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The DM-EMG portable heating blanket is intended to efficiently keep hypothermia under control and to counteract accidental hypothermia of accident victims and patients during emergency rescue / transport (helicopter, ambulance, automobile, sea and other rescue means). Additionally it can also be used during the routine transport and warming of patients to counteract hypothermia, encountered during a surgical procedure or medical crisis.

The DM --EMG portable warming device is made up of 5 major components: 1. Heating mattress SCL-EMG, 2. Cable DC-DC for the connection to the 12Vdc, 3. Rechargeable battery pack NL2024HD22, 4. Dedicated electronic converter VAR100A-EMG, 5. DM-ZN1 Carrying Case.

Acceptance Criteria and Device Performance for DM-EMG Hypothermic Therapy System

This document outlines the acceptance criteria and the results of a study conducted to demonstrate the performance of the DM-EMG Hypothermic Therapy System.

1. Table of Acceptance Criteria and Reported Device Performance

The provided document does not explicitly state formal "acceptance criteria" with quantitative thresholds for all attributes in the same way one might find for a diagnostic algorithm. Instead, it presents performance characteristics and safety standards that the device was tested against and met. The "reported device performance" is derived from the "Non Clinical Performance Studies" section and the "Independent Study" section.

2. Sample Size and Data Provenance

• Test Set (for the Independent Study):

  • Sample Size: 25 patients (12 in the active warming group, 13 in the passive warming group).
  • Data Provenance: Prospective, from the Regional Helicopter Rescue Service in Bergamo, Orio al Serio, Italy. The study involved a "field comparison" during actual helicopter rescue operations.

• Training Set: Not applicable as this is a medical device (warming blanket) and not an AI/algorithm-driven system that requires a "training set" in the conventional sense. The device's performance is tested through physical operational attributes and clinical efficacy, not through learning from data.

3. Number of Experts and Qualifications for Ground Truth

• For Operational Verification Studies (USA1-4): These were "lab test" studies performed by GVP Elettronica srl. While implicitly requiring expert knowledge in engineering and device testing, the document does not specify the "number of experts" or their specific qualifications (e.g., "electrical engineer with X years of experience") for establishing the ground truth of these physical tests. The tests themselves provide objective measurements against defined parameters.

• For Independent Study (Clinical Efficacy): The study was conducted by the "Regional Helicopter Rescue Service, Bergamo in Orio al Serio Italy." The "ground truth" (patient core temperature, shivering presence, subjective well-being, complications) was established by the medical personnel involved in the rescue operations. The document does not specify the exact number of experts or their specific qualifications (e.g., "paramedic with X years of experience," "emergency physician"). However, it implies medically qualified personnel given the context of a "Helicopter Rescue Service."

4. Adjudication Method

• For Operational Verification Studies (USA1-4): No explicit adjudication method is mentioned. These are lab tests generating objective data (temperatures, timings). The results are presented as direct measurements.

• For Independent Study (Clinical Efficacy): No explicit adjudication method is described. Data (core temperature, subjective feeling, shiver presence, complications) was presumably gathered by the medical team involved in the rescue operation.

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

• No, an MRMC comparative effectiveness study was not done. This type of study is typically performed for diagnostic devices or AI systems where human readers interpret medical images or data, and the AI's effect on their performance is measured (e.g., improved accuracy, reduced reading time). The DM-EMG is a therapeutic warming device, and its efficacy is measured directly on patients, not through human interpretation of data.

6. Standalone Performance Study (Algorithm Only Without Human-in-the-Loop)

• Yes, in essence, the "Non Clinical Performance Studies" (USA1-4) represent standalone performance. These studies test the device's inherent functional capabilities (warming infusion bags, blanket temperature stabilization, thermal cut-off efficacy) independent of human-in-the-loop operation, although a human operator would initiate and monitor the device in a real-world setting. The "Independent Study" involves the device's performance in situ with patients. Given the nature of a warming blanket, an "algorithm only" standalone performance is not directly applicable as it's a physical device, not a diagnostic algorithm.

7. Type of Ground Truth Used

• For Operational Verification Studies (USA1-4): The ground truth was objective physical measurements (e.g., temperature readings, time) in a controlled lab environment, verifying the device's intended physical and electrical functions against internal specifications and safety standards.
• For Independent Study (Clinical Efficacy): The ground truth was a combination of:
  • Clinical Measurements: Patient mean core temperature (objective).
  • Clinical Observation: Presence/absence of shivering (objective observation, though can have subjective component).
  • Patient Reported Outcomes: Subjective feeling of well-being (subjective, patient-reported).
  • Absence of Adverse Events: No complications (objective clinical outcome).

8. Sample Size for the Training Set

• Not applicable. As stated in section 2, the DM-EMG is a physical medical device (warming blanket) and not an AI/algorithm-driven system that requires a "training set."

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

• Not applicable. See section 8.

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