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The Electrode Market Disposable Surface Electrodes are intended for non-invasive use with recording and monitoring equipment, (active and reference), of Electromyography (EMG), Electroencephalograph (EEG) and Evoked Potentials (EP). The electrodes are designed for single use.

Electrode Market Disposable Surface Electrodes are non-invasive. Cutaneous devices are used in the acquisition of signals for the purpose of monitoring and recording Electroencephalograph (EEG), surface Electromyography (EMG) and Evoked Potentials (EP). The electrodes are designed for single use. Because of the adhesive nature of the gel, no securing material is required for fixating the electrode to the patient's skin. The electrodes with lead wire have a safety DIN 42802 connector, several lengths and color combinations.

This document describes the FDA's 510(k) clearance for Electrode Market Disposable Surface Electrodes (K211839). The information provided is primarily focused on demonstrating substantial equivalence to a predicate device rather than detailing studies to prove the device meets specific acceptance criteria in the context of AI/ML performance.

Therefore, the following information is not present in the provided text:

• A table of acceptance criteria and reported device performance (for AI/ML).
• Sample sizes for test sets, data provenance, number of experts, qualifications of experts, and adjudication methods for establishing ground truth for test sets.
• Information regarding a multi-reader, multi-case (MRMC) comparative effectiveness study, including effect size.
• Information regarding a standalone algorithm-only performance study.
• The type of ground truth used (e.g., pathology, outcomes data) in the context of AI/ML.
• Sample size for training sets and how ground truth for training sets was established.

However, the document does contain information about the non-clinical tests performed to demonstrate the safety and effectiveness of the device as a medical electrode. This can be interpreted as the studies done to meet the acceptance criteria for a medical electrode.

Here's a summary of what's provided related to device performance and testing:

1. A table of acceptance criteria and the reported device performance

The document doesn't provide a table of acceptance criteria in the explicit format requested for AI/ML performance metrics. Instead, it refers to compliance with established standards for medical electrodes. The "performance" is demonstrated by meeting these standards.

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

The document does not specify sample sizes for the tests mentioned (Biocompatibility, Electrical Property, Shelf-life, Electrical Safety), nor does it describe data provenance in terms of country of origin or whether the studies were retrospective or prospective. These tests are typically laboratory-based and performed on representative samples of the manufactured device.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

Not applicable. The tests performed are engineering and biological evaluations, not diagnostic interpretations requiring expert consensus for ground truth.

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

Not applicable. Adjudication methods are relevant for human-in-the-loop diagnostic studies, which this is not.

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 disposable surface electrode, not an AI diagnostic tool.

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

Not applicable. This device is a disposable surface electrode, not an AI algorithm.

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

For the non-clinical tests, the "ground truth" is defined by the requirements and measurement methods specified in the cited international and national standards (ISO, AAMI/ANSI, ASTM, IEC). For example, a successful biocompatibility test means the material does not induce a harmful biological response above a certain threshold as defined by the standard.

8. The sample size for the training set

Not applicable. There is no AI model or training set described.

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

Not applicable. There is no AI model or training set described.

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