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The 700-MP Series Radiolucent Multi-pad electrodes are disposable electrodes for external cardiac stimulation and monitoring. Electrodes of this design are suitable for external pacing, external defibrillation, synchronized cardioversion and ECG monitoring. The MP designation refers to the multifunctionality of these electrodes wherein the separate ECG monitoring elements allow for continuous ECG monitoring through the attachment of separate ECG leadwires. The radiolucent substrate of these electrodes makes them particularly well suited for certain clinical applications involving radiographic viewing. The expected patient population for the use of these devices is primarily adults. The environment for use includes all areas of the hospital, ambulance, and prehospital (paramedic) situations. Individual catalog numbers are labeled for more specific use based primarily on the interface connector and cable system which defines the host external device, such as an external defibrillator.

The devices covered by this premarket notification provide an interface from the skin to a number diagnostic or therapeutic devices and are labeled with one or more of the following intended uses:

• External Defibrillation External Pacing ECG Monitorina Synchonized Cardioversion
  As with all electrodes of this type, labeling indicates that separate ECG electrodes are required for monitoring during external pacing. In the case of 700-MP Radiolucent Multi-Pad Electrodes these separate ECG monitoring electrodes are provided on the same foam backing for the optional attachment of separate ECG leadwires.

The 700-MP Radiolucent Multi-Pad electrodes consist of a foam backing material, a laminated metallic substrate which is covered by a conductive adhesive (hydrogel). This hydrogel is then surrounded by an adhesive coated foam ring and covered by a removable release liner. The electrodes have an integral lead wire for attachment to the interface cable of the defibrillator/pacemaker/monitor. In addition, the 700-MP electrodes provide separate ECG monitoring elements on the same foam backing material for the attachment of standard ECG leadwires.

Upon use, the release liner is removed from the electrode, exposing the hydrogel and adhesive areas. Each electrode of the set is then applied to the patient's chest in the selected set and pressed to ensure adhesion. The electrode is then attached to the host device via the interface cable and treatment is performed in accordance with established protocols. Optionally, the separate leadwires may be attached to the ECG monitoring elements provided on the foam back area.

The 700-MP Radiolucent Multi-Pad electrodes are produced only in the Adult configuration. Leadwire sets having various lengths and interface connectors are added to the basic electrode style and may result in different catalog numbers to obtain combinations of end product design. The product line is further differentiated through trade name identification.

This document describes the 700-MP Series Multi-pad Electrodes, which are disposable accessories used for external cardiac stimulation and monitoring. The information provided outlines the device's characteristics, intended use, and a performance evaluation to assert its substantial equivalence to previously approved devices.

Acceptance Criteria and Device Performance

The acceptance criteria for the 700-MP Series electrodes are based on the ANSI/AAMI DF-39 standard (subsection 3.3.19) for electrical performance parameters, as well as manufacturer-developed mechanical performance parameters. Biocompatibility testing was also conducted.

Study Details

The provided document describes a "Performance Evaluation" which consists of bench testing (electrical and mechanical), biocompatibility studies, and in vivo animal testing.

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

   • Bench Testing (Electrical & Mechanical): The document does not specify the exact sample size for the electrodes tested in the bench tests. It broadly states "a battery of both electrical and mechanical tests." Data provenance is not explicitly stated but implies internal testing by Cardiotronics Systems, Inc. The nature of these tests suggests they are prospective, conducted specifically for this submission.
   • Biocompatibility Studies: The sample size for biocompatibility testing (Cytotoxicity, Primary Skin Irritation, Delayed Contact Sensitization, Primary Skin Insult Patch test) is not specified. The tests were performed on the hydrogel conductive adhesive and the adhesive foam ring. Data provenance is not explicitly stated. These would be prospective tests.
   • In vivo Animal Studies: "a limited number of electrodes of similar construction were tested on live pigs over a twenty four hour period" and "Additional electrodes of similar construction were tested on live pigs over an eight hour period." The exact number of electrodes or pigs is not provided. The data provenance is from in vivo animal (pig) testing. These were prospective studies.

2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
   The document does not mention the use of human experts to establish ground truth for this device's performance evaluation. The "ground truth" for electrical performance is based on the ANSI/AAMI DF-39 standard. For mechanical performance, it's based on internal manufacturer-developed parameters. For biocompatibility, it's based on standard biological testing methods. For in vivo animal studies, the "ground truth" would be direct observation of energy delivery, ECG signal sensing, and skin changes in the live pigs.

3. Adjudication method for the test set:
   Not applicable, as this is a device performance evaluation based on objective measurements against established standards and internal parameters, rather than an assessment requiring adjudication of human judgment on a test set (e.g., medical image interpretation).

4. 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 is not an AI/software device and therefore an MRMC study comparing human readers with and without AI assistance was not conducted. The submission is for a physical medical electrode.

5. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
   Not applicable, as this is not an algorithm or AI device. The evaluations described are for the physical electrode's performance.

6. The type of ground truth used:

   • Electrical Performance: Conformance to an established industry standard (ANSI/AAMI DF-39).
   • Mechanical Performance: Manufacturer-defined parameters and direct measurement.
   • Biocompatibility: Results from standardized in vitro (Cytotoxicity, Sensitization) and in vivo (Irritation, Patch) biological tests.
   • In vivo Animal Studies: Direct observation and measurement of physiological responses (energy delivery, ECG signal, skin changes) in live animals.

7. The sample size for the training set:
   Not applicable. This is not a machine learning or AI device that requires a training set.

8. How the ground truth for the training set was established:
   Not applicable. As there is no training set for this device.

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The 700-F series electrodes are disposable electrodes for external cardiac stimulation and monitoring. Electrodes of this design are suitable for external pacing, external defibrillation, synchronized cardioversion and ECG monitoring. The expected patient population for the use of these devices includes adults and children. The environment for use includes all areas of the hospital, ambulance, and prehospital (paramedic) situations. The duration for use is to be less than 24 hours. Individual catalog numbers are labeled for more specific use based primarily on the Interface connector and cable system which defines the host external device, such as an external defibrillator.

The devices covered by this premarket notification provide an interface from the skin to a number diagnostic or therapeutic devices and are labels with one or more of the following intended uses:

External Defibrillation

External Pacing

ECG Monitoring

Synchonized Cardioversion

The 700-F Series electrodes consist of a foam backing material, a laminated metallic substrate which is covered by a conductive adhesive (hydrogel). This hydrogel is then surrounded by an adhesive coated foam ring and covered by a removable release liner. The electrodes have an integral lead wire for attachment to the interface cable of the defibrillator/pacemaker/monitor.

Upon use, the release liner is removed from the electrode, exposing the hydrogel and adhesive areas. Each electrode of the set is then applied to the patient's chest in the selected set and pressed to ensure adhesion. The electrode is then attached to the host device via the interface cable and treatment is new accordance with established protocols.

The 700-F Series electrodes are produced in two basic styles; Adult and Child. Leadwire sets having various lengths and interface connectors are added to the basic electrode styles to obtain many combinations of end product design. The product line is further differentiated through trade name and OEM identification.

The provided text is a 510(k) summary for the Cardiotronics Systems 700-F Series Disposable Cardiac Stimulation/Monitoring Electrodes. This document describes the device, its intended use, and substantial equivalence to a predicate device, focusing on bench testing, biocompatibility, and limited animal testing.

Here's a breakdown of the requested information based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly list acceptance criteria in a quantitative table format. Instead, it states that the device's performance was evaluated against specific standards and general suitability.

2. Sample Size Used for the Test Set and Data Provenance

• Sample Size: The document mentions "a limited number of electrodes were tested on live pigs" for the animal study. For bench testing (electrical and mechanical), biocompatibility, the specific number of units tested is not provided.
• Data Provenance: The animal study was conducted on "live pigs." The location (country of origin) is not specified. The studies appear to be prospective, specifically designed to test the new device.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

This type of information is not applicable and therefore not provided in the document. The studies described are technical performance evaluations (bench and animal) rather than human-expert-driven evaluations requiring ground truth establishment by experts in the context of diagnostic interpretations.

4. Adjudication Method (e.g., 2+1, 3+1, none) for the Test Set

Not applicable. As described above, the studies involve direct measurement of device performance, not interpretation by human experts.

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. The device is a physical electrode, not an AI or diagnostic tool that would involve human readers or AI assistance in interpretation.

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

Not applicable. This device is an electrode, not an algorithm. However, the bench and animal tests can be considered "standalone" in the sense that they evaluate the device's technical performance directly, without human "in-the-loop" interpretation for the ground truth establishment.

7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.)

The "ground truth" for these studies is based on:

• Established Standards: Conformance to ANSI/AAMI DF-39 for electrical performance.
• Manufacturer-Developed Parameters: For mechanical performance.
• Biocompatibility Standards: Implicitly, standard methods for cytotoxicity, irritation, and sensitization tests.
• Direct Observation/Measurement: In the animal study, effectiveness in energy delivery, ECG signal sensing, and absence of skin changes would be directly observed or measured against expected physiological responses.

8. The Sample Size for the Training Set

Not applicable. This device is an electrode, not an AI model that requires a "training set."

9. How the Ground Truth for the Training Set was Established

Not applicable for the same reason as point 8.

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