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The IQoolTM Warm System is a temperature regulating system indicated for monitoring and controlling patient temperature.

The IQool™ Warm System is a non-invasive, thermal regulating system that monitors and controls patient temperature within a range of 32°C to 38.5°C (89.6°F to 101.3°F). The IQooL™ Warm System consists of: ECU 100 – refrigeration and control unit – an integrated control system operated via a touch screen monitor. BC COOL– a cooling liquid consisting of diluted monopropylene glycol (MPG5). The dilution is made by BrainCool AB to optimally serve the IQool TM Warm System. Five liters of BC COOL are delivered with the system. Cooling Pads – the single use pads are the only skin contacting component and can be fitted to the head/neck, torso, and thigh. Liquid coolant is circulated from the tank through the pads to control patient temperature. The pads are designed and molded to give a good fit during treatment and are intended for single patient use. Stabilization insulation – the patented stabilization insulation is made of insulating and moisture-absorbing neoprene which supports the cooling pads and insulates against the ambient environment condensation. The elasticity of the stabilization insulation keeps the cooling pads in place during treatment and ensures maximum contact between the skin and the surface of the cooling pad. The stabilizing insulation is intended for single use only. Accessories: BC Stick – a USB flash drive used to save system configurations, specifically prepared to communicate with the program of the IQoolTM Warm System. The BC stick does not store or capture any user identifying information. It can also be used to save a log file for system troubleshooting or to update the software. Filling pitcher – for refilling the tank with BC COOL (coolant). Fill the tank with coolant before or directly after start to avoid damage to the system.

This document is a 510(k) Premarket Notification from Brain Cool AB for their IQool™ Warm System (K180375), seeking to demonstrate substantial equivalence to a predicate device, the Arctic Sun® Temperature Management System (K101092). The information provided focuses on the device's characteristics and a comparison to the predicate, rather than a clinical study establishing acceptance criteria through human performance or expert consensus.

Therefore, many of the requested elements for describing "acceptance criteria and the study that proves the device meets the acceptance criteria" in terms of AI/algorithm performance (e.g., sample size for test set, number of experts for ground truth, MRMC study, standalone performance, training set details) are not applicable to this type of device submission. This is a medical device regulation document, not a clinical study report for an AI-powered diagnostic tool.

The "study" referenced in this document is primarily bench testing and a comparison of technical specifications to a predicate device to demonstrate substantial equivalence under regulatory guidelines. The acceptance criteria are therefore focused on the device's ability to perform its core function (temperature regulation) within specified ranges, as well as adherence to safety and design standards already established by the predicate device.

Here's an breakdown based on the provided document, addressing the applicable points:

Device Name: The IQool™ Warm System
Regulatory Submission: 510(k) Premarket Notification (K180375)

1. A table of acceptance criteria and the reported device performance:

Since this is a 510(k) submission for a thermal regulating system, the acceptance criteria are based on demonstrating comparable performance to a legally marketed predicate device (Arctic Sun® Temperature Management System, K101092) and adhering to established engineering and safety standards. The "reported device performance" is framed in terms of its technical characteristics matching or being similar to the predicate.

2. Sample size used for the test set and the data provenance:

• This submission relies primarily on bench testing (simulated testing) rather than a clinical human subject test set for proving device performance. The specific "sample size" is not quantitated as it would be for a clinical trial with human subjects.
• Data Provenance: The testing is laboratory-based ("simulated testing"). No information on geographical origin (country) or retrospective/prospective nature of a human data set is provided, as it's not a clinical study involving patients.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

• Not applicable. The "ground truth" for this device's performance is its ability to accurately control temperature, which is verified through engineering principles, bench testing, and comparison to the known performance of the predicate device and established medical literature on therapeutic hypothermia. This does not involve expert readers establishing ground truth on medical images or diagnoses.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:

• Not applicable. This pertains to expert review and potential disagreement resolution in studies involving subjective assessment (e.g., image interpretation). The evaluation here is based on objective physical measurements and comparisons.

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 AI-assisted diagnostic tool for human readers. No MRMC study was performed.

6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done:

• Not applicable in the context of an AI algorithm. However, the device's automated temperature control function can be thought of as "standalone" in that it performs its function without continuous human intervention to manually control temperature once set. Its performance was assessed through engineering and bench testing.

7. The type of ground truth used:

• The "ground truth" for this device's effectiveness is its ability to accurately and reliably regulate temperature within specified ranges, as determined by physical measurements, engineering specifications, and comparison to the established performance characteristics of the legally marketed predicate device (Arctic Sun® Temperature Management System) and general therapeutic hypothermia practice.

8. The sample size for the training set:

• Not applicable. This is not an AI/machine learning device that requires a training set.

9. How the ground truth for the training set was established:

• Not applicable. This is not an AI/machine learning device.

Summary of the Study Proving Acceptance Criteria (Substantial Equivalence):

The IQool™ Warm System's acceptance criteria are met by demonstrating substantial equivalence to the predicate device (Arctic Sun® Temperature Management System, K101092). The "study" proving this involved:

• Comparative analysis: Detailed comparison of the IQool™ Warm System's indications for use, technological characteristics, and performance specifications against the predicate device.
• Bench Testing / Simulated Testing: The sponsor submitted "simulated testing" for the new rewarming features. This testing demonstrated the device's ability to cool patients to hypothermia, maintain patient temperature, and rewarm patients to normothermia comparably to the predicate device, based on published cooling times for the predicate and general therapeutic hypothermia practice.
• Cross-referencing to a previously cleared device (K162523): Information regarding cooling pads, accessories, shelf-life, sterilization, and biocompatibility was referenced from a prior 510(k) submission for a related IQool system, as these components were identical.
• Software Validation: New software testing was conducted and submitted, adhering to FDA guidance for software in medical devices, to ensure appropriate level of concern was addressed for the added rewarming capability.

The conclusion is that the differences between the IQool™ Warm System and the predicate are minor and do not raise new questions of safety and effectiveness, thus meeting the requirements for 510(k) clearance by demonstrating substantial equivalence.

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