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The subject devices are ECG surface electrodes and will be manufactured in two configurations: one for diagnostic ECG use (CenterRidge Diagnostic ECG Electrode) and one for monitoring ECG use (CenterRidge Monitoring ECG Electrode).

The CenterRidge Diagnostic ECG Electrode is a diagnostic, single use (single patient), disposable ECG electrode. This electrode is intended to acquire ECG signals from the surface of the body. The intended population is adults and pediatrics. The intended duration of body contact is less than 24 hours.

The CenterRidge Monitoring ECG Electrode is a monitoring, single use (single patient), disposable ECG electrode. This electrode is intended to acquire ECG signals from the surface of the body. The intended population is adults and pediatrics. The intended duration of body contact is greater than 24 hours but less than 30 days.

The CenterRidge ECG Electrodes are non-traditional tab electrodes, capable of diagnostic or monitoring use, depending on materials used in construction, and are intended to acquire ECG signals from the surface of the body. Both the CenterRidge Diagnostic ECG Electrode and CenterRidge Monitoring ECG Electrode are of multilayer construction, using medical grade foam or cloth backing material, a silver/silver chloride coated sensing element and solid hydrogel. The raw materials used in the CenterRidge Electrodes are equivalent to the materials used in the predicate legally marketed ECG electrodes specified above. The intended patient population is adult and pediatric. The skin surface contact area and proportional electrode size will be adjusted to fit the specific procedure and patient population.

The primary difference between the CenterRidge Electrodes and the predicate devices are geometry and shape. The 3M Health Care model 2330 and the Bio-Detek model DE1070 are traditional tab electrodes with a tab sensing element located on the perimeter of the electrode, whereas the Team Innovation CenterRidge electrode has the sensing element located within the body of the electrode. The internal location of the CenterRidge sensing element emulates the snap on the Bio-Detek models LT301SG(PSG), LT401SG(PSG) and LT401SG(PSG).

The document describes the acceptance criteria and the study conducted for the CenterRidge Diagnostic ECG Electrode and CenterRidge Monitoring ECG Electrode.

1. Table of Acceptance Criteria and Reported Device Performance:

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

The document states that the electrodes "were not clinically tested." Testing was non-clinical, bench testing. Therefore, there is no test set in the sense of patient data.

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

Not applicable, as no clinical test set was used. The device underwent non-clinical bench testing for electromagnetic compatibility.

4. Adjudication method for the test set:

Not applicable, as no clinical test set was used.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, and the effect size of how much human readers improve with AI vs without AI assistance:

Not applicable. This device is an ECG electrode, not an AI-assisted diagnostic tool for human readers.

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

The device's performance was evaluated in a standalone manner without human-in-the-loop performance in the context of its electrical characteristics. The testing focused on the electrode's ability to conform to electrical standards.

7. The type of ground truth used:

The ground truth for the non-clinical testing was defined by the specifications and requirements of the industry standard ANSI/AAMI EC12:2000/(R)2005 for electromagnetic compatibility and electrical performance.

8. The sample size for the training set:

Not applicable. This is a medical device (ECG electrode), not a machine learning algorithm that requires a training set.

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

Not applicable.

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