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GT5 conductive & abrasive gel is intended for use in clinical and research EEG/EP recordings from humans. It can be not only used as skin-prep gel to abrade the skin surface lightly in order to reduce impedance to alternating current) efficiently, but also used as the conductor between the scalp and the external electrodes to reduce impedance between the electrode surface and the skin. GT5 conductive & abrasive gel is not intended for use with stimulating electrodes.

GT5 conductive & abrasive gel is intended for use in clinical and research EEG/EP recordings from humans. It can be not only used as skin-prep gel to abrade the skin surface lightly in order to reduce impedance (resistance to alternating current) efficiently, but also used as the conductor between the scalp and the external electrodes to reduce impedance between the electrode surface and the skin. The electrical activity of the brain is transferred to the electrode and then to EEG instruments and computer equipment. GT5 conductive & abrasive gel is for use with external electrodes only.

GT5 conductive & abrasive gel is an off-white color, opaque, no adverse smell gel with sodium chloride as the conductive material combined with thickening agents, emulsifiers, humectants, preservatives and abrasive particles. With the abrasive particles in the gel, the gel can be also used as skin preparation by being applied to the skin surface to rub the skin lightly in order to reduce skin impedance efficiently and increase signal quality recorded with EEG electrodes.

The composition of GT5 conductive & abrasive gel is as follows:

Glycerin, Sodium chloride, Water, Methylparaben, Sodium Carboxymethyl cellulose, Alkyl indican, Aluminum Oxide.

The pH range is 6.5-7.5, and the impedance at 10Hz is 0.2K Ohm or less. The conductivity is 18±0.5 mS/cm. GT5 conductive & abrasive gel is available in the following sizes: a pre-filled syringe of 20g, a tube of 100g, a bottle container of 473g, a bottle container of 946g. Shelf life is 3 years if stored properly, i.e. kept with containers tightly closed and at room temperature.

The provided text describes the regulatory submission for the GT5 conductive & abrasive gel. It is a Class II medical device (electroconductive media) and the submission (A 510(K) premarket notification) attests to its substantial equivalence to previously cleared predicate devices.

The document does not contain information about a study proving the device meets acceptance criteria in the context of an AI/ML algorithm's performance. Instead, it details the acceptance criteria for the physical and chemical properties of the gel and internal performance testing to demonstrate these criteria are met. Therefore, many of the requested elements for an AI/ML algorithm study cannot be populated from the provided text.

Here's an attempt to answer the questions based on the provided text, with clear indications where information is not available or not applicable.

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria here refer to the physical and chemical properties of the conductive gel, not the performance of an AI/ML diagnostic algorithm.

2. Sample size used for the test set and the data provenance:
This information is not applicable and not provided. The testing relates to the physical and chemical properties of the gel, not a data-driven AI/ML test set. The shelf-life testing involved "accelerated aging," but the sample size of tested units is not specified. All testing appears to be internal ("tested internally").

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):
This information is not applicable and not provided. "Ground truth" in this context would refer to established chemical and physical standards or measurements, not expert radiographic reads.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
This information is not applicable and not provided. Adjudication methods are typically employed in clinical studies involving human interpretation or consensus for ground truth, not for physical property testing of a gel.

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:
This information is not applicable. The device is a conductive and abrasive gel, not an AI-powered diagnostic tool, so no MRMC study would be performed.

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 conductive and abrasive gel, not a standalone algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
The "ground truth" for the physical and chemical properties of the gel would be established by standard analytical chemistry and materials science methodologies, such as:

• pH measurement: Using a calibrated pH meter.
• Impedance/Conductivity measurement: Using appropriate electrical testing equipment validated against known standards.
• Appearance/Color/Odor: Visual and olfactory inspection against a defined standard or reference.
• Shelf-life: Stability testing over time (accelerated aging).

8. The sample size for the training set:
This information is not applicable and not provided. There is no AI/ML model involved requiring a training set.

9. How the ground truth for the training set was established:
This information is not applicable. There is no AI/ML model involved.

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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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