(135 days)
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.
| Acceptance Criteria (Inferred from standards) | Reported Device Performance |
|---|---|
| Safety & Essential Performance: | Functioned as intended. Demonstrated equivalent performance to LUCAS 2. |
| - Compliance with ANSI/AAMI ES 60601-1:2005(R)2012 (Medical Electrical Equipment) | Complies |
| - Electromagnetic compatibility (IEC 60601-1-2:2007/AC2010) | Complies |
| - Usability (IEC 60601-1-6:2010 + A1:2015) | Complies |
| - Alarm systems (IEC 60601-1-8:2007 + A1:2013) | Complies |
| - Emergency medical services environment (IEC 60601-1-12) | Complies |
| Battery Safety: | |
| - Compliance with IEC 62133:2012 (Secondary cells and batteries) | Complies |
| Environmental/Operational: | |
| - Road Ambulance compatibility (EN 1789:2014) | Complies |
| - Air Ambulance compatibility (EN 13718-1:2014) | Complies |
| Functional Equivalence: | Functioned as intended. Demonstrated equivalent performance to LUCAS 2. |
| - Delivery of effective, consistent, and continuous chest compressions | Demonstrated equivalent performance to LUCAS 2. |
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.
§ 870.5200 External cardiac compressor.
(a)
Identification. An external cardiac compressor is an externally applied prescription device that is electrically, pneumatically, or manually powered and is used to compress the chest periodically in the region of the heart to provide blood flow during cardiac arrest. External cardiac compressor devices are used as an adjunct to manual cardiopulmonary resuscitation (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).(b)
Classification. Class II (special controls). The special controls for this device are:(1) Nonclinical performance testing under simulated physiological conditions must demonstrate the reliability of the delivery of specific compression depth and rate over the intended duration of use.
(2) Labeling must include the following:
(i) The clinical training necessary for the safe use of this device;
(ii) Adjunctive use only indication prominently displayed on labels physically placed on the device and in any device manuals or other labeling;
(iii) Information on the patient population for which the device has been demonstrated to be effective (including patient size and/or age limitations,
e.g., adult, pediatric and/or infant); and(iv) Information on the time necessary to deploy the device as demonstrated in the performance testing.
(3) For devices that incorporate electrical components, appropriate analysis and testing must demonstrate that the device is electrically safe and electromagnetically compatible in its intended use environment.
(4) Human factors testing and analysis must validate that the device design and labeling are sufficient for effective use by the intended user, including an evaluation for the time necessary to deploy the device.
(5) For devices containing software, software verification, validation, and hazard analysis must be performed.
(6) Components of the device that come into human contact must be demonstrated to be biocompatible.