(69 days)
The WElkins EMT Temperature Management System is a thermal regulating system, indicated for temperature reduction in patients where clinically indicated.
The WElkins ICU Temperature Management System is a thermal regulating system, indicated for temperature reduction in patients where clinically indicated and monitoring of patient temperature.
The WElkins EMT/ICU Temperature Management System is a thermoregulatory device that reduces and/or maintains patient body temperature within a range of 30℃ (86°F) to 37°C (98.6°F). The System delivers temperature-controlled coolant ranging between 5°C (41°F) and 25°C (77°F) from one of two Conditioning Units (EMT or ICU) to a patientcontacting Cooling Pad, resulting in heat exchange between the coolant and the patient.
The EMT Conditioning Unit is a lightweight, battery-powered pack for use in the field; patient temperature is controlled manually, by modulating the temperature of coolant circulated to the Cooling Pad, and must be monitored regularly during treatment. The ICU Conditioning Unit is an enhanced, microprocessor-driven version of the EMT Conditioning Unit designed for use in the hospital setting: it features a touchscreen graphical user interface and automatic patient temperature control, in addition to the same core hydraulic and pneumatic cooling system used in the EMT Conditioning Unit. A patient temperature probe connected to the ICU Conditioning Unit provides biofeedback to an internal control algorithm, which automatically modulates coolant temperature to achieve a patient target temperature determined by the clinician.
The Cooling Pad comes in Universal and Head-Neck configurations. The safety and effectiveness of the Cooling Pad has not been demonstrated for treatment of stroke or head trauma, and is not indicated for use in their treatment.
The provided text describes a 510(k) submission for the WElkins EMT/ICU Temperature Management System. This is a medical device for thermal regulation, not an AI/ML powered device, therefore most of the requested information (such as sample sizes for test/training sets, experts, adjudication methods, MRMC studies, standalone performance, and ground truth establishment) is not applicable or not available in the provided document.
However, based on the available information, here's a breakdown of the testing and performance data provided:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly state quantitative acceptance criteria or detailed reported device performance in a table format. Instead, it lists the types of testing performed to demonstrate substantial equivalence. The overall "acceptance criterion" in this context is demonstrating substantial equivalence to predicate devices for the FDA's 510(k) clearance.
| Acceptance Criteria (Implied) | Reported Device Performance (Summary) |
|---|---|
| Biocompatibility | Testing performed to affirm safety |
| Electromagnetic Compatibility | Testing performed to affirm safety and functionality |
| Electrical Safety | Testing performed to affirm safety |
| Functional Performance | Testing performed to demonstrate intended operation and effectiveness for thermal regulation within specified temperature ranges (30℃ to 37°C patient temp; 5°C to 25°C coolant temp). Specific performance metrics are not detailed, but the device is stated to reduce and/or maintain patient body temperature. |
| Substantial Equivalence | Determined to be substantially equivalent to existing legally marketed devices based on intended use, design, materials, principle of operation, and overall technological characteristics. |
2. Sample size used for the test set and the data provenance
Not applicable. The document describes a medical device, not an AI/ML algorithm that would use a test set in this manner. The "testing" refers to standard medical device verification and validation activities (biocompatibility, electrical safety, functional performance) rather than a dataset for evaluating an algorithm.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable. No "ground truth" in the AI/ML sense is mentioned or relevant for this device's submission.
4. Adjudication method for the test set
Not applicable.
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 a thermal regulating system, not an imaging analysis or diagnostic AI tool that would involve human readers.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. The device is a physical system, not an algorithm. The ICU Conditioning Unit features a "microprocessor-driven version... with an internal control algorithm," which automatically modulates coolant temperature based on a patient temperature probe. This algorithm operates in a "standalone" capacity within the device to regulate temperature, but it's not a standalone AI diagnostic tool evaluated in the context of the requested question.
7. The type of ground truth used
Not applicable in the context of AI/ML performance evaluation. For functional performance, the "ground truth" would be the actual patient temperature and coolant temperature measurements, and the device's ability to maintain or adjust these within specified ranges.
8. The sample size for the training set
Not applicable. The device is not an AI/ML model that requires a training set.
9. 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).