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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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