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The Concord Medical Products MobileAED, MobileALS, MobileAED+ and AdvantageAED products are designed for emergency treatment of cardiac arrest by trained personnel to terminate potentially fatal arrhythmias. The user assesses the patient's condition and confirms that the patient is unconscious, absence of a pulse or signs of circulation and has an absence of normal breathing prior to use of the device.

When the patient is a child or infant, up to 8 years of age or up to 55 lbs (25Kg), the Concord Medical Pediatric Defibrillation Pad which attenuates the energy should be used. Therapy should not be delayed to determine the patient's exact age or weight.

The Concord Medical Adult Pad should be used for patients over 8 years old and over 55 Ibs (25Kg).

The MobileALS and MobileAED+ products are the MobileAED with an option to provide manual control for defibrillation for use by advanced cardiac life support (ALS) users.

The rescuer may use the ECG monitoring mode cable feature to provide a non-diagnostic ECG rhythm display of a breathing or responsive patient regardless of age. Connection of the ECG monitoring mode cable disables the defibrillation feature and allows ECG analysis either in background or by pressing the analyze button.

Contraindications for Use - Defibrillation

Do not use the MobileAED for defibrillation when the patient;

Is conscious; or Is breathing; or Has a detectable pulse or other signs of circulation

The MobileAED is a Biphasic AED which is a portable battery operated semiautomatic low power DC defibrillator. The device's ECG analysis algorithm analyzes the patient's cardiac rhythm to determine if a shockable versus nonshockable ECG rhythm is present. The operator follows the device instructions and presses the shock button to deliver a defibrillation shock.

The MobileAED and AdvantageAED product features include a Status Indicator, Graphic Display, Voice Messages, Buttons for Power and Shock, ECG algorithm analysis, Biphasic truncated exponential waveform, Lithium Manganese Dioxide Battery, and disposable Pads for defibrillation.

The MobileALS manual control features include Energy selection button, Charge button, Analysis button, and Sync button

The provided document is a 510(k) summary for the Concord Medical Products MobileAED, MobileALS, MobileAED+, and AdvantageAED. It focuses on establishing substantial equivalence to predicate devices and demonstrating compliance with industry standards. However, it does not contain the detailed clinical study information typically found for AI/ML device submissions that would include acceptance criteria, specific performance metrics, sample sizes, ground truth establishment, or multi-reader multi-case study results.

Therefore, the requested information, specifically regarding an acceptance criteria table, detailed study results proving device performance against acceptance criteria, sample sizes for test and training sets, data provenance, number and qualifications of experts, adjudication methods, MRMC study details (including effect size), and standalone performance, cannot be extracted from this document.

This document primarily states:

• Performance Data: "The performance and safety test data demonstrate that the device meets all of its functional and performance specifications and complies with FDA guidelines and industry standards including the applicable sections of AAMI DF80, IEC 60601-1, IEC 60601-2-4 standards."
• Conclusion: "Test data demonstrate that the safety and effectiveness of the features and functions in the MobileAED and AdvantageAED products with the Biphasic waveform is substantially equivalent to the listed predicate devices with regard to performance, safety and effectiveness."

These statements are general and refer to compliance with functional and safety standards (like electrical safety, electromagnetic compatibility, and basic defibrillator performance for analyzing rhythms and delivering shocks), rather than a specific clinical performance study with the metrics and methodology you've requested for AI/ML devices. The "ECG analysis algorithm" is mentioned, but no specific performance metrics (sensitivity, specificity, PPV, NPV) for this algorithm are provided in this summary.

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