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Essenz HLM is intended to be used during cardiopulmonary bypass for procedures lasting six (6) hours or less.

Essenz ILBM is indicated for supplementary, in-line monitoring of the extracorporeal arterial oxygen partial pressure, venous oxygen saturation, venous hematocrit/hemoglobin, and arterial and venous temperature during cardiopulmonary bypass procedures up to six (6) hours.

Essenz HLM is a modular heart-lung machine. The device consists of a central console base for support, positioning mobility and power supply, roller and centrifugal pumps, user interface displays, controls, clamps and sensors for the monitoring of extracorporeal perfusion.

The Essenz HLM is configurable to user needs with different system components. The main configurable and optional system components consist of: Console, Cockpit, Control Units/ Console Control Units, Pumps, Bubble sensor, Level sensor, Temperature sensor, Pressure sensor, Flow Sensor, Manual Venous Occluder, Venous Clamp, Arterial Clamp, EP-Pack/ Power Pack, Cabinet (Enclosure), Mast.

Essenz ILBM is used for in-line continuous monitoring of patient's blood parameters during procedures requiring extracorporeal circulation when used with a compatible heart-lung machine.

Provided in-line measured parameters of Essenz ILBM are: In the Venous line: Haematocrit / Haemoqlobin (Hct/Hb), Venous blood oxygen saturation (sO2), Venous blood temperature (venT). In the Arterial line: Arterial blood oxygen partial pressure (pO2), Arterial blood temperature (artT).

The duration of application is limited to 6 hours of continuous use.

Essenz ILBM consists of the following components / disposables: B-Capta Venous and Arterial Sensors, Essenz ILBM Sensor Module, B-Capta Venous and Arterial Reference Element Holders, B-Capta disposable Venous and Arterial Cuvettes.

The B-Capta venous sensor is an optical sensor which measures hematocrit/hemoglobin and oxygen saturation using an optical reflectance technology when connected to its dedicated disposable cuvette. Infrared technology is used to measure the temperature of the venous blood.

The B-Capta arterial sensor is an optical sensor which measures, partial pressure of oxygen using an optical fluorescence technology when connected to its dedicated disposable cuvette. Infrared technology is used to measure the temperature of the arterial blood.

Both sensors are functionally connected to the compatible heart-lung machine. Data are displayed on the graphical user interface of the compatible heart-lung machine.

The provided document is a 510(k) premarket notification for two devices, Essenz HLM and Essenz ILBM, and focuses on demonstrating their substantial equivalence to predicate devices rather than proving performance against specific acceptance criteria through a clinical study.

Therefore, the document does not contain the detailed information to answer most of your questions regarding acceptance criteria, study design, sample sizes, expert qualifications, or ground truth establishment as it would for a device undergoing de novo review or requiring clinical trials for efficacy.

Here's a breakdown of what can be answered based on the provided text, and what cannot:

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

• Cannot be provided. The document states "No clinical testing was conducted in support of the Essenz HLM and Essenz ILBM as the technological characteristics and indications for use are equivalent to those of the predicate devices." Instead, the submission relies on non-clinical testing (electrical safety, EMC, performance testing, software verification and validation) to demonstrate substantial equivalence to the predicate devices, implying that their performance is similar to already cleared devices. No specific performance metrics or acceptance criteria are detailed in this summary.

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

• Cannot be provided. No clinical test set data is described. The non-clinical testing does not typically refer to "sample size" in the same way a clinical study would (e.g., number of patients or cases).

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)

• Cannot be provided. Since no clinical test set requiring expert ground truth establishment was conducted, this information is not available.

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

• Cannot be provided. 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

• Cannot be provided. The devices (Heart-Lung Machine and Extracorporeal Blood-Gas Monitor) are not AI-assisted devices that would involve human readers or MRMC studies.

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

• Partially applicable, but for different device types. The devices described (Essenz HLM and Essenz ILBM) are medical devices, not AI algorithms. Their "standalone performance" is assessed through the non-clinical testing mentioned (electrical safety, EMC, performance testing, software V&V) rather than solely as an algorithm. The document explicitly states "No clinical testing was conducted."

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

• Cannot be provided. As no clinical studies demanding ground truth were performed, this information is not present. For non-clinical tests, "ground truth" would be defined by engineering specifications, reference measurements, and standard testing methodologies.

8. The sample size for the training set

• Cannot be provided. These are not machine learning/AI devices where a "training set" would be applicable in the context of clinical data.

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

• Cannot be provided. See answer to #8.

In summary, the provided FDA 510(k) summary focuses on demonstrating substantial equivalence through non-clinical testing (electrical safety, EMC, performance testing, software verification and validation) rather than presenting results from a clinical study with detailed acceptance criteria and ground truth validation.

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Essenz HLM is intended to be used during cardiopulmonary bypass for procedures lasting six (6) hours or less.

Essenz HLM is a modular heart-lung machine like its primary predicate Stöckert S5 System. The device consists of a central console base for support, positioning mobility and power supply, roller and centrifuqal pumps, user interface displays, controls, clamps and sensors for the monitoring of extracorporeal perfusion. The Essenz HLM is configurable to user needs with different system components. The main configurable and optional system components consist of: Console, Cockpit, Control Units/ Console Control Units, Pumps, Bubble sensor, Level sensor, Temperature sensor, Pressure sensor, Flow Sensor, Manual Venous Occluder, Electrical venous occluder (EVO), Arterial Clamp/ Electric Remote Control, EP-Pack/ Power Pack, Cabinet (Enclosure), Mast.

This FDA 510(k) summary for the Essenz HLM heart-lung machine does not contain information on acceptance criteria for device performance or a study proving that the device meets those criteria. In fact, it explicitly states "CLINICAL TESTING: None required" and "ANIMAL TESTING: None required."

The document details non-clinical testing for verification and validation, but these tests are against recognized standards for electrical safety, EMC, software, human factors, and mechanical performance, rather than specific, quantified device performance acceptance criteria.

Therefore, I cannot provide the requested information from the provided text.

Here's why the document doesn't contain the requested information in the typical format for AI/ML device evaluations:

• Device Type: The Essenz HLM is a hardware medical device (a heart-lung machine console) used for cardiopulmonary bypass. The questions you've asked (acceptance criteria, study design, sample size, ground truth, expert consensus, MRMC studies, standalone performance) are highly relevant to AI/Machine Learning (AI/ML) driven medical devices, especially those involved in diagnostic or predictive tasks where performance metrics like sensitivity, specificity, or AUC are critical and need to be validated against expert ground truth.
• Regulatory Pathway: This is a 510(k) submission, which demonstrates substantial equivalence to a predicate device. For hardware devices like this, substantial equivalence is often established through detailed comparisons of technological characteristics, materials, and non-clinical performance (electrical safety, EMC, mechanical testing, software verification) against recognized standards, rather than clinical efficacy studies on patient outcomes or AI model performance.
• Focus of the Document: The document focuses on demonstrating that the Essenz HLM is as safe and effective as its predicate through engineering verification and validation testing, not through a study evaluating its diagnostic accuracy or predictive capability.

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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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ESSENZ Patient Monitor is a modularly structured program package that is exclusively used with LivaNova Heart-Lung Machines. The system allows detailed recording of perfusion data during cardiopulmonary bypass as well as the processing and evaluation of this data. The data may be recorded automatically or entered manually.

The ESSENZ Patient Monitor is used to collect and view data generated during cardiopulmonary bypass surgery. It interfaces with LivaNova Heart-Lung machines to capture this data.

The ESSENZ Patient Monitor includes the following main components:

• Software: The data-recording software installed on the Perfusion System Monitor hardware; known as "ESSENZ Patient Monitor". It is used to save and process the collected data.
• Hardware: The Perfusion System Monitor. It is used to display and transfer the collected data.
• Hardware: A mast holder to mount the Perfusion System Monitor on a vertical mast of the respective LivaNova HLM.

This document describes the ESSENZ Patient Monitor, a device used with LivaNova Heart-Lung Machines to record, process, and evaluate perfusion data during cardiopulmonary bypass. The information provided is for a 510(k) premarket notification (K212003).

Here's an analysis of the acceptance criteria and supporting studies based on the provided text:

1. Table of Acceptance Criteria and the Reported Device Performance:

The document does not explicitly present a table of acceptance criteria with specific numerical targets. Instead, it states that the device was evaluated against recognized standards and through various non-clinical tests to demonstrate substantial equivalence to a predicate device (Sorin CONNECT, K170460). The general acceptance criterion is that the modified device is "as safe and effective" as the predicate.

For the purpose of this request, we can infer the categories of acceptance criteria from the performed tests and their general outcome:

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

• Test Set Sample Size: The document does not specify a quantitative "test set sample size" in terms of patient data or specific number of tests. The testing described (Electrical Safety, EMC, Performance, Software V&V, Human Factors, Shipping) is related to hardware and software requirements, not clinical data sets in the typical sense of a diagnostic or therapeutic algorithm.
• Data Provenance: The tests conducted are non-clinical hardware and software verification and validation tests performed by the manufacturer, LivaNova Deutschland GmbH. The data provenance is internal to the manufacturer's testing processes. There is no mention of country of origin for a clinical data set because no clinical testing was performed or relied upon. The report states, "No animal testing was submitted to support the substantial equivalence of the modified device to the cleared Sorin CONNECT," and "No clinical testing was conducted in support of ESSENZ Patient Monitor."

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

This information is not applicable to the submitted document. The "ground truth" in this context refers to the compliance with engineering and regulatory standards established through non-clinical testing. These tests are evaluated against predefined specifications and industry standards, not against an expert-established clinical ground truth for a diagnostic outcome.

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

This information is not applicable. Adjudication methods like 2+1 or 3+1 are typically used in clinical studies for interpretation of images or clinical outcomes, which were not part of this 510(k) submission for the given device. The testing was against engineering specifications and recognized standards.

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 MRMC study was conducted or is relevant to this device's submission. The ESSENZ Patient Monitor is a data management system for perfusion data during cardiopulmonary bypass; it is not an AI-assisted diagnostic tool that would involve human readers or image interpretation.

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

The concept of "standalone performance" for an algorithm often applies to diagnostic or predictive AI. In this case, the "standalone performance" can be considered as the device's ability to accurately record, process, and evaluate perfusion data according to its specifications and in compliance with the relevant standards (IEC 60601-1, IEC 60601-1-2, IEC 62304, etc.) without human intervention in the data handling itself. The software verification and validation, along with performance testing, would cover this aspect. However, the device is explicitly used "with LivaNova Heart-Lung Machines" and the data can be "recorded automatically or entered manually," implying it is part of a larger system where human interaction remains.

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

The "ground truth" for the non-clinical testing of the ESSENZ Patient Monitor is compliance with established engineering and safety standards (e.g., IEC 60601 series, IEC 62304, ISO 14971). The ground truth for its functional performance (data recording, processing, evaluation) would be derived from comparisons against expected computational and display outputs based on defined inputs, ensuring accuracy and reliability as specified in the device's design.

8. The sample size for the training set:

This information is not applicable. The ESSENZ Patient Monitor is a data management system, not a machine learning or AI model that requires a "training set." The software is re-engineered from a legacy version and verified/validated against specifications.

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

This information is not applicable, as there is no "training set" for this device.

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The Stöckert SS System is intended to be used during cardiopulmonary bypass for procedures lasting six (6) hours or less.

The S5 System is configurable to user needs with different system components. The main configurable and optional system components consist of: Console, System Panel, Pumps, Bubble detector, Level control, Temperature monitor, Pressure control, Cardioplegia Control, Electronic gas blender, Serial Data interface, Venous line clamps (manual), Electrical venous occlude (EVO).

The provided text is a 510(k) summary for the Stöckert S5 System, a Class II medical device (Heart-Lung Machine). It describes the device, its intended use, and the non-clinical testing performed to demonstrate substantial equivalence to a predicate device.

Here's an analysis of the acceptance criteria and the study that proves the device meets them, based on the provided text:

No specific acceptance criteria (numerical thresholds for performance metrics) or a study proving that the device meets those criteria is explicitly provided in the typical format one would expect for an AI/ML device.

The document is a 510(k) Pre-market Notification, which focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than proving a device meets specific performance acceptance criteria against a clinical endpoint with defined sensitivity/specificity/accuracy thresholds. The studies described are primarily verification and validation (V&V) testing to ensure the device performs as intended and is safe and effective compared to its predicate.

Therefore, the interpretation below will focus on understanding the "acceptance criteria" through the lens of substantial equivalence and the "study" as the non-clinical testing performed for this purpose.

1. Table of Acceptance Criteria and Reported Device Performance

As noted, the document doesn't provide a typical table of acceptance criteria with numerical targets (e.g., sensitivity, specificity, accuracy). Instead, the "acceptance criteria" are implied by compliance with recognized standards and successful completion of various V&V tests, demonstrating that the device functions correctly and safely. The "reported device performance" is the successful completion of these tests.

Regarding the remaining requested information, it's important to understand that this document describes a hardware/software medical device (a Heart-Lung Machine) and not an AI/ML diagnostic or prognostic algorithm. Therefore, many of the requested fields are not applicable or cannot be answered from the provided text because they relate specifically to AI/ML performance evaluation.

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

• Not Applicable / Not Provided: The nature of the testing (electrical safety, EMC, mechanical, software V&V) does not typically involve "test sets" of patient data or data provenance in the way an AI/ML diagnostic device would. These tests are performed on the device itself or its components. The document does not specify sample sizes for these engineering tests (e.g., how many units were tested for electrical safety).

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

• Not Applicable: This type of medical device (Heart-Lung Machine) does not involve establishing ground truth from expert interpretation in the context of diagnostic or prognostic tasks. The "ground truth" for its performance is determined by meeting engineering specifications and safety standards.

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

• Not Applicable: Adjudication methods are relevant for resolving discrepancies in expert interpretations of data, typically in AI/ML performance studies. This is not described for the V&V testing of a Heart-Lung Machine.

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, a MRMC study was not done. This is a non-AI/ML device. The "multi reader multi case" paradigm and "human readers improve with AI" concepts are not applicable to the S5 System as described.

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

• Not Applicable / Not Relevant in the AI/ML sense: The device is a standalone hardware/software system designed to perform its functions. The V&V testing assesses its performance in this standalone capacity. However, this is not equivalent to a "standalone" AI algorithm performance evaluation, as it's an operational medical device with human interaction as part of its intended use.

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

• Engineering Specifications and Recognized Standards: The "ground truth" for the device's performance is compliance with established engineering specifications, design requirements, and recognized international standards (e.g., IEC 60601 series, IEC 62366-1, IEC 62304, ISO 14971) for safety and effectiveness.

8. The sample size for the training set

• Not Applicable: This device is not an AI/ML system that uses a "training set" of data.

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

• Not Applicable: This device is not an AI/ML system that uses a "training set" of data.

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B-Capta is indicated for supplementary, in-line monitoring of the extracorporeal arterial oxygen partial pressure, venous oxygen saturation, venous hematocrit/hemoglobin, and arterial and venous temperature during cardiopulmonary bypass procedures up to six hours.

B-Capta is intended to be used for in-line continuous monitoring of patient's blood parameters during procedures requiring extracorporeal circulation.

B-Capta is designed to work with a Stöckert S5 System (K071318) heart-lung machine.

Provided in-line measured parameters of B-Capta are: In the Venous line:

• Haematocrit / Haemoglobin (Hct/Hb)
• Venous blood oxygen saturation (sO2)
• Venous blood temperature (venT)

In the Arterial line:

• Arterial blood oxygen partial pressure (pO2)
• Arterial blood temperature (artT)

The duration of application is limited to 6 hours of continuous use.

B-Capta consist of the following components / disposables:

• B-Capta Venous and Arterial Sensors
• B-Capta Sensor Module
• B-Capta Venous and Arterial Reference Element Holders
• B-Capta disposable Venous and Arterial Cuvettes

B-Capta is a microprocessor based device. The venous sensor is an optical sensor which measures, when connected to its dedicated disposable cuvette, hematocrit/hemoglobin and oxygen saturation using an optical reflectance technology. Moreover, an infrared technology is used to measure the temperature of the venous blood.

The arterial sensor is an optical sensor which measures, when connected to its dedicated disposable cuvette, partial pressure of oxygen using an optical fluorescence technology. Moreover, an infrared technology is used to measure the temperature of the arterial blood.

Both sensors are functionally connected to the compatible heart-lung machine via a cable plugged in the sensor module and communicate with B-Capta firmware via a RS232 interface according to a dedicated communication protocol. Data are displayed on the graphical user interface of the heart-lung machine.

The provided text describes a 510(k) premarket notification for the B-Capta device. This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than providing extensive de novo clinical study data to establish acceptance criteria and prove device performance against them.

Therefore, many of the requested details about acceptance criteria, specific study designs, sample sizes, and expert qualifications for ground truth are not present in this regulatory document. The document primarily highlights non-clinical testing performed to support substantial equivalence.

Here's a breakdown based on the information available:

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

This information is not explicitly available in the provided text. The document states "Design functionality testing confirms that the product meets its product requirements," but it does not specify what those requirements (acceptance criteria) are or provide quantitative performance results against them.

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 available. The document mentions "Design Verification and Validation Testing" and "Software verification and validation testing," but it does not provide details on sample sizes, data provenance, or the nature of these "test sets" for performance evaluation in a clinical or simulated clinical context.

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 available. Given that no clinical testing was required or submitted, there's no mention of experts establishing a ground truth for a test set.

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

This information is not available. No adjudication method is mentioned as there's no reported test set requiring expert 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

This information is not applicable/not available. The B-Capta is an on-line blood gas monitor, not an AI-assisted diagnostic imaging device that would involve human readers or MRMC studies.

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

The B-Capta device itself is a standalone measurement device, intended for in-line continuous monitoring. Its performance is evaluated on its ability to accurately measure blood parameters. While "standalone performance" was implicitly assessed through design verification and validation, the document does not present this as a separate study with specific metrics (e.g., sensitivity, specificity) against a reference standard in the way an AI algorithm's standalone performance might be described. It focuses on functional compliance and safety.

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

For the performance of measuring blood parameters, the ground truth would typically be established by:

• Reference laboratory methods: For blood gas parameters, this usually involves validated laboratory blood gas analyzers.
• Traceable standards: For temperature measurements, calibrated temperature probes.

The document does not explicitly state the specific "ground truth" methods used during its design verification and validation, but these would be the standard approaches for such a device.

8. The sample size for the training set

This information is not available. The B-Capta is described as a "microprocessor based device" with optical and infrared sensors. It's not explicitly framed as a machine learning/AI device requiring a "training set" in the typical sense of deep learning or predictive models. Its functionality is based on established physical principles for sensing.

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

This information is not available and likely not applicable, as explained in point 8.

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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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