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The CritiCool is a thermal regulating system, indicated for monitoring and controlling patient temperature.

The CritiCool system consists of the following elements:

• Temperature controlled garment .
• . Body sensors
• Connecting flexible water pipes .
• Heating/Cooling Unit .

The system is operated by circulating water by a pump in a closed loop between the device and a disposable garment - CureWrap, worn by the patient. The water circulates through the thermoregulating unit. Temperature (body) sensors are placed on the patient's skin to measure surface temperature and in the rectum, nasopharynx or esophagus to measure core temperature. The operator selects the desired patient core temperature (between 30-40°C) and the unit automatically controls it via a feedback loop. The heating / cooling unit is based on a solid-state thermo-electric device, which operates as a heat pump

The provided document is a 510(k) premarket notification for the CritiCool System, a thermal regulating device. This type of submission focuses on demonstrating substantial equivalence to a predicate device, rather than providing extensive clinical study data proving efficacy or meeting specific acceptance criteria in the way a new drug or novel medical device might.

Therefore, the document does not contain a detailed study proving the device meets acceptance criteria in the format requested. Instead, it relies on demonstrating that the CritiCool device has similar specifications and indications for use as previously cleared predicate devices (ArcticSun and Allon 2001 Version 5).

However, I can extract the relevant information regarding performance specifications and any implied "acceptance criteria" through comparison with the predicate devices.

Here's a breakdown of the requested information based on the provided text, with clarifications where the information is not explicitly stated in the context of a "study":

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria are implied by the specifications of the predicate devices. The CritiCool device is considered "substantially equivalent" if its performance matches or is within acceptable limits of these predicate devices.

The document states that the CritiCool system's specifications are "compares to the predicate, ArcticSun and Allon 2001version 5." The table above focuses on direct comparisons to the primary predicate, Allon 2001 Version 5, where the values for CritiCool match exactly, indicating that these specifications are the "reported performance" and are accepted because they are equivalent to the cleared predicate.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

This 510(k) submission primarily relies on design specifications and functional comparisons to predicate devices. It does not describe a clinical study with a "test set" of patient data in the typical sense.

The document mentions "Materials were tested and proven for biocompatibility (see part 15)," which refers to a separate section not provided here. Such testing would involve laboratory samples, not human patient data in a "test set."

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 submission does not describe a study involving expert-established ground truth for a test set of patient data, as it is not a diagnostic device.

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

Not applicable, as there is no described test set requiring adjudication.

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 a diagnostic imaging device that would involve human "readers" or AI assistance for interpretation.

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

This refers to the performance of the device's automatic control system. The "standalone" performance is described by its specifications (e.g., patient temperature control range and accuracy, alarm thresholds) which are directly compared and found equivalent to the predicate device. The claim of "automatic" control mode performance for CritiCool (matching Allon 2001) implies that the algorithm controlling the heating/cooling unit functions autonomously to maintain the set temperature within specified ranges.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

The "ground truth" for this type of device's performance is typically established through:

• Engineering verification and validation testing: Confirming that the device meets its design specifications (e.g., temperature accuracy, flow rates, alarm functionality) under various simulated and real-world conditions. This would involve calibrated instruments as the "ground truth" reference.
• Comparison to predicate device specifications: The fundamental "ground truth" for FDA clearance via 510(k) is demonstrating that the new device's specifications and performance are substantially equivalent to a legally marketed predicate device.

The document does not detail specific "ground truth" for a patient study, as that is not the primary mechanism for demonstrating substantial equivalence for this type of device.

8. The sample size for the training set

Not applicable. This device does not use machine learning or AI that would require a "training set" of data in the common sense.

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

Not applicable, as there is no "training set."

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