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LUCAS® External Cardiac Compressor is to be used for performing external cardiac compressions on adult patients who have acute circulatory arrest defined as absence of spontancous breathing and pulse, and loss of consciousness.

LUCAS® can be used in cases where manual chest compression would be used.

LUCAS® is only intended for temporary use.

LUCAS is a pneumatically powered mechanical chest compression system providing controlled automated chest compressions on adult patients who have acute circulatory arrest.

LUCAS consists of an upper part containing a pneumatically driven piston rod, which acts on the patient's chest via a pressure pad. The pressure pad is surrounded by a suction cup.

The support legs of the upper part are fastened to the back plate prior to starting compressions.

LUCAS can be powered by oxygen or air from a wall outlet in a hospital or an ambulance, or from a cylinder.

LUCAS is designed to provide:

• · Consistent and uninterrupted compressions according to the guidelines given by American Heart Association (AHA);
• · Good circulation during the patient transport process;
• · Safety during transportation for both emergency medical personnel and patient, allowing emergency medical personnel to wear safety belts during transportation while LUCAS delivers continuous, consistent and uninterrupted compressions;
• · Hands-free compressions in any situation.

LUCAS can be applied to the patient in less than 20 seconds.

This document, K053403, is a 510(k) summary for the LUCAS® external cardiac compressor. It outlines the device, its intended use, and its substantial equivalence to predicate devices, but it does not contain information about the acceptance criteria or a specific study proving the device meets acceptance criteria.

The document states that "Appropriate product testing was conducted and included a number of function tests during different operating conditions. These tests demonstrated that the functionality, safety and capability of the LUCAS comply with the product specifications and supports substantial equivalence to predicate devices." However, it does not provide details of these tests, specific acceptance criteria, or the reported performance data in a quantifiable manner.

Therefore, I cannot fulfill your request for a table of acceptance criteria and reported device performance, or details regarding sample sizes, ground truth establishment, or specific study designs (such as MRMC or standalone studies), as this information is not present in the provided text.

The document primarily focuses on demonstrating substantial equivalence to existing predicate devices (Thumper 1007 and Autopulse model 100) based on similar function, indications for use, and materials, rather than presenting a performance study against novel acceptance criteria.

Key takeaway: This 510(k) summary does not include the detailed performance study information you are asking for. It asserts that testing was done and compliance achieved, but does not provide the specifics of those tests or results.

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