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The Grass "DE-48-Plus Disposable Electrodes" are intended for non-invasive use with recording and monitoring equipment, (active and reference), of Electromyography (EMG), Electroencephalograph (EEG) and Evoked Potentials.

The Grass Technologies DE48-Plus Disposable Electrodes (various lengths) are noninvasive, cutaneous devices, applied directly to the skin, and used in the acquisition of physiological signals for the purpose of montoring and recording Electroencephalograph (EEG), PSG and similar physiological parameters.

Non-invasive, disposable surface electrode discs (Cutaneous Electrodes), as included in this submission, are applied to the skin using a cream or gel for adhesion. Their purpose is to pick up and transfer microvoltage signals, as generated by the body, to recording equipment, for the purpose of monitoring and recording associated with electroencephalography and electromyography. The new Grass DE-48-Plus electrodes, as with the BNT predicate, are manufactured with a circular, raised cup body molded from ABS plastic and coated with silver chloride (Ag/AgCl). The disc is adhered to a lead wire which is covered with heat shrink tubing and terminates with a molded connector that conforms to DIN 42-802 for electrical safety. Grass DE-48-Plus Electrodes connect to, and work with, any EEG equipment, without special attachments.

The DE-48-Plus electrodes are made up of the following materials (same or equivalent to the Rhythmlink predicate).

Cup Disk: ABS Plastic with an Aq/AqCl coating which is nominally measured at 10mm (8.5 to 10mm).

The connecting wire which is manufactured from 28AWG stranded Tin Copper conductor with soft PVC insulation.

Wire crimped to Cup Electrode using Tin plated copper tubing.

Terminal connected with Alex crimp type, 24-30AWG Brass, Tin plated, Molded in Palprene.

This document describes a 510(k) summary for the DE-48-Plus Disposable Electrodes, a non-invasive cutaneous device for physiological signal acquisition. The submission focuses on demonstrating substantial equivalence to predicate devices rather than proving specific performance against defined acceptance criteria through a clinical study. Therefore, many of the requested criteria for a clinical study are not applicable or explicitly stated.

Here's an analysis based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

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

• Test Set Sample Size: Not explicitly stated. The document mentions "appropriate testing" but does not detail the number of electrodes or tests conducted for Resistance, Model Surface, Impedance, and Frequency Response.
• Data Provenance: Not explicitly stated, but it's implied that the testing was conducted by Grass Technologies as part of their submission process. Given the nature of a 510(k) for a medical device, this would typically involve laboratory testing, not human clinical trials. It's likely retrospective in the sense that it compares features and performance to existing, legally marketed predicate devices.

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

• Not Applicable. For this type of device (electrodes for acquiring physiological signals), ground truth isn't established by expert consensus on clinical findings. Instead, the "truth" is based on objective measurements of physical and electrical properties compared against established product specifications or the properties of predicate devices.

4. Adjudication method for the test set

• Not Applicable. As there's no clinical "ground truth" to adjudicate, this concept does not apply to the device's testing for substantial equivalence.

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 an electrode, not an AI diagnostic tool or system that assists human readers. Therefore, an MRMC study and AI-related effectiveness are irrelevant.

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

• Not Applicable. This is a hardware device (electrode), not an algorithm or software. "Standalone performance" in this context would refer to its physical and electrical characteristics, which were assessed as described in the "Performance Data" section.

7. The type of ground truth used

• The "ground truth" for demonstrating substantial equivalence was the established characteristics and performance of the identified predicate devices: the Rhythmlink Disc Electrodes (K061148) and Grass Technologies' Gold Electrodes (marketed prior to 1976).
• For the technical characteristics (Resistance, Model Surface, Impedance, Frequency Response), the ground truth would be the measured values from the predicate devices which the DE-48-Plus aimed to match or be "substantially equivalent" to.

8. The sample size for the training set

• Not Applicable. This is a physical medical device, not a machine learning model. Therefore, there is no "training set."

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

• Not Applicable. (See point 8).

Summary of the Study:

The "study" referenced in the document is not a traditional clinical trial but rather a series of bench tests and comparative analyses conducted by Grass Technologies to demonstrate that the DE-48-Plus Disposable Electrodes are "substantially equivalent" to legally marketed predicate devices.

The tests focused on physical and electrical performance characteristics such as Resistance, Model Surface, Impedance, and Frequency Response. The results of these tests, although not numerically detailed in the summary, reportedly showed that the DE-48-Plus electrodes were "found, through appropriate testing to be substantially equivalent" to the Rhythmlink Disc Electrodes and existing Grass Technologies' Gold Electrodes. Material composition and design were also compared directly to the predicates.

The purpose of this submission (510(k)) is to demonstrate that the new device is as safe and effective as a legally marketed device, not to prove novel performance through a clinical trial with human subjects.

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