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The Terumo® Advanced Perfusion System 1 is indicated for use for up to six hours in the extracorporeal circulation of blood for arterial perfusion, regional perfusion, and cardiopulmonary bypass procedures, when used by a qualified medical professional who is experienced in the operation of this or similar equipment.

The centrifugal pump is indicated for use in cardiopulmonary bypass procedures only.

The Terumo® Advanced Perfusion System 1 (System 1) is a configurable heart-lung system with a distributed network architecture that allows the user to customize the number and types of system components, which can then be configured, displayed, and controlled from a central monitor. The system is designed to enable users to choose from the Terumo CVS supplied components to define and configure a heart-lung system to meet individual institution requirements.

The System 1 components are listed below.

• . System 1 Base:
  • Chassis platform Provides operating power and back up battery power for all system O components (100/120V or 220/240V)
  • Central Control Monitor (CCM) A display used for configuration and control of o system components
  • Two roller pump hand cranks and hand crank bracket O
• Pump(s) and pump mounting hardware Up to eight pumps can be used with System 1, ● including the following:
  • 0 6" Roller Pump
  • 0 4" Roller Pump
  • O Centrifugal Control Unit with Centrifugal Drive Motor (up to 2)
• Pods
  • Air Bubble Detection Pod Used to detect air bubbles in the extracorporeal circuit, in O conjunction with the air sensor
  • Level Detection Pod Used to monitor liquid levels within a hard shell reservoir. O
  • O Pressure Pod - Used to monitor the pressure in the extracorporeal circuit
  • Temperature Pod Used to monitor the temperature in the extracorporeal circuit and / O or the patient
  • Flowmeter Pod Used to monitor flow volume and generate an alarm if backflow is O detected
  • Venous Line Occluder Pod Used with the Occluder Head to provide a computer O controlled tube clamping mechanism to regulate flow in the venous line
  • Interface Pods to enable data transfer between cardiac monitoring and data display o systems (i.e., Terumo CDI™ 500 Monitor, and TLink™ Data Management System)
• Electronic Patient Gas System (EPGS) Provides control and monitoring of the gas output to . the oxygenator
• Flexible Lamps (15 inch or 33 inch) for local illumination .
• . Mounting hardware (e.g., center poles, crossbars, and brackets)

This document refers to the Terumo® Advanced Perfusion System 1, a cardiopulmonary bypass heart-lung machine console (K221895). The submission is a 510(k) for a modified device, claiming substantial equivalence to a predicate device (K172220). The modifications primarily involve updating the Central Control Monitor (CCM) hardware and associated software due to component obsolescence. As such, the study does not involve evaluating the primary clinical performance of the heart-lung machine in a traditional sense, but rather the performance of the updated components to ensure they meet the existing safety and effectiveness standards.

Given the nature of the device (a heart-lung machine console) and the modifications being for component obsolescence, the "device performance" in relation to acceptance criteria primarily revolves around technical and functional verification rather than clinical metrics like sensitivity or specificity.

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample Size for the Test Set and Data Provenance

Due to the nature of the device modification (component obsolescence and software updates for an existing heart-lung machine console), the "tests" described are primarily engineering verification and validation activities rather than clinical trials with patient data.

• Test Set Sample Size: Not explicitly stated in terms of patient data or typical "test set" in an AI/imaging context. The testing involved various units of the device (or components thereof) for hardware and software verification. For usability validation, it involved "external perfusionists" as "usability testers," but the number of such testers is not specified.
• Data Provenance: Not applicable in the context of patient data for clinical performance. The data provenance described is from internal and external engineering testing, demonstration, inspection, and analysis by the manufacturer (Terumo Cardiovascular Systems Corporation) and external testing facilities for specific standards (e.g., electrical safety, EMC).

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

• Number of Experts: For the hardware validation (usability testing), "external perfusionists" were used as "usability testers." The specific number of these experts is not defined.
• Qualifications of Experts: They are described as "external perfusionists," implying they are qualified medical professionals experienced in operating such equipment, as per the device's indications for use.

4. Adjudication Method for the Test Set

Not applicable. The reported tests are primarily engineering and functional verification, and usability testing by qualified professionals, rather than diagnostic interpretation requiring adjudication of results.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done

No, an MRMC comparative effectiveness study was not done. This type of study is typically performed to evaluate the diagnostic performance of an AI-powered system, often in comparison to human readers, and the current submission is for a hardware/software update of an existing mechanical device, not an AI diagnostic tool.

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

The device is a heart-lung machine console, which by its nature requires human operators (qualified medical professionals). Therefore, "standalone" performance in the context of an AI algorithm is not directly applicable. The device's software performance was validated through various engineering tests (system-level testing, boundary tests, code reviews, integration testing), but always in the context of its function within the complete system operated by a human.

7. The Type of Ground Truth Used

The "ground truth" here is defined by:

• Engineering Specifications and Requirements: For all hardware and software verification tests.
• Industry Standards: For electrical safety (IEC 60601-1), EMC (IEC 60601-1-2), shipping and vibration (ISTA-3A, MIL-STD-810G).
• User Needs and Risk Mitigations: For the hardware validation/usability testing.

8. The Sample Size for the Training Set

Not applicable. This submission is for a hardware/software update to an existing medical device, not an AI/machine learning algorithm requiring a "training set" of data in the conventional sense. The "software updates" mentioned are traditional programming changes to address component obsolescence and improve existing functionalities.

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

Not applicable, as there is no "training set" in the context of an AI algorithm.

Ask a specific question about this device

The Terumo® Advanced Perfusion System 1 is indicated for use for up to 6 hours in the extracorporeal circulation of blood for arterial perfusion, regional perfusion, and cardiopulmonary bypass procedures, when used by a qualified medical professional who is experienced in the operation of this or similar equipment.

The centrifugal pump is indicated for use in cardiopulmonary bypass procedures only.

The Advanced Perfusion System 1) is a configurable heart-lung system with a distributed network architecture that allows the user to customize the number and types of system components, which can then be configured, displayed, and controlled from a central monitor. The system is designed to enable users to choose from the Terumo CVS supplied components to define and configure a heart-lung system to meet individual institution requirements.

The System 1 components are listed below.

• · System 1 Base:
  • Chassis platform Provides operating power and back up battery power for all o system components (100/120V or 220/240V)
  • Central Control Monitor (CCM) A touch screen display used for o configuration and control of system components
  • o Two roller pump hand cranks and hand crank bracket
• · Pump(s) and pump mounting hardware Up to eight pumps can be used with System 1, including the following:
  • 6' Roller Pump O
  • o 4" Roller Pump
  • Centrifugal Control Unit with Centrifugal Drive Motor (up to 2) O
• Pods
  • Air Bubble Detection Pod Used to detect air bubbles in the extracorporeal O circuit, in conjunction with the air sensor
  • o Level Detection Pod Used to monitor liquid levels within a hard shell reservoir.
  • O Pressure Pod - Used to monitor the pressure in the extracorporeal circuit
  • Temperature Pod Used to monitor the temperature in the extracorporeal O circuit and / or the patient
  • Flowmeter Pod Used to monitor flow volume and generate an alarm if O backflow is detected
• Venous Line Occluder Pod Used with the Occluder Head to provide a O computer controlled tube clamping mechanism to regulate flow in the venous line
• Interface Pods to enable data transfer between cardiac monitoring and data o display systems (i.e., Terumo CDI™ 500 Monitor, and TLink™ Data Management System)
• · Electronic Patient Gas System (EPGS) Provides control and monitoring of the gas output to the oxygenator
• Flexible Lamps (15 inch or 33 inch) for local illumination
• · Mounting hardware (e.g., center poles, crossbars, and brackets)

The provided text describes a 510(k) premarket notification for the Terumo Advanced Perfusion System 1, which involves software modifications to an existing device. It discusses software verification and validation, and design validation testing, but does not provide explicit acceptance criteria or detailed study results in the format requested.

Here's an analysis based on the information provided and what is missing:

The document states: "Software verification and validation testing were conducted and discussion of the these activities (i.e. protocols, acceptance criteria, and test results) at the unit, integration, and system level are included as recommended by FDA's Guidance for Industry and FDA Staff, "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices."". However, the actual acceptance criteria and test results are not included in the provided text.

Similarly, for design validation: "Design validation testing was conducted and demonstrates that the System 1 performs within the defined design input requirements for the proposed modifications. The following testing was performed on the subject device: . Simulated use case testing . Validation of the Instructions For Use changes". Again, the specific acceptance criteria and detailed results are not provided.

Therefore, I cannot populate the table and answer all questions directly from the given text.

Based on the available information, here's what can be extracted and what remains unknown:

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

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

• Test set sample size: Not specified in the provided text.
• Data provenance: Not specified (e.g., country of origin, retrospective/prospective). The studies are internal manufacturer testing.

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

• Number of experts: Not specified.
• Qualifications of experts: Not specified. The document mentions "qualified medical professional who is experienced in the operation of this or similar equipment" for the device's use, which might imply involvement in validating the simulated use cases, but this is an inference, not a direct statement about ground truth establishment.

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

• Adjudication method: Not specified.

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

• MRMC study: No. This device is a heart-lung machine console, not an AI diagnostic tool involving human readers.
• Effect size: Not applicable.

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

• Not applicable in the context of an "algorithm only" device in this submission. The software modifications are for a console that operates a heart-lung machine; its performance is intrinsically linked to the machine's function.

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

• For the software verification and validation, and design validation, the "ground truth" would likely be adherence to defined software requirements, design input requirements, and successful operation during simulated use testing. Specific "ground truth" types like pathology or outcomes data are not relevant for this type of device modification.

8. The sample size for the training set

• Not applicable. This is not a machine learning/AI model that requires a training set in the conventional sense. The "training" here would refer to the software development and testing cycles.

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

• Not applicable for the reasons stated in point 8.

Ask a specific question about this device

The Terumo® Advanced Perfusion System 1 is indicated for use for up to 6 hours in the extracorporeal circulation of blood for arterial perfusion, regional perfusion, and cardiopulmonary bypass procedures, when used by a qualified medical professional who is experienced in the operation of this or similar equipment.

The centrifugal pump is indicated for use in cardiopulmonary bypass procedures only.

The Advanced Perfusion System 1) is a configurable heart-lung system with a distributed network architecture that allows the user to customize the number and types of system components, which can then be configured, displayed, and controlled from a central monitor. The system is designed to enable users to choose from the Terumo CVS supplied components to define and configure a heart-lung system to meet individual institution requirements.

The System 1 components are listed below.

• · System 1 Base:
  • Chassis platform Provides operating power and back up battery power for all o system components (100/120V or 220/240V)
  • Central Control Monitor (CCM) A touch screen display used for o configuration and control of system components
  • o Two roller pump hand cranks and hand crank bracket
• Pump(s) and pump mounting hardware Up to eight pumps can be used with System 1, including the following:
  • 6'' Roller Pump O
  • o 4" Roller Pump
  • Centrifugal Control Unit with Centrifugal Drive Motor (up to 2) O
• Pods
  • Air Bubble Detection Pod Used to detect air bubbles in the extracorporeal O circuit, in conjunction with the air sensor
  • o Level Detection Pod Used to monitor liquid levels within a hard shell reservoir.
  • O Pressure Pod - Used to monitor the pressure in the extracorporeal circuit
  • Temperature Pod Used to monitor the temperature in the extracorporeal O circuit and / or the patient
  • Flowmeter Pod Used to monitor flow volume and generate an alarm if O backflow is detected
• Venous Line Occluder Pod Used with the Occluder Head to provide a o computer controlled tube clamping mechanism to regulate flow in the venous line
• Interface Pods to enable data transfer between cardiac monitoring and data o display systems (i.e., Terumo CDI™ 500 Monitor, and TLink™ Data Management System)
• · Electronic Gas Blender Provides control and monitoring of the gas output to the oxygenator
• Flexible Lamps (15 inch or 33 inch) for local illumination
• · Mounting hardware (e.g., center poles, crossbars, and brackets)

This document describes a 510(k) premarket notification for the Terumo® Advanced Perfusion System 1, focusing on modifications to the device. Please note that this submission primarily addresses engineering modifications (hardware and software) to an existing device and therefore does not include information typically found in studies for a novel AI device, such as training sets, ground truth establishment for AI, expert adjudication methods, or MRMC studies.

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

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria are not explicitly listed in a detailed table format within the document. However, the performance data section indicates that the device was evaluated against existing safety and performance standards for medical devices. The reported device performance is that it complies with these standards.

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

The document does not specify a distinct "test set" in the context of an AI/ML model for which a sample size or data provenance would be relevant. The testing performed was on the modified System 1 device itself.

• Sample Size for Test Set: Not applicable in the context of an AI/ML test set. The entire modified device was subjected to testing.
• Data Provenance: Not applicable. The testing relates to the function of hardware and software modifications of the device, not analysis of external data.

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

Not applicable. This submission is for engineering modifications to a medical device, not an AI/ML model that requires human expert annotation for ground truth.

4. Adjudication Method for the Test Set

Not applicable. No expert adjudication method is mentioned as the testing performed was focused on device functionality and compliance with engineering 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. An MRMC study was not conducted or mentioned, as this submission is not for an AI-assisted diagnostic or therapeutic device.

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

Not applicable. The device is not an algorithm-only product. It is a cardio-pulmonary bypass machine. Software verification and validation were performed on the embedded software within the device, which is an integral part of its function, not a standalone algorithm.

7. The Type of Ground Truth Used

The "ground truth" in this context refers to the defined engineering specifications and regulatory standards that the device performance was measured against.

• Type of Ground Truth: Engineering specifications for hardware and software functionality, and compliance with recognized Consensus Standards (IEC 60601-1, IEC 60601-1-2) and FDA guidance for software in medical devices.

8. The Sample Size for the Training Set

Not applicable. There is no mention of a "training set" in the context of an AI/ML model. The software modifications were developed and verified, but this is distinct from training an AI model on a dataset.

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

Not applicable. As there is no AI/ML training set, the establishment of ground truth for such a set is not relevant to this submission.

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The Small (4") and Large (6") Roller Pumps for the Terumo® Advanced Perfusion System 1 are indicated for use for up to 6 hours in the extracorporeal circulation of blood for arterial perfusion, regional perfusion, and cardiopulmonary bypass procedures, when used by a qualified medical professional who is experienced in the operation of this or similar equipment.

The Small (4") and Large (6") Roller Pumps of the Terumo® Advanced Perfusion System 1 (System 1) are peristalic pumps with 4 inch and 6 inch diameter raceways. The pumps can be mounted on the base of the System 1 console or can be positioned in an optimal location in the perfusion circuit by mounting to the system poles. Operation of the pumps can be configured using the System 1 Central Control Monitor (CCM). Local user interface displays and control panels are also located on the front of the large and small roller pumps. The small roller pump can accommodate applications requiring flow rates up to 4 L/min including pediatric arterial, adult and pediatric cardioplegia, vent and suction pumping, whereas the large roller pump can accommodate applications requiring flow rates up to 10 L/min including adult and pediatric arterial, cardioplegia, vent and suction pumping. The small and large roller pumps both have variable tube clamp mechanisms that accommodate a variety of tubing sizes, including dual tube sets.

This document, K162843, is a 510(k) premarket notification for updates to the Terumo Advanced Perfusion System 1 Roller Pumps. The main change described is the inclusion of medical grade silicone tubing as a compatible tubing option for both the Small (4") and Large (6") Roller Pumps. Since the device is substantially equivalent to a previously cleared predicate device (K153376), it primarily relies on demonstrating that the new tubing material does not adversely affect the device's safety and effectiveness.

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

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state "acceptance criteria" in a quantitative table format with corresponding "reported device performance" values for all functionality. Instead, it leverages the substantial equivalence to a predicate device and focuses on confirming that the new medical grade silicone tubing does not compromise the established performance.

However, based on the Functional Summary and Flow Range Accuracy sections, we can infer some performance characteristics and the implicit "acceptance criteria" that the subject device (with silicone tubing) must meet by being "Identical to predicate device."

The "Reported Device Performance" column essentially states "met" or "identical to predicate device" because the core of this 510(k) is to demonstrate that the addition of silicone tubing compatibility maintains the performance characteristics of the already cleared predicate device. The conclusion explicitly states: "Performance testing has confirmed that the design input requirements were met demonstrating that medical grade silicone tubing can be used with the Small and Large System 1 Roller Pumps."

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

The document states: "Performance testing of medical grade silicone tubing with the Small and Large System 1 Roller Pumps has been completed successfully." However, it does not specify the sample size (e.g., number of pumps, number of tests, duration of tests) used for this performance testing.

Regarding data provenance, the document does not explicitly state the country of origin or if the study was retrospective or prospective. It implies the testing was conducted by Terumo Cardiovascular Systems Corporation as part of their 510(k) submission, suggesting it was likely prospective testing specifically for this change.

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

The document does not mention the use of human experts to establish ground truth for performance testing in the context of device function for roller pumps. Performance criteria for such devices (flow rate accuracy, speed accuracy, tubing compatibility, etc.) are typically established through engineering specifications and objective measurements, not subjective expert assessment. Therefore, this question is not directly applicable to the type of device and testing described.

4. Adjudication Method for the Test Set

The document does not mention an adjudication method. As noted above, the performance testing for this device is based on objective measurements against engineering specifications, not on subjective assessments that would require adjudication.

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

No, an MRMC comparative effectiveness study was not done for this device. This type of study is typically used for diagnostic devices where human interpretation of images or data is involved, and the goal is to evaluate the effectiveness of AI assistance on human reader performance. The Terumo roller pumps are mechanical devices, and their performance is evaluated through objective measurements and engineering tests.

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

While the term "standalone" typically refers to AI algorithm performance without human intervention, in the context of this mechanical device, the "performance testing" described can be considered analogous to "standalone" in that it evaluates the device's function (with the new tubing) based on its intrinsic capabilities against predefined criteria, without an explicit "human-in-the-loop" interaction as part of the primary performance assessment. The device is designed to operate mechanically, and the performance tests verify its mechanical and fluid dynamics properties.

7. The Type of Ground Truth Used

The ground truth used for this device's performance testing consists of:

• Engineering Specifications: Predefined quantitative thresholds for parameters like flow rate accuracy, speed accuracy, and dimensions.
• Functional Equivalence: The expectation that the subject device, with the new tubing, performs identically or equivalently to the predicate device in terms of all functional aspects (e.g., pump configurations, controls, safety).
• Biocompatibility (implied): The "medical grade silicone tubing" implies that material properties and safety (e.g., non-toxicity, durability) were assessed, although specific details are not provided in this summary.

8. The Sample Size for the Training Set

The concept of a "training set" is relevant to machine learning/AI devices. Since the Terumo roller pump is a mechanical device, there is no training set in the AI/ML sense. Its design and performance are based on engineering principles and physical testing, not data-driven learning.

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

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

Ask a specific question about this device

The Terumo® Advanced Perfusion System 1 is indicated for use for up to 6 hours in the extracorporeal circulation of blood for arterial perfusion, regional perfusion, and cardiopulmonary bypass procedures, when used by a qualified medical professional who is experienced in the operation of this or similar equipment.

The centrifugal pump is indicated for use in cardiopulmonary bypass procedures only.

The Advanced Perfusion System 1) is a configurable heartlung system with a distributed network architecture that allows the user to customize the number and types of system components, which can then be configured, displayed, and controlled from a central monitor. The system is designed to enable users to choose from the Terumo CVS supplied components to define and configure a heart-lung system to meet individual institution requirements.

The System 1 components are listed below.

• · System 1 Base:
  • Chassis platform Provides operating power and back up battery power for all O system components (100/120V or 220/240V)
  • Central Control Monitor (CCM) A touch screen display used for O configuration and control of system components
  • Two roller pump hand cranks and hand crank bracket O
• · Pump(s) and pump mounting hardware Up to eight pumps can be used with System 1, including the following:
  • 6" Roller Pump O
  • 4" Roller Pump o
  • Centrifugal Control Unit with Centrifugal Drive Motor (up to 2) O
• Pods
  • Air Bubble Detection Pod Used to detect air bubbles in the extracorporeal O circuit, in conjunction with the air sensor
  • Level Detection Pod Used to monitor liquid levels within a hard shell o reservoir.
  • Pressure Pod Used to monitor the pressure in the extracorporeal circuit O
  • Temperature Pod Used to monitor the temperature in the extracorporeal O circuit and / or the patient
  • Flowmeter Pod Used to monitor flow volume and generate an alarm if O backflow is detected
• Venous Line Occluder Pod Used with the Occluder Head to provide a O computer controlled tube clamping mechanism to regulate flow in the venous line
  • Interface Pods to enable data transfer between cardiac monitoring and data o display systems (e.g., Terumo CDI™ 100 Monitor, CDI™ 500 Monitor, and TLink™ Data Management System)
• · Electronic Gas Blender Provides control and monitoring of the gas output to the oxygenator
• Flexible Lamps (15 inch or 33 inch) for local illumination
• · Mounting hardware (e.g., center poles, crossbars, and brackets)

This document pertains to the resubmission of the Terumo Advanced Perfusion System 1 (K153376) due to a hardware modification. As such, the information provided focuses on the substantial equivalence to a previously cleared device (K151349) rather than a full de novo acceptance criteria study for a new device. Therefore, many of the typical study details for an AI/algorithm-based device are not applicable or not provided in this regulatory document.

However, based on the provided text, I can infer and extract the following:

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

Explanation: The primary goal of the hardware modification was to address a potential issue with the On/Off switch that could lead to power loss. The "acceptance criteria" here is implicitly that the modification successfully resolves this issue. The "reported device performance" directly states that the modification achieves this.

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

• Sample Size for Test Set: Not specified. The document states "successful design verification and validation testing," but does not provide details on the number of units or test scenarios used.
• Data Provenance: Not specified. Given this is a hardware modification for an existing device, it's likely testing was conducted internally by the manufacturer, Terumo Cardiovascular Systems Corporation, based in Ann Arbor, Michigan, USA. The nature of testing points to prospective testing of the modified hardware.

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):

• Number of Experts: Not applicable. This is a hardware modification of a medical device, not an AI/algorithm-based diagnostic or prognostic tool that relies on expert interpretation for ground truth. The "ground truth" here is the functional performance of the hardware.
• Qualifications of Experts: Not applicable in the context of expert review for ground truth as described for AI/algorithm studies. The testing would have been performed by engineers and quality assurance personnel.

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

• Adjudication Method: Not applicable. This is not a study requiring adjudication of interpretations from multiple experts. The "ground truth" is determined by successful functional testing of the hardware.

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:

• MRMC Study: No. This document describes a hardware modification to an existing heart-lung machine console, not an AI-assisted diagnostic or therapeutic device. Therefore, a MRMC comparative effectiveness study involving human readers and AI assistance is not relevant and was not conducted.

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

• Standalone Performance Study: Not applicable. This device is a console that requires human operation ("when used by a qualified medical professional who is experienced in the operation of this or similar equipment"). It is not an algorithm that performs a function independently.

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

• Type of Ground Truth: The "ground truth" for this hardware modification is the demonstrable stable and reliable operation of the On/Off switch and the prevention of inadvertent power loss, as confirmed by design verification and validation testing. This would involve functional tests, electrical safety tests, and potentially stress tests to ensure the new component meets its intended performance specifications.

8. The sample size for the training set:

• Sample Size for Training Set: Not applicable. This device is a hardware system, not an AI/machine learning algorithm that requires a training set.

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

• How Ground Truth for Training Set was Established: Not applicable, as there is no training set for this hardware device.

Ask a specific question about this device

The Terumo® Advanced Perfusion System 1 is indicated for use for up to 6 hours in the extracorporeal circulation of blood for arterial perfusion, regional perfusion, and cardiopulmonary bypass procedures, when used by a qualified medical professional who is experienced in the operation of this or similar equipment.

The centrifugal pump is indicated for use in cardiopulmonary bypass procedures only.

The Advanced Perfusion System 1) is a configurable heartlung system with a distributed network architecture that allows the user to customize the number and types of system components, which can then be configured, displayed, and controlled from a central monitor. The system is designed to enable users to choose from the Terumo CVS supplied components to define and configure a heart-lung system to meet individual institution requirements.

The System 1 components are listed below.

• · System 1 Base:

  • Chassis platform Provides operating power and back up battery power for all o system components (100/120V or 220/240V)
  • Central Control Monitor (CCM) A touch screen display used for o configuration and control of system components
  • Two roller pump hand cranks and hand crank bracket o

• · Pump(s) and pump mounting hardware Up to eight pumps can be used with System 1, including the following:

  • 6" Roller Pump o
  • 4" Roller Pump o
  • Centrifugal Control Unit with Centrifugal Drive Motor (up to 2) O

• Pods

• Air Bubble Detection Pod Used to detect air bubbles in the extracorporeal O circuit, in conjunction with the air sensor

• Level Detection Pod Used to monitor liquid levels within a hard shell o reservoir.

• Pressure Pod Used to monitor the pressure in the extracorporeal circuit O

• Temperature Pod Used to monitor the temperature in the extracorporeal O circuit and / or the patient

• Flowmeter Pod Used to monitor flow volume and generate an alarm if O backflow is detected

• Venous Line Occluder Pod Used with the Occluder Head to provide a O computer controlled tube clamping mechanism to regulate flow in the venous line

  • Interface Pods to enable data transfer between cardiac monitoring and data o display systems (e.g., Terumo CDI™ 100 Monitor, CDI™ 500 Monitor, and TLink™ Data Management System)

• · Electronic Gas Blender Provides control and monitoring of the gas output to the oxygenator

• · Flexible Lamps (15 inch or 33 inch) for local illumination

• · Mounting hardware (e.g., center poles, crossbars, and brackets)

I am sorry, but based on the provided text, there is no information about acceptance criteria or a study that proves the device meets specific acceptance criteria using metrics such as sensitivity, specificity, or AUC.

The document is a 510(k) summary for a software modification to the Terumo® Advanced Perfusion System 1. It states that "The device software has been revised to improve system performance" and that "Software verification and validation has confirmed that the modifications improve system performance." However, it does not provide details on:

• Specific performance metrics (e.g., accuracy, precision, recall)
• Quantitative acceptance criteria for these metrics
• The results of any performance study against those criteria
• Details about the test set, ground truth, or expert involvement

The document focuses on demonstrating substantial equivalence to a previously cleared device (K131041) based on identical intended use, indications for use, operating principles, and technical specifications, where the primary change is software modification "to improve system performance." The "Performance Testing" section only broadly mentions "software verification and validation testing at the unit, integration, system, and regression levels" but does not elaborate on the specific performance results against pre-defined acceptance criteria for medical device efficacy or safety.

Ask a specific question about this device

The Terumo® Advanced Perfusion System 1 is indicated for use for up to 6 hours in the extracorporeal circulation of blood for arterial perfusion, regional perfusion, and cardiopulmonary bypass procedures, when used by a qualified medical professional who is experienced in the operation of this or similar equipment. The centrifugal pump is indicated for use in cardiopulmonary bypass procedures only.

The Advanced Perfusion System 1 is a configurable heart-lung system with a distributed network architecture that allows the user to customize the number and types of system components, which can then be configured, displayed, and controlled from a central monitor. The system is designed to enable users to choose from the TCVS supplied components to define and configure a heart-lung system to meet individual institution requirements.

The provided text describes a 510(k) summary for a medical device called the "Advanced Perfusion System 1" from Terumo Cardiovascular Systems Corporation. This document concerns modifications made to a previously cleared heart-lung machine, primarily for compliance with electromagnetic compatibility standards (IEC 60601-1-2) and software updates. It does not present a study with specific acceptance criteria and reported device performance metrics in the format requested, such as sensitivity, specificity, or AUC.

Instead, the document focuses on demonstrating substantial equivalence to a predicate device (the Advanced Perfusion System 1 K022947) through performance testing related to safety and functionality, rather than a clinical efficacy study with quantitative performance measures.

Therefore, many of the requested fields cannot be directly extracted from the provided text. I will fill in the available information and indicate where information is not present.

1. Table of Acceptance Criteria and Reported Device Performance

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

• Sample size for test set: Not specified. The document refers to "third party testing," "software verification and validation testing," and "functionality testing" but does not quantify the number of units or test cases used.
• Data provenance: Not explicitly stated as retrospective or prospective data from a specific country, as this was a device modification and testing performed for regulatory submission, likely in a controlled lab environment by Terumo and a third-party testing facility.

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

• This information is not provided in the document. The testing described appears to be technical in nature (electromagnetic compatibility, software, functionality) rather than clinical validation requiring expert ground truth in the context of diagnostic interpretation.

4. Adjudication method for the test set

• This information is not provided in the document, as it's not applicable to the type of technical performance testing 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

• No, an MRMC comparative effectiveness study was not done. This submission is for modifications to a heart-lung machine, not an AI-powered diagnostic device, so this type of study is not relevant here.

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

• This question is not applicable as the device is a heart-lung machine, an active medical device, not a diagnostic algorithm. Performance is assessed through compliance with standards and functional testing, inherently involving the device's operational capabilities.

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

• The "ground truth" for the performance testing described would be defined by the technical specifications and standards (e.g., IEC 60601-1-2 for electromagnetic compatibility, and internal design specifications for software and functionality). It is not clinical ground truth established by medical experts or pathology in the typical sense for an AI/diagnostic device.

8. The sample size for the training set

• This concept is not applicable to the type of device described. A heart-lung machine does not typically involve training sets in the context of machine learning or AI algorithm development.

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

• This question is not applicable as there is no mention of a training set for this device.

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The Large (6") Roller Pump for the Terumo Advanced Perfusion System 1 is indicated for use for up to 6 hours in the extracorporeal circulation of blood for arterial perfusion, regional perfusion, and cardiopulmonary bypass procedures, when used by a qualified medical professional who is experienced in the operation of this or similar equipment.

The Large (6") Roller Pump for the Terumo Advanced Perfusion System 1 is a component of the Terumo Advanced Perfusion System 1. It is a large roller pump with a 6" race that can accommodate applications requiring flow rates up to 10 L/min including adult and pediatric arterial, cardioplegia, vent and suction pumping. It uses commercially available medical grade PVC tubing with 11/16" OD (max) and 1/16" - 3/32" wall thickness. It has a front panel for user interface controls, functional displays, and alarm conditions. The pump can be configured using the System 1 Central Control Monitor (CCM) as an Arterial pump or Cardioplegia pump. The Arterial pump can be run in Continuous, Pulse, Servo, or Master/Follower mode. The pump continuously monitors its own performance and reports status information and problems to the user via the pump display panel alarms and to the CCM. Pump responses to detected problems can include Stop, Pause, Reduce Speed, or Message Only. The pump can be mounted on System 1 base or pole.

The Terumo Cardiovascular Systems Corporation Large (6") Roller Pump K131618 is substantially equivalent to the predicate device K112587. The modification made to the device involved software updates.

Here's a breakdown of the acceptance criteria and study information:

1. Acceptance Criteria and Reported Device Performance

The submission states that the modified device has the "same intended use, substantially equivalent indications for use, and the same or substantially equivalent operating principles and technical specifications" as the predicate device. The performance specifications are identical to the predicate device, K112587.

The study supporting the acceptance criteria explicitly states: "Software and system testing have confirmed that the modifications improve device performance."

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

The submission does not specify a distinct "test set" in the context of clinical data or patient samples. The performance testing described relates to software verification and validation testing at unit, integration, and system levels. Therefore, there is no mention of data provenance (e.g., country of origin, retrospective/prospective) typically associated with clinical studies.

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

Not applicable. The performance testing was for software verification and validation, not for establishing clinical ground truth on patient data.

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

Not applicable. The testing was for software and system performance, not for clinical assessment 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

Not applicable. This device is a medical pump, not an AI-assisted diagnostic or interpretive system that would involve human readers.

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

The performance testing focused on the software modifications to the device, confirming improved device performance through unit, integration, and system level testing. This implies a "standalone" evaluation of the software's functionality and its impact on the device's overall operation, without direct human interaction as part of the performance measurement.

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

For software verification and validation, the "ground truth" would be established specifications, requirements, and expected operational parameters of the device. The software was tested against these predefined functional and performance requirements.

8. The sample size for the training set

Not applicable. This device is a medical pump with software modifications; there is no indication of a machine learning or AI model that would require a "training set" in the context of image analysis or similar applications. The software was developed and then verified/validated.

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

Not applicable, as there is no "training set." The software's correct functioning is validated against engineering specifications and expected device behavior.

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The Large (6") Roller Pump for the Terumo® Advanced Perfusion System 1 is indicated for use for up to 6 hours in the extracorporeal circulation of blood for arterial perfusion, regional perfusion, and cardiopulmonary bypass procedures, when used by a qualified medical professional who is experienced in the operation of this or similar equipment.

The image shows a device description and indications for use of the APS 1 Large (6") Roller Pump. The device is a peristaltic pump with a 6 inch diameter race that can be mounted on the base of the Advanced Perfusion System 1 (APS1) console or positioned in an optimal location in the perfusion circuit by mounting on the pole. The large roller pump can accommodate applications requiring flow rates up to 10 L/min.

Here's a breakdown of the acceptance criteria and study information 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

The document does not explicitly state the numerical sample size used for the test set in the performance studies. It mentions "new and aged parts" but no specific quantity.

The data provenance is not explicitly stated in terms of country of origin or whether it was retrospective or prospective. Given the nature of a 510(k) submission for a design change, the testing would generally be prospective, conducted in a laboratory setting by the manufacturer.

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

This information is not provided in the document. The performance tests appear to be engineering-based (strength, reliability/durability) rather than requiring expert clinical interpretation for ground truth.

4. Adjudication Method for the Test Set

This information is not provided. Given the nature of the tests (Pass/Fail based on engineering criteria), formal adjudication by clinical experts is unlikely.

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

No, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. This device is a mechanical pump, not an AI-powered diagnostic or interpretive tool that would involve human readers.

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

Yes, the performance tests described (Strength, Reliability/Durability) are standalone tests of the device's mechanical integrity and function. The device itself (a roller pump) is a standalone piece of equipment. The assessment of its performance did not involve a "human-in-the-loop" component for interpretation of results, but rather its mechanical operation and ability to withstand stress.

7. Type of Ground Truth Used

The ground truth used for these performance tests appears to be engineering specifications and pre-defined acceptance criteria. For "Strength," the ground truth is defined by the "Knob/Cam Follower Impact Strength Verification" protocol. For "Reliability/Durability," the ground truth is established by "Simulated use testing... under worst-case conditions." The "Pass" result indicates that the device met these engineering and design validation targets.

8. Sample Size for the Training Set

This information is not applicable and therefore not provided. The device is a mechanical pump, not an AI/ML-based system that requires a "training set" in the context of machine learning. The design and manufacturing process would involve internal testing and validation, but not a "training set" in the computational sense.

9. How Ground Truth for the Training Set Was Established

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

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The Terumo® Advanced Perfusion System 1 is indicated for up to 6 hours of use in extracorporeal circulation of blood for arterial perfusion, regional perfusion, and cardiopulmonary bypass procedures only, and intended to be used by a qualified perfusionist who is experienced in the operation of Sarns™ brand or similar equipment.

The centrifuqal pump is indicated for use in cardiopulmonary bypass procedures only.

The Terumo® Advanced Perfusion Svstem 1 is a highly configurable system with a distributed network architecture that allows the user to customize the number and types of system components, which can then be configured, displayed, and controlled from a central monitor. Within reason, the system should allow users to define and configure a system to meet their individual requirements, and as needed, adapt the configuration as their needs change. The basic Terumo® Advanced Perfusion System 1 consists of a Chassis platform which provides operating power and battery back-up power for all other devices of the system that enable, facilitate or improve the intended use of the product and integrated functions, the Central Control Monitor which through its software and display touch screen facilitates the configuration and control of all other components, the Air Bubble Detect Module which is used to detect gross air bubbles in the arterial line of the perfusion circuit with the Terumo® Air Sensor, and the Level Detect Module which is used to monitor blood levels within a hard shell reservoir with the Terumo® Level Sensors. The following modules may also be used to enhance the abilities of the Terumo® Advanced Perfusion System 1: Temperature Module, Pressure Module, Flowmeter Module, Occluder Module, RS-232 Interface Module, RS-485 Interface Module, CDI™ 100 Interface Module, CDI™ 500 Interface Module, 6" diamter race Roller Pump, 4" diameter race Roller Pump, Centrifuqal Control Module, and a 33" or 15" Lamp. This design allows perfusionists to select the number and types of the accessory devices needed to control and monitor patient perfusion during cardiopulmonary bypass.

The provided document is a 510(k) summary for the Terumo® Advanced Perfusion System 1. It details the device's description, indications for use, and a comparison to predicate devices, along with a statement about performance testing. However, it does not include specific quantitative acceptance criteria or detailed results from a study proving the device meets those criteria.

The document states: "The performance characteristics of the Terumo® Advanced Perfusion System 1 were exhaustively tested and compared with the performance characteristics of the currently marketed Sarns™ 8000 Modular Perfusion System, Sarns™9000 Heart-Lung Console, Sarns™ 8000 Roller Pump, Sarns™ 9000 Universal Roller Pump, Flow Sensor Centrifugal Control Module, and Delphin II/Stand-Alone Centrifugal Module. All new and existing performance characteristics of the Terumo® Advanced Perfusion System 1 have been validated."

And "The Terumo® Advanced Perfusion System 1 perform as intended according to its performance specifications. The Terumo® Advanced Perfusion System 1 is substantially equivalent to its predicated devices."

This indicates that internal performance specifications were used as acceptance criteria, and testing was conducted to demonstrate substantial equivalence to predicate devices. However, the specific metrics, thresholds, and study designs are not disclosed in this summary.

Therefore, based on the provided text, I cannot complete a table of acceptance criteria with reported device performance, nor can I provide answers to most of the specific questions regarding the study design (sample size, ground truth, experts, adjudication, MRMC, or standalone performance).

The document focuses on demonstrating substantial equivalence to existing devices rather than providing detailed quantitative efficacy data that would be typical for an AI/ML diagnostic device with clear performance metrics.

Here's what can be extracted and what cannot be from the provided document:

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

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

• Sample Size for Test Set: Not specified.
• Data Provenance: Not specified (e.g., country of origin, retrospective or prospective). The testing appears to be non-clinical, likely laboratory-based, comparing performance to predicate devices.

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)

• Number of Experts: Not applicable/Not specified. This is a medical device (perfusion system), not an AI/ML diagnostic requiring expert ground truth in the same way. The "ground truth" would be established by engineering specifications and direct measurement/testing.
• Qualifications of Experts: Not applicable/Not specified.

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

• Adjudication Method: Not applicable/Not specified. This type of adjudication is typically for subjective interpretations, which isn't directly relevant to the performance testing of a perfusion system described here.

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

• MRMC Study: No. This is not an AI/ML diagnostic requiring human reader interpretation. The device is for "extracorporeal circulation of blood" and operated by a "qualified perfusionist."
• Effect Size: Not applicable.

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

• Standalone Performance: Not applicable as an AI/ML algorithm. The device itself is a system with components, and its "standalone" performance would refer to its functional operation as designed, independent of human interaction beyond normal operation by a perfusionist. The document states its performance was "exhaustively tested."

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

• Type of Ground Truth: For this type of medical device, the "ground truth" for performance testing would be established by engineering specifications, direct physical measurements, and comparison to the known performance of predicate devices under controlled conditions. It's not based on expert consensus, pathology, or outcomes data in the way an AI diagnostic would be.

8. The sample size for the training set

• Sample Size for Training Set: Not applicable. This device is not an AI/ML algorithm that requires a "training set." Its design and functionality are based on established engineering principles and existing technologies.

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

• Ground Truth for Training Set: Not applicable. There is no AI/ML training set mentioned or implied for this device.

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