(119 days)
LUCAS 2 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 2 must only be used in cases where chest compressions are likely to help the patient.
LUCAS 2 is an electrically powered mechanical chest compression system providing controlled automated chest compressions on adult patients who have acute circulatory arrest. LUCAS 2 consists of an upper part containing the electrically driven piston rod, which acts on the patients 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.
The provided text describes the Jolife LUCAS 2, an electrically powered mechanical chest compression system. However, the document only discusses the device's design, intended use, and substantial equivalence to predicate devices, along with regulatory approval. It does not include detailed information about specific acceptance criteria or a study proving the device meets those criteria in the way typically expected for a medical device performance study, especially for AI/algorithm-based devices.
The "Testing" section broadly 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, efficacy and capability of LUCAS 2 comply with the product specifications and safety standards and support substantial equivalence to predicate devices." This is a general statement and does not provide the specifics requested in your prompt.
Therefore, I cannot fully answer your request based on the provided text. The document is a 510(k) summary, which focuses on demonstrating substantial equivalence to previously cleared devices rather than providing a detailed de novo clinical or performance study report with specific acceptance criteria and detailed study methodology.
Below is a breakdown of what can be inferred or what is explicitly missing based on your questions:
1. Table of Acceptance Criteria and Reported Device Performance:
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Not Specified | The document states: "In all instances, the LUCAS 2 functioned as intended and all results observed were as expected." This is a general statement and does not provide specific performance metrics or acceptance criteria. |
| Functionality, Safety, Efficacy, and Capability | "Comply with the product specifications and safety standards and support substantial equivalence to predicate devices." (No specific metrics provided). |
2. Sample size used for the test set and the data provenance:
- Not specified. The document mentions "a number of function tests during different operating conditions" but does not give sample sizes for any test sets or specific data provenance (e.g., country of origin, retrospective/prospective).
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable/Not specified. This type of information is relevant for studies involving human interpretation or expert-driven assessments, typically for diagnostic or imaging devices. The LUCAS 2 is a mechanical chest compression system, and its performance evaluation would likely involve engineering and physiological metrics, not expert ground truth in the diagnostic sense. The document does not mention any expert panel for ground truth.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not applicable/Not specified. Similar to point 3, adjudication methods are typically used for expert assessments, which are not detailed or implied for this device's testing.
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:
- No. An MRMC study is not relevant for a mechanical chest compression device. This type of study assesses reader performance, typically in imaging. The LUCAS 2 is a standalone mechanical device, not an AI or imaging assistance tool for human readers.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Yes, effectively. The "Testing" section implies standalone testing of the device's mechanical functions: "Appropriate product testing was conducted and included a number of function tests during different operating conditions." The device itself is a standalone mechanical system. The performance evaluated would be the device's ability to deliver compressions according to guidelines, maintain consistent operation, and ensure safety, independent of human interaction during the compression delivery. The function tests described are inherently standalone performance evaluations for a mechanical device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- Not explicitly stated, but implied to be engineering/physiological specifications. For a mechanical chest compression device, "ground truth" would likely refer to its ability to meet predefined physical compression parameters (depth, rate, recoil) as per AHA guidelines, safety standards, and product specifications. This would be measured instrumentally rather than through expert consensus, pathology, or outcomes data in the traditional sense used for diagnostic devices.
8. The sample size for the training set:
- Not applicable/Not specified. This device is a mechanical system, not an AI/machine learning algorithm that requires a "training set."
9. How the ground truth for the training set was established:
- Not applicable/Not specified. As there is no AI/ML component or "training set" mentioned, this question is not relevant.
Summary of what is known from the document regarding testing:
- Device: LUCAS 2, an electrically powered mechanical chest compression system.
- Purpose of testing: To demonstrate functionality, safety, efficacy, and capability, and to support substantial equivalence to predicate devices (LUCAS 1, Thumper 1008, Autopulse Model 100).
- Nature of testing: "A number of function tests during different operating conditions."
- Outcome: "In all instances, the LUCAS 2 functioned as intended and all results observed were as expected."
- Type of equivalence: Substantial equivalence to predicate devices is claimed, meaning the new device has "the same intended use and substantially similar indications for use, basic overall function, and performance." It is compared to predicate devices like LUCAS 1 (cleared under K062401).
The provided text focuses on regulatory clearance via the 510(k) pathway, which often relies on demonstrating equivalence rather than extensive de novo clinical trials with detailed performance metrics and acceptance criteria for a novel technology.
§ 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.