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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.

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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.

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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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