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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 spontaneous breathing and pulse, and loss of consciousness.

LUCAS® must only 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 patients chest via a pressure pad integrated into the suction cup.

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

LUCAS® is powered by compressed air from a wall outlet in a hospital or an ambulance, or from a cylinder.

The provided text describes the 510(k) summary for Jolife's Modified LUCAS® external cardiac compressor. It does not contain information about acceptance criteria, device performance metrics, or a study that proves the device meets specific criteria in the format requested.

The document is a regulatory submission for premarket notification (510(k)) to demonstrate substantial equivalence to predicate devices, not a clinical study report with detailed performance metrics against acceptance criteria.

Based on the provided text, the requested information cannot be fully extracted as it is not present.

Here's a breakdown of what can be inferred or stated about the requested points, and what is explicitly missing:

1. A table of acceptance criteria and the reported device performance

• Missing from the text. The document states that the device provides compressions "according to the guidelines given by the American Heart Association (AHA)," but it does not specify quantitative acceptance criteria (e.g., minimum compression depth, rate, or recoil) or report specific device performance metrics against such criteria.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

• Missing from the text. No information on a test set sample size or data provenance is provided. The document mentions "Appropriate product testing was conducted and included a number of function tests during different operating conditions," but these appear to be engineering/functional tests rather than clinical or performance studies with a "test set" of patients or data.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

• Missing from the text. No information about experts establishing ground truth for a test set is provided.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

• Missing from the text. No adjudication method for a test set is mentioned.

5. 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

• Missing from the text. This device is a mechanical chest compressor, not an AI-assisted diagnostic tool for human "readers." Therefore, an MRMC study related to human interpretation with/without AI assistance would not be applicable to this product.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

• Partially addressed/Inferred: The device is a standalone mechanical compressor. Its performance is described as "consistent and uninterrupted compressions according to the guidelines given by the American Heart Association (AHA)" and it allows for "hands-free compressions." The testing section (Section 6) states, "These tests demonstrated that the functionality, safety and capability of LUCAS® comply with the product specifications and support substantial equivalence to predicate devices. In all instances, the LUCAS® functioned as intended and all results observed were as expected." This indicates standalone functional testing was performed, but no specific performance metrics are reported.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

• Inferred/Contextual: The "ground truth" for this device, which performs chest compressions, would be its ability to deliver compressions that meet established medical guidelines for CPR (e.g., AHA guidelines for depth, rate, recoil). The text does not elaborate on how this "ground truth" was explicitly measured or used in the "functional tests."

8. The sample size for the training set

• Missing from the text. No training set is mentioned as this is a mechanical device, not a machine learning algorithm requiring a training set in the typical sense.

9. How the ground truth for the training set was established

• Missing from the text. See point 8.

Summary of Device and Regulatory Context (from the provided text):

• Device Name: Jolife's Modified LUCAS® External Cardiac Compressor (referred to as LUCAS®)
• Intended Use: Performing external cardiac compressions on adult patients with acute circulatory arrest (absence of spontaneous breathing and pulse, loss of consciousness), where manual chest compression would be used. Intended for temporary use.
• Mechanism: Pneumatically powered mechanical chest compression system with an upper part containing a pneumatically driven piston rod and a pressure pad integrated into a suction cup.
• Modification in K062401: This 510(k) is for a modification to re-introduce "active decompression" by eliminating holes in the suction cup, which were previously added to "deactivate" this component. The sponsor states active decompression will be limited to 3lbs. The FDA considered this a "change in fundamental scientific technology as compared to the predicate [compression only] device" and required clinical data for the active decompression component.
• Predicate Devices: Lucas (K053403), Thumper model 1007 (K972525), Autopulse model 100 (K040453).
• Substantial Equivalence: The submission claims substantial equivalence based on indications for use, basic overall function, and materials used being equivalent to predicate products.
• Testing: "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 LUCAS® comply with the product specifications and support substantial equivalence to predicate devices. In all instances, the LUCAS® functioned as intended and all results observed were as expected."

Conclusion:

The provided 510(k) summary focuses on demonstrating substantial equivalence of the modified LUCAS® device to predicate devices through functional testing and comparison of core features, rather than presenting detailed acceptance criteria and a study demonstrating the device's performance against those criteria in a quantitative, clinical manner. It highlights the FDA's concern regarding the active decompression feature, deeming it a "fundamental scientific change" that would typically require clinical data, but the document does not present such data.

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