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• Defibrillation ●
• Cardioversion ●
• Noninvasive Pacing o
• ECG Monitoring ●
• CPR Sensor .

For use on adult patients with ZOLL® R Series® defibrillator by trained personnel only, including:

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

The OneStep CPR II Adult Electrodes are not indicated for use on a patient less than 8 years of age or weighing less than 55 lbs (25kg).

As with the cleared predicate device (K110742), the OneStep CPR II MFE is intended for use with ZOLL R Series defibrillators for ECG Monitoring, Defibrillation, External Noninvasive Pacing, Cardioversion and CPR Feedback for adult patients in either the hospital or pre-hospital environment. The currently marketed OneStep CPR MFE provides users with accurate depth compression feedback when CPR is performed on a firm surface - a known recommended practice. A recent publication by the AHA acknowledges that "accelerometers are insensitive to mattress compression" and stresses the need for "continued development of optimal and widely available CPR monitoring".

The proposed device incorporates a second motion sensor on the posterior electrode which will allow rescuers to obtain accurate depth compression feedback when CPR is performed on soft/ compressible surfaces. The dual sensor technology works by detecting motion in the posterior sensor and communicating it to the anterior sensor to allow for compensation for a compressible surface underneath the patient. The accelerometers in each CPR sensor work in series to provide a signal to the defibrillator which interprets that signal to determine actual chest compression depth when compressions are performed on a compressible surface. The dual sensor technology can also be used on a solid surface as the design of the posterior sensor is not influenced by lack of movement.

As with the predicate device, the proposed electrode and wire harness with a ZOLL proprietary connector will have a pre-connect feature that enhances the user's ability to deliver immediate therapy. And like the predicate device. the OneStep CPR II electrode will also have the ability to perform a defibrillation self test and expiration date identification with the ZOLL R Series Defibrillator. Each electrode pad is structurally comprised of a solid hydrogel with a pure tin electrical conductive element having a polyethylene terephtalate (PET) backing with an adhesive perimeter suitable for coupling to patient skin during rescue and/or treatment.

I am sorry, but the provided text does not contain the requested information about acceptance criteria and a study proving the device meets those criteria. The document is an FDA 510(k) clearance letter and summary for a medical device (OneStep CPR II Adult Multi-Function Electrode).

It describes the device, its intended use, and states that it has been subjected to "extensive performance testing to ensure the device meets all of its functional requirements and performance specifications as defined in applicable National/International recognized standards." However, it does not provide the specific acceptance criteria, the results of the performance testing, the study design, sample sizes, ground truth establishment, or any details about multi-reader multi-case studies or standalone algorithm performance.

To answer your request, I would need a different document, likely a detailed study report or validation protocol (e.g., from Section 18 mentioned in the text).

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