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LMI Medical considers their ElectroBlue® ECG Electrodes to be safe and effective for use with electrocardiograph monitors which are used for recording the electric activity of the myocardium to detect abnormal transmission of small electrical impulses through the conductive tissue surrounding the heart, when used according to the intended procedures as related in the instructions accompanying the product. The function of the LMI Medical ElectroBlue® Electrodes is to detect and transmit these small electrical impulses to the electrocardiograph monitors where they are processed and plotted.

The products are all the same in their construction using medical grade foam, polypropylene cloth, clear vinyl, medical grade adhesive, silver coated carbon loaded ABS snaps, and a conductive hydrogel with a polyurethane cover release liner.

This document is a 510(k) Premarket Notification for ElectroBlue® ECG Electrodes. It describes the safety and effectiveness of the device by comparing it to an established standard and existing market products.

Here's an analysis of the provided text based on your request:

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

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

The document does not explicitly state the sample size used for the test set (i.e., the number of ElectroBlue® ECG Electrodes tested). It also does not provide details on the data provenance (e.g., country of origin, retrospective or prospective nature of the testing). It only states that the "results are on file at LMI Medical."

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

This information is not applicable and not provided. The "ground truth" for this device's performance is established by meeting the objective, standardized physical and biological requirements outlined in the ANSI/AAMI EC12-1991 standard, not by expert consensus on interpretations of data.

4. Adjudication method for the test set

Not applicable. As mentioned above, the performance is measured against objective standards, not subject to expert adjudication.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done

No, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. This type of study is typically used for diagnostic devices where human interpretation is involved. For ECG electrodes, the effectiveness is determined by their adherence to electrical and biological performance standards.

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

This question is not applicable to an ECG electrode. An ECG electrode is a passive device; it does not have an "algorithm" or standalone "performance" in the sense of AI or software. Its performance is measured by its material properties and ability to conduct electrical signals and be biologically safe.

7. The type of ground truth used

The "ground truth" for demonstrating the device's safety and effectiveness is compliance with the established technical and biological performance requirements of the ANSI/AAMI standard EC12-1991. This standard specifies objective, measurable criteria for various aspects like electrical performance, biological response, and packaging/shelf life.

8. The sample size for the training set

This concept is not applicable to the evaluation of this device. A "training set" is relevant for machine learning algorithms. The ElectroBlue® ECG Electrodes are physical medical devices, and their performance is proven through direct testing against a standard.

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

Not applicable. As explained above, there is no "training set" in the context of this device's evaluation.

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