(183 days)
The RapidCool™ Patient Temperature Management System is a thermal regulating system indicated for temperature reduction in patients where clinically indicated, e.g. in hyperthermic patients, and monitoring of patient temperature.
The RapidCool™ Patient Temperature Management System reduces, and/or maintains patient body temperature at a desired level by removing heat from a patient's body. The major components of the RapidCool system consist of a Control Console, body surface cooling appliances, tubing sets, and an esophageal temperature sensor. The body surface cooling appliances consist of a back cooling pad, a right axilla-cooling pad, a neck cooling pad, and a head-cooling cap. The control console supplies cold water to the surface cooling appliances, and controls the operation of the system. Tubing sets connect the control console to the surface cooling appliances. The esophageal temperature sensor is connected to the control console and is used to display and patient body temperature.
Body temperature can be reduced and/or maintained in a temperature range between 32 to 37 degrees centigrade by a thermostatic control feature of the control console. The operator can select the desired body temperature within this range.
The provided text describes the RapidCool™ Patient Temperature Management System, which is a thermal regulating system. It outlines the device's description, indications for use, and a statement about performance data, but does not contain the detailed study information required to answer all parts of your request.
The document states: "Performance data was submitted which demonstrated that the system performs as intended." However, it does not elaborate on the specific acceptance criteria, the study design, sample sizes, expert qualifications, or ground truth methods.
Here's a breakdown of what can be extracted and what is missing based on the provided text:
1. A table of acceptance criteria and the reported device performance
- Acceptance Criteria: Not explicitly stated in the document. The general indication is "temperature reduction in patients where clinically indicated" and "monitoring of patient temperature." Specific numerical or performance targets (e.g., cooling rate, accuracy of temperature maintenance, or deviation from a set point) are not provided.
- Reported Device Performance: The document only states: "Performance data was submitted which demonstrated that the system performs as intended." No specific quantitative results or performance metrics are reported in this summary.
2. Sample size used for the test set and the data provenance
- Sample Size (Test Set): Not mentioned in the provided text.
- Data Provenance: Not mentioned in the provided text (e.g., country of origin, retrospective or prospective).
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- This information is not provided. The document doesn't detail any study involving human experts establishing ground truth.
4. Adjudication method for the test set
- This information is not provided as no specific study involving adjudication is described.
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/Not mentioned. This device is a temperature management system, not an AI-assisted diagnostic tool that would typically involve human readers.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable. This is a medical device, not an algorithm in the context of typical AI medical device studies. The performance assessment would focus on the device's physical function. While the system has "thermostatic control features," the performance reported is not about an "algorithm only" in the sense of AI.
7. The type of ground truth used
- Not explicitly stated. For a thermal regulating system, "ground truth" would likely refer to the actual patient temperature achieved or maintained, perhaps measured by a highly accurate reference thermometer, compared against the device's readings and control capabilities. However, the document does not specify.
8. The sample size for the training set
- Not applicable/Not mentioned. This device does not appear to be an AI/machine learning device that requires a "training set" in the traditional sense. Its function is based on physical principles of heat exchange and thermostatic control.
9. How the ground truth for the training set was established
- Not applicable/Not mentioned for the same reasons as #8.
In summary, the provided 510(k) summary is a high-level document that confirms performance data was submitted, but it lacks the detailed description of the performance study and acceptance criteria that you are requesting.
§ 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).