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The Geratherm SOS-Vacutherm is a temperature-controlled electric whole body warming system intended for use in preventing or treating the effects of incidental hypothermia in adults while at the rescue scene or during transport by air or ground to a medical facility

The Geratherm SOS-Vacutherm System is a combination product made of two primary components:

1. An electrically warmed panel. - Class II

2. A integrated vacuum mattress / stretcher - Class I (exempt from 510(k) premarket notification).

The provided text describes the Geratherm® SOS-Vacutherm, a thermal regulating system designed to prevent or reduce hypothermia. The submission focuses on demonstrating substantial equivalence to a predicate device and adherence to various standards rather than presenting extensive device performance data against specific acceptance criteria.

Therefore, the response will reflect the information available in the provided document.

Acceptance Criteria and Device Performance

The submission primarily focuses on functional equivalence to a predicate device and adherence to safety standards, rather than defining specific numerical acceptance criteria for clinical performance.

Study Information

1. Sample Size used for the test set and the data provenance:

   • Clinical Study: The clinical performance data references a study: Alexander Kober, MD; Thomas Scheck, BS; Béla Fülesdi, MD; Frank Lieba, BS; Wolfgang Vlach, BS; Alexander Friedman, MD; & Daniel I. Sessler, MD. "Effectiveness of Resistive Heating Compared With Passive Warming in Treating Hypothermia Associated With Minor Trauma: A Randomized Trial," Mayo Clinic Proc. 2001;76:369-375.
     • Sample Size: The document does not explicitly state the sample size (number of patients) used in this randomized trial. The provided document only references the publication.
     • Data Provenance: The study was conducted at the Mayo Clinic, implying US-based data. It is described as a "Randomized Trial," indicating it was a prospective study.
   • Non-Clinical Performance Data: The document mentions studies conducted by CE-LAB GmbH, iMG gGmbH, TREO Electrooptik GmbH, and TÜV GmbH, focusing on adherence to various technical standards. No sample sizes are applicable for these standard compliance tests.
   • Verification of Operation Under Non-Laboratory Conditions: The device was tested by several European rescue organizations (SAMU 38 - Helicopter Mountain Rescue Grenoble, France; ADAC Helicopter Rescueservice Munich, Germany; Royal Dutch Army, Helicopter Catastrophe Rescueteam Netherlands; REGA - Mountain rescue service REGA - Centre Zürich Airport Zürich, Switzerland). The document does not specify a "sample size" for these real-world verifications, nor does it detail the specific data collected, but rather states the device was "found to prevent or reduce hypothermia."

2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

   • For the clinical study ("Effectiveness of Resistive Heating Compared With Passive Warming in Treating Hypothermia Associated With Minor Trauma: A Randomized Trial"), the authors listed include MDs (Alexander Kober, Béla Fülesdi, Alexander Friedman, Daniel I. Sessler) and BS (Thomas Scheck, Frank Lieba, Wolfgang Vlach). Daniel I. Sessler, MD, is a well-known expert in perioperative temperature management. The "ground truth" in this context would be the measured patient core body temperature and the diagnosis of hypothermia, which would be established by medical professionals involved in the care and monitoring of the patients receiving the treatment, as per the randomized trial protocol. The document does not specify the exact number of experts involved in establishing this clinical ground truth beyond the listed authors, nor does it give specific years of experience for each, but refers to them as medical professionals at the Mayo Clinic.

3. Adjudication method for the test set:

   • The document does not explicitly detail an adjudication method (such as 2+1 or 3+1) for the clinical study's outcomes. In a randomized controlled trial measuring physiological parameters like body temperature, the "adjudication" is typically inherent in the standardized measurement protocols and statistical analysis of the collected data. The outcome (degree of hypothermia) would be objectively measured, not subjectively adjudicated by experts beyond the initial data collection.

4. 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 MRMC or AI-assisted comparative effectiveness study was conducted or mentioned. The device is a physical warming blanket system, not an AI-enabled diagnostic or assistance tool that would involve human readers/interpreters.

5. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:

   • Not applicable. The device is a hardware system, not an algorithm.

6. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):

   • For the clinical study, the ground truth was clinical outcomes data, specifically patient core body temperature measurements and the clinical determination of hypothermia based on those measurements.
   • For regulatory compliance and non-clinical testing, the "ground truth" was adherence to established international and national standards (e.g., IEC, EN, NATO, ISO, UL).

7. The sample size for the training set:

   • Not applicable as this is a hardware device where the clinical study focused on performance rather than training a machine learning model.

8. How the ground truth for the training set was established:

   • Not applicable for the reasons stated above.

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