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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.

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The Allon 2001 version 5 is intended to maintain pre- set body temperature as determined by the physician. It can also be utilized to maintain normal body temperature during surgical procedures. It is indicated for use in hospital invasive and coronary care units, in operating, recovery and emergency rooms, in burn units, and on medical / surgical floors. This system can be used with adult and pediatric patients.

The Allon 2001 vesion 5 system consists of the following elements:

• Temperature controlled disposable 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 worn by the patient. The water circulates through the heating/ cooling unit. Temperature (body) sensors are placed on the patient and in the rectum, nasopharynx or esophageal to measure core temperature. The operator selects the desired patient core temperature and the unit operates in an automatic mode. Patient temperature is controlled and maintained at any set point between 30-40°C using a feedback loop and sensors placed on the patient's body.
  The heating/cooling unit is based on a solid-state thermo-electric device, which operates as a heat pump. The system is intrinsically safe, due to the characteristics of the thermo-electric device, heating capacity drops off as the Thermo Electro Cooler (TEC) temperature rises. Hence, if for any reason, flow of coolant is interrupted, the TEC will overheat and the power output will fall, thus limiting water temperature rise.
  The disposable garment is provided in a variety of shapes and sizes, which are manufactured of the same materials and by the same process as those already cleared under K001546, K992386 and K003349.

This submission describes the Allon 2001 version 5 Thermal Regulating System, a device intended to maintain pre-set body temperature as determined by a physician, including during surgical procedures, for adult and pediatric patients in various hospital settings.

Here's an analysis of the provided information regarding acceptance criteria and studies:

1. Table of Acceptance Criteria and Reported Device Performance

The provided document does not explicitly state "acceptance criteria" in a formal, quantifiable manner for clinical performance. Instead, it focuses on demonstrating substantial equivalence to predicate devices (Allon 2001 - K003349 and Cincinnati Subzero - Blanketrol II) by comparing functional and safety specifications.

The table below summarizes the key performance specifications listed for the Allon 2001 version 5 and its predicate devices:

Note: The submission aims to demonstrate substantial equivalence, meaning the new device is as safe and effective as the predicate devices. The "acceptance criteria" here are implicitly met if the device's specifications are equivalent or improved without raising new safety or effectiveness concerns compared to the legally marketed predicates.

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

The document does not describe a clinical study with a "test set" in the context of diagnostic accuracy or performance on patient data. This is a temperature regulating medical device, and the submission focuses on engineering specifications and comparison to predicate devices, not on a clinical trial with a patient test set.

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" establishment by experts on a test set is described for this type of device submission. The device's performance is assessed against technical specifications and comparison to existing devices, not a clinical gold standard review.

4. Adjudication method for the test set

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

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.

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

Not applicable, as this is a physical medical device, not a standalone algorithm.

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

Not applicable. The ground truth for this device's safety and effectiveness is established through adherence to engineering design principles, international standards (implied via safety features), and comparison to the established performance and safety profiles of predicate devices that have been deemed safe and effective for their intended use.

8. The sample size for the training set

Not applicable. The submission does not describe a machine learning model or a "training set."

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

Not applicable.

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The Allon 2000 System is intended to maintain pre-set body temperature as determined by the physician. It can also be utilized to maintain normal body temperature during surgical procedures.

The Allon 2000 System is indicated primarily for use in hospital invasive and coronary care units, in operating, recovery and emergency rooms, in burn units, and on medical/surgical floors. This system can be used with adult and pediatric patients.

The Allon 2000 Hyper-Hypothermia system is used to either lower or raise a patient's temperature and/or maintain a desired patient temperature using a garment, which is wrapped around the body during and after surgery to achieve maximum coverage. This, for example, minimizes the tendency of the body to cool down as a result of anesthesia and exposure. The garment can be configured to cover any surface area of the patient's body and yet not to interfere with areas that must be exposed during surgery. As a flow of cooled or heated water is forced through the garment by the pump of the Allon 2000 System, the heat is exchanged with the body. The water temperature is controlled and maintained at any temperature between 59 and 104.3ºF (15 - 40.2ºC) using a feedback loop based on surface and core thermostat sensor readings.

Here's the information regarding the acceptance criteria and study for the Allon 2000 System, based on the provided 510(k) summary:

This document is a 510(k) summary for a medical device (Allon 2000 System) seeking clearance from the FDA. It does not describe the AI/ML device approval process, but rather a traditional medical device approval. Therefore, many of the requested fields pertaining to AI/ML device evaluation (like MRMC studies, ground truth for training/test sets, number of experts for ground truth, sample sizes for training/test sets in the context of AI) are not applicable or not provided in this type of submission.

The "acceptance criteria" for this device are broadly defined by its ability to meet established safety and performance standards, and its substantial equivalence to a predicate device.

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

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

• Sample Size: Not specified in the provided text. The document generically states "clinical studies."
• Data Provenance: Not specified in the provided text. The submitting company is from Israel (M.T.R.E. Advanced Technologies Ltd., Caesarea Industrial Park, Israel). Clinical studies could have been conducted there or elsewhere. The study type (retrospective or prospective) is not specified.

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 / Not Provided: This device is a thermal regulation system, not an AI/ML diagnostic or prognostic device that relies on expert interpretation for ground truth in its performance assessment. Its performance is measured directly by its ability to control temperature. The "experts" involved would likely be clinicians or engineers overseeing the animal and clinical studies, but their role is not to establish a "ground truth" in the AI sense.

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

• Not Applicable / Not Provided: Adjudication methods like 2+1 or 3+1 are typically used in studies where there is subjective human interpretation that needs to be reconciled to establish a consensus ground truth, common in AI/ML performance evaluation. This is not relevant for a device like Allon 2000, whose performance is based on objective physiological measurements (temperature control).

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-assisted device. Therefore, no MRMC study or assessment of human reader improvement with AI assistance would have been performed.

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

• Not Applicable: This is a physical thermal regulation device, not an algorithm. Its performance is inherent in its operation, not in an independent algorithm.

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

• Physiological Measurements/Observed Outcomes: For a thermal regulation system, the "ground truth" for its performance would be the actual body temperature measurements of the subjects (in-vitro, animal, and clinical) and whether the device successfully maintained the pre-set or desired temperature. Outcomes data would relate to the success of temperature regulation and patient safety.

8. The sample size for the training set

• Not Applicable / Not Provided: This is not an AI/ML device that requires a "training set" in the computational sense. If "training set" refers to data used during early development or optimization, those details are not provided. The document mentions "in vitro, animal and clinical studies" to establish effectiveness.

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

• Not Applicable / Not Provided: As this is not an AI/ML device, the concept of establishing ground truth for a "training set" is not relevant here. The device's efficacy is established through direct experimental evidence in controlled study environments.

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