(369 days)
Geratherm UniqueTemp® is a thermal regulating system for adult patients in order to prevent hypothermia in the operating theater. It is suitable for pre-, intra- and post-operative use. The device is not life-supporting. It is intended for use by appropriately trained healthcare professionals in clinical environments.
Geratherm UniqueTemp® has been developed for the prevention of hypothermia. The Geratherm warming blankets can be used for covering the patient in various ways without restricting the surgical area and provide active warming to the patient. All the blankets can be freely combined. The flexibility of the blankets makes it possible to warm the patient, even if complicated positioning on the operating table is required. After being placed over the patient, Geratherm UniqueTemp® can itself be covered with surgical drapes. Geratherm UniqueTemp® is suitable for use with adult patients of all sizes. The blankets should not be used for children. Geratherm UniqueTemp® is intended to be used during lengthy operations as well as by hypothermic patients. The device is not life-supporting. Geratherm UniqueTemp® should be operated only by qualified medical professionals. The Geratherm UniqueTemp9 consists of the following components: Control unit, Holding claw, Mains cable, Arm/shoulder blanket, Reusable cover for arm/shoulder blanket, Torso blanket, Reusable cover for torso blanket, Leg blankets, Reusable cover for leg blankets, Connecting cable, Body temperature sensor. The Controller is made of anodized aluminum (colorless or black); furthermore, the control unit has a glass screen. All blankets and covers have a PU coated material. The connecting cable is made of silicone.
The provided text describes the Geratherm UniqueTemp® Patient Warming System and its 510(k) summary. However, it does not contain specific acceptance criteria, a detailed study protocol for performance, or quantitative results that would allow for the direct completion of the requested table and study details.
The document primarily focuses on demonstrating substantial equivalence to a predicate device (Hot Dog Patient Warming System K052392) through comparisons of intended use, indications for use, safety characteristics, and compliance with various international standards.
Therefore, I cannot extract the specific acceptance criteria and detailed study information as requested.
However, I can summarize what is available in the document regarding performance and regulatory compliance:
Summary of Device Performance Information from the Document:
The document states:
- "The presented data which was conducted using the Geratherm UniqueTemp®, in comparison to the predicate device, shows that the product is safe and effective for its intended use." - This is a general claim rather than specific performance metrics.
- "Both devices are similar regarding the performance characteristics and reach a similar maximum temperature of 42°C and 43°C respectively." - This indicates a performance characteristic (maximum temperature) but does not provide acceptance criteria or a study comparing the devices' ability to maintain a target temperature or prevent hypothermia.
- "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 refers to testing against general standards, not specific clinical performance criteria.
- The device meets the requirements of Council Directive 93/42 EEC on Medical Devices and specific IEC standards (60601-1, 60601-1-2, and 80601-2-35). These standards cover general safety, electromagnetic compatibility, and particular requirements for heating devices, implying compliance with their respective criteria, but the document doesn't detail what these criteria are or the specific test results.
In the absence of the requested data, I will present the information that can be inferred or directly stated from the provided text, and explicitly note where the requested information is not available.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Inferred/General) | Reported Device Performance (Summary from Text) |
|---|---|
| Safety: Device is safe for intended use. | "The presented data... shows that the product is safe... for its intended use." |
| Effectiveness: Device is effective for intended use (prevention of hypothermia). | "The presented data... shows that the product is... effective for its intended use." |
| Biocompatibility: Product components are biocompatible. | "Successfully tested for biocompatibility according to international standards." |
| Electromagnetic Compatibility (EMC): Device meets EMC requirements. | "Successfully tested for electromagnetic compatibility... according to international standards." (Specifically cites IEC 60601-1-2) |
| Functionality: Device functions as intended. | "Successfully tested for... functionality... according to international standards." |
| General Safety (Electrical/Mechanical): Device meets general safety requirements for medical electrical equipment. | Complies with IEC 60601-1 (General requirements for safety). |
| Particular Safety for Heating Devices: Device meets specific safety requirements for heating blankets. | Complies with IEC 80601-2-35 (Particular requirements... of heating devices using blankets, pads and mattresses...). |
| Maximum Temperature Output: Comparable to predicate device. | Reaches a "similar maximum temperature of 42°C." (Predicate reaches 43°C). |
| Quality Management System: Ensures requirements are met. | EN ISO 13485 certified quality management system. |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Sample Size for Test Set: Not specified. The document refers to "presented data" and "successful testing" but does not provide details on the number of subjects (if clinical) or units (if bench testing) used in performance tests.
- Data Provenance: Not specified. The document does not mention the country of origin of the data or whether the tests were retrospective or prospective. Given the manufacturer is German and the correspondent is also in Germany, it's plausible testing was conducted in Europe, but this is not explicitly stated.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Not Applicable. This type of information (expert consensus for ground truth) is typically relevant for diagnostic devices or those involving interpretation of medical images/data. The Geratherm UniqueTemp® is a patient warming system, where "ground truth" would likely refer to objective physical measurements (e.g., temperature) or established safety standards, rather than expert interpretation.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set
- Not Applicable. Adjudication methods are typically used in studies where multiple human readers assess a case and their discrepancies need to be resolved to establish ground truth (e.g., in diagnostic imaging studies). This is not relevant for a patient warming device.
5. 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. This type of study is entirely irrelevant for a patient warming device. An MRMC study is designed for diagnostic systems that involve human interpretation, often assisted by AI. The Geratherm UniqueTemp® is a therapeutic device that performs a function directly.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Yes, implicitly. The "Non-Clinical Performance Data" section and the statement "The product components... have been successfully tested for biocompatibility, electromagnetic compatibility, functionality and safety according to international standards" indicate that testing of the device's technical performance and safety characteristics was done in a standalone manner, without explicit human interaction being part of the primary performance measurement (other than operation). The device's function (heating) is inherently "standalone" in its operation once set.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- Known Standards and Objective Measurements. For a device like a warming system, "ground truth" would be established by:
- Compliance with International Standards: The document explicitly states compliance with IEC 60601-1 (general safety), IEC 60601-1-2 (EMC), and IEC 80601-2-35 (specific heating device requirements). These standards define objective performance and safety criteria.
- Objective Physical Measurements: Testing would involve measuring temperature output, power consumption, safety cut-offs, material properties, etc., against predefined specifications derived from product design and regulatory requirements.
- Comparison to Predicate Device: The concept of "substantial equivalence" means the new device's performance is compared to a legally marketed predicate device, implying the predicate device's performance serves as a benchmark for effectiveness and safety.
8. The sample size for the training set
- Not Applicable/Not Provided. The concept of a "training set" typically applies to AI/machine learning algorithms. The Geratherm UniqueTemp® is not described as an AI-powered device. Therefore, there is no training set in that context. If "training set" refers to developmental or internal testing, that information is not provided.
9. How the ground truth for the training set was established
- Not Applicable. (See point 8).
§ 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).