(294 days)
Geratherm UniqueResc is a thermal regulating system for adult patients in order to prevent hypothermia in preclinical settings or treatments on-site. It is intended for use while at the rescue scene, during patient transport by air or ground to a medical facility or e.g. during disaster operation in first aid tents. The device should be used by appropriately trained healthcare professionals.
Geratherm UniqueResc* has been developed for the prevention and treatment of hypothermia. The warming blankets are light-weight, comfortable and easily transportable. The use of several blankets per patient is possible. The flexibility of the blankets makes it possible to warm the patient even during complicated rescue operating conditions. Geratherm UniqueResc is suitable for use with adult patients of all sizes. The blankets should not be used for children. Geratherm UniqueResc should be operated only by qualified medical professionals. The benefits of Geratherm UniqueResc+ are: Active warming applied to the patient from superior side. State-of-the-art conductive material provides exceptionally uniform heating. Microprocessor-controlled Functions noiselessly Simple and easy to use Highly durable and easy to clean The optional Geratherm ACDC Power Supply Adapter (see section 12.3 of the instruction manual for detailed description) functions with all alternating current mains power sources (100240VAC, 50~60 Hz). Other optional power sources include 15VDC 2590 Li-Ion Battery and 12VDC-28VDC Onboard Power.
The provided text is a 510(k) Summary for the Geratherm UniqueResc device, a thermal regulating system. It describes the device, its intended use, and compares it to a predicate device. However, it does not detail specific acceptance criteria for device performance or a study proving it meets those criteria.
The document states:
"The presented data that was conducted on the Geratherm UniqueResc shows in its results, and in comparison to the predicate device, that the product is safe and effective for its intended use. The product components which are covered by this 510(k) premarket notification have been successfully tested for biocompatibility, electromagnetic compatibility, functionality and safety according to international standards."
This is a general statement about testing but lacks the specific details requested in your prompt. Therefore, I cannot provide the requested information from the given text.
Specifically, the document does not include:
- A table of acceptance criteria and the reported device performance: No such table or specific performance metrics are mentioned.
- Sample size used for the test set and the data provenance: No information on sample sizes or data origin is provided for performance validation.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable as no specific clinical performance study with ground truth establishment is described.
- Adjudication method for the test set: Not applicable.
- If a multi-reader multi-case (MRMC) comparative effectiveness study was done, and the effect size: Not applicable; this is a thermal regulating system, not an AI diagnostic tool requiring MRMC studies.
- If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: Not applicable; this is a physical medical device.
- The type of ground truth used: Not applicable. The "ground truth" for a thermal system would be its ability to maintain or change temperature, but specific performance criteria are not detailed.
- The sample size for the training set: Not applicable.
- How the ground truth for the training set was established: Not applicable.
§ 870.5900 Thermal regulating system.
(a)
Identification. A thermal regulating system is an external system consisting of a device that is placed in contact with the patient and a temperature controller for the device. The system is used to regulate patient temperature.(b)
Classification. Class II (performance standards).