(81 days)
The Arctic Sun™ Temperature Management System is a thermal regulating system, indicated for monitoring and controlling patient temperature.
The Arctic Sun Temperature Management System is a device used to monitor and control patient temperature. It consists of single-use heat transfer pads, which are adhered to areas of the patient's skin, and a control module that circulates temperature-controlled water. The control module is connected to the pads by flexible tubing. A commercially available temperature probe connected to the control module senses the patient's core temperature. The system can control the patient's core temperature by altering the temperature of the circulating water.
The provided text is a 510(k) summary for the Arctic Sun™ Temperature Management System, Model 2000. It details the device's purpose, comparison to predicate devices, and conclusions about safety and effectiveness. However, it does not include specific information about acceptance criteria or a detailed study proving the device meets those criteria in the way typically expected for an AI/ML medical device.
Here's an analysis based on the limited information provided and what is missing:
The document describes a thermal regulating system, not an AI/ML device. Therefore, the questions related to AI/ML specific studies (e.g., sample size for test set, data provenance, number of experts for ground truth, MRMC studies, standalone performance, training set details) are not applicable to this submission.
The "study" mentioned is primarily focused on electrical safety and functional performance testing in accordance with existing standards, rather than a clinical study evaluating diagnostic or prognostic accuracy with a defined ground truth.
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Electrical safety in accordance with IEC601/EN60601 series. | Tested and demonstrated compliance. |
| Functional safety and performance as a thermal regulating system. | Performs as intended; raises no new safety or effectiveness issues. |
| Substantial equivalence to predicate devices. | Determined to be substantially equivalent to K010338, K912051, K811742. |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Not applicable / Not explicitly stated. The testing described is for electrical safety and functional performance of the device unit, not clinical data involving patient test sets.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
- Not applicable. This device is a thermal regulating system, not an AI/ML diagnostic or prognostic tool that requires expert-established ground truth for a test set.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not applicable. See #3.
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 is not an AI/ML device, so an MRMC study is not relevant.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable. This is a physical medical device, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- Not applicable. For this type of device, ground truth relates to the accuracy of temperature regulation and safety, established through engineering and performance testing against defined specifications, rather than clinical outcomes or diagnostic accuracy.
8. The sample size for the training set
- Not applicable. This is not an AI/ML device.
9. How the ground truth for the training set was established
- Not applicable. This is not an AI/ML device.
Summary of what the document does indicate about the "study":
The "study" referred to in the document is primarily engineering and performance testing of the device's control unit.
- Testing Scope: Electrical safety testing (IEC601/EN60601 series) and functional safety and performance testing.
- Conclusion: Based on this testing and comparison to predicate devices, the Arctic Sun™ Temperature Management System, Model 2000, performs as intended and raises no new safety or effectiveness issues, supporting its substantial equivalence claim.
§ 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).