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The HeartStart MRx is for use for the termination of ventricular tachycardia and ventricular fibrillation.

The device is for use by qualified medical personnel trained in the operation of the device and qualified by training in basic life support, advanced cardiac support, or defibrillation. It must be used by or on the order of a physician.

AED Therapy: To be used in the presence of a suspected cardiac arrest on patients of at least 8 years of age that are unresponsive, not breathing and pulseless.

Manual Defibrillation: Asynchronous defibrillation is the initial treatment for ventricular fibrillation and ventricular tachycardia in patients that are pulseless and unresponsive. Synchronous defibrillation is indicated for termination of atrial fibrillation.

Noninvasive External Pacing Therapy: The pacing option is intended for treating patients with symptomatic bradycardia. It can also be helpful in patients with asystole, if performed early.

Pulse Oximetry: The SpO2 option is intended for use when it is beneficial to assess a patient's oxygen saturation level.

Noninvasive Blood Pressure Monitoring: The NBP option is intended for noninvasive measurement of a patient's arterial blood pressure.

End-tidal CO2: The EtCO2 option is intended for monitoring of a patient's exhaled carbon dioxide and to provide a respiration rate.

12-Lead ECG: The 12-Lead ECG function is to provide a conventional diagnostic 12-Lead ECG report, which may include measurements and interpretative statements.

Q-CPR: The Q-CPR option provides feedback designed to encourage rescuers to perform resuscitation in accordance with AHA/ERC guidelines for chest compression rate, depth, and duty cycle and ventilation rate, volume and flow rate (inflation time).

The Q-CPR option is contraindicated as follows:
The Q-CPR option is contraindicated for use on neonatal and pediatric patients (under 8 years of age or weighing less that 25 kg).
The Q-CPR option is not for use when CPR is contraindicated.

Invasive Pressure: The Invasive Pressure option is indicated for measuring arterial, venous, intracranial and other physiological pressures on patients.

Temperature: The Temperature option is indicated for measuring temperature in patients.

The HeartStart MRx is a lightweight, portable external defibrillator, offering two modes of operation for defibrillation: manual mode and semi-automatic mode (AED). The HeartStart MRx can also be used for ECG monitoring of a patient, non-invasive external pacing, 12-Lead ECG, non-invasive blood pressure, end-tidal CO2 (EtCO2), pulse oximetry (SpO2), Q-CPR™, invasive pressure and temperature measurements.

This 510(k) summary for the Philips HeartStart MRx Invasive Pressure Option and Temperature Option does not contain any information regarding acceptance criteria or a study that proves the device meets specific acceptance criteria in the format requested.

The document states:

• "The tests used in the determination of substantial equivalence included only bench testing, Bench testing includes hardware and software testing demonstrating that the performance of the device meets its specifications." (Page 2)
• "Based on the results of the testing described above, it is concluded that the HeartStart MRx with Invasive Pressure and Temperature Options does not raise any different questions regarding the safety or effectiveness as compared with the predicate devices. It is considered to be substantially equivalent to the predicate devices." (Page 2)

This indicates that the submission relied on bench testing to show the device met its own specifications and was substantially equivalent to predicate devices, rather than providing details on specific acceptance criteria for performance metrics (like sensitivity, specificity, or accuracy) and a clinical or comparative study demonstrating compliance with those criteria.

Therefore, I cannot populate the table or answer the specific questions about sample sizes, ground truth, expert qualifications, adjudication, or MRMC studies. This information is not present in the provided text.

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