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Disposable EEG Electrodes (MODEL: DL, E-CAP, FLEX-CAP) is intended for use in routine clinical settings where rapid placement of a number of EEG electrodes is desired.

Disposable EEG Electrodes includes three models: DL, E-CAP, FLEX-CAP. The models E-CAP and FLEX-CAP are EEG electrode positioning systems used to place a number of EEG electrodes in a uniform and consistent manner on the head in order to transmit electrophysiological signals from an individual to data collection devices. The model E-CAP is made from spandex type material with silver/silver chloride-plated ABS electrodes in silicone base attached to the cap. The model FLEX-CAP is made from spandex type material with silver/silver chloride ink printed electrodes on PET in silicone base attached to the cap, the cap covering the entire scalp and is held in place with chin straps. The spandex type material holds the electrodes securely in position during an EEG recording. The electrodes on the caps connect to the EEG equipment either through an adapter cable or in some instances, special connector on match EEG equipment. The electrical activity of the brain is transferred via the electrolyte to the electrode and then to the EEG equipment for evaluation. The models E-CAP and FLEX-CAP have been built with the placement of 2-128 electrodes, the size of cap is from 26 to 66 cm. The model DL is a silver/silver chloride-plated ABS electrode with shrink tubing and connector, which is used on the model E-CAP. In addition, model DL can be used alone on the scalp for EEG monitoring. The electrodes on the Disposable EEG Electrodes (MODEL: DL, E-CAP, FLEX-CAP) are positioned according to the International Ten-Twenty System (10-20) of Electrode Placement. In addition, Disposable EEG Electrodes (MODEL: DL, FLEX-CAP) with as a few as 2 or as many as 128 electrodes, have been mounted in a place according to the 10-10 American Electroencephalographic Society positioning system. Disposable EEG Electrodes (MODEL: DL, FLEX-CAP) can also be custom-made, in which the numbers of electrodes and placement of electrodes are made under an instruction from customs.

This document describes a 510(k) submission for Disposable EEG Electrodes (MODEL: DL, E-CAP, FLEX-CAP). The submission asserts substantial equivalence to a predicate device and includes performance data based on non-clinical testing.

Here's an analysis of the acceptance criteria and the supporting study information provided:

1. Table of Acceptance Criteria and Reported Device Performance

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

• Sample Size for Test Set: The document does not specify a separate "test set" sample size in terms of the number of electrodes or subjects used for electrical performance testing. It refers to "electrode characterization test" and "performance test," implying these were conducted on the device models. No human subjects were involved.
• Data Provenance: The tests were conducted by Wuhan Greentek Pty Ltd in China. The data would be considered prospective for the purposes of this submission, as they were generated to support the 510(k).

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. This device is an EEG electrode, and the performance characteristics (resistance, impedance, offset voltage, noise, bias current tolerance) are objective electrical measurements, not subjective interpretations requiring expert consensus for ground truth. Biocompatibility testing follows established ISO standards.

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

Not applicable, as no subjective human interpretation or diagnostic ground truth was established for the performance tests. The performance criteria are quantitative and based on physical measurements against established electrical and biocompatibility 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

No MRMC comparative effectiveness study was done. This device is an EEG electrode, a hardware component for signal acquisition, not an imaging or analytical AI software that assists human readers.

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

A standalone performance evaluation was done for the device's electrical characteristics and biocompatibility. The performance tests ("electrode characterization test", "performance test") and biocompatibility tests assess the device itself, without human interpretation or intervention in the performance measurement. The clinical test section explicitly states "Clinical testing is not required."

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

The ground truth for the performance criteria is derived from established engineering and biocompatibility standards:

• Electrical Performance: The ground truth is the quantitative limits defined in the FDA guidance "Cutaneous Electrodes for Recording Purposes - Performance Criteria for Safety and Performance Based Pathway." This is an objective, standardized metric.
• Biocompatibility: The ground truth is compliance with the pass/fail criteria specified in ISO 10993-1, ISO 10993-5, and ISO 10993-10 standards. This is also an objective, standardized metric.
• Electrical Safety: Conformance with AAMI / ANSI ES60601-1 is the ground truth.

8. The sample size for the training set

Not applicable. This submission concerns a physical medical device (EEG electrodes), not a machine learning or AI algorithm, so there is no "training set."

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

Not applicable, as there is no training set for this type of device.

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