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The Hemotherm Dual Reservoir Cooler/Heater is used to lower, maintain, or raise the temperature of the water flowing through a Blood Oxygenator/Heat Exchanger that is used to cool or warm blood during cardiopulmonary bypass procedures lasting six hours or less. The Hemotherm Dual Reservoir Cooler/Heater may also be used with a hyper/hypothermia blanket under the patient to provide warming through conductive heat transfer.

The Hemotherm® Model 400CE Cooler/Heater System is a dual reservoir, water recirculating device that supplies temperature controlled water to a heat exchanger. The device, in conjunction with a heat exchanger, is used to warm or cool the blood that enters and exits a blood heat exchanger for adult, pediatric or infant patients. The device uses conductive heat transfer. When ordered by the health care professional, the device can also simultaneously supply temperature controlled water to a blanket to provide additional patient re-warming therapy. If the blanket is used at the same time as the heat exchanger, the blanket is supplied the same water that circulates to the heat exchanger.

Here's a breakdown of the acceptance criteria and study information for the Hemotherm Model 400CE based on the provided text:

Acceptance Criteria and Device Performance

Additional Study Information

There is limited information provided in the 510(k) summary regarding specific aspects of the studies typically found for AI/ML device evaluations. This submission is for a traditional 510(k) for a hardware device, not an AI/ML software device, which explains the absence of certain categories.

2. Sample Size Used for the Test Set and Data Provenance:
* Sample Size: Not specified. The document states the "Hemotherm 400CE system was subjected to and passed" various tests, but does not detail the number of units or test points used.
* Data Provenance: Not applicable in the context of patient data for a medical device that does not directly interact with patients or process patient data. The provenance would refer to the testing environment and protocols, which are covered by the standards cited (e.g., IEC, ASTM, ISTA).

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications:
* Not applicable. This device is a cooler/heater system, and its performance (e.g., temperature accuracy, electrical safety) is evaluated against objective engineering standards and physical measurements, not subjective expert assessment of medical imaging or clinical data.

4. Adjudication Method for the Test Set:
* Not applicable. As noted above, the evaluation relies on objective measurements against established technical standards, not on expert consensus or 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:
* No, an MRMC study was not done. This is a hardware device (cooler/heater system) and not an AI/ML diagnostic or assistive technology for human readers. Therefore, this type of study is not relevant.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done:
* No, a standalone algorithm performance study was not done. This device does not have an AI/ML algorithm. Its performance is evaluated in a standalone manner as a mechanical/electrical system.

7. The Type of Ground Truth Used:
* Objective Engineering Standards and Physical Measurements: The ground truth for this device's performance is derived from internationally recognized electrical safety standards (IEC60601-1), electromagnetic compatibility standards (IEC60601-1-2), packaging and transportation standards (ISTA), and performance standards related to temperature and pressure (ASTM F-2196). These standards define acceptable ranges and parameters for the device's operation.

8. The Sample Size for the Training Set:
* Not applicable. As a hardware device without AI/ML components, there is no "training set" in the context of machine learning.

9. How the Ground Truth for the Training Set Was Established:
* Not applicable, for the same reason as above.

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The WarmAir® 135 patient warming system is intended to prevent hypothermia and/or reduce cold discomfort before, during, and after surgical procedures. The thermal regulating system is used to raise a patient's temperature and/or maintain a desired patient temperature through convective heat transfer from the controller to a warm-airheated blanket. The single-patient use blankets transfer the thermal energy to adult, pediatric or neonate patients to obtain/maintain normal body temperature. It is intended for use by appropriately trained healthcare professionals in clinical environments.

The WarmAir 135 Hyperthermia System is a patient temperature management device which provides forced air warmed by the controller to a blanket that is placed over or under adult, pediatric or neonatal patients in order to warm them. The heated air is blown through connecting flexible hose to a disposable blanket to provide patient therapy by the means of warmed air.

The provided document is a 510(k) summary for a Special 510(k) submission regarding a modification to the WarmAir® Model 135 Hyperthermia System. This type of submission is a premarket notification to the FDA to demonstrate that a device is substantially equivalent to a legally marketed predicate device.

The core of this submission is to add a modified blanket to the family of WarmAir 135 blankets. The changes to the blanket are that it is now provided sterile, differs in size, and includes a flap for groin access.

Crucially, this document describes a modification to an existing device, and the evaluation focuses on showing that the modified device is "substantially equivalent" to an already cleared device, not on proving new clinical effectiveness or performance against specific, quantifiable clinical acceptance criteria through a full-scale clinical study for the entire system. The "study" mentioned here is primarily about verifying the effect of the modification (sterilization) on the blanket's ability to meet the same specifications as the non-sterile predicate.

Therefore, many of the requested items related to comprehensive clinical studies, such as multi-reader multi-case studies, standalone algorithm performance, large training/test sets, and expert adjudication, are not applicable or not present in this type of submission for this particular modification.

Here's the breakdown based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly present a table of acceptance criteria with reported numerical values for clinical performance as one might see in a de novo submission or a comprehensive clinical trial report. Instead, the "acceptance criteria" discussed are primarily related to design control verification and ensuring the modified sterile blanket still meets the same specifications as the non-sterile predicate.

2. Sample Size Used for the Test Set and Data Provenance

• Test Set Description: The "test set" here refers to the modified blanket itself which underwent testing. It is not a patient cohort or a dataset in the context of an AI/algorithm study.
• Sample Size: Not specified in terms of numerical count for physical units tested, but it would have involved a sufficient number of blanket samples to perform the required ASTM F-2196 temperature testing effectively.
• Data Provenance: The testing was done internally by the manufacturer, Cincinnati Sub-Zero Products, Inc. (implied from the document). It is not country-specific in the way clinical trial data might be. The testing is likely prospective in the sense that the sterile blanket modification was created, then tested.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications

Not applicable. This submission is for a medical device modification (blanket) and its performance is evaluated against engineering/material specifications (like temperature delivery), not against expert clinical diagnoses or ground truth established by medical experts for a diagnostic algorithm.

4. Adjudication Method for the Test Set

Not applicable. See point 3. Adjudication methods like 2+1 or 3+1 are used for establishing ground truth in expert-dependent diagnostic studies, not for evaluating the direct physical performance of a warming blanket.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

No. An MRMC study is relevant for evaluating human reader performance with and without AI assistance in diagnostic tasks. This device is a warming blanket, not a diagnostic tool incorporating AI.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

No. This device does not incorporate an algorithm that operates in a standalone capacity.

7. The Type of Ground Truth Used

The "ground truth" for the blanket's performance is established by engineering specifications and recognized standards, specifically the "specification for maximum temperature delivered to the patient (per ASTM F-2196)". This is an objective, measurable physical property.

8. The Sample Size for the Training Set

Not applicable. There is no "training set" in the context of this device modification. This is not an AI/machine learning device. The design and manufacturing processes are established based on engineering principles and prior device experience, not a data training set.

9. How the Ground Truth for the Training Set Was Established

Not applicable. See point 8.

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The Norm-O-Temp® Model 111Z hyperthermia system is intended to prevent hypothermia during surgical procedures and to reduce cold discomfort before, during, and after a surgical procedure. The thermal regulating system is used to keep a patient comfortable by maintaining blanket/pad water temperature through conductive heat transfer. The water heated blankets transfer the thermal energy to adult, pediatric, and infant (includes neonates) patients to keep a patient at a comfortable temperature. The Norm-O-Temp system is composed of a heater, circulating pump, and blankets/pads. It is intended for use by appropriately trained healthcare professionals in clinical environments.

The Cincinnati Sub-Zero Norm-O-Temp (Model 111Z) is a water re-circulating system providing either hyperthermia or normothermia treatment as determined by the health care provider. It is a total body hyperthermia system used to keep a patient comfortable by maintaining blanket/pad water temperature through conductive heat transfer. Water is heated and pumped from the device, through connecting flexible tubing, to disposable or reusable blankets/pads. The blankets/pads rest under, on top of and/or around the patient and are designed so that the water circulates through the blankets/pads and returns back to the device. The device is designed to operate based on the temperature of the circulating water. The system is used in Operating rooms, Post Anesthesia Care Units, Recovery rooms, Intensive Care Units, and Emergency Rooms with adult, pediatric and infant (including neonate) patients. The blankets/pads that are used with the Norm-O-Temp system are offered in a variety of sizes from large to small to meet the needs of the patients.

The Cincinnati Sub-Zero Norm-O-Temp® Model 111Z Hyperthermia System is a temperature management system designed to prevent hypothermia and reduce cold discomfort in patients during and after surgical procedures. The device operates by recirculating heated water through blankets/pads to transfer thermal energy to the patient via conductive heat transfer.

Here's an analysis of the acceptance criteria and the study that proves the device meets them:

1. Table of Acceptance Criteria and Reported Device Performance:

2. Sample Size Used for the Test Set and Data Provenance:

The provided document describes bench testing. For bench testing, the "sample size" refers to the number of devices or components tested. The document does not explicitly state the number of Norm-O-Temp Model 111Z Hyperthermia Systems that underwent the listed tests.

The data provenance is from bench laboratory testing, likely conducted by the manufacturer, Cincinnati Sub-Zero Products, Inc. The testing is for design validation and to demonstrate substantial equivalence, indicating it is prospective testing for a new device. There is no information regarding the country of origin of the data beyond the manufacturer's location in Cincinnati, Ohio, USA.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications:

This information is not applicable to the type of study conducted. Bench testing for a medical device like a hyperthermia system does not typically involve human experts establishing "ground truth" in the way clinical studies or diagnostic AI algorithms do. Instead, the "ground truth" or acceptance criteria are derived from established industry standards (e.g., ASTM, IEC) and the device's design specifications. The performance is measured against these objective standards.

4. Adjudication Method for the Test Set:

This information is not applicable. Since the testing involves objective measurements against established technical standards, there is no need for human adjudication of results in the traditional sense of a clinical or image-based study. Device performance either meets the objective criteria or it does not.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:

No, an MRMC comparative effectiveness study was not performed. This type of study is relevant for diagnostic devices that involve human interpretation of medical data (e.g., radiologists reading images) and the impact of AI assistance on that interpretation. The Norm-O-Temp system is a therapeutic device, and its effectiveness is assessed through its physical performance and safety features, not through human reader interpretation.

6. Standalone (Algorithm Only Without Human-in-the-Loop) Performance:

This concept is not applicable to the Norm-O-Temp Model 111Z Hyperthermia System in the way it is used for AI-powered diagnostic algorithms. The device itself is a standalone medical device that performs its function (heating water and circulating it) without an "algorithm" in the AI sense that would require human-in-the-loop interaction for interpretation or decision-making. Its performance is measured directly through its physical outputs (temperature, safety limits).

7. Type of Ground Truth Used:

The "ground truth" for this study is based on objective technical specifications and established industry standards. Specifically:

• ASTM F-2196: Standard Test Method for Measuring Performance of Thermal Regulating Systems for Patient Warming and Cooling. This standard defines how to measure temperature performance and safety limits.
• IEC 60601-1 and IEC 60601-1-2: International standards for the safety and electromagnetic compatibility of medical electrical equipment.
• Company's specified design requirements: The manufacturer's internal criteria for the device's functionality and safety.

8. Sample Size for the Training Set:

This information is not applicable. The Norm-O-Temp Model 111Z is a physical medical device, not an AI model that requires a "training set" of data for machine learning. Its operation is based on hardware and software logic, not statistical learning from data.

9. How the Ground Truth for the Training Set Was Established:

This information is not applicable, as there is no "training set" in the context of this device. The device's functionality is designed and engineered according to specifications and validated through testing against those specifications and relevant standards.

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The Blanketrol II Model 222S Hyper-Hypothermia Temperature Management System is used to lower or to raise a patient's temperature and/or maintain a desired patient temperature through conductive heat transfer. The system is composed of a heater, a compressor, a circulating pump and blankets/pads.

The Blanketrol II Model 222S is a water (liquid) recirculating device providing either hypothermia, hyperthermia or normothermia treatment as determined by the health care provider. Water is either heated or cooled depending on the need of the patient. The heated or cooled water is pumped through connecting flexible tubing to a disposable or reusable pad or blanket to provide patient therapy for a site specific external surface area or for whole body surface temperature therapy by the means of conductive heat transfer.

The provided text is a 510(k) Premarket Notification for a device modification and does not contain detailed information about a study proving the device meets acceptance criteria in the format typically used for AI/ML device evaluations. The document focuses on demonstrating substantial equivalence to a predicate device based on design changes and standard adherence.

However, I can extract the information that is present and indicate where certain requested information is not available in the given text, reinterpreting "acceptance criteria" and "device performance" in the context of this 510(k) submission.

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

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

• Sample Size for Test Set: Not explicitly stated. The document refers to "Testing was performed on the proposed Blanketrol II Model 222S" for functional and safety verification. This implies testing on the actual device hardware, not a clinical data set.
• Data Provenance: Not applicable in the context of this device modification. The testing relates to the device's operational characteristics and adherence to standards, not patient data. It is device-centric testing rather than data-centric.
• Retrospective or Prospective: Not applicable.

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

• This information is not provided because the "ground truth" here is the proper functioning of the device according to its design specifications and standard requirements, not the interpretation of clinical data. The verification testing would have been conducted by engineers or technicians within the company, according to established test protocols.

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

• Not applicable. Adjudication methods like 2+1 or 3+1 typically refer to expert review processes for clinical data, which is not the subject of this 510(k) submission.

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

• No. This is not an AI/ML device. It is a physical medical device (temperature management system) with minor modifications. Therefore, an MRMC study and AI-related effect sizes are not relevant.

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

• No. This is not an AI/ML algorithm.

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

• The "ground truth" for this device modification is its successful operation according to engineering and safety specifications. This would involve successful execution of predefined test cases (e.g., verifying buttons work, water temperature control is accurate, safety limits are met) against a baseline of expected performance (predicate device's performance, design specifications, and relevant IEC standards).

8. The sample size for the training set

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

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

• Not applicable. This is not an AI/ML device that requires a training set or ground truth for algorithmic development.

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The Blanketrol III Model 233 and CoolBlue Model 25-01 Hyper-Hypothermia Temperature Management Systems are used to lower or to raise a patient's temperature and/or maintain a desired patient temperature through conductive heat transfer. The system is composed of a heater, a compressor, a circulating pump and blankets/pads.

The Blanketrol III/CoolBlue Hyper-Hypothermia System is a water (liquid) recirculating device providing either hypothermia, hyperthermia or normothermia treatment as determined by the health care provider. Water is either heated or cooled depending on the need of the patient. The heated or cooled water is pumped through connecting flexible tubing to a disposable or reusable pad or blanket to provide patient therapy for a site specific external surface area or for whole body surface temperature therapy by the means of conductive heat transfer.

The provided text describes a 510(k) premarket notification for the Blanketrol III Model 233 and CoolBlue Model 25-01 Hyper-Hypothermia Systems. This device is a thermal regulating system.

Based on the provided text, the device is not an AI/ML powered device, and therefore, many of the requested fields regarding AI/ML performance, training, and ground truth are not applicable. The submission focuses on demonstrating substantial equivalence to predicate devices through bench testing.

Here's a breakdown of the requested information based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

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

• Sample size for the test set: Not specified in the document. The testing described is bench testing of the physical device, not a study involving patient data or images.
• Data provenance: Not applicable. The "tests" are physical bench tests of the device.

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

• Not applicable. Ground truth as typically understood for AI/ML models is not relevant for bench testing of a thermal regulating system. The "ground truth" for these tests would be the physical specifications and performance targets of the device.

4. Adjudication method for the test set

• Not applicable. This is not a study requiring expert adjudication of results.

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 not an AI-powered diagnostic or interpretive tool, so MRMC studies are not relevant.

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

• Not applicable. This is a physical thermal regulating system, not an algorithm.

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

• Not applicable in the AI/ML sense. The "ground truth" for the bench tests would be the established engineering specifications, safety limits, and performance standards relevant to thermal regulating systems.

8. The sample size for the training set

• Not applicable. This device does not involve a training set as it is not an AI/ML product.

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

• Not applicable. This device does not involve a training set.

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