Search Results

The device is an external device that is manually powered and is used to compress the chest periodically in the region of the heart to provide blood flow during cardiac arrest for adult patients.

The ENERTRON CPR JACK is a portable cardiopulmonary resuscitation device with a patented feature of consistent and precision compression depth. It includes a frame structure and a compression mechanism. The compression mechanism has a handle connected with a connecting bar to drive a plunger. The compression mechanism keeps the plunging movements in a perpendicular direction. A depth controlling scale is included on the frame structure for presetting the compression depth of the plunger.

Here's an analysis of the provided text regarding the ENERTRON CPR JACK, structured according to your requested information:

Acceptance Criteria and Device Performance Study for ENERTRON CPR JACK

1. Table of Acceptance Criteria and Reported Device Performance

The core performance claims of the ENERTRON CPR JACK revolve around its ability to maintain consistent compression depth.

Note: The document focuses primarily on the device's ability to maintain a consistent, adjustable compression depth within the recommended AHA guidelines. The 'acceptance criteria' are inferred from these stated performance goals and the comparison to predicate devices, particularly concerning the AHA recommendations for CPR effectiveness.

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

• Sample Size for Test Set:
  • "4000-stroke test": The number of individual compression strokes performed in one test.
  • "250,000-stroke test": The number of individual compression strokes performed in another test.
  • It's important to note this is the sample size of strokes or cycles, not necessarily patients or human subjects. The tests appear to be mechanical performance tests rather than clinical trials with patient data.
• Data Provenance: The document does not specify the country of origin for these performance tests. It refers to American Heart Association (AHA) guidelines, suggesting adherence to US standards, but the testing itself is stated as being conducted by Enertron. The tests are prospective in the sense that they were designed and executed to evaluate the device's performance.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications

• Number of Experts: Not applicable. The "ground truth" for these tests was derived from mechanical measurements of compression depth during simulated use (strokes), benchmarked against established guidelines from the American Heart Association (AHA).
• Qualifications of Experts: Not applicable. The ground truth is a technical specification (target compression depth) and a performance standard (consistency).

4. Adjudication Method for the Test Set

• Adjudication Method: Not applicable. As the tests were mechanical performance tests evaluating physical parameters (compression depth, durability over strokes) against a pre-defined standard (AHA guidelines), there was no requirement for expert adjudication of results in the traditional sense of clinical or diagnostic studies. The evaluation was based on direct measurement and comparison to a quantitative range.

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

• MRMC Study: No. The provided information does not describe any MRMC comparative effectiveness study involving human readers or AI assistance. The device is an external cardiac compressor, not an AI-driven diagnostic or assistive tool for human interpretation.

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

• Standalone Performance: Not applicable in the context of AI. The ENERTRON CPR JACK is a mechanical device, manually powered. Its "standalone performance" is its ability to consistently deliver chest compressions within specified parameters, which was evaluated through the 4,000 and 250,000 stroke tests. There is no algorithm or AI component mentioned.

7. The Type of Ground Truth Used

• Type of Ground Truth: The ground truth used was objective performance metrics (consistent compression depth within 1.5" to 2.0" and durability over a large number of strokes) derived from accepted medical guidelines (American Heart Association 1996 CPR laboratory study recommendations which stated "Consistence of chest compression or blood flow is desirable to ensure returning of live" and also a 2.00 inches maximum compression depth).

8. The Sample Size for the Training Set

• Sample Size for Training Set: Not applicable. The ENERTRON CPR JACK is a mechanical medical device, not an AI or machine learning system. Therefore, there is no "training set" in the computational sense. The device's design and engineering would have been informed by general engineering principles and medical guidelines, but no data-driven training set was used.

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

• How Ground Truth for Training Set was Established: Not applicable, as there is no training set for this mechanical device. The design principles and functional requirements (which might be considered analogous to "ground truth" in a broader sense) were established based on medical guidelines from organizations like the American Heart Association concerning effective CPR techniques (e.g., recommended compression depth).

Ask a specific question about this device