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The Heater-Cooler 3T System is used to circulate water through heat exchangers to warm or cool a patient during cardiopulmonary bypass procedures lasting 6 hours or less.

The Heater-Cooler System 3T is an independent (i.e., independent of the water supply) 3circuit heating/cooling base unit that includes three water circuits for the patient supplied by one tank (for the heating/cooling blanket, the oxygenator) and one interchangeable heating/cooling circuit for cardioplegia. If required, patient and cardioplegia circuits can be switched off separately, in order to increase the activated functional group's heating and/or cooling performance. The following optional components and accessories are also available for the Heater-Cooler System 3T: 1. Heating-cooling blankets; 2. Water circuit tubing; and 3. Various cables. The Heater-Cooler System 3T includes a disposable aerosol collection set that consists of a canister connected to the Heater-Cooler System 3T and the user facility's vacuum source that captures emissions that are drawn from the tank using negative pressure created by the user facility's vacuum. The changes proposed in the current 510(k) include the offering of a Deep Cleaning service by LivaNova to customers. The safety of the Heater-Cooler System 3T is ensured by the regular disinfection and cleaning, monitoring of the bacteria levels and by the aerosol collection set, as described in the Operating Manual that was cleared in K191402. The Deep Cleaning service is intended to address cases where heavily contaminated devices cannot meet the acceptable level described in section 6.5.2 of the Operating Instructions. In this situation, to allow the device to return to clinical use, the customer may choose to return the device for the Deep Cleaning service. The Deep Cleaning service is intended to reduce bioburden levels within the water circuit, thereby reducing the risk of NTM Aerosolization in the clinical setting. There are no changes to design or intended use.

This document describes the FDA's clearance of the LivaNova Heater-Cooler System 3T with a "Deep Cleaning" service. It does not contain information about an AI/ML device or its performance study. Therefore, I cannot extract the requested information regarding AI device acceptance criteria and study details.

The document primarily focuses on:

• The regulatory clearance of a medical device (Heater-Cooler System 3T).
• The addition of a "Deep Cleaning" service to this existing device.
• The substantial equivalence determination based on non-clinical testing (process validation of the deep cleaning service).

There is no mention of "AI", "ML", "algorithms", "human readers", "ground truth", "training set", or "test set" in the context of an AI/ML assessment. The performance data section explicitly states that "Clinical testing was not required to demonstrate the substantial equivalence" and "Animal testing was not required". The only "performance data" mentioned is process validation for the deep cleaning service.

Therefore, I cannot provide the requested table and study details as they are not present in the provided text.

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The Spectrum Medical Quantum Heater-Cooler is intended to provide temperature-controlled fluid to compatible Quantum PureFlow heat exchanger devices (cardiopulmonary bypass heat exchangers and cardioplegia heat exchangers) to warm or cool a patient during cardiopulmonary bypass procedures lasting six (6) hours or less.

The Quantum Heater-Cooler is only intended to be used by trained Clinicians in a clinical environment.

The Quantum Heater-Cooler consists of the following components:

• . Quantum Heater-Cooler Unit (including connection hoses and heat transfer fluid)
• . Quantum Pure Flow Heat Exchangers (standard and cardioplegia, manufactured by Qura S.r.l.)
• External cold storage charger .

The Quantum Heater-Cooler is intended for cooling and warming patients during cardiothoracic surgeries requiring cardiopulmonary bypass with extracorporeal circulation (procedures lasting six (6) hours or less). The system regulates the temperature of circulating blood and cardioplegia solution using a proprietary glycol-based heat transfer fluid. Thermal energy carried by the heat transfer fluid is transferred from the heater-cooler unit to the patient perfusion circuit via Quantum PureFlow heat exchangers specifically developed for both the arterial and cardioplegia circuits. The heater-cooler, in conjunction with the heat exchangers, forms a closed circuit and no direct contact with the patient's blood or body fluids takes place at any time.

Heating of the heat transfer fluid is accomplished through electrical heaters. For fluid cooling, the Quantum Heater-Cooler utilizes a Phase Change Material as a cold energy storage. This Phase Change Material needs to be routinely recharged between surgeries using an external cold storage charger outside of the operating room environment.

The provided text is a 510(k) summary for the Spectrum Medical Quantum Heater-Cooler. This document details the device's characteristics, intended use, and comparison to a predicate device to demonstrate substantial equivalence, a process which does not involve clinical studies or a study design with acceptance criteria, sample sizes, or expert adjudication as typically seen in efficacy or diagnostic accuracy studies for AI/ML medical devices.

The document is a submission for a Class II medical device (Cardiopulmonary bypass temperature controller), and the FDA has determined it is substantially equivalent to legally marketed predicate devices. This means that extensive clinical trials, as one might expect for a novel AI/ML diagnostic or prognostic tool, are not reported here.

Therefore, the requested information regarding acceptance criteria, study design for proving device performance (including sample sizes, expert involvement, and ground truth establishment), MRMC studies, or standalone performance evaluation is not applicable to this type of regulatory submission (510(k) for a hardware medical device without AI/ML components for diagnostic purposes).

The performance data listed in Section VII, "PERFORMANCE DATA - NON-CLINICAL TESTING," are engineering and safety tests, not clinical performance studies in the vein of diagnostic accuracy. These include:

• Electrical safety
• Electromagnetic compatibility (EMC)
• Electrosurgery interference
• Hardware testing
• Aerosolization testing
• Software verification and validation
• Evaluation of heat transfer fluid for microbial suppression
• Shelf life testing of heat transfer fluid
• Usability evaluation

These are standard engineering and safety tests for such a device, and the document explicitly states "No clinical data were submitted to support the substantial equivalence of the Quantum Heater-Cooler to the Sorin/LivaNova Stöckert Heater-Cooler System 3T."

In summary, none of the requested information regarding acceptance criteria for diagnostic performance, sample sizes for test sets, expert ground truth, adjudication methods, MRMC studies, or standalone performance studies are present in this 510(k) summary because it is not a submission for an AI/ML diagnostic product, but rather for a hardware medical device demonstrating substantial equivalence to a predicate.

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The Heater-Cooler System 3T is used to circulate water through heat exchangers to warm or cool a patient during cardiopulmonary bypass procedures lasting 6 hours or less.

The 3T System is an independent (i.e., independent of the water supply) 3-circuit heating/cooling base unit that includes three water circuits (two circuits for the patient supplied by one tank (for the heating/cooling blanket, the oxygenator) and one interchangeable heating/cooling circuit for cardioplegia. If required, patient and cardioplegia circuits can be switched off separately, in order to increase the activated functional group's heating and/or cooling performance.

The following optional components and accessories are also available for the 3T System:

• 1. Heating-cooling blankets;
• 2. Water circuit tubing; and
• 3. Various cables.
     The 3T System includes a disposable aerosol collection set that consists of a canister connected to the 3T System and the user facility's vacuum source that captures emissions that are drawn from the tank using negative pressure created by the user facility's vacuum.

The Heater-Cooler System 3T is used to circulate water through heat exchangers to warm or cool a patient during cardiopulmonary bypass procedures lasting 6 hours or less.

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

1. Table of Acceptance Criteria and Reported Device Performance

• Microbiological testing verified the hydrophobic filter of the disposable aerosol collection set's canister adequately prevents contamination of the user facility's vacuum source.
• Microbiological and orthogonal assay testing verified the seven-day use period of the disposable aerosol collection set. |
  | Aerosol Collection Set Integrity and Efficacy | Testing verified the chemical resistance of materials, integrity, and efficacy of the disposable Aerosol Collection Set, as well as the integrity of its packaging design. |
  | Heating and Cooling Functions | Testing verified the performance of the heating and cooling functions of the 3T System using a patient simulator circuit. |
  | Corrosion and Erosion Resistance | Testing evaluated the chemical resistance of the metallic and plastic components and materials of the 3T System. |
  | Cleaning, Disinfection, and Preservation of Water Circuit (Intermediate Level) | Validation testing demonstrated an intermediate level of disinfection. Long-term testing (58 weeks) verified that the instructions adequately prevent contamination of the device. |
  | Cleaning and Disinfection of 3T System Surfaces | Validation testing of the 3T System surface cleaning instructions was performed. |
  | Transportation and Storage Packaging | Testing of the transportation and shipping packaging of the 3T System was performed. |
  | Production Disinfection and Drying Process Qualification | Process validation testing of the production disinfection and drying processes was conducted. |
  | Human Factors | Human factors validation testing of the 3T System Operating Instructions was performed. |
  | Substantial Equivalence to Predicate Device (Stöckert Heater-Cooler System 3T) | The Final Configuration 3T System has very similar indications for use, the same fundamental scientific technology, and similar technological characteristics. Performance and validation testing demonstrate that the modified 3T System is as safe and effective as the predicate device. |

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

The provided text does not explicitly state the specific, quantitative sample sizes for each of the performance tests. It describes the types of testing performed (e.g., microbiological, orthogonal assay testing, long-term testing for 58 weeks).

The data provenance is not explicitly stated in terms of country of origin or whether it was retrospective/prospective. The testing appears to be laboratory-based performance testing conducted by the company.

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

This information is not provided in the document. The studies appear to be laboratory performance tests rather than clinical studies requiring expert ground truth for interpretation. For example, microbiological testing determines contamination levels, and heating/cooling tests measure temperature changes against predefined specifications.

4. Adjudication Method for the Test Set

This information is not applicable and thus not provided. Since the tests are described as performance and validation testing (e.g., measuring emissions, verifying filter efficacy, testing heating/cooling functions), there isn't a "ground truth" established by multiple experts that would require an adjudication method. The results are likely binary (pass/fail) or quantitative measurements compared against specifications.

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

An MRMC comparative effectiveness study was not conducted. This device is a medical apparatus (heater-cooler system) and not an AI-powered diagnostic or assistive technology that would involve human readers interpreting cases.

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

This concept is not applicable to the Heater-Cooler System 3T. It is a physical medical device, not an algorithm, so standalone algorithm performance is not relevant.

7. The Type of Ground Truth Used

The "ground truth" for the various performance tests appears to be based on:

• Established industry standards/specifications: For performance aspects like heating/cooling efficiency, corrosion resistance, transportation, and surface cleaning.
• Microbiological control principles: For assessing the reduction in emissions, filter efficacy, and prevention of contamination. This involves measuring microbial counts against acceptable limits.
• Chemical and material science principles: For testing chemical resistance and material integrity.
• FDA guidance: Specifically referenced for "Reprocessing Medical Devices in Health Care Settings: Validation Methods and Labeling" for cleaning, disinfection, and water preservation.

8. The Sample Size for the Training Set

This device does not involve a "training set" in the context of machine learning or AI. The performance testing focuses on the physical and functional aspects of the hardware and associated procedures.

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

As there is no training set for this device, this question is not applicable.

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The Sorin FlexTherm Heater-Cooler System is used with a Stöckert S3 heart-lung machine and / or any other heart-lung machine featuring a separate temperature control for extracorporeal perfusion of durations of up to 6 hours.

Sorin FlexTherm is designed to provide temperature control during extracorporeal procedures. The device can be used in conjunction with heat exchangers tubing sets and heating/cooling blankets present on the market with an intended use in ECC (cardiopulmonary bypass heat exchangers, cardioplegia heat exchangers) and able to withstand a pressure of at least 2 bar. The device is used to warm or cool a patient during cardiopulmonary bypass procedures lasting up to six (6) hours.

As the unmodified device, the Sorin FlexTherm is a software-controlled device provided with hardware elements.

The main components for both devices are the housing provided with wheels, compressor, condenser unit, evaporator, expansion valves, water tanks, heaters, pumps, valves, sensors and a user interface/display.

Here's a breakdown of the acceptance criteria and study information for the Sorin FlexTherm device, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance:

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

• Sample Size for Test Set: The document does not specify a numerical sample size for the in-vitro performance tests. It only states that "Comparative tests were performed according to internal methods developed by the manufacturer."
• Data Provenance: The document does not provide information on the country of origin of the data or whether the tests were retrospective or prospective. It only mentions in vitro testing.

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

• Not Applicable: This information is not provided. The study conducted was in vitro testing, not a clinical study involving expert assessment of patient data for ground truth establishment. The ground truth for these tests would likely be the known physical properties and expected performance of the device and simulators.

4. Adjudication Method for the Test Set:

• Not Applicable: Adjudication methods like 2+1 or 3+1 are typically used in clinical studies for resolving discrepancies in expert interpretations of data (e.g., image readings). Since this was an in vitro performance study, such adjudication methods would not be relevant.

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

• No, an MRMC study was NOT done. The document primarily describes in vitro testing and compliance with safety standards, and software validation. There is no mention of human readers, comparative effectiveness with or without AI assistance, or any effect sizes related to human performance improvement.

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

• Yes (implicitly). The in vitro tests described ("Functional performances without patient simulator" and "Functional performances with patient simulator") are solely focused on the device's inherent performance. The software validation also indicates an assessment of the algorithm's functionality independently. There is no human intervention in the device's operational performance being evaluated in these tests, making them standalone assessments of the device's capabilities.

7. Type of Ground Truth Used:

• The ground truth for the in vitro tests would be based on known physical parameters, engineering specifications, and established performance benchmarks for temperature control, precision, and pump capacity. For example, if a target temperature is 37°C, the ground truth is simply 37°C, and the device's output is measured against that. For electrical safety and EMC, the ground truth is compliance with the specified IEC standards.

8. Sample Size for the Training Set:

• Not Applicable / Not Provided: This device is a hardware heater-cooler system with embedded software. While the software was developed and validated, the document does not indicate that it uses machine learning or AI models that require a "training set" in the conventional sense (i.e., a large dataset for model training). The software development followed standard life cycle processes, which involves design, coding, and validation, rather than data-driven machine learning training.

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

• Not Applicable / Not Provided: As noted above, the concept of a "training set" and associated ground truth establishment for machine learning models does not appear to apply to this device's software development as described in the document. The software validation relied on established software engineering principles and FDA guidance.

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The HCU 40 is intended to circulate water through heat exchange circuits to warm or cool a patient during short duration cardiopulmonary bypass procedures lasting 6 hours or less.

The Heater-Cooler Unit HCU 40 is used to supply temperature-controlled water to regulate the patient temperature during extracorporeal circulation (ECC). Further application areas are warming and/or cooling therapies. The device can also be used to control the temperature of a cardioplegia solution. Therefore the Heater-Cooler Unit HCU 40 contains two independent water circuits. One circuit (main circuit) can be connected to the blood heat exchanger (part of the oxygenator) and/or to the warming/cooling blanket. The other circuit (cardioplegia circuit) can be connected to the cardioplegia heat exchanger. The use of an UV treatment does significantly enhance the water quality between the water change intervals. The heat exchange with the patient and the cardioplegia fluid occurs when the water passes the heat exchangers and/or the blanket. The water temperature of the main and the cardioplegia circuit can be regulated independently from each other.

Here's an analysis of the provided text regarding the MAQUET HCU 40 Heater-Cooler Unit, focusing on the acceptance criteria and study details.

Important Note: The provided document is a 510(k) summary for a medical device. This type of submission primarily focuses on demonstrating "substantial equivalence" to a predicate device rather than conducting extensive clinical efficacy studies as one might find for a novel drug or a high-risk Class III device. Therefore, the information regarding acceptance criteria and performance studies will be different from what you might expect for an AI/ML-based diagnostic device.

1. Table of Acceptance Criteria and Reported Device Performance

Based on the provided document, the "acceptance criteria" for the HCU 40 are primarily demonstrated through its substantial equivalence to its predicate device, the HCU 30. The performance is assessed through non-clinical tests verifying that the device meets its design requirements and is safe and effective.

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

This document describes a medical device (Heater-Cooler Unit), not an AI/ML diagnostic system. Therefore, the concept of a "test set" in the context of an algorithm's performance is not applicable here.

• Test Set Sample Size: Not applicable. The device undergoes engineering verification and validation testing, not a "test set" of patient data for AI model evaluation.
• Data Provenance: Not applicable in the AI/ML sense. The non-clinical tests are performed on the device itself and its components. The device manufacturer is MAQUET Cardiopulmonary AG, located in Rastatt, Germany, and the contact person is in Wayne, NJ, USA.

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

Not applicable. This is not an AI/ML diagnostic device requiring expert interpretation for ground truth establishment. The "ground truth" for this device's performance would be derived from engineering specifications, established medical device standards, and the performance characteristics of its predicate device as verified through non-clinical testing.

4. Adjudication Method for the Test Set

Not applicable. There is no "test set" in the context of human-reviewed cases for AI ground truth adjudication. Non-clinical testing results would be reviewed and accepted by internal engineering and quality personnel according to established protocols.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size of How Much Human Readers Improve with AI vs. Without AI Assistance

Not applicable. This is not an AI-assisted diagnostic device. No MRMC study was conducted or is relevant for this type of device submission. The document explicitly states: "No clinical evaluation of the modified device was conducted or required."

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

Not applicable. This device is not an algorithm. It is a physical medical device.

7. The Type of Ground Truth Used

The "ground truth" for this device is effectively its ability to meet engineering specifications, safety standards, and functional requirements as verified through laboratory and bench testing, and its equivalence to a legally marketed predicate device. This is primarily based on:

• Engineering Specifications: The design requirements for temperature control, flow rates, safety features, etc.
• Regulatory Standards: Compliance with relevant national and international medical device standards.
• Predicate Device Performance: The HCU 30's established safety and effectiveness.

8. The Sample Size for the Training Set

Not applicable. This device does not use machine learning or AI algorithms, so there is no "training set."

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

Not applicable, as there is no training set for an AI/ML algorithm.

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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 CardioQuip Modular Cooler-Heater (MCH) is indicated to supply temperature-controlled water to heat exchange devices (e.g.; CPB Heat Exchangers, Cardioplegia Heat Exchangers and thermal regulating system blankets) to help control a patient's temperature during cardiopulmonary bypass procedures lasting not longer than six hours.

Not Found

I apologize, but the provided text only contains an FDA 510(k) clearance letter for the CardioQuip Modular Cooler-Heater (MCH). This document does not contain any information about acceptance criteria, study details, or performance data of the device.

Therefore, I cannot fulfill your request to describe the acceptance criteria and the study that proves the device meets them, as the necessary information is not present in the given text.

The document primarily focuses on:

• Confirming the substantial equivalence of the CardioQuip MCH to a legally marketed predicate device.
• Outlining regulatory requirements and guidance for the manufacturer (CardioQuip, LLP).
• Stating the intended "Indications For Use" for the CardioQuip MCH.

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The Terumo® HX2™ Temperature Management System is indicated for use to supply temperature regulated water to heat exchangers during open heart surgery.

The Terumo® HX2™ Temperature Management System provides temperature control of two independent water circuits that directly control the temperature of patient blood and cardioplegia solution during cardiovascular bypass surgery.

The system consists of a water tank, circulating pumps, heater manifolds, mercury free temperature sensors, water detectors, mixing valves and a tank divider which is provided to partition the tank into two separate channels (Left and Right).

The system will have the capacity to circulate water at least 6.5 gal/min (25 L/min) with no load connected.

The system is capable of heating and cooling for a single channel or for both channels.

Channels are configurable such that different waterlice mixture ratios can be obtained. Manually added ice is the only means of obtaining the cool water supply. If a channel should fail during use, the user may switch the water hose connections to the other channel allowing the user to be operational in less than or equal to a minute.

Software is used to adjust and display channel set temperatures, acquire and display actual temperatures, automatically regulate temperatures to the entered setpoint, perform system diagnostics, and present visual and audible indications of faults that may occur.

The provided text describes a 510(k) premarket notification for the Terumo® HX2™ Temperature Management System. This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than providing extensive clinical study data with specific acceptance criteria, sample sizes, and expert ground truth establishment for AI/Machine Learning performance.

Therefore, the requested information regarding acceptance criteria, study details, and AI-specific metrics (like MRMC or standalone performance, training data, etc.) is not applicable to this traditional 510(k) submission as it is not an AI/ML device.

The document states that the device's performance was "exhaustively tested and compared with the performance characteristics of the currently marketed Sarns™ Dual Cooler/Heater and the Sarns™ Temperature Control and Monitor System (TCM II)." It also concludes that "The Terumo® HX2 ™ Temperature Management System performed as intended according to its performance specifications." However, the specific acceptance criteria and the detailed results of these tests (e.g., in a table format) are not provided in this summary.

General Summary of the Device and its Testing as per the Document:

• Device: Terumo® HX2™ Temperature Management System
• Indication for Use: To supply temperature regulated water to heat exchangers during open heart surgery.
• Legal Basis: 510(k) premarket notification, demonstrating substantial equivalence to predicate devices (Sarns™ Dual Cooler/Heater and Sarns™ Temperature Control and Monitor System (TCM II)).
• Performance Evaluation: Non-clinical performance testing was conducted where the HX2™ system's characteristics were compared to its predicate devices.
• Conclusion: The device performed as intended based on its performance specifications and was found to be substantially equivalent to its predicate devices.

Specific answers to the requested points, based only on the provided text:

1. Table of acceptance criteria and the reported device performance:
   • Acceptance Criteria: Not explicitly stated in a quantitative table. The general acceptance criterion is that the device "performed as intended according to its performance specifications" and its characteristics were successfully "compared with the performance characteristics" of the predicate devices.
   • Reported Device Performance:
     • Circulate water at least 6.5 gal/min (25 L/min) with no load.
     • Capable of heating and cooling for a single channel or both channels.
     • User can switch water hose connections to the other channel allowing operation in ≤ 1 minute if a channel fails.
     • Automated control for both heating and cooling.
     • Improvements to priming and draining.
     • Range of user temperature setpoints for both channels (compared to 4 hardware-limited setpoints of predicate).
     • New system diagnostics display error codes.
     • Temperature display accuracy "better than analog temperature display on Dual Cooler Heater."
     • Operation within 10° to 40°C,

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The Stöckert Heater-Cooler System 3T is intended to provide temperature-controlled water to heat exchanger devices (cardiopulmonary bypass heat exchangers, cardioplegia heat exchangers, and thermal regulating blankets) to warm or cool a patient during cardiopulmonary bypass procedures lasting six (6) hours or less.

The Stöckert Heater-Cooler System 3T is used with a Stöckert S3 heart-lung machine and/or any other heart lung machine featuring a separate temperature control for extracorporeal perfusion of durations of up to 6 hours.

The Sorin Group Deutschland GmbH Stöckert Heater-Cooler System 3T consists of standard and optional components. The standard components comprise the heater-cooler base unit, water connectors, CAN-connecting cable for the S3 System, potential equalization cable, and Operating Instructions. Patient blankets used with the System are already legally marketed in the United States.

The provided text describes a 510(k) premarket notification for the Sorin Group Deutschland GmbH Stöckert Heater-Cooler System 3T. This type of regulatory submission focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than providing extensive independent clinical study data to prove the device meets specific acceptance criteria based on performance metrics.

Therefore, the document does not contain the information requested regarding acceptance criteria and a study proving the device meets those criteria, as typically seen in submissions requiring clinical performance data.

Specifically, the document states:

• "Testing submitted in this premarket notification demonstrates that the Stockert Heater-Cooler System 3T complies with specifications, meets user requirements, and the differences between the proposed device and cited predicate devices do not raise new issues of safety or effectiveness."

This indicates that internal testing was performed to ensure the device met its design specifications and user requirements, which is a standard part of device development. However, the details of these "specifications" and "user requirements" are not provided, nor is information on the methodology, sample size, or outcomes of such testing in the context of comparative performance against specific, quantifiable acceptance criteria that would typically be described in a clinical study report.

In summary, the document addresses substantial equivalence based on technological characteristics and intended use, and mentions compliance with specifications and user requirements, but it does not detail a study proving the device meets acceptance criteria in the manner of performance, diagnostic accuracy, or clinical outcome as would be required for a different kind of regulatory submission or a standalone effectiveness study.

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The Jostra HCU 30 is intended to circulate water through heat exchange circuits to warm or cool a patient during short duration cardiopulmonary bypass procedures lasting 6 hours or less.

The Jostra Heater-Cooler Unit HCU 30 supplies temperature-controlled water for cardioplegia heat exchangers, for blood heat exchangers in extra corporeal circulation and for blankets with which patients can be warmed or cooled. The water temperature is adjustable from 1°C to 41°C. A 26 litre tank with ice and approx. 1ºC cold water assures quick cooling of the patient. Two independent circuits with separate temperature controls can be attached (the main side has two connections). A safety system monitors the regulation in order to prevent the temperature from rising above 42°C.

Unfortunately, the provided text does not contain the specific details required to complete your request in full regarding acceptance criteria, study design, and performance metrics. The document is primarily a 510(k) summary for a medical device, which focuses on demonstrating substantial equivalence to a predicate device rather than presenting detailed study results in the format you've requested for AI/ML device evaluations.

Here's a breakdown of what can be extracted and what is missing based on your criteria:

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

The document lists "Technical Characteristics Comparison" between the Jostra HCU 30 and the predicate device (Terumo TCM II). While it doesn't explicitly state "acceptance criteria," the comparison table implies that the performance of the Jostra device is deemed acceptable if it is comparable to or better than the predicate device's specifications for relevant parameters.

Note on Interpretation: This table presents a comparison, and the "acceptance criteria" are implied by the performance of the legally marketed predicate device. The Jostra HCU 30 is considered acceptable if its performance is comparable and safe for its intended use. In many cases, the Jostra device meets or exceeds the predicate's specifications.

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

This information is not provided in the document. The document mentions "Performance testing" and "Constructional Safety testing," but does not detail the nature of these tests in terms of sample size for a test set, data provenance, or whether they involved human subjects or real-world data in the context of an AI/ML device. For a physical device like a heater-cooler unit, these tests would likely involve bench testing and simulations rather than patient data.

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)

This information is not provided. This concept of "ground truth" established by experts is typically relevant for diagnostic AI/ML devices where human interpretation is involved. For a physical device like a heater-cooler unit, ground truth would be established by objective measurements against known standards.

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

This information is not provided. Adjudication methods are relevant for subjective evaluations, often in clinical trials or image interpretation, where a consensus among experts is needed. This is not applicable to the type of device 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

There is no indication of an MRMC study, nor is "AI assistance" relevant for this device. This is a physical medical device (heater-cooler unit), not a diagnostic AI/ML system.

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

This concept is not applicable to the Jostra HCU 30. It is a physical device that performs a function (heating/cooling water) that is directly controlled by the device itself, not an "algorithm only" or an AI system that provides an output requiring human interpretation. Its performance is inherent to its design and operation.

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

Given the nature of the device (a heater-cooler unit), the "ground truth" would be objective physical measurements and engineering standards. For example:

• Temperature accuracy: Measured against calibrated thermometers.
• Flow capacity: Measured using flow meters.
• Pressure: Measured using pressure gauges.
• Safety features: Tested to ensure they activate at specified thresholds (e.g., temperature alarms, over-pressure relief).

The document mentions "Performance testing included: Heating mode test, Cooling mode test, Cleaning cycle test, Alarm function test, Interface test with RCU30 and HL30, Reliability test, Pressure regulation test, Flow capacity test" and "Constructional Safety testing included: Electrical Safety, Electromagnetic compatibility EMC, Package and Transportation." These tests inherently involve measuring against defined physical and electrical standards, which serve as the "ground truth."

8. The sample size for the training set

This information is not provided and is not applicable. This device is not an AI/ML model that requires a "training set." Its design and performance are based on engineering principles and physical components, not machine learning.

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

This information is not provided and is not applicable as there is no training set for this type of device.

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