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The CDI OneView Monitoring System is a patient parameter monitoring system to be used on a single patient during cardiopulmonary bypass procedures. By measurement or acquisition from other devices, it displays and outputs information to provide continuous, in-line monitoring of various patient parameters contained within the extracorporeal perfusion circuit and patient. The following parameters are available, based on configuration:
·Potential of Hydrogen (pH)
·Partial Pressure of Carbon Dioxide (pCO2)
·Partial Pressure of Oxygen (pO2)
·Potassium Ion (K+)
·Oxygen Saturation (SO2)
·Hematocrit (HCT)
·Hemoglobin (Hgb)
·Blood Flow Rate (Q)
·Cardiac Index (CI)
·Base Excess (BE)
· Bicarbonate (HCO3- )
·Oxygen Consumption (VO2)
·Indexed Oxygen Consumption (VO2i)
·Oxygen Delivery (DO2)
·Indexed Oxygen Delivery (DO2i)
· Cerebral Regional Oxygen Saturation (rSO2)
·Oxygen Extraction Ratio (O2ER)
· Body Surface Area (BSA)
·Shunt Sensor Temperature

The CDI OneView Monitoring System is an AC-powered (battery back-up) microprocessor-based device used with the following components/accessories:

• . Core: Core Processing Unit, all other elements connect to the Core
• Display: Touchscreen display with cable ●
• . HSAT Probe: Hematocrit/Saturation probe with cable, interfaces with disposable Cuvette(s)
• BPM Probe: Blood Parameter Module with cable, interfaces with disposable . Shunt Sensor
• Calibrator: Gas calibrator for BPM/Shunt Sensor with cable, interfaces with disposable gas bottles
• Flow Module & Sensor: Flow sensor connected to an external interface ● module with cable.
• . HLM External Device Module: Heart Lung Machine (HLM) interfacing module and cable
• DMS External Device Module: Data output for data management system ● (DMS) interfacing module and cable
• rSO2 External Device Module: Cerebral Oximetry device interfacing module ● and cable
• . Mounting accessories: Different mounting features are used to securely mount elements of the system on an HLM pole during a cardiopulmonary bypass (CPB) case.
• Disposable accessories: The CDI OneView Monitoring System hardware ● connects to disposable accessories which are in-line with the extracorporeal circuit. The BPM probe is attached to Shunt Sensors, the HSAT probe is attached to Cuvette(s) during a CPB case for blood parameters measurement during monitoring. Disposable Gas Bottles (Gas 1 & Gas 2) are used with the Calibrator.

The CDI OneView Monitoring System uses the following measurement technologies:

• Optical fluorescence technology to measure partial pressure of oxygen and . carbon dioxide, pH and potassium ion concentration.
• . Optical reflectance technology to measure oxygen saturation, hematocrit, and hemoglobin within the blood.
• Thermistor (resistive) sensing technology to measure blood temperature. ●
• Non-invasive acoustical sensing technology to measure blood flowrate. ●

The CDI OneView Monitoring System measures blood parameters in real time by utilizing a microprocessor-based core, electro-optics modules (i.e., BPM and H/S probe), flow probe (includes flow module and flow sensor), fluorescence chemistry technology, optical reflectance technology and non-invasive acoustical sensing technology. The electro-optics modules connect the core to the disposables (i.e., shunt sensor or cuvette) which are inserted into the extracorporeal circuit. The flow module connects the core to the flow sensor that use clamp-on mechanism to fit around tubing of the extracorporeal circuit. Light is emitted from the modules, optical responses from the blood and the Ultrasonic/acoustical generated signal measurements via the sensor(s) are measured by the core. The blood parameters are measured or calculated by the CDI OneView Processing Core in real time and displayed to the user via a Touchscreen Display.

The provided text is a 510(k) summary for the Terumo CDI OneView Monitoring System. It outlines the device, its intended use, a comparison to a predicate device, and performance data required for substantial equivalence.

Based on the provided text, here's an analysis of the acceptance criteria and study information:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state a table of quantitative acceptance criteria with corresponding device performance for each measured parameter (e.g., specific accuracy ranges for pH, pCO2, pO2). Instead, it relies on general statements about design verification and validation.

However, the "Design Verification and Validation Testing" section states:

• "Design verification testing was conducted and demonstrates that the CDI OneView Monitoring System performs pursuant to the defined design input requirements for the subject device."
• "Design validation, including simulated use testing, was conducted and demonstrates that the CDI OneView Monitoring System meets the defined design input requirements for the subject device."

This implies that there were "defined design input requirements" which served as acceptance criteria, and the device met them. The specific numerical values or ranges for these criteria are not provided in this summary. The "Performance Data" section primarily focuses on:

• Electrical Safety and EMC: Compliance with IEC 60601-1 and IEC 60601-1-2 standards.
• Software Verification and Validation Testing: Successfully completed, with the software considered a "moderate" level of concern.
• Design Verification and Validation Testing: Performed as described above.

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

The document does not provide information on specific sample sizes for test sets used for measuring the accuracy or performance of the individual blood parameters. Given that clinical studies and animal studies were not required or included, the "test set" would likely refer to engineering and simulated use testing.

The data provenance is not explicitly stated in terms of country of origin or whether it's retrospective/prospective clinical data, because clinical studies were not performed. The testing appears to be primarily laboratory-based and simulated use testing.

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

This information is not provided as there were no clinical studies mentioned that would typically involve experts establishing ground truth for patient outcomes or diagnostic accuracy. For engineering and simulated use testing, "ground truth" would likely be established by reference instruments or calibrated standards.

4. Adjudication Method for the Test Set

This information is not provided as there were no clinical studies or multi-reader scenarios described that would necessitate an adjudication method.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size of Human Improvement

No MRMC comparative effectiveness study was done. The document explicitly states: "Clinical testing was not required to demonstrate the substantial equivalence of the CDI OneView Monitoring System to the predicate device and is not included as part of this premarket notification." Therefore, there is no information on human reader improvement with or without AI assistance as this device is a monitoring system and not primarily an AI-driven image interpretation or diagnostic aid tool.

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

The device is a "monitoring system" that "displays and outputs information to provide continuous, in-line monitoring of various patient parameters." It is not presented as an AI algorithm for diagnosis or interpretation that would have standalone performance measured against human-in-the-loop performance. Its primary function is to measure and display physiological parameters, which is inherently a "standalone" algorithmic function in that the measurements are provided by the device itself.

7. The Type of Ground Truth Used (Expert Consensus, Pathology, Outcomes Data, etc.)

Given the nature of the device (a blood parameter monitoring system) and the absence of clinical studies, the "ground truth" for verifying the accuracy of the measured parameters (pH, pCO2, pO2, K+, SO2, HCT, Hgb, Blood Flowrate) would implicitly be based on calibrated reference standards and/or laboratory reference methods for these specific physiological measurements during design verification and validation testing. The text does not specify which exact methods were used, but for such devices, it's standard practice to compare the device's readings to highly accurate laboratory analyzers or calibrated simulation fluids.

8. The Sample Size for the Training Set

This information is not applicable/not provided in the context of machine learning training data. The device is a measurement and monitoring system that utilizes "optical fluorescence technology," "optical reflectance technology," "Thermistor (resistive) sensing technology," and "Non-invasive acoustical sensing technology." While these technologies involve algorithms for signal processing and parameter calculation, the document does not describe the use of machine learning models that would require a "training set" in the typical sense of AI/ML devices.

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

This information is not applicable/not provided for the same reasons as #8. If any internal algorithms were developed for parameter calculation, their "ground truth" (or basis) would likely stem from established physiological principles, known optical/acoustical properties, and extensive calibration using reference materials, rather than a "training set" with expert-labeled ground truth like in AI/ML applications.

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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 Capiox® iCP Centrifugal Pump with Xcoating™ is a sterile, single use device, used as an extracorporeal blood pump for use in cardiopulmonary bypass procedures for up to 6 hours.

The pump is intended for use with Terumo® Advanced Perfusion System 1 / Sams™ Centrifugal Pump Systems or may be used with the Stockert / Sorin Centrifugal Pump Consoles.

The Capiox® iCP Centrifugal Pump with Xcoating™ is a sterile, single use device, used as an extracorporeal blood pump.

This document is a 510(k) clearance letter from the FDA for a medical device called the "Capiox iCP Centrifugal Pump with Xcoating". It confirms that the device is substantially equivalent to legally marketed predicate devices.

However, the provided text does not contain any information regarding acceptance criteria, device performance testing data, sample sizes, expert qualifications, ground truth establishment, or any details typically found in a study proving a device meets acceptance criteria.

The document is primarily an administrative letter granting market clearance based on substantial equivalence, not a detailed report of the studies performed to demonstrate that equivalence. It refers to the "Indications for Use" but does not detail the technical performance or the studies that underpinned the clearance.

Therefore, I cannot fulfill your request for:

1. A table of acceptance criteria and reported device performance.
2. Sample sizes and data provenance for a test set.
3. Number and qualifications of experts for ground truth.
4. Adjudication method.
5. MRMC study details or effect size.
6. Standalone performance details.
7. Type of ground truth used.
8. Training set sample size.
9. Ground truth establishment for the training set.

The provided text does not contain the information necessary to answer your questions.

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The CDI System 550 provides continuous, on-line monitoring of the extracorporeal partial pressure of oxygen and carbon dioxide, pH, potassium, oxygen saturation, hemoglobin and temperature. In addition, calculated values of base excess, bicarbonate, oxygen saturation, oxygen delivery and oxygen consumption may also be provided. These parameters are displayed at either actual temperature or adjusted to 37°C. For documentation purposes, the systems integral printer provides a hard copy of displayed parameters.

The CDI System 550 is an AC-powered (battery back-up) microprocessor-based device used with the following components/accessories:

• CDI 550 Monitor ●
• Arterial and/or Venous Blood Parameter Modules (BPM) ●
• CDI Hematocrit/Saturation (H/S) Probe ●
• CDI 540 Gas Calibrator and Calibration Gases (A and B) ●
• CDI 510H Shunt Sensor ●
• Shunt Bypass Line
• CDI H/S Cuvette with or without extension tubing ●
• Monitor Mounting Hardware (Pole Clamp and Cable Head Bracket) ●
• Printer Paper ●

The CDI System 550 measures blood parameters in real time by utilizing a microprocessor based monitor, electro-optics modules (i.e., BPM and H/S probe), fluorescence chemistry technology, and optical reflectance technology. The electro-optics modules connect the monitor to the disposables (i.e., shunt sensor or cuvette) which are inserted into the extracorporeal circuit. Light is emitted from the modules, and the optical responses from the blood via the sensor(s) are measured by the monitor. The blood parameters are measured or calculated by the CDI 550 Monitor in real time, and displayed to the user via a graphical LED display.

The information provided does not contain a study that proves the device meets specific acceptance criteria in terms of clinical performance metrics (e.g., sensitivity, specificity, accuracy) for diagnosis or treatment. The document is a 510(k) premarket notification for the CDI Blood Parameter Monitoring System 550, asserting substantial equivalence to a predicate device (CDI Blood Parameter Monitoring System 500, K133658).

The "Performance Data" section primarily addresses:

• Biocompatibility Testing: Not required as the device does not contact the patient and disposables haven't changed.
• Electrical Safety and Electromagnetic Compatibility (EMC): Compliance with IEC 60601-1 and IEC 60601-1-2.
• Software Verification and Validation Testing: Completed successfully as per FDA guidance for "moderate" level of concern software.
• Design Verification and Validation Testing: Conducted to demonstrate the device performs according to defined design input requirements and meets them through simulated use testing.
• Animal Study: Not required.
• Clinical Studies: Not required.

The document discusses modifications to the device (new calculated parameter, alarm scheme updates, expanded operating ranges for hematocrit/hemoglobin, improved temperature correction algorithm, improved pre-in-vivo calibration performance). These modifications resulted in "modified blood parameter module (BPM) accuracy claims" and expanded "hematocrit (HCT) and hemoglobin (Hgb) operating ranges and their corresponding modified accuracy claims." However, the specific acceptance criteria for these accuracy claims or the data supporting these claims are not detailed in the provided text.

Therefore, many of the requested items cannot be fully answered from the given document as it focuses on demonstrating substantial equivalence through engineering and software testing rather than clinical performance studies with defined acceptance criteria.

Here's a breakdown of what can be extracted and what is missing:

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. The document mentions "Design verification and validation testing" and "simulated use testing" but does not detail the sample sizes for these tests. There were no clinical studies.
• Data Provenance: Not specified. As clinical studies were not performed or required, there is no mention of country of origin or whether data was retrospective/prospective.

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 as no clinical studies with expert-established ground truth were performed or referenced for performance evaluation in this document. The testing described is engineering and software validation.

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

• Not applicable as no clinical studies with adjudicated ground truth were performed or referenced.

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 blood parameter monitoring system, not an AI-assisted diagnostic tool involving human readers.

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

• The document implies standalone performance testing for the device's measurements and calculations through "Design verification and validation testing." However, the raw data or detailed results of this standalone performance are not provided, only a summary statement of successful completion.

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

• For the engineering and software validation, the "ground truth" would be established by design specifications, industry standards (e.g., IEC 60601-1), and potentially comparison to reference instruments or methods during bench testing. Specific details are not provided in the document. No clinical ground truth (like pathology or outcomes data) was used based on the stated lack of clinical studies.

8. The sample size for the training set

• Not applicable. This is a medical device, not an AI/machine learning algorithm requiring a separate training set in the typical sense. The "training" would be the device's internal calibration and programming based on established physical and chemical principles.

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

• Not applicable. As above, this is a monitoring device based on established technology, not an AI algorithm that learns from a training set with specific ground truth labels. Its "ground truth" is intrinsically linked to the physical and chemical principles it measures and calculates, developed and verified during its design and engineering phases.

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The Capiox® NX19 Oxygenator with Integrated Arterial Filter and UltraPrime™ Technology is intended to be used to exchange gases between blood and a gaseous environment to satisfy the gas exchange needs of adult and small adult patients during cardiopulmonary bypass surgery.

The integrated arterial filter is intended to filter non-biologic particles and emboli and to facilitate air bubble removal from the blood flowing through the cardiopulmonary bypass circuit. The integrated heat exchanger is used to warm or cool blood and/or perfusion fluid as it flows through the device.

The hardshell reservoir is used to store blood during extra-corporeal circulation from the venous line and the cardiotomy line. The reservoir contains a venous section that is comprised of a filter and defoamer to facilitate air bubble removal. The cardiotomy section of the reservoir contains a filter to remove particulate matter and a defoamer to facilitate air bubble removal. The 4-liter reservoir may be used for Vacuum Assisted Drainage procedures and Post-Operative Chest Drainage Procedures.

The Capiox® NX19 Oxygenator with Integrated Arterial Filter and UltraPrime™ Technology is for use with patients when the required blood flow rate will not exceed 8.0 L/min.

The Capiox® NX19 Oxygenator with Integrated Arterial Filter and UltraPrime™ Technology can be used in procedures lasting up to 6 hours.

The Capiox® NX19 Oxygenator utilizes porous fiber technology to facilitate the transfer of gases between a blood-phase environment and a gas-phase environment for the intent of satisfying the gas exchange needs of a patient during cardiopulmonary bypass surgery. A fiber bundle offers the porous membrane surface to sufficiently permit the movement of gases through the walls of the hollow fibers via diffusion.

The Capiox® NX19 Oxygenator device has an integrated heat exchanger that is comprised of Polyethylene Terephthalate tubes arranged in a cylindrical shape. The circulating blood contacts the exterior surface of these tubes. Temperature-controlled water distributed from an external water bath fills the interior of the tubes. The heat exchanger material permits heat transfer to occur across the walls of the heat exchanger tubes to achieve the necessary temperature of the circulating blood.

The Capiox® NX19 Oxygenator device can be operated at flow rates up to 8 liters per minute (1/min) and at a minimum flow rate of 2.0 liters per minute (1/min) or 0.5 liters per minute (1/min) for up to 2 hours.

The integrated arterial filter of the Capiox® NX19 Oxygenator device relies upon mechanical entrapment of particulates and emboli within the filter mesh as a means to remove those particulates from the blood.

The Capiox® NX19 Oxygenator device also includes a 4-liter hardshell reservoir used to store blood during extra-corporeal circulation from the venous line and the cardiotomy line. The reservoir contains a venous section with a filter and defoamer and a cardiotomy section with a filter and defoamer.

This document describes the premarket notification (510(k)) for the Terumo Capiox NX19 Oxygenator with Integrated Arterial Filter and other components, seeking to demonstrate its substantial equivalence to a predicate device. This is NOT a study proving the device meets acceptance criteria in the context of an AI/ML medical device, but rather an FDA submission for a traditional medical device (oxygenator) based on non-clinical performance testing and comparison to a predicate device.

Therefore, I cannot fulfill the request to provide information regarding acceptance criteria and a study proving device performance as if it were an AI/ML medical device submission, as the provided text pertains to a traditional medical device submission. The concepts of "test set," "ground truth," "expert adjudication," "MRMC studies," "human readers improve with AI," and "standalone algorithm performance" are not applicable here.

However, I can extract the acceptance criteria and performance data for the physical medical device based on the provided text, reinterpreting "acceptance criteria" as the performance benchmarks established by comparison to predicate/reference devices.

Re-interpretation of Acceptance Criteria and Performance for the Terumo Capiox NX19 Oxygenator:

The document states that Terumo conducted in-vitro performance evaluations to demonstrate substantial equivalence to the predicate Capiox FX25 Advance Oxygenator. The acceptance criteria essentially infer that the performance of the NX19 must be "substantially equivalent" to or better than the predicate and reference devices for various functional parameters.

Here's a breakdown of what can be inferred, framed as closely as possible to the requested structure, though with caveats for the fundamental difference in device type:

1. Table of Acceptance Criteria and Reported Device Performance

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

• Sample Size: Not explicitly stated as "sample size" in the context of an AI test set. The document refers to "in-vitro performance evaluations" and "verification testing." The number of units tested for each in-vitro evaluation (e.g., how many oxygenators were subjected to gas transfer tests, hemolysis, etc.) is not detailed in this summary.
• Data Provenance: The studies were in-vitro performance evaluations conducted by Terumo Cardiovascular Systems. They are not clinical studies involving patients. The provenance is internal company testing to demonstrate substantial equivalence to legally marketed predicate devices. It is a prospective set of tests designed for this 510(k) submission.

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

• This is not applicable to this type of traditional medical device submission. Ground truth, in the AI/ML sense, is not established by human experts reviewing data for the device's performance. The "ground truth" for these physical tests is typically the measured physical performance against engineering specifications or established performance of the predicate device.

4. Adjudication Method for the Test Set

• Not applicable. There is no "adjudication" in the sense of reconciling expert opinions for test set ground truth as would be found in an AI/ML study.

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

• No. This type of study is relevant for AI/ML diagnostic devices where human readers (clinicians) interact with the AI. This is a physical oxygenator. The document explicitly states: "Clinical studies involving patients are not necessary to demonstrate substantial equivalence of the subject device to the predicate device."

6. If a Standalone (i.e. Algorithm Only Without Human-in-the-Loop Performance) Was Done

• Not applicable. This concept pertains directly to AI/ML algorithms, not a physical medical device like an oxygenator. The "standalone performance" is the device's measured in-vitro performance.

7. The Type of Ground Truth Used

• The "ground truth" for the performance comparison is the established performance characteristics of the legally marketed predicate device (Capiox FX25 Advance Oxygenator - K151791) and other reference devices (Sorin Inspire 8F Oxygenator - K121536, and Terumo Capiox NX19 - K172071).
• These are based on previously accepted engineering and performance specifications and in-vitro testing results for those devices.

8. The Sample Size for the Training Set

• Not applicable. This device is not an AI/ML algorithm that is "trained" on data. It is a manufactured physical product.

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

• Not applicable. There is no "training set" or "ground truth" establishment in the context of machine learning for this device. The design and materials are based on engineering principles and knowledge of the predicate device.

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The Capiox® NX19 Oxygenator with Integrated Arterial Filter and UltraPrime™ Technology is intended to be used to exchange gases between blood and a gaseous environment to satisfy the gas exchange needs of adult and small adult patients during cardiopulmonary bypass surgery.

The integrated arterial filter is intended to filter non-biologic particles and emboli and to facilitate air bubble removal from the blood flowing through the cardiopulmonary bypass circuit. The integrated heat exchanger is used to warm or cool blood and/or perfusion fluid as it flows through the device.

The hardshell reservoir is used to store blood during extra-corporeal circulation from the venous line and the cardiotomy line. The reservoir contains a venous section that is comprised of a filter and defoamer to facilitate air bubble removal. The cardiotomy section of the reservoir contains a filter to remove particulate matter and a defoamer to facilitate air bubble removal. The 4-liter reservoir may be used for Vacuum Assisted Drainage procedures and Post-Operative Chest Drainage Procedures.

The Capiox® NX19 Oxygenator with Integrated Arterial Filter and UltraPrime™ Technology is for use with patients when the required blood flow rate will not exceed 8.0 L/min.

The Capiox® NX19 Oxygenator with Integrated Arterial Filter and UltraPrime™ Technology can be used in procedures lasting up to 6 hours.

The Capiox® NX19 Oxygenator with Integrated Arterial Filter and UltraPrime™ Technology is a device used during cardiopulmonary bypass surgery. It includes an oxygenator that utilizes porous fiber technology for gas exchange, an integrated heat exchanger made of Polyethylene Terephthalate tubes for warming or cooling blood, an integrated arterial filter for removing particles and emboli, and a hardshell reservoir for storing blood. The reservoir has sections for venous and cardiotomy blood, each with filters and defoamers. The device is designed for blood flow rates up to 8.0 L/min and procedures lasting up to 6 hours.

The provided text describes the Terumo Capiox NX19 Oxygenator with Integrated Arterial Filter and the study performed to demonstrate its substantial equivalence to a predicate device (Capiox FX25 Advance Oxygenator) and a reference device (Sorin Inspire 8F Oxygenator).

Here's an analysis of the acceptance criteria and study details based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance:

The document doesn't explicitly present a direct side-by-side table of acceptance criteria and reported device performance values. Instead, it describes various performance evaluations conducted and states that the NX19's performance features are "deemed substantially equivalent" to the predicate and reference devices. The text indicates that the acceptance criteria for performance testing for the NX19 were set using the Sorin Inspire 8F as a reference device. It implies that the NX19 met these criteria to be considered substantially equivalent.

However, based on the text, we can infer the categories of performance for which criteria exist and that the device met these criteria:

Note 1: These tests were conducted on the NX19 Oxygenator.
Note 2: These tests were conducted on the reservoir and cleared with the predicate FX25 in K151791. The NX19 uses the exact same reservoir.

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

The document does not explicitly state the numerical sample sizes for each in-vitro performance test. It refers to these as "in-vitro performance evaluations." The data provenance is in-vitro testing conducted by Terumo Cardiovascular Systems Corporation. There is no mention of country of origin of the data for these specific tests, but the company is based in the US (Elkton, Maryland). The nature of "in-vitro" implies a controlled laboratory environment rather than retrospective or prospective patient data for these performance evaluations.

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 performance evaluations are in-vitro physical and functional tests, likely assessed against pre-defined engineering and performance specifications derived from the predicate and reference devices, rather than expert review of clinical data.

4. Adjudication method for the test set:

This information is not applicable/provided. For in-vitro performance tests, adjudication methods like 2+1 or 3+1 (typically used for clinical image review or diagnostic assessments) are not relevant. The assessment would involve comparing quantitative measurements against established criteria.

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/provided. The device is an oxygenator and integrated components for cardiopulmonary bypass surgery, not an AI-assisted diagnostic tool for human readers. Therefore, an MRMC study or evaluation of AI assistance for human readers is not relevant to this device.

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

This information is not applicable/provided. The device is a physical medical device (oxygenator, filter, heat exchanger, reservoir) and does not involve an algorithm or AI. The performance studies are for the device's physical functions.

7. The type of ground truth used:

The ground truth for the performance evaluations is based on established engineering and performance specifications derived from the legally marketed predicate device (Capiox FX25 Advance Oxygenator) and further informed by the reference device (Sorin Inspire 8F Oxygenator). The goal was to demonstrate "substantial equivalence" to these devices, meaning the NX19's performance met comparable levels.

8. The sample size for the training set:

This information is not applicable/provided. As a physical medical device, there is no "training set" in the context of machine learning or AI models. The device's design and manufacturing are based on engineering principles and material science.

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

This information is not applicable/provided for the same reason as point 8.

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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.

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The VirtuoSaph® Plus Endoscopic Vessel Harvesting System is indicated for use in minimally invasive surgery allowing access for vessel harvesting, and is primarily indicated for patients undergoing endoscopic surgery for arterial bypass. It is indicated for cutting tissue and controlling bleeding through coagulation, and for patients requiring blunt dissection of tissue including dissection of blood vessels and dissection of blood vessels of the extremities. Extremity procedures include tissue dissection and/or vessel harvesting along the saphenous vein for coronary artery bypass grafting and peripheral artery bypass grafting or radial artery for use in coronary artery bypass grafting.

The VirtuoSaph® Plus Endoscopic Vessel Harvesting System is an endoscopic vessel harvesting system that relies upon bipolar radio frequency (RF) energy to cauterize and seal vessels that are to be harvested. The RF current is transmitted across two electrodes in order to effect the necessary cauterization/sealing of the tissue when the tissue is appropriately positioned between the two electrodes. The device also uses bipolar RF energy for cutting tissue. The system is designed to be used with an endoscope. Components include a Trocar, Dissector Rod, Harvester Rod, and Endoscope (reusable device packaged separately).

The provided text describes a 510(k) premarket notification for the Terumo VirtuoSaph® Plus Endoscopic Vessel Harvesting System, seeking to expand the list of compatible electrosurgical generators. The submission aims to demonstrate substantial equivalence to its predicate device (an earlier version of the same system) by showing that the device performs safely and effectively with the additional generators.

Here’s a breakdown of the requested information based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly present a table of acceptance criteria with numerical targets. Instead, it states that the studies were designed "to ensure that the proposed generators each satisfy appropriate device performance specifications, and to ensure that customer requirements are met." It also concludes that "There are no appreciable differences between the performance of the VirtuoSaph® Plus System when used with the new generators verses performance when used with the existing generators."

The performance evaluations mentioned are:

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

The document states that "performance studies with each of the four additional generators that can be used with the VirtuoSaph® Plus System" were conducted. These were "in-vitro performance evaluations."

• Sample Size: Not explicitly stated. The number of samples for each test (Vessel Burst, Spot Cautery, Sealing/Hemostasis) with each of the four new generators is not provided.
• Data Provenance: In-vitro (laboratory) studies. The country of origin is not specified but assumed to be where the manufacturer (Terumo Cardiovascular Systems Corporation) conducts its testing, likely in the US (Elkton, Maryland). The studies are prospective in the sense that they were conducted specifically for this submission to evaluate the expanded compatibility.

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 and not present in the document. The studies were in-vitro performance evaluations, not clinical studies involving human observers or ground truth established by experts.

4. Adjudication Method for the Test Set

This information is not applicable and not present in the document because the studies were in-vitro performance evaluations, not involving human adjudication of clinical outcomes or imaging.

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. The device is a surgical instrument (Endoscopic Vessel Harvesting System) and not an AI-powered diagnostic or assistive tool for human readers/clinicians that would typically undergo an MRMC study.

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

This information is not applicable. The device is a surgical instrument, not an algorithm. The "performance evaluations" mentioned are for the physical device's function when used with different power generators.

7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.)

For the in-vitro performance evaluations (Vessel Burst Testing, Spot Cautery Testing, Sealing/Hemostasis), the "ground truth" would be established by objective, measurable physical parameters. For example:

• Vessel Burst Testing: Measured pressure at which a vessel bursts after sealing, compared against a predefined threshold or performance of the predicate device.
• Spot Cautery Testing: Visual assessment or measurement of the cauterized tissue's characteristics (e.g., degree of coagulation, charring) against acceptance criteria.
• Sealing/Hemostasis: Measurement of leakage or blood flow post-sealing under specified pressure conditions, compared against a predefined threshold or performance of the predicate device.

The document implies that the comparison to the existing generators serves as the benchmark for "ground truth" performance.

8. The Sample Size for the Training Set

This information is not applicable. The device is a physical medical instrument, not a machine learning model, so there is no "training set."

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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