human experts when establishing ground truth for diagnostic tasks. This device underwent non-clinical testing against established standards.

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

Not Applicable. This device is a needle electrode, a hardware medical device for signal acquisition, not an AI algorithm designed to assist human readers in interpreting medical data. Therefore, an MRMC study related to AI assistance is irrelevant.

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

Not Applicable. This is a physical medical device (needle electrode), not an algorithm.

7. The type of ground truth used

The "ground truth" for this device's regulatory clearance is compliance with the detailed standards and regulations listed for sterilization, shelf life, biocompatibility, electromagnetic compatibility, electrical safety, and material performance (e.g., ISO, ASTM, USP, IEC standards).

8. The sample size for the training set

Not Applicable. This is a physical medical device. It does not involve a "training set" in the context of machine learning or AI.

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

Not Applicable. As above, this is a physical medical device, not an AI algorithm requiring a training set with established ground truth.

Summary for the provided document:

The regulatory submission for the E-Shield Multi-paired Subdermal Needle Electrodes demonstrates its safety and effectiveness through non-clinical testing against a comprehensive set of national and international standards. These tests cover sterilization, shelf life, biocompatibility, electromagnetic compatibility, electrical safety, and material performance. The device was found to meet all pre-defined acceptance criteria derived from these standards. No clinical trial data or AI/algorithm performance studies were conducted or required, as the device is a needle electrode and not a diagnostic or AI-driven system. The substantial equivalence argument relies on comparing the device's intended use, design, technological characteristics, and materials to a legally marketed predicate device, with the only difference being the addition of a new needle length specification and revised product categories, which did not raise new safety or effectiveness concerns after testing.

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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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