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The VitalFlow™ Centrifugal Pump is intended to pump blood through the extracorporeal circuit for circulatory support up to 48 hours, in adult patients with acute respiratory failure or acute cardiopulmonary failure, where other available treatment options have failed, and continued clinical deterioration is expected or the risk of death is imminent.

The VitalFlow™ Centrifugal Pump is driven by the VitalFlow™ Console and Drive Motor, or the Emergency Handcrank.

The VitalFlow Centrifugal Pump is a sterile, single-use centrifugal blood pump. It is a non-invasive, nonpyrogenic device designed to move blood through the extracorporeal circuit by centrifugal force. The pump is the disposable portion of the pumping system and it is electromagnetically coupled to an instrument that monitors and displays the flow and pressure of the blood. Blood enters the inlet port of the pump, where a cone with impeller blades within the pump housing rotates and the blood is gently accelerated toward the outlet of the pump.

The VitalFlow Centrifugal Pump can be driven through magnetic coupling by an External Drive Motor or the Emergency Handcrank.

The provided document is a 510(k) Summary for the VitalFlow™ Centrifugal Pump, a Class II medical device. It details the device's indications for use, description, and studies conducted to demonstrate its substantial equivalence to predicate and reference devices.

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 present a table of "acceptance criteria" with quantitative targets in the way one might expect for a diagnostic AI device (e.g., target specificity, sensitivity). Instead, the acceptance criteria are framed within the context of demonstrating substantial equivalence to predicate devices and meeting specific "Special Controls" outlined in 21 CFR 870.4100. The performance is assessed through various bench, animal, and real-world clinical data.

Therefore, the table below summarizes the Special Controls as acceptance criteria and how the device's performance, as reported, addresses them.

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

The document describes several types of studies:

• Bench Performance Evaluations: No specific sample size is given for individual tests, but it states "Design verification studies were performed by the original manufacturer... and supplemented by MC3 bench performance testing, including long-term characterization." This implies multiple samples were tested for each characteristic.
• Animal Studies (In vivo evaluation): A sample size of 13 sheep was used for the 96-hour study. The data provenance is a controlled research environment.
• Clinical Performance (Real-world evidence): This utilized 1048 reports from the ELSO.org registry for the Affinity CP Centrifugal Blood Pump (AP40 group). The document states this is a "summary of real-world evidence," implying retrospective data extraction from an international registry. The country of origin for the data isn't explicitly stated but the ELSO registry collects data internationally. The comparison group ("All Other Pumps") involved 51,032 reports.

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

This device is not an AI diagnostic device that relies on expert interpretation of images or signals to establish a "ground truth" in the traditional sense. The "ground truth" for its performance is established through objective measures in bench testing (e.g., flow, pressure, mechanical integrity), physiological parameters in animal studies (e.g., presence/absence of clots, functionality), and reported clinical outcomes in the ELSO registry.

Therefore, there is no mention of "experts" establishing ground truth in the context of adjudication for a test set. Design verification and animal study results would be assessed by engineers, veterinarians, and researchers involved in those studies. Clinical outcomes in the ELSO registry are reported data.

4. Adjudication Method for the Test Set

Given that this is not an AI diagnostic device evaluating, for example, medical images requiring consensus on findings, there is no adjudication method (e.g., 2+1, 3+1) mentioned or applicable for the test sets described.

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 typically assesses the performance of human readers (e.g., radiologists) with and without AI assistance for tasks like diagnosis or detection. The VitalFlow™ Centrifugal Pump is a mechanical device, not an AI diagnostic tool, so such a study is not relevant.

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

No, a standalone (algorithm-only) performance study was not done, as the VitalFlow™ Centrifugal Pump is a physical medical device. The "standalone" performance here would refer to the device's function outside of a human-in-the-loop context, which is effectively what the bench and animal studies demonstrate regarding its mechanical integrity and ability to pump blood.

7. The Type of Ground Truth Used

The "ground truth" for evaluating the VitalFlow™ Centrifugal Pump's performance is multi-faceted:

• Bench Testing: Engineering specifications and performance metrics (e.g., pressure-flow curves, durability, wear, integrity, blood trauma data).
• Animal Studies: Direct observation of device functionality, physiological parameters, and absence of adverse events like clot formation in a living system over a defined period (96 hours).
• Clinical Performance (Real-world evidence): Reported clinical outcomes and complication rates from a large patient registry (ELSO.org), providing real-world data on pump failure, hemolysis, circuit changes, and other adverse events. This relies on the accuracy of data submitted to the registry.

8. The Sample Size for the Training Set

The document is for a traditional medical device (centrifugal pump), not an AI/Machine Learning device. Therefore, there is no "training set" in the context of AI model development that would typically have a distinct sample size. The design verification, bench testing, and animal studies serve as part of the overall development and validation process.

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

As there is no AI training set, this question is not applicable. The "ground truth" for the device's design and engineering would be based on established medical and engineering principles, material science, and regulatory requirements, which are then verified through rigorous testing, as mentioned above.

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The Anivia SG1000 Pump Console is intended to pump blood through the extracorporeal bypass circuit for extracorporeal support for periods appropriate to cardiopulmonary bypass (up to 6 hours).

The Anivia SG1000 Pump Console is a device for pumping blood without direct contact in an extracorporeal blood circulation circuit. The device is prescribed (Rx) by specialists to be used in Cardiopulmonary Bypass (CPB) procedures. The Anivia SG1000 Pump Console consists of the following modules: Display & Control Module, Pump Driver Module, Flow Bubble Sensor Module, and Backup Battery Module. It is intended to be used in conjunction with other previously 510(k)-cleared devices and sterile accessories such as cannulas, catheters, oxygenators, luer connectors and single use centrifugal pump heads, supplied by hospital users or other manufacturers.

The provided text describes the Anivia SG1000 Pump Console, a device intended to pump blood through an extracorporeal bypass circuit for cardiopulmonary bypass procedures (up to 6 hours). The 510(k) summary focuses on demonstrating substantial equivalence to a predicate device (Medtronic Bio-console® 560 Extracorporeal Blood Pumping Console, K131964).

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 list a table of acceptance criteria with specific numerical targets and corresponding reported device performance values for the Anivia SG1000 Pump Console. Instead, it broadly states that "All testing met predetermined acceptance criteria." The performance characteristics are described in comparison to the predicate and reference devices in the "Technological Characteristics" table, implying that the acceptance criteria for these characteristics are met by being "Same as predicate" or by having differences that "do not raise different questions of safety and effectiveness."

Here's a breakdown of the performance characteristics provided, and where the device's performance aligns with or is considered equivalent to the predicate:

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

The document does not specify a "test set" in the context of clinical data for algorithmic performance, as this device does not involve AI or machine learning that would typically use such a test set. The non-clinical tests involved "system bench testing, mechanical testing, electrical safety and electromagnetic interference and compatibility testing, software testing, reliability, and usability testing." The sample size for these engineering and performance tests is not quantified (e.g., number of devices tested, number of test runs).

Data provenance is not applicable since no clinical data or patient data was used to assess the device's performance in this 510(k) submission. All tests mentioned are non-clinical, benchtop, or simulated use.

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

Not applicable. This device does not involve a "ground truth" derived from expert review or clinical annotations for an algorithm. The evaluation relies on engineering tests and compliance with recognized standards.

4. Adjudication Method (e.g., 2+1, 3+1, none) for the Test Set

Not applicable, as there is no "test set" in the context of human-reviewed data where adjudication would be necessary.

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 cardiopulmonary bypass pump console, not an AI/ML-driven diagnostic or interpretative tool that would involve human readers or an MRMC study.

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

Not applicable. This device is electro-mechanical hardware with software controls, not a standalone algorithm.

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

Not applicable. For this type of medical device (a pump console), "ground truth" is established through engineering specifications, validated test methods (e.g., measuring pump speed, flow rate, alarm accuracy), and compliance with international consensus standards. There is no biological or imaging "ground truth" involved.

8. The Sample Size for the Training Set

Not applicable. This device does not involve machine learning or AI, and therefore does not have a "training set." The software embedded in the device undergoes traditional software verification and validation.

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

Not applicable, as there is no training set.

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The Novalung System is indicated for long-term (> 6 hours) respiratory/cardiopulmonary support that provides assisted extracorporeal circulation and physiologic gas exchange (oxygenation and CO2 removal) of the patient's blood in adults with acute respiratory failure or acute cardiopulmonary failure, where other available treatment options have failed, and continued clinical deterioration is expected or the risk of death is imminent. These may include:

• · Failure to wean from cardiopulmonary bypass following cardiac surgery in adult patients
• · ECMO-assisted cardiopulmonary resuscitation in adults

The Novalung System is a blood oxygenation and carbon dioxide removal system designed to provide extracorporeal cardiac and/or pulmonary support. The following therapies are available with the Novalung System:

• Extracorporeal CO2 removal (ECCO2R)
• Extracorporeal membrane oxygenation (ECMO) ●
  The Novalung System consists of the Novalung console and XLung kit. The Novalung console is composed of the following components:
• Control panel ●
• Power supply ●
• Sensor box ●
• . Pump drive
  The Novalung console powers and monitors the operation of the blood pump head in the extracorporeal circuit. The control panel has a touchscreen display on which all data, parameters, and values are displayed. Parameters can be selected and adjusted by pressing the touchscreen as well as by using the control panel function keys and the center knob. The control panel is attached to the power supply, which provides power to the console. The console also provides two (2) battery packs that supply power to the console if there is a power failure.
  The sensor box allows data to be transferred to the console and displayed on the control panel. It has connectors for pressure sensors that connect to the XLung kit tubing set and a flow sensor.
  The XLung kit contains a disposable tubing set and accessories (gas line, priming line, stopcocks, luer caps, Christmas tree connector, tubing clamps, cable ties). The tubing set is pre-connected to a hollow fiber membrane oxygenator (XLung oxygenator) and blood pump head (Deltastream DP3 3/8"), which forms an extracorporeal circuit. All blood-contacting surfaces of the tubing set, except for the blood pump head, are coated with x.ellence coating.
  The XLung kit tubing has 3 integrated pressure sensors (IPS) that connect to the sensor box. The flow sensor detects air bubbles in the extracorporeal circuit and measures blood flow. The XLung kit provides treatment for a blood flow range of 1-7 L/min and has a total extracorporeal priming volume of 605 mL ± 10%.
  The blood pump head is pre-connected to the XLung kit tubing set, which is provided sterile. Blood flow in the XLung kit tubing set is driven by the pump drive when it is connected to the blood pump head.
  The following accessories are available with the Novalung System:
• Bracket and rail connector
• Flow sensor ●
• Pressure sensor connecting cables
• System cart ●
• Compact holder spike and bracket
• Pump drive holders ●
• . Infusion holder

The provided text describes the Novalung System, an extracorporeal circuit and accessories for long-term respiratory/cardiopulmonary failure. It outlines the device's indications for use, its components, and various tests conducted to demonstrate its substantial equivalence to predicate devices. However, the document does not present a table of specific acceptance criteria alongside reported device performance for these tests. Instead, it generally states that "All testing met predetermined acceptance criteria" and provides summaries of the types of tests performed and their overall conclusions.

Therefore, many of the requested details about acceptance criteria, specific performance metrics, sample sizes for test sets, expert qualifications, and ground truth establishment cannot be extracted directly from this document.

Here's a summary of the information that can be extracted or inferred from the provided text, and an explanation for what cannot:

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

The document states: "All testing met predetermined acceptance criteria." However, it does not provide a specific table with numerical or qualitative acceptance criteria for each test (e.g., "Oxygen transfer rate > X mL/min," "Pressure drop

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The FloPump 32mL Centrifugal Pump is a device that uses a method other than revolving rollers to pump the blood through an extracorporeal circuit for periods lasting less than 6 hours for the purpose of providing either:

i) Full or partial cardiopulmonary bypass (i.e., circuit includes an oxygenator) during open surgical procedures on the heart or great vessels; or

ii) Temporary circulatory bypass for diversion of flow around a planned disruption of the circulatory pathway necessary for open surgical procedures on the aorta or vena cava.

The FloPump 32mL is a single use disposable centrifugal pump has an inlet that draws blood from a patient and an outlet that pushes the blood out, where it then passes through an oxygenator and back to the patient. The pump mates with the Maquet RotaFlow console and rotates the internal impeller using a magnetic driver. The FloPump 32mL is a non-occlusive pump. The pump has a spinning rotor with flow channels which imparts rotary motion to the incoming blood, directing it through a spiral housing to the outflow port. The FloPump 32mL is part of the extracorporeal circuit, and is therefore in contact with the patient's blood while circulating. The FloPump 32mL does not have any other patient contact.

The provided text describes a medical device, the FloPump 32mL Centrifugal Pump, and its 510(k) summary for FDA clearance. However, it does not describe acceptance criteria and a study proving a device meets them in the context of an AI/algorithm-based medical device.

The information provided is for a physical medical device and primarily focuses on demonstrating substantial equivalence to predicate devices through non-clinical testing. Therefore, I cannot extract the requested information regarding AI/algorithm performance.

Here's an analysis of why the requested information isn't present:

• No AI/Algorithm: The FloPump 32mL Centrifugal Pump is a physical device that functions to pump blood through an extracorporeal circuit. It does not employ any AI or algorithms for decision-making or analysis.
• No Diagnostic or Predictive Outputs: The device's function is mechanical (pumping blood), not diagnostic or predictive in nature. Therefore, there are no performance metrics like sensitivity, specificity, accuracy, or AUC that would be typically associated with AI/algorithm acceptance criteria.
• Focus on Substantial Equivalence: The 510(k) summary emphasizes "substantial equivalence" to predicate devices based on design, materials, specifications, and non-clinical testing (flow curves, heat generation, hemolysis, etc.).
• No Clinical Study for Performance: The document explicitly states, "Clinical testing was not required" for this device clearance. This further confirms the absence of studies designed to evaluate AI performance or human reader improvements.

Therefore, since the input document describes a physical medical device and not an AI-powered one, I cannot fulfill the request to provide acceptance criteria and study details related to AI/algorithm performance.

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The LIFEBRIDGE B2T System is indicated for use as an extracorporeal blood oxygenation system for patients needing short term, 6 hours or less, cardiac and/or pulmonary support.

The LIFEBRIDGE B2T SYSTEM is a compact, pre-assembled, modular system consisting of: 1. Patient module housing an extracorporeal circuit comprised of several previously 510k-cleared devices. The circuit includes a rigid reservoir bag, a centrifugal pump, oxygenator, arterial filter, active air management system, tubing and connectors. 2. Sensors, including flow, pressure, level and bubble to read system parameters. 3. Control module that contains the electronics and user interface. 4. Base module that contains a touch screen, the main power connection and acts as a stable frame for the system. The following LIFEBRIDGE ByT SYSTEM components have been previously 510(k)-cleared for use in cardiopulmonary bypass: oxygenator, arterial filter, centrifugal pump, level sensors, and bubble detector.

The provided document is a 510(k) summary for the LIFEBRIDGE B2T System, a cardiopulmonary support system. It focuses on demonstrating substantial equivalence to predicate devices rather than providing detailed acceptance criteria and a study proving device performance against those criteria in the way one might expect for novel technology or a software algorithm.

Here's an analysis based on the provided text, addressing your points where information is available:

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

The document does not specify quantitative "acceptance criteria" or present a table of reported device performance in the context of a formal study demonstrating compliance with such criteria. Instead, it states:

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

The document does not describe a clinical "test set" with a specific sample size or data provenance. The assessment for this device appears to be based on:

• Non-clinical tests: The document mentions "Non-clinical tests performed on the LIFEBRIDGE B2T SYSTEM provide evidence of the safety and effectiveness of the device for its intended use." Details of these tests (e.g., number of runs, specific parameters) are not provided.
• Comparison to predicate devices: The primary argument for approval is based on substantial equivalence to existing, legally marketed cardiopulmonary bypass systems. This implies that the safety and effectiveness of the components and overall system are inferred from the established performance of the 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)

This information is not applicable to this 510(k) submission. There is no mention of an expert-adjudicated test set or ground truth establishment in the context of human expert review. The submission relies on non-clinical testing and comparison to predicate device characteristics.

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

Not applicable. No expert adjudication method is described because there is no expert-adjudicated test set in the provided document.

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 document describes a medical device (a cardiopulmonary support system), not an AI algorithm. Therefore, an MRMC study related to AI assistance is not relevant to this submission.

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

Not applicable. This is a hardware medical device, not a standalone algorithm.

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

The concept of "ground truth" as typically applied in AI/diagnostic device studies (e.g., expert consensus, pathology, clinical outcomes) is not explicitly detailed in this 510(k) summary. The "ground truth" for demonstrating safety and effectiveness of a cardiopulmonary support system in this type of submission is typically derived from:

• Engineering specifications and performance standards: Non-clinical tests verify the device meets these standards (e.g., flow rates, pressure limits, oxygenation efficiency, material biocompatibility).
• Established performance of predicate devices: The "truth" of what constitutes a safe and effective cardiopulmonary bypass system is based on the long history and regulatory clearance of the predicate devices.

8. The sample size for the training set

Not applicable. This pertains to an AI/machine learning model, which is not what the LIFEBRIDGE B2T System is.

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

Not applicable. This pertains to an AI/machine learning model, which is not what the LIFEBRIDGE B2T System is.

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