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The Cardio Med Pediatric Radiotranslucent Multifunction Electrodes, Various Models are indicated for use in external pacing, defibrillation and monitoring applications as a non-sterile, disposable device for single patient use only. The electrodes provide the conductive interface between the defibrillator and/or the external transcutaneous (noninvasive) cardiac pacemaker and the patient's skin. The electrode is intended for use on pediatric patients whose weight is less than 10 kg (22 lbs). When a patient requires defibrillation, cardioversion or external pacing, these electrodes will be applied to the patient and connected to the instrument. This device is intended for use on defibrillators whose output is classified as low power (30 joule maximum).

These are single use, non-sterile, self stick defibrillator electrodes packaged in pairs. Effective electrode area = 46.43 cm² (7.1967 in²) They are radiotranslucent. They come in various connector styles to match the specific defibrillator. (See intended use statement below.) The construction and materials employed are identical to the predicate. The patient contact material is a conductive adhesive hydrogel identical to the material used in the predicate devices. These pads meet the AAMI Standard ANSI/AAMI DF80:2003 and the connectors meet the FDA performance standard for touch proof ECG connectors.

The provided text describes a 510(k) premarket notification for Cardio Med Pediatric Radiotranslucent Multifunction Electrodes. This document focuses on demonstrating substantial equivalence to a predicate device through nonclinical bench testing. It does not contain information typically found in studies for AI/machine learning medical devices, such as those related to reader performance, clinical outcomes, or large-scale data analysis for algorithm development.

Therefore, many of the requested categories related to AI device studies (e.g., sample size for test/training sets, experts for ground truth, MRMC studies, standalone performance) cannot be addressed from the given text.

Here's a summary based on the available information:

1. Table of Acceptance Criteria and Reported Device Performance

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

• Sample Size: "Various different lots containing multiple samples each" were subjected to AAMI tests. The exact number of samples or lots is not specified.
• Data Provenance: Not applicable in the context of this device. The testing was nonclinical bench testing, not involving human data.

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

• Not applicable. This was bench testing against engineering standards, not diagnostic device validation requiring expert-established ground truth.

4. Adjudication method (e.g., 2+1, 3+1, none) for the test set

• Not applicable. This was bench testing against engineering standards. Results would be pass/fail based on direct measurement and comparison to thresholds rather than expert adjudication.

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

• No, an MRMC comparative effectiveness study was not done. This device is a passive electrode, not an AI or diagnostic imaging device that would involve human readers or AI assistance.

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

• No, a standalone algorithm performance study was not done. This device does not involve an algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

• The "ground truth" for the bench testing was defined by the quantitative limits specified in the AAMI Standard ANSI/AAMI DF80:2003 and the FDA performance standard for touch-proof ECG connectors. Biocompatibility was assessed against standard biological safety test protocols.

8. The sample size for the training set

• Not applicable. This device does not involve a training set for an algorithm.

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

• Not applicable. There is no training set for an algorithm.

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The Cardio Med DEFIBRILLATION/CARDIOVERSION/MONOPHASIC OR BIPHASIC PACING/ ECG ELECTRODES are indicated for use in external pacing, defibrillation and monitoring applications as a non-sterile, disposable device for single patient use only. The electrodes provide the conductive interface between the defibrillator and/or the external transcutaneous (noninvasive) cardiac pacemaker and the patient's skin. The electrode is intended for use on adult patients. When a patient requires defibrillation, cardioversion or external pacing, these electrodes will be applied to the patient and connected to the instrument. This device is intended for use on defibrillators whose output is classified as low power (360 joule maximum).

Compatible with Cardiac Science (ANDERSON connectors), PHILIPS MEDICAL, PHYSIO-CONTROL, and ZOLL MEDICAL models of monophasic and bi-phasic defibrillators, external pacemakers.

These are single use, non-sterile, self stick defibrillator electrodes packaged in pairs. 104 cm² (16.1 in²) They are radiotranslucent. They come in various connector styles to match the specific defibrillator. (See intended use statement below.) The construction and materials employed are identical to the predicate. The patient contact material is a conductive adhesive hydrogel identical to the material used in the predicate devices. These pads meet the AAMI Standard ANSI/AAMI DF80:2003 and the connectors meet the FDA performance standard for touch proof ECG connectors.

Here's an analysis of the provided 510(k) summary regarding the acceptance criteria and study proving device performance:

1. Table of Acceptance Criteria and Reported Device Performance

The device (Cardio Med DEFIBRILLATION/CARDIOVERSION/MONOPHASIC OR BIPHASIC PACING/ECG ELECTRODES) was tested against the AAMI Standard ANSI/AAMI DF80:2003.

Additionally, the device was subjected to an accelerated age shelf life test:

• Acceptance Criteria: Maintain compliance with the above AAMI tests after 36 months of accelerated aging.
• Reported Device Performance: All units passed the tests after the accelerated age shelf life test.

Furthermore, Biocompatibility testing was performed on the patient contact material Hydrogel, and the material passed.
Finally, Compliance with the FDA performance standard for touch-proof ECG connectors was verified by inspection.

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

• Sample Size for Test Set:
  • For the AAMI electrical performance tests: Three different lots, with six samples each (total of 18 samples).
  • For the 36-month accelerated age shelf life test: Three different lots, with two samples each (total of 6 samples).
  • For Biocompatibility testing: Not specified, but performed on the patient contact material (hydrogel).
  • For Connector compliance: Verified by inspection of the connectors (number of units not specified).
• Data Provenance: The nature of these tests (bench testing, accelerated aging, biocompatibility) indicates that the data is prospective and generated in a laboratory setting, rather than being collected from patients. The country of origin for the data is not explicitly stated in the provided text.

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

This type of submission is for a medical device (defibrillator electrodes) and primarily relies on bench testing against established industry standards (AAMI Standard ANSI/AAMI DF80:2003) and conformance to FDA performance standards for connectors.

• Experts for Ground Truth: There is no mention of human expert consensus being used to establish a "ground truth" for the performance of these basic electrical and material properties tests. The "ground truth" is defined by the objective, quantifiable limits set forth in the AAMI standard itself and FDA regulations for connectors. The testing would be conducted by qualified laboratory personnel, but their role is to measure and report, not to interpret complex clinical data for ground truth establishment.

4. Adjudication Method for the Test Set

Not applicable. As described above, the determination of "passing" is based on objective measurements against pre-defined numerical limits in a standard, not on the subjective interpretation of expert reviewers that would require an adjudication method.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size of AI Improvement

No. This submission is for a physical medical device (defibrillator electrodes), not an AI algorithm. Therefore, an MRMC comparative effectiveness study involving human readers and AI assistance is not relevant and was not performed.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done

No. This is not an AI algorithm.

7. The Type of Ground Truth Used

The ground truth used for proving the device meets acceptance criteria is based on:

• Industry Standards: Specifically, the AAMI Standard ANSI/AAMI DF80:2003 for electrical performance characteristics of defibrillator electrodes.
• FDA Regulations/Performance Standards: For "touch-proof" ECG connectors and biocompatibility.
• Objective Measurements: These standards define quantifiable limits (e.g., ≤100 mV for DC Offset, ≤3,000 Ohms for AC Small Signal Impedance) against which the device's measured performance is compared.

8. The Sample Size for the Training Set

Not applicable. As this is not an AI/algorithm-based device, there is no "training set" in the context of machine learning.

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

Not applicable, as there is no training set for this type of device submission.

Ask a specific question about this device

The Cardio Med DEFIBRILLATION/CARDIOVERSION/MONOPHASIC OR BIPHASIC PACING/ ECG ELECTRODES are indicated for use in external pacing, defibrillation and monitoring applications as a non-sterile, disposable device for single patient use only. The electrodes provide the conductive interface between the defibrillator and/or the external transcutaneous (noninvasive) cardiac pacemaker and the patient's skin. The electrode is intended for use on adult patients. When a patient requires defibrillation, cardioversion or external pacing, these electrodes will be applied to the patient and connected to the instrument. This device is intended for use on defibrillators whose output is classified as low power (360 joule maximum). Compatible with Cardiac Science (ANDERSON connectors), PHILIPS MEDICAL, PHYSIOCONTROL, and ZOLL MEDICAL models of monophasic and bi-phasic defibrillators, external pacemakers.

These are single use, non-sterile, self stick defibrillator electrodes packaged in pairs. Effective electrode area = 98 cm2 (15.2 in2). They are radiotransparent. They come in various connector styles to match the specific defibrillator. The construction and materials employed are identical to the predicate. The patient contact material is a conductive adhesive hydrogel identical to the material used in the predicate devices. These pads meet the AAMI Standard ANSI/AAMI DF80:2003 and the connectors meet the FDA performance standard for touch proof ECG connectors.

Acceptance Criteria and Device Performance Study for Cardio Med Defibrillation/Cardioversion/Monophasic or Biphasic Pacing/ECG Electrodes (K103154)

1. Table of Acceptance Criteria and Reported Device Performance

The Cardio Med Defibrillation/Cardioversion/Monophasic or Biphasic Pacing/ECG Electrodes were tested against the AAMI Standard ANSI/AAMI DF80:2003 for defibrillator pads.

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

Sample Size: For the AAMI bench tests, three different lots were used, with six samples from each lot subjected to the tests. Additionally, the same testing routine (three lots, two samples each) was applied to a 36-month accelerated age shelf life test.
Data Provenance: The data is reported from nonclinical bench testing performed by the manufacturer, Cardio Medical Products, Inc. This is prospective data generated specifically for the premarket notification. The country of origin of the data is not explicitly stated in the provided text but is implied to be within the United States, given the FDA submission.

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

This study involved bench testing against established engineering standards (AAMI, FDA performance standard). It did not involve human interpretation or subjective assessment of medical images or patient data. Therefore, there were no experts used to establish ground truth in the context of medical diagnosis or interpretation for this specific type of device testing. The "ground truth" was the objective measurement against the specified engineering limits.

4. Adjudication method for the test set

Not applicable. As this was bench testing against objective engineering standards, there was no subjective judgment or adjudication required. Each test result was either within the specified limits ("Passed") or not.

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

No, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. This device is a defibrillator electrode and does not involve AI or human interpretation of medical data in its primary function.

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

Not applicable. This device is a physical medical device (defibrillator electrode), not an algorithm or AI software. Therefore, no standalone algorithm-only performance study was conducted.

7. The type of ground truth used

The ground truth used was based on objective engineering and performance standards established by the Association for the Advancement of Medical Instrumentation (AAMI Standard ANSI/AAMI DF80:2003) and FDA performance standards for ECG connectors. For biocompatibility, the ground truth was meeting established biocompatibility testing protocols for patient contact materials.

8. The sample size for the training set

Not applicable. This is a physical medical device. There was no machine learning or AI algorithm that required a "training set."

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

Not applicable, as there was no training set for this device.

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