(246 days)
The Hot Dog Patient Warming System is intended to prevent or treat hypothermia and to provide warmth to patients. The Hot Dog Patient Warming System should be used in circumstances in which patients could become cold.
The system in intended primarily for use in hospitals and surgical centers including without limitation operating, recovery and emergency rooms, burn units and on medical/surgical floors.
The Hot Dog Patient Warming System is designed to compensate for body heat loss before, during and after surgery and in other situations in which a patient could become cold.
The device consists of four primary components, the outer Warming Blanket (disposable), the Warming Pad, Connecting, Cable and the Temperature Controller.
The outer Warming Blanket is placed atop the patient, and the Warming Pad is placed over the outer Warming Blanket.
The microprocessor based Temperature Controller uses 110-240 VAC line voltage and is connected to the Warming Pad via a cable. The Controller output to the Warming Pad is 48 VDC or less.
The provided text is related to a Premarket (510k) Summary for a medical device called the "Hot Dog Patient Warming System." This type of document is for regulatory clearance and focuses on demonstrating substantial equivalence to a predicate device, rather than detailed performance studies like those typically conducted for AI or imaging devices.
Therefore, many of the requested categories (e.g., sample size for test/training sets, expert qualifications, adjudication methods, MRMC studies, standalone performance for algorithms) do not apply to this document and the type of device described. The study described here is a functional and safety testing of a physical patient warming system, not an analysis of data by an algorithm.
However, I will extract the relevant information where possible, based on the provided text.
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| No unacceptable risk of thermal injury from simulated skin temperatures under functional and normal operating conditions. | Functional temperature testing shows that the warming system does not result in simulated skin temperatures that would cause thermal injury. |
| All safety systems operate as intended. | Safety system validation testing shows that all systems operate as intended. The primary and secondary over-temperature protection systems shut down power to the warming pad before pad surface temperatures reached unsafe temperatures. |
| Similar performance to the predicate device (Bair Hugger™ Temperature management system) in terms of contact surface temperature, uniformity, and response to normal and single fault conditions. | Side-by-side testing of the electrically powered warming pads and the Bair Hugger™ Temperature management system showed similar performance for both devices. The average contact surface temperature for both devices falls into the 39 - 42 °C range in steady state testing. The "Hot Dog Patient Warm System™ exhibits satisfactory temperature uniformity and responds satisfactorily in normal and single fault conditions. |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
This document describes a physical device's functional and safety testing, not a dataset analysis. Therefore, the concept of a "test set" in the context of data provenance and sample size of data points is not directly applicable. The testing was conducted on the device itself and its components. The document does not specify the number of units tested, the country of origin of the testing, or whether the testing was retrospective or prospective (though functional and safety testing is inherently prospective for the device being evaluated).
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. The ground truth for device performance (temperature, safety shutdown) is based on physical measurements and engineering specifications, not expert interpretation of data.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. This concept applies to human interpretation of data, not physical device testing.
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 is not an AI or imaging device, and no human reader study was conducted.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is not an algorithmic device. The device's standalone performance was evaluated through functional and safety testing, as described in the table above.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
The ground truth for the device's performance was established through physical measurements and engineering standards/specifications for temperature and safety features. For example, "simulated skin temperatures that would cause thermal injury" serves as a benchmark, and the target "39 - 42 °C range" for contact temperature is a performance benchmark.
8. The sample size for the training set
Not applicable. This is a physical device, not an AI model, so there is no training set.
9. How the ground truth for the training set was established
Not applicable. There is no training set for this device.
§ 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).