The BodyTrode is a short term, single use (disposable), adult and pediatric ECG electrode which is applied to the intact skin surface to acquire electrocardiographic activity of the heart which can be displayed and analyzed when used in combination with leadwires, cables, and a monitor. They are intended to be used in both hospital and prehospital settings under the direction of a licensed health care practitioner.

Device Description

The Marquette BodyTrode ECG Electrodes are adhesive hydrogelled, single use ECG electrodes intended for use with adult and pediatric patients. The product is a polymer electrode comprised of three elements: a top polymer, a conductive adhesive hydrogel, and a radiotranslucent stud. The BodyTrode electrodes are applied to the patient's skin surface to acquire electrocardiographic activity of the heart. They are used in combination with patient leadwires, cables, and a monitor to display and/or analyze a patient's ECG.

AI/ML Overview

This document describes the testing and acceptance criteria for the "BodyTrode" Electrocardiograph (ECG) Electrode.

1. Acceptance Criteria and Device Performance

Acceptance Criteria	Device Performance (Reported)
Adherence to ANSI/AAMI EC12-1991 standard	"Testing done on the proposed BodyTrode and the predicate Marquette ECG electrode (PN 9408-401) indicates that the proposed provides an equivalent when compared to the ANSI/AAMI standard of EC12-1991"
Biocompatibility (ISO 10993-1:1992 and FDA Matrix)	"Bio-compatibility tests were conducted for the patient contact materials (the hydrogel). The tests were selected in accordance to ISO 10993-1:1992 and the FDA Matrix."
Equivalence to Predicate Device	"Marquette Electronics, Inc. concludes that the proposed BodyTrode is as safe and effective and performs substantially equivalent to the predicate Marquette ECG Electrode."

2. Sample Size and Data Provenance

The document does not explicitly state the sample size used for the tests. It mentions "package aging using both real time and the Von't Hoff rule" for the ANSI/AAMI standard tests, and "biocompatibility tests... for the patient contact materials (the hydrogel)." The data provenance is not specified regarding country of origin or whether it was retrospective or prospective, though the nature of the tests suggests prospective lab-based testing.

3. Number of Experts and Qualifications for Ground Truth

This type of device (ECG electrode) does not typically involve interpretation by human experts to establish ground truth in the way AI/ML algorithms might. The "ground truth" for these tests are objective technical and biological standards. Therefore, information on the number and qualifications of experts for establishing ground truth is not applicable and not provided.

4. Adjudication Method

Adjudication methods (like 2+1, 3+1) are typically used in clinical studies involving human interpretation or subjective assessments. For the objective technical and biocompatibility testing of an ECG electrode against established standards, such adjudication methods are not applicable and not mentioned.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

A multi-reader multi-case (MRMC) comparative effectiveness study was not done. This study type is relevant for evaluating the impact of AI algorithms on human reader performance, which is not applicable to the evaluation of an ECG electrode.

6. Standalone (Algorithm Only) Performance Study

A standalone performance study was not done in the context of an AI algorithm. This device is a physical electrode, and its performance is assessed through its ability to meet established technical and biological standards, not through an algorithm's output.

7. Type of Ground Truth Used

The ground truth used was based on objective technical standards (ANSI/AAMI EC12-1991 for ECG electrode performance) and biocompatibility standards/guidelines (ISO 10993-1:1992 and the FDA Matrix).

8. Sample Size for the Training Set

This question is not applicable to the evaluation of a physical medical device like an ECG electrode. There is no AI/ML algorithm involved, and therefore, no "training set."

9. How Ground Truth for the Training Set was Established

This question is not applicable, as there is no training set for an AI/ML algorithm in the context of this device.

Summary

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510(k) SUMMARY OF SAFETY AND EFFECTIVENESS Section 16: April 2, 1996

1. Establishment Information

Manufacturer/Submitter:	Marquette Electronics, Inc.
	100 Marquette Drive
	Jupiter, FL 33469
Contact Name/Phone #	Michael Laughran
	Regulatory Affairs
	Marquette Electronics, Inc.
	Phone: (407) 574-5000

2. General Device Information

Common/Usual Name:	Electrocardiograph (ECG) Electrode
Trade/Proprietary Name:	BodyTrode
Classification Name:	Electrocardiograph electrode (CFR
	870.2360)
Device Classification:	Class II
Performance Standards:	None established under section 514

3. Substantial Equivalence:

BodyTrode is substantially equivalent to Marquette ECG electrodes which are currently legally marketed under 510(k) 833695.

4. Device Description:

5. Intended Use:

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510(k) SUMMARY OF SAFETY AND EFFECTIVENESS (continued) Section 16:

6. Comparison to legally marketed predicate device.

CHARACTERISTIC	PREDICATE DEVICEPN 9408-401	PROPOSED DEVICEBODYTRODE
----------------	---------------------------------	------------------------------

Intended Use	A disposable device for the detection ofphysiological potentials such as ECG, EEG,etc. through skin surface contact.	The BodyTrode is a short term, single use(disposable), adult and pediatric ECGelectrode which is applied to the intact skinsurface to acquire electrocardiographicactivity of the heart which can be displayedand analyzed when used in combination withleadwires, cables, and a monitor. They areintended to be used in both hospital andprehospital settings under the direction of alicensed health care practitioner.
Materials/Construction	Oval lamination consisting of an adhesivecoated foam pad and ring, a styrene ring,and conductive gel which is connected by asilver/silver chloride coatedradiotranslucent plastic electrode and stud.The assembly is placed in a plastic holderand packaged in foil coated paper.	Round lamination consisting of a layer ofconductive adhesive hydrogel and a toppolymer with a silver/silver chloride coatedradiotranslucent plastic stud. The assemblyis placed in a plastic holder and packaged infoil coated paper.
Expiration Date	15 months from date of manufacture	12 months from date of manufacture

7. The following non-clinical tests were conducted and submitted for determination of substantial equivalence.

Tests recommended in ANSI/AAMI voluntary standard of EC12-1991 with package aging using both real time and the Von't Hoff rule were conducted to demonstrate performance and technological characteristics.
Bio-compatibility tests were conducted for the patient contact materials (the hydrogel). The tests were selected in accordance to ISO 10993-1:1992 and the FDA Matrix.

8. Conclusion

Testing done on the proposed BodyTrode and the predicate Marquette ECG electrode (PN 9408-401) indicates that the proposed provides an equivalent when compared to the ANSI/AAMI standard of EC12-1991 and ISO 10993-1:1992 and the FDA Matrix when tested as specified in the pre-market submission.

Marquette Electronics, Inc. concludes that the proposed BodyTrode is as safe and effective and performs substantially equivalent to the predicate Marquette ECG Electrode.

Regulation Number and Section

§ 870.2360 Electrocardiograph electrode.

(a)
Identification. An electrocardiograph electrode is the electrical conductor which is applied to the surface of the body to transmit the electrical signal at the body surface to a processor that produces an electrocardiogram or vectorcardiogram.(b)
Classification. Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 870.9. The special control for this device is the FDA guidance document entitled “Class II Special Controls Guidance Document: Electrocardiograph Electrodes.” See § 870.1(e) for availability information of guidance documents.