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LUCAS Chest Compression System 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 chest compressions are likely to help the patient.

The LUCAS device is intended for use as an adjunct to manual CPR when effective manual CPR is not possible (e.g., during patient transport or extended CPR when fatigue may prohibit the delivery of effective/ consistent compressions to the victim, or when insufficient EMS personnel are available to provide effective CPR).

The LUCAS Chest Compression System is a portable tool designed to overcome problems identified with manual chest compressions. The LUCAS device assists rescuers by delivering effective, consistent and continuous chest compressions as recommended in the American Heart Association guidelines and the European Resuscitation Council guidelines.

The LUCAS Chest Compression System can be used in a wide variety of situations and settings; on the scene, during patient movement, during transportation in road and air ambulances, in hospitals and catheterization laboratories.

The main parts of the LUCAS Chest Compression System include:

• . A Back Plate which is positioned underneath the patient as a support for the external chest compressions.
• . An Upper Part which contains the proprietary and rechargeable LUCAS Battery and the compression mechanism with the disposable Suction Cup.
• . A Stabilization Strap which helps to secure the position of the device in relation to the patient.
• . A Carrying Case.

In addition the following optional Accessories are offered as part of the system:

• LUCAS Battery, Dark Grey .
• . LUCAS Power Supply
• . LUCAS Car Power Cable, 12-28VDC
• . LUCAS PCI Back Plate
• o LUCAS Battery Charger
• o LUCAS Anti Slip, Slim Back Plate
• . LUCAS Trolley

The LUCAS 3 version 3.1 is the same device as the cleared LUCAS 3 device (K161768) with exception of the option to change device factory default settings according to local protocols. LUCAS 3 version 3.1 in its factory default settings has identical performance characteristics as the predicate device LUCAS 3.

The provided text describes the LUCAS 3 version 3.1 Chest Compression System. However, it does not contain specific acceptance criteria or a detailed study proving the device meets those criteria other than general statements about software verification and validation.

Here's an analysis based on the information provided and what is missing:

1. Table of Acceptance Criteria and Reported Device Performance:

The document describes the ability to configure settings like compression rate, depth, ventilation alerts, etc., but does not provide a table with specific quantitative acceptance criteria for these parameters (e.g., "Compression depth must be X mm +/- Y mm") nor does it report the device's measured performance against such criteria.

2. Sample Size for Test Set and Data Provenance:

The document states: "No new clinical testing has been performed for this version." This implies no specific test set was used to empirically demonstrate performance against new acceptance criteria for the LUCAS 3 version 3.1 itself. The assessments are "based on already available clinical data in combination with recommendations by the American Heart Association (AHA)."

Therefore, sample size for a device-specific test set and data provenance related to this version are not applicable/not provided.

3. Number of Experts and Qualifications for Ground Truth:

Since no new clinical testing was performed and the assessments are based on existing clinical data and AHA recommendations, the document does not describe the use of experts to establish ground truth for a test set specific to the LUCAS 3 version 3.1. The ground truth (AHA recommendations, existing clinical data) is implied to be established by the broader medical community and previous research.

4. Adjudication Method:

Given the lack of a specific test set requiring expert review, no adjudication method is described.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:

No MRMC study is mentioned. The device is an automatic chest compression system, not a diagnostic aid where human readers would typically be involved in interpreting results with/without AI assistance.

6. Standalone Performance:

The device is a standalone (algorithm only) device in the sense that it performs automated chest compressions. The performance data mentioned refers to "Nonclinical performance testing under simulated physiological conditions... demonstrating the reliability of delivering specific compression depth and rate over the intended duration of use." However, specific quantifiable results of this standalone performance are not provided in the document.

7. Type of Ground Truth Used:

The ground truth for the device's operational parameters is implicitly the American Heart Association (AHA) and European Resuscitation Council (ERC) guidelines for CPR, along with "already available clinical data."

8. Sample Size for the Training Set:

The device is not an AI/machine learning model that typically has a "training set" in the conventional sense. Its "intelligence" is made up of CPUs and software following programmed logic consistent with resuscitation guidelines. Therefore, a training set sample size is not applicable.

9. How Ground Truth for the Training Set was Established:

As mentioned above, the concept of a training set for this device type is not applicable. The device's operational parameters are based on established medical guidelines (AHA, ERC) and existing clinical knowledge pertaining to effective CPR.

In summary, the provided document focuses on demonstrating substantial equivalence to predicate devices and adherence to established medical guidelines for CPR, rather than presenting a detailed study with specific acceptance criteria and performance metrics for the LUCAS 3 version 3.1 itself. The changes in version 3.1 primarily involve software modifications to allow configuration of settings and wireless data transmission, with the claim that its factory default settings have "identical performance characteristics as the predicate device LUCAS 3." The performance testing mentioned is general verification and validation of the software and non-clinical testing under simulated conditions, but specific data is not presented.

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LUCAS Chest Compression System 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 chest compressions are likely to help the patient.

The LUCAS device is intended for use as an adjunct to manual CPR when effective manual CPR is not possible (e.g., during patient transport or extended CPR when fatigue may prohibit the delivery of effective/consistent compressions to the victim, or when insufficient EMS personnel are available to provide effective CPR).

The LUCAS 3 Chest Compression System is a portable tool designed to serve as an adjunct to manual chest compressions. The LUCAS device assists rescuers by delivering effective, consistent and continuous chest compressions as recommended in the American Heart Association quidelines and the European Resuscitation Council quidelines.

The LUCAS chest compression system can be used in a wide variety of situations and settings; on the scene, during patient movement, during transportation in road and air ambulances, in hospitals and catheterization laboratories.

The device consists of the following components:

• . A Back Plate which is positioned underneath the patient as a support for the external chest compressions.
• An Upper Part which contains the proprietary and rechargeable LUCAS Battery and the ● compression mechanism with the disposable Suction Cup.
• A Stabilization Strap which helps to secure the position of the device in relation to the ● patient.
• A Carrying Case. ●

In addition the following optional Accessories are offered as part of the system:

• LUCAS Battery, Dark Grey ●
• LUCAS Power Supply
• LUCAS Car Power Cable, 12-28VDC ●
• LUCAS PCI Back Plate ●
• LUCAS Battery Charger ●
• LUCAS Anti Slip, Slim Back Plate
• o LUCAS Trolley

The LUCAS 3 CHEST COMPRESSION SYSTEM captures data for post event review which may be transmitted locally using Bluetooth (transmission only available when device is powered OFF).

LUCAS 3 has substantially the same performance characteristics as the predicate device LUCAS 2.

The provided 510(k) summary for the LUCAS 3 Chest Compression System does not contain specific acceptance criteria tables nor detailed performance study results that would allow for a complete description as requested. It is a summary arguing substantial equivalence to a predicate device (LUCAS 2) based on general performance testing and compliance with various standards.

However, I can extract and infer some information based on the document's content:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not provide a table of acceptance criteria with corresponding performance metrics like sensitivity, specificity, or specific precision values. Instead, it asserts compliance with various safety and performance standards.

2. Sample Size Used for the Test Set and Data Provenance

The document states that "Appropriate performance testing has been conducted by both external and internal parties." However, it does not provide specific details on the sample size used for any test sets or the data provenance (e.g., country of origin, retrospective or prospective).

3. Number of Experts Used to Establish Ground Truth and Qualifications

This information is not provided in the document. The type of device (mechanical chest compression system) does not typically involve expert review for diagnostic ground truth in the same way an AI diagnostic algorithm would. The "ground truth" here is compliance with technical specifications and standards for chest compression parameters (depth, rate).

4. Adjudication Method

This information is not provided. Given the nature of the device testing (compliance with technical standards and functional performance), an adjudication method like 2+1 or 3+1 (common for expert review in diagnostic studies) would likely not be relevant.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done

No, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. This type of study is relevant for comparing the performance of human readers, often with and without AI assistance, especially in image-based diagnostics. The LUCAS 3 is a mechanical device for chest compressions, not a diagnostic AI.

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

This concept is not directly applicable to the LUCAS 3 Chest Compression System as it is a mechanical device, not an AI algorithm performing a diagnostic task. The device's performance stands alone in delivering compressions, but it is operated by a human, making it implicitly "human-in-the-loop" in its application. However, the performance assessment described focuses on the device's ability to meet its technical specifications independent of human variability in manual CPR, thus in a sense its mechanical output is "standalone." The document mentions that the LUCAS 3 itself delivers compressions without explicitly comparing it to human performance in a quantitative study.

7. The Type of Ground Truth Used

The "ground truth" used for this device's performance is primarily compliance with recognized standards for medical electrical equipment, battery safety, and ambulance compatibility. Additionally, the device's functional characteristics (e.g., ability to deliver chest compressions at a certain depth and rate) would have been validated against its product specifications and the performance of the predicate device (LUCAS 2).

8. The Sample Size for the Training Set

This information is not applicable as the LUCAS 3 Chest Compression System is a mechanical device, not an AI or machine learning algorithm that requires a "training set."

9. How the Ground Truth for the Training Set Was Established

This information is not applicable for the same reason as point 8.

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