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

The Geratherm SOS-Rescue Bag is made up of five major components: 1. Bag: The main functional element is 78.75 inches (200cm) by 31.5 inches (80 cm) comprised of two primary elements: (a) The bag is constructed like a sleeping bag with an actively warmed upper panel and insulated bottom panel. The upper warming cover uses electrically resistive woven carbon fiber elements to generate warmth. The warming elements are sandwiched between two layers of Dacron® polyester hollow fiber insulating fleece. Lastly, the polvester fleece/carbon fiber layers are encapsulated with a waterproof polyurethane / polyester cloth laminate outside layer. A permanently attached power is cable located near the upper corner of the active warming cover. The free end is plugged into the power control module via color-coded quick-connect power connectors. The top warming cover is permanently sewn along one entire side to the insulated "bottom" panel. This arrangement allows top panel to be folded over the patient and secured once the patient has been placed in a prone position on the bottom panel. The bottom panel has 9 (nine) handholds around its perimeter that lets rescue personnel carry or move a supine patient without the use of a stretcher. (b) A removable waterproof polyurethane / polyester cloth laminate protective liner is attached to the bag's inner surface. The protective cover is held in place to the bag's inner surfaces with Velcro® attachments. This attachment system permits easy removal for machine washing and disinfecting. 2. Control Module: The control module is a impact plastic housing that contains the electronic circuitry. The module regulates bag temperature through a feedback circuit employing two thermistor temperature sensing systems. Operator control is achieved through the use of four buttons located on the face of the module: an on button, off button, a 37° C (98.6°F) select button, and a 42° C (107.6°F) select button. The control module uses LED arrays to display both bag temperature and battery power status. Normal functions are monitored both through visual displays and audible signal. Power sources include the following: the auxiliary battery, an automotive type power supply outlet, or an aircraft power supply outlet. Either 12 volt DC automotive or 24-28 volt DC aircraft power sources may be used to power the unit. 3. Battery: The Geratherm SOS-Rescue Bag uses a sealed lead-acid gel rechargeable battery of 10-ampere hour capacity. 4. Cabling: The Geratherm SOS-Rescue Bag has a power cable permanently attached to the upper corner. The cable attaches directly to the Control Module, The cable supplying power to the power module has a color-coded quick connect on the module end and a connecter that fits the auxiliary battery or automotive/aircraft DC power outlets on the other. 5. AC Charger: The Geratherm SOS-Rescue Bag employs a 12 volt, DC, 2ampere hour output battery charger to charge the battery or maintain full battery status. The charger may be used with either 110 or 240 Volt, 50 or 60 Hertz, AC input electric current.

The Geratherm® SOS-Rescue Bag is a thermal regulating system designed to prevent and counteract accidental hypothermia. The acceptance criteria and supporting studies are detailed below:

1. Table of Acceptance Criteria and Reported Device Performance

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

The documentation refers to one formal clinical evaluation:

• Clinical Study: "Effectiveness of Resistive Heating Compared With Passive Warming in Treating Hypothermia Associated With Minor Trauma: A Randomized Trial" by Alexander Kober et al., published in Mayo Clinic Proc. 2001:76:369-375.
  • Sample Size: Not explicitly stated in the provided text, but it is a "Randomized Trial," implying a statistically significant number of participants.
  • Data Provenance: The study was conducted at the Mayo Clinic, indicating a U.S. prospective clinical trial setting. The text states "Patients who were transported with Geratherm (Thermamed) electric / carbon fiber active warming systems experienced significantly lower degrees of hypothermia than those who were transported using passive warming techniques." This indicates the study was likely comparing outcomes between an active warming group (using the Geratherm device) and a passive warming (control) group.

Additional "Verification of Operation Under Non-Laboratory Conditions" was reported by:

• 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

These appear to be field evaluations and practical use cases rather than formal clinical trials with specific sample sizes. The provenance is primarily European (France, Germany, Netherlands, Switzerland). These are likely retrospective reports of device use or observational studies.

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

For the formal clinical study:

• The cited paper authors are: Alexander Kober, MD; Thomas Scheck, BS; Béla Fülesdi, MD; Frank Lieba, BS; Wolfgang Vlach, BS; Alexander Friedman, MD; & Daniel I. Sessler, MD.
• The primary qualification listed is MD (Medical Doctor) for several authors, with others holding BS (Bachelor of Science). Daniel I. Sessler, MD, is a well-known expert in perioperative thermoregulation. Their collective expertise as medical professionals and researchers would have established the ground truth (e.g., patient hypothermia status, temperature measurements, observed outcomes) in the clinical trial.

For the "Verification of Operation Under Non-Laboratory Conditions":

• The "experts" would implicitly be the medical and rescue personnel from the listed organizations (SAMU 38, ADAC, Royal Dutch Army, REGA). Their qualifications would be those of trained medical and rescue professionals involved in acute patient care and transport in challenging environments. The number of such personnel or specific individuals is not stated.

4. Adjudication Method (for the test set)

• The provided text for the Kober et al. study describes it as a "Randomized Trial." While specific adjudication methods (e.g., 2+1, 3+1 consensus) are not detailed in this summary, in a randomized controlled trial, the primary "ground truth" for efficacy (e.g., body temperature, incidence of hypothermia) is typically established through direct, objective physiological measurements. The study's results indicating "significantly lower degrees of hypothermia" suggest statistically analyzed objective data rather than subjective expert consensus on "truth."

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

• No, an MRMC comparative effectiveness study was not done. The clinical study cited is a "Randomized Trial" comparing an active warming device against passive warming techniques directly on patients, focusing on physiological outcomes (hypothermia levels). MRMC studies are typically used for evaluating diagnostic imaging systems where multiple readers interpret cases and their performance is compared.

• Effect Size (if applicable): Since it was not an MRMC study, an effect size for human readers improving with AI vs. without AI assistance is not applicable here. However, the study did find that patients in the active warming group (using Geratherm) "experienced significantly lower degrees of hypothermia" compared to the passive warming group, indicating a clinical effectiveness for the device.

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

• Yes, in a sense. The non-clinical performance data details numerous standards (e.g., EMC, Medical Safety IEC 60601-1, IEC 60601-2-35, ISO 13485) and specific tests (e.g., Cytotoxicity) that the device underwent. These are standalone tests of the device's physical, electrical, and material properties and performance against established specifications, without human interaction in the performance measurement itself.
• The "Verification of Operation Under Non-Laboratory Conditions" also reports on the device's ability to "prevent or reduce hypothermia" in real-world scenarios, which implies the device's standalone functional performance was observed and confirmed by various rescue organizations.

7. The Type of Ground Truth Used

• Clinical Study (Kober et al.): The ground truth was primarily outcomes data and physiological measurements, specifically the degree of hypothermia experienced by patients. This would involve objective temperature readings and potentially other patient vital signs or clinical assessments.
• Non-Clinical Studies & Standards: The ground truth was based on adherence to international standards (e.g., IEC, EN, ISO, UL) for safety, electrical performance, biocompatibility, and electromagnetic compatibility, as well as the device's ability to meet its own specifications for temperature regulation and alarm functions.
• Field Verification: The "Verification of Operation Under Non-Laboratory Conditions" implies observational outcomes data from real-world usage, where the device was found to "prevent or reduce hypothermia" by the rescue organizations.

8. The Sample Size for the Training Set

• This information is not applicable. The Geratherm SOS-Rescue Bag is a medical device for therapeutic warming, not an AI/machine learning system. Therefore, there is no "training set" of data in the context of machine learning model development. The device's design and functionality are based on engineering principles and established medical knowledge, not data-driven training.

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

• This information is also not applicable, as there is no training set for this device.

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