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Intended Use:

• Defibrillation
• Cardioversion
• Noninvasive Pacing
• ECG Monitoring

For use with ZOLL® Defibrillators:

• ZOLL Defibrillators, such as;
• R Series
• M Series
• E Series

By Trained Personnel only, Including:

• Physicians
• Nurses
• Paramedics
• Emergency Medical Technicians
• Cardiovascular Laboratory Technicians

The OneStep Pediatric Electrodes are indicated for use on a patient less than 8 years of age or weighs less than 55 Lbs. (25Kg).

The OneStep pediatricElectrode System is intended for use with ZOLL Defibrillators, such as, R Series M Series, and E Series for ECG monitoring, defibrillation, noninvasive pacing and cardioversion of pediatric patients in either the hospital environment. The system is comprised of a single use, disposable electrode made of conductive hydrogel with a metal conductor and adhesive perimeter suitable for coupling to patient skin during rescue and/or treatment.

This submission for the OneStep™ Pediatric Multi-function Electrode is a 510(k) premarket notification claiming substantial equivalence to previously cleared devices. It doesn't describe a study designed to establish acceptance criteria for a novel device, but rather uses nonclinical testing to demonstrate that the new device meets established functional requirements and performance specifications defined in applicable national/international standards, and performs comparably to predicate devices.

Therefore, many of the requested sections (sample size for test set, data provenance, number of experts for ground truth, adjudication method, MRMC study, sample size for training set, how training ground truth was established) are not explicitly detailed in the provided document, as they would typically be for a de novo device or a more complex AI/diagnostic system.

Here's an analysis based on the provided text:

Acceptance Criteria and Device Performance

The device leverages existing, recognized national and international standards for multi-function electrodes used with defibrillators. The acceptance criterion is essentially compliance with these standards and demonstrating comparable performance to the predicate devices.

Study Details

1. Sample size used for the test set and the data provenance:
   The document does not specify a "test set" in the context of clinical data for performance evaluation in the typical sense (e.g., patient cases). The evaluation relies on "extensive performance testing" against standards. The data provenance is nonclinical (laboratory/engineering testing) rather than patient data.

2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
   Not applicable, as this was a nonclinical performance validation against engineering standards and comparison to predicate devices, not a diagnostic or AI-based study requiring expert ground truth in clinical cases.

3. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
   Not applicable.

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 a medical device (electrode) for therapy and monitoring, not an AI-assisted diagnostic tool.

5. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
   Not applicable. This is an electrode, not an algorithm. Its performance is inherent in its design and material properties.

6. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
   The "ground truth" for this submission are the established performance specifications and functional requirements outlined in the ANSI/AAMI DF80 and EN 60601-2-4 standards, as well as the demonstrated safe and effective operation of the predicate devices.

7. The sample size for the training set:
   Not applicable. No "training set" is mentioned as this is not an AI/machine learning device.

8. How the ground truth for the training set was established:
   Not applicable.

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