(191 days)
Thermogard HO™ Temperature Management System Temperature reduction in adult patients where clinically indicated, e.g., in hyperthermic patients.
Thermogard XP® Temperature Management System Temperature reduction in adult patients where clinically indicated, e.g., in hyperthermic patients.
The subject of this 510(k) is the new surface feature which makes minor modifications to the existing IVTM Start-Up Kits (SUKs) to enable connection of a Thermogard console to the STx™ Vest provides for circulation of thermally conditioned fluid supplied by the Thermogard console (either Thermogard HQ™ or Thermogard XP®). Transfer of heat between the patient and the circulating fluid results in modification of patient core temperature for the purpose of therapeutic patient temperature modulation.
The existing, commercialized Thermogard Systems (Thermogard HQTM and Thermogard XP®) are used in conjunction with catheters placed in the vasculature to support intravascular cooling. The TGHQ-SURF accessory is a modification of the model TGHQ-500D accessory which was verified, validated, and commercialized. The CG-SURF accessory is a modification of the model CG-500D accessory which was verified, validated, and commercialized. These Surface SUK models are identical to their predecessors with the exception of longer inflow and outflow tubing lengths and replacing the Luers for catheters with 0.25inch hose barb valved connectors for the STx™ Vest. The Surface SUK also has a label on the fluid spike to indicate the size of bag of fluid (3000ml) to use and to mark it as non-sterile. The Surface SUKs are otherwise identical to their predecessors in terms of materials that contact the heat exchange fluid (i.e., saline), manufacturing process, and packaging materials.
There are no changes to the commercially available Thermogard XP® (K213031) and Thermogard HO™ (K220008) consoles.
There are no changes to the commercially available STxTM Vest.
The provided document is an FDA 510(k) summary for a medical device called the "Thermogard HQ™ Temperature Management System" and "Thermogard XP® Temperature Management System." These devices are thermal regulating systems used for temperature reduction in adult hyperthermic patients.
The document does not describe:
- Acceptance criteria for an AI/ML powered device. This device is a hardware system, not an AI/ML product.
- Performance metrics like sensitivity, specificity, or AUC, which are common for AI/ML diagnostic tools.
- Any information regarding training sets, test sets, ground truth establishment by experts, or MRMC studies.
Therefore, the requested information cannot be extracted from this document, as it pertains to a different type of medical device lacking AI/ML components and the typical studies associated with them.
To directly answer your request based on the lack of relevant information in the provided text:
1. A table of acceptance criteria and the reported device performance:
Not applicable. The document describes a physical temperature management system, not a device with acceptance criteria based on AI/ML performance metrics like sensitivity or specificity. Performance testing mentioned is related to dimensional verification, functional testing, temperature behavior, shipping and handling, and electrical/EMC standards, not diagnostic accuracy.
2. Sample size used for the test set and the data provenance:
Not applicable. There is no mention of a "test set" in the context of an AI/ML algorithm's performance evaluation. The document refers to "performance testing" of the hardware system, but provides no sample sizes or data provenance (country of origin, retrospective/prospective) for such tests.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
Not applicable. Ground truth establishment by experts is relevant for AI/ML diagnostic devices, not for this hardware temperature management system.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:
Not applicable. Adjudication methods are used in studies involving human interpretation or AI/ML model output validation, which is not described here.
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:
Not applicable. This device is not an AI-assisted diagnostic tool, so an MRMC study is irrelevant.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
Not applicable. There is no AI algorithm in this device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
Not applicable. Ground truth as typically understood in AI/ML validation is not relevant for this device. The "ground truth" for a temperature management system would be its ability to accurately and safely control patient temperature, which is assessed through engineering and functional testing, not diagnostic ground truth methods.
8. The sample size for the training set:
Not applicable. There is no AI/ML component that requires a training set.
9. How the ground truth for the training set was established:
Not applicable. As above, there is no AI/ML component or training set.
In summary, the provided FDA 510(k) summary is for a traditional medical device (hardware for temperature management) and does not contain the information requested regarding acceptance criteria and studies for an AI/ML powered device. The document explicitly states "Clinical performance data to demonstrate substantial equivalence was not required." meaning the evaluation was based on non-clinical (engineering and functional) tests.
§ 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).