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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 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 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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