(86 days)
The HotDog Patient Warming System is intended to prevent or treat hypothermia and to provide warmth to patients. The HotDoq Patient Warming System should be used in circumstances in which patients may not maintain a state of normothermia. The patient warming system can be used with adult and pediatric patients.
The System is intended primarily for use in hospitals and surgical centers including without limitation operating, recovery and emergency rooms and on medical/surgical - floors.
The HotDog Patient Warming System consists of a temperature control unit that monitors and controls the temperature of a patient warming blanket or mattress. The blankets and mattresses are composed of a conductive polymer coated fabric heater encased in a polymer shell. The mattress also contains a pressure relieving foam pad.
The provided 510(k) summary for the HotDog Patient Warming System (K112488) does not describe a study involving an AI/Machine Learning device or an algorithm's performance against acceptance criteria in the way a typical diagnostic or image analysis AI study would.
Instead, this submission is for a medical device (a thermal regulating system) and its performance evaluation focuses on engineering benchmarks and safety standards. Therefore, many of the requested categories (like sample size for test/training sets, experts for ground truth, MRMC studies, standalone performance, etc.) are not applicable to this type of device and submission.
Here's an analysis based on the information provided, tailored to the context of this specific device:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Specific Criteria (Performance Standard) | Reported Device Performance |
|---|---|---|
| Safety and Performance | IEC 60601-1: Medical Electrical Equipment - Part 1: General Requirements For Basic Safety And Essential Performance, edition 2. | Bench testing was performed to demonstrate substantial equivalence to predicate devices. Temperature characteristics and safety systems were compared and found to be comparable. The system is designed to meet this standard. |
| Electromagnetic Compatibility (EMC) | IEC 60601-1-2: Medical Electrical Equipment - Part 1-2: General Requirements for Safety - Collateral standard: Electromagnetic Compatibility - Requirements and Tests, edition 2. | Bench testing was performed to demonstrate substantial equivalence to predicate devices. Temperature characteristics and safety systems were compared and found to be comparable. The system is designed to meet this standard. |
| Programmable Electrical Medical Systems | IEC 60601-1-4:2000. Medical electrical equipment - Part 1: General requirements for safety - 4 - Collateral standard: Programmable electrical medical systems, edition 1.1. | Bench testing was performed to demonstrate substantial equivalence to predicate devices. Temperature characteristics and safety systems were compared and found to be comparable. The system is designed to meet this standard. |
| Specific Requirements for Warming Blankets/Pads/Mattresses | IEC 60601-2-35: Particular requirements for the safety of blankets, pad and mattresses intended for heating in medical use, edition 1. | Bench testing was performed to demonstrate substantial equivalence to predicate devices. Temperature characteristics and safety systems were compared and found to be comparable. The system is designed to meet this standard. |
| Substantial Equivalence | Equivalence to predicate device (HotDog Patient Warming System K052392) in technological characteristics and indications for use. | Non-Clinical Data: Bench testing performed demonstrated that the proposed warming system is substantially equivalent to the predicate devices. Temperature characteristics and safety systems were compared and found to be comparable. |
| Conclusion: The HotDog Patient Warming System was found to be equivalent to the predicate device in technological characteristics and indications for use. |
2. Sample size used for the test set and the data provenance
- Sample Size: Not applicable in the context of clinical or image data. The "test set" here refers to the physical device units subjected to bench testing against engineering and safety standards. The document does not specify the number of units tested.
- Data Provenance: Not applicable in terms of country of origin for clinical data. The "data" comes from non-clinical bench testing conducted by the manufacturer, Augustine Biomedical & Design, LLC.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Number of Experts/Qualifications: Not applicable. Ground truth for this type of device (thermal regulating system) is established by conformance to recognized engineering standards and performance specifications, not often by human experts interpreting clinical data in the same way as an AI diagnostic device. The "experts" involved would be engineers and quality assurance professionals ensuring compliance with the cited IEC standards.
4. Adjudication method for the test set
- Adjudication Method: Not applicable. Adjudication methods like 2+1 or 3+1 are used for reconciling discordant expert opinions on clinical cases. Here, the "truth" is determined by meeting objective engineering and safety standards, not by consensus on subjective interpretations.
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
- MRMC Study: No, an MRMC comparative effectiveness study was not done. This type of study is relevant for diagnostic AI devices, not for a patient warming system.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Standalone Performance: Not applicable. This is not an algorithm-only device. The "device" is a physical patient warming system.
7. The type of ground truth used
- Type of Ground Truth: The "ground truth" for this submission is conformance to established international medical device safety and performance standards (IEC 60601 series) and demonstrated substantial equivalence to a previously cleared predicate device (K052392) through direct comparison of engineering characteristics and safety systems.
8. The sample size for the training set
- Sample Size for Training Set: Not applicable. There is no AI model or algorithm being "trained" for this device.
9. How the ground truth for the training set was established
- Ground Truth for Training Set: Not applicable, as there is no training set for an AI model.
§ 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).