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The Medi-Therm is intended for use in supplying warm or cold water at controlled temperatures via water circulating blankets or body wraps for the application of regulating patient temperature in situations where a physician determines that temperature therapy is necessary and desirable.

Indications for use for the Medi-Therm thermal regulating system include:
a. To maintain pre-set body temperature as determined by the physician
b. To maintain normal body temperature during surgical procedures
c. For use in all hospital areas including invasive and coronary care units, in operating, recovery and emergency rooms, in burn units and on medical/surgical floors
d. This system can be used with adult and pediatric patients
e. Monitoring and controlling patient temperature
f. Temperature reduction in patients where clinically indicated, e.g. in hyperthermic patients

The Gaymar Medi-Therm device provides a means of regulating patient temperature by supplying temperature-controlled water through a connector hose to accessory Gaymar Hyper/Hypothermia blanket/s)/body wrap(s). The blanket/body wrap provides an interface for heating or cooling the patient. Accessory YSI 400 series patient probe interfaces between the Medi-Therm and patient to sense patient temperature, which is displayed on the device's control panel. The Medi-Therm device controls output water temperature by mixing hot and cold water using hot and cold solenoid valves under microprocessor control. The device includes a circulating pump, heater and refrigeration system.

The Medi-Therm controller, connector hose, blanket/body wrap and patient probe comprise the Medi-Therm Hyper/Hypothermia System.

The provided document is a 510(k) summary for the Gaymar Medi-Therm Hyper/Hypothermia System. It primarily focuses on demonstrating substantial equivalence to predicate devices and detailing the technological characteristics, intended use, and general safety and effectiveness.

Based on the provided text, there is no information available regarding a study that assesses device performance against specific acceptance criteria in the format you requested (e.g., diagnostic accuracy metrics like sensitivity, specificity, or reader improvement with AI).

The document mentions "Bench testing was conducted to confirm the MTA6900 and MTA7900 and their disposable accessories operate as described in this submission and therefore are as safe and effective as the predicate devices to which it claims substantial equivalence." The types of bench testing listed are:

• Temperature Control Performance
• Temperature Stability and Flow
• Biocompatibility (ISO 10993-5; ISO10993-10; 16 CFR 1500)
• Ship Testing (ISTA 1A)

However, the document does not provide:

• Specific acceptance criteria for these tests (e.g., "temperature control performance must maintain patient temperature within +/- 0.5°C").
• Reported device performance against such criteria in a quantitative table.
• Details about sample sizes, data provenance, ground truth establishment, expert involvement, or MRMC studies. The context of this device (a thermal regulating system) does not typically involve the kinds of diagnostic accuracy studies (MRMC, standalone, human-in-the-loop) that would require such detailed information on ground truth, expert consensus, and reader performance.

Therefore, I cannot populate the table or answer most of your specific questions as the necessary information is not present in the provided 510(k) summary. The document focuses on demonstrating that the device meets safety and performance standards generally expected for its product classification and is substantially equivalent to existing devices through engineering and functional comparisons, not clinical performance metrics in the way a diagnostic AI device would be evaluated.

Table of Acceptance Criteria and Reported Device Performance:

Detailed Study Information (Based on the document):

1. Sample size used for the test set and the data provenance: Not applicable/not provided. The document refers to "Bench testing," which implies laboratory-based tests rather than patient data test sets.
2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable/not provided. Ground truth establishment with experts is typically for diagnostic devices assessing images or other complex data.
3. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable/not provided.
4. If a multi-reader multi-case (MRMC) comparative effectiveness study was done: No. This type of study is not mentioned and is not typically relevant for a thermal regulating system.
5. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable/not provided. This refers to diagnostic algorithm performance.
6. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not applicable/not provided. For bench testing, the "ground truth" would be the expected physical or electrical output/behavior based on design specifications or industry standards.
7. The sample size for the training set: Not applicable/not provided. This device is not described as involving machine learning or algorithms that require a "training set" in the context of data analysis. Its "microprocessor control" refers to conventional programming.
8. How the ground truth for the training set was established: Not applicable/not provided.

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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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