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The CentriMag™ Blood Pump for use with CentriMag™ Acute Circulatory Support System (Motor, Monitor, Console, and Flow Probes) is indicated for controlling blood flow as part of an extracorporeal membrane oxygenation (ECMO) circuit. ECMO is intended to provide assisted extracorporeal circulation and physiologic gas exchange of the patients' blood for adult patients with acute respiratory failure and/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 CentriMag™ Blood pump for use with CentriMag™ Acute Circulatory Support System (hereafter referred to as the CentriMag System) is designed to provide assisted extracorporeal circulation and physiologic gas exchange of patients' blood for adult patients with acute respiratory and/or acute cardiopulmonary failure. The CentriMag System was designed to provide temporary mechanical circulatory support. The CentriMag System provides circulatory assistance for patients in acute hemodynamic compromise, a population whose treatment options are limited. The system includes: CentriMag 2nd Generation Primary Console, CentriMag Motor, CentriMag Blood Pump, Flow Probe, and Mag Monitor (optional). The CentriMag System features a centrifugal flow pump with inflow and outflow ports that are at right angles to one another, and a magnetically levitated impeller (Full MagLev™ technology). The CentriMag Motor is a reusable, non-sterile component of the CentriMag Acute Circulatory Support System. The CentriMag Motor holds the blood pump and drives the impeller inside the blood pump. When the pump is inserted into the motor and activated, the internal impeller is electromagnetically levitated and centered, eliminating the need for shafts, seals, and bearings in the pump. Utilizing magnetic levitation technology (Full MagLev™ technology) to suspend and spin the impeller eliminates bearing and seal friction, resulting in minimal heat generation and wear of the pump components. the console is used to control pump speed, the resultant blood flow, and monitor the operation of the system. A cable connects the console to the motor, allowing flexibility in the pump motor and pump positioning.

The provided text describes the CentriMag™ Blood Pump for use with the CentriMag™ Acute Circulatory Support System. While it details extensive performance testing and claims substantial equivalence, it does not present acceptance criteria in terms of specific quantitative metrics (e.g., sensitivity, specificity, accuracy) that would apply to an AI/ML device, nor does it provide a study that explicitly demonstrates the device meets these types of criteria using methods common for AI/ML performance evaluation (like those involving expert consensus for ground truth).

Instead, the document focuses on the engineering and clinical performance of a mechanical circulatory support system. The "acceptance criteria" appear to be implicit in meeting the special controls outlined in 21 CFR 870.4100(b) and demonstrating substantial equivalence to a predicate device through various non-clinical and clinical evaluations.

Here's a breakdown of the information that is present, interpreted in the context of the prompt, and highlighting what is not present but would be typical for AI/ML device evaluation:

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

The document does not provide a table with explicit acceptance criteria (e.g., target percentages for accuracy, sensitivity, specificity) and corresponding reported device performance for an AI/ML component. The "acceptance criteria" for this device seem to be implicitly tied to meeting regulatory requirements for extracorporeal circuits and accessories, and demonstrating performance comparable to a predicate device through a range of engineering and clinical tests.

Reported Device Performance (based on the provided text):

The performance of the CentriMag System was demonstrated through a comprehensive set of tests:

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

• Sample Size for Test Set: Not explicitly stated as a test set in the traditional AI/ML sense. The "clinical summary" refers to a "pre-specified statistical analysis plan from the ELSO Registry," which is a real-world clinical data source. The number of patients included in this propensity-matched analysis is not provided.
• Data Provenance: The data comes from the ELSO Registry, which is a registry for Extracorporeal Life Support Organization, suggesting a multi-center, international scope. The analysis was retrospective (utilizing existing registry data).

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

Not applicable in the typical AI/ML context. The clinical study used the ELSO Registry, which records actual clinical outcomes and complications. The "ground truth" here is the aggregated, documented patient outcomes from the registry, not an expert-annotated dataset for an algorithm.

4. Adjudication method for the test set

Not applicable. As the "ground truth" is derived from a clinical registry of patient outcomes, there's no mention of an adjudication method used by experts for a test set. The registry likely has its own data entry and validation protocols.

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 such study was conducted or mentioned, as the device is a mechanical circulatory support system, not an AI-assisted diagnostic or decision support tool for human readers.

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

This question is not applicable to the CentriMag Blood Pump, as it is a mechanical device, not an algorithm.

7. The type of ground truth used

For the clinical evaluation, the "ground truth" consists of outcomes data from the ELSO Registry, specifically ECMO-related clinical complications and other patient outcomes.

8. The sample size for the training set

Not applicable. The CentriMag Blood Pump is a hardware device; it does not involve a training set for an AI/ML algorithm.

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

Not applicable. There is no training set mentioned for this device.

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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 Affinity™ CP Centrifugal Blood Pump with Carmeda® BioActive Surface is used to pump blood through the extracorporeal bypass circuit for extracorporeal circulatory support for periods appropriate to cardiopulmonary bypass (up to 6 hours).

It is also indicated for use in extracorporeal support systems (for periods up to 6 hours) not requiring complete cardiopulmonary bypass (e.g. valvuloplasty, circulatory support during mitral valve reoperation, surgery of the vena cava or aorta, liver transplants).

The Affinity™ CP Centrifugal Blood Pump with Carmeda® BioActive Surface is driven by the External Drive Motor or the Emergency Handcrank.

The Affinity™ CP Centrifugal Blood Pump with Carmeda® Bioactive Surface is intended to be used in medical procedures requiring extracorporeal circulation circuits. Functionality and intended use of the coated pump are the same as those for the uncoated pump. The pump is designed to move blood by centrifugal force generated by a combination of a smooth rotating cone and low-profile impeller fins. Energy is transferred from the pump in the form of pressure and velocity as the blood is driven toward the outlet port of the pump. The pump utilizes a pivot bearing design on a dual ceramic pivot.

The Affinity CP Centrifugal Blood Pump with Carmeda Bioactive Surface is coated with a nonleaching bioactive surface (heparin) to enhance blood compatibility and provide thromboresistant blood-contacting surfaces.

As with the uncoated Affinity CP pump the Affinity CP Centrifugal Blood Pump with Carmeda Bioactive Surface is driven by the External Drive Motor or the Emergency Handcrank (K100631). There have been no changes to these accessory devices.

This 510(k) summary describes a modification of an existing device, the Affinity CP Centrifugal Blood Pump, by adding a Carmeda BioActive Surface. Therefore, the "acceptance criteria" discussed are largely related to demonstrating that the coated pump is substantially equivalent to the uncoated predicate device and another coated predicate device. The performance data presented shows that the modified device meets the necessary safety and effectiveness requirements for this substantial equivalence claim.

Acceptance Criteria and Reported Device Performance

The document does not explicitly present a table of numerical acceptance criteria with corresponding performance values in the way one might see for a diagnostic device's sensitivity/specificity. Instead, it lists the types of performance testing conducted to demonstrate substantial equivalence. The "acceptance criteria" implicitly are that the device performs comparably to the predicate devices and meets relevant safety standards for each test.

Study Details:

This document is a 510(k) summary, which provides a high-level overview of the device and the studies supporting its substantial equivalence. It does not contain detailed study protocols, raw data, or comprehensive statistical analysis that would typically be found in a full study report.

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

   • The document does not specify the sample sizes (e.g., number of pumps tested) for any of the verification and validation tests listed.
   • The data provenance (e.g., country of origin, retrospective/prospective) is not mentioned. These types of tests are typically prospective laboratory bench and animal tests, not human clinical trials, when demonstrating substantial equivalence for a device modification like this.

2. 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 document describes engineering and biological performance testing for a medical device, not a diagnostic algorithm. Therefore, the concept of "ground truth established by experts" in the context of image interpretation or clinical diagnosis by human readers is not applicable here. The "ground truth" for these tests would be established by validated measurement techniques and established engineering/biological standards in a laboratory setting.

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

   • Not applicable. Adjudication methods like 2+1 or 3+1 are used for establishing ground truth in human-AI interpretation studies, usually for clinical endpoints or image readings. This document discusses bench and biocompatibility testing for a blood pump.

4. 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 is a physical medical device (blood pump), not an AI diagnostic tool. Therefore, MRMC studies are not relevant.

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

   • Not applicable. This is a physical medical device (blood pump), not an AI algorithm.

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

   • For the performance tests listed (flow rates, heat generation, hemolysis, bioactivity, etc.), the "ground truth" would be established by standardized laboratory measurement protocols and validated analytical tests. For example, hemolysis would be measured using spectrophotometry against established benchmarks, and bioactivity (heparin effectiveness) would be measured through anti-coagulant assays. These are objective, quantitative measures rather than subjective expert consensus.

7. The sample size for the training set:

   • Not applicable. This refers to a physical medical device, not an AI model that requires a training set.

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

   • Not applicable. As above, this document does not describe an AI model.

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The Capiox SP Pump is used to facilitate blood flow in the extracorporeal circuit for circulatory support during extracorporeal circulation for up to 6 hours.

The Capiox® SP Pump is a sterile, single use device. The pump is a non-roller type pump that couples magnetically to, and is magnetically driven by the BioMedicus BioConsole Models 540, 550 and 560 via the pumphead adaptor. The device is a hardshell housing that contains a blood compartment (blood chamber) and a non-blood compartment (rear chamber). Within the blood chamber is a rotating impeller-type component that imparts centrifugal force upon blood as it enters the device. These centrifugal forces move the blood out of the device via the outlet port - and propel the blood through the bypass circuit.

Here is a summary of the acceptance criteria and the study that proves the device meets them, based on the provided text:

Device: Terumo Capiox® SP Pump

Reason for Submission: To add an indication for use with the BioMedicus BioConsole Model 560.

1. Table of Acceptance Criteria and Reported Device Performance

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

The document does not explicitly state numerical sample sizes for the "test set" for the performance evaluations. Instead, it mentions "in-vitro performance evaluations" which are typically laboratory-based tests. The data provenance is not explicitly linked to specific countries or retrospective/prospective clinical data, as the studies are stated to be in-vitro (bench testing), not clinical trials.

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

This information is not applicable to this submission. The "ground truth" here is based on engineering specifications and performance benchmarks for medical devices, rather than expert interpretation of medical images or clinical outcomes. The "experts" would be the engineers and scientists conducting the in-vitro performance evaluations and comparing them against established technical standards and predicate device performance. Their qualifications are implicitly assumed to be appropriate for conducting such technical evaluations.

4. Adjudication Method for the Test Set

This information is not applicable, as the studies are in-vitro performance evaluations, not studies involving human interpretation or adjudication. The "results" are quantitative measurements directly from the device's operation.

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

No, an MRMC comparative effectiveness study was not conducted. The submission explicitly states that "Clinical studies involving patients are not necessary to demonstrate substantial equivalence of the subject device to the predicate device." The evaluations were limited to in-vitro performance testing.

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

This question is not applicable as the device is a physical medical pump (Capiox® SP Pump), not an algorithm or AI software. The performance evaluated refers to the physical operation of the pump.

7. The Type of Ground Truth Used

The "ground truth" for the in-vitro performance evaluations appears to be a combination of:

• Predicate Device Performance: Direct comparison to the established performance of Terumo's Capiox® SP Pump (K012209 and K962981) and Medtronic's BPX-80 Bio-Pump® (K973011) when used on the BioMed 560 console.
• Established Engineering/Regulatory Standards: Implied adherence to safety (e.g., decoupling) and durability requirements for such devices, as well as AAMI guidelines for sterilization.
• Biocompatibility Standards: Adherence to FDA General Program Memorandum #G95-1 and ISO 10993.

8. The Sample Size for the Training Set

This information is not applicable. The submission describes a physical medical device, not a machine learning model, so there is no concept of a "training set" in this context.

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

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

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The AB-180 XC Blood Pump is a single use, disposable centrifugal blood pump designed to circulate blood through an extracorporeal circuit. The AB-180 XC Blood Pump is intended for extracorporeal circulatory support using an extracorporeal bypass circuit. Intended duration of use is for periods appropriate to cardiopulmonary bypass, up to six hours. It is also intended to be used as an extracorporeal circulatory support system (for periods up to six hours) for procedures not requiring complete cardiopulmonary bypass (e.g. valvuloplasty, mitral valve reoperation, surgery of the vena cava and/or aorta, liver transplant, etc.)

The AB-180 XC Blood Pump provides extracorporeal circulatory system support with the unique ability to locally deliver an anticoagulant through the infusate system. The Pump is electrically driven and can only be used with the AB-180 XD Blood Pump Controller. The AB-180 XD Blood Pump Controller provides pump monitoring, manual pump speed variability and a constant flow of infusate to the Pump.

The AB-180 XC Blood Pump consists of an upper and lower housing. The upper housing encloses the blood contact area of the Pump and holds the impeller, which propels the blood through the Pump. This chamber has a low priming volume. Two tubes connect to this chamber allowing easy connection to extracorporeal circulatory support circuits. The lower housing contains the main rotating component (the rotor) and has an inlet port for the infusion fluid. This infusate acts as a fluid bearing and a local anticoagulation delivery system.

This 510(k) summary describes a submission for a Class III centrifugal blood pump. The review process concluded with a substantial equivalence determination to previously approved devices. Therefore, the device did not require a full clinical trial for approval. The acceptance criteria, study design and results from the provided text are summarized below:

1. Table of Acceptance Criteria and Reported Device Performance

• Hydraulic Performance Tests
• Safety and Environmental Tests (meeting IEC 60601-1, IEC 60601-1-2 and IEC 68 standards)
• Hemolysis Testing | Demonstrated substantial equivalence to commercially distributed centrifugal blood pumps, specifically the Medtronic BP-80 Bio-Pump®, across these tests. |
  | Biocompatibility | Must be biocompatible and non-toxic, safe for intended use. Testing performed in accordance with FDA Blue Book Memorandum - G95-1 and appropriate sections of Biological Evaluation of Medical Devices Guidance - International Standard ISO 10993-1. | Testing demonstrated the device is biocompatible and non-toxic, thus safe for its intended use. No biocompatibility issues associated with the infusate. |
  | Sterilization | Sterility Assurance Level (SAL) of $10^{-6}$.
  EtO dissipation curves must assure residual concentrations of ethylene oxide and ethylene chlorohydrin meet limits in ANSI Standard Number ANSV/AAMI/ISO 10993-7:1995. | Sterilization validated to achieve SAL of $10^{-6}$.
  EtO dissipation curves confirm compliance with residual concentration limits. |
  | Pyrogens | LAL testing performed, and release criteria must be in accordance with the December 1987 Guideline of the FDA, Office of Compliance (Guideline of Validation of the Limulus Amebocyte Lysate Test as an End-Product Endotoxin Test for Human and Animal Parenteral Drugs, Biological Products, and Medical Devices). | LAL testing performed and meets the specified release criteria. |

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

The provided text only discusses in-vitro bench testing and does not mention human subject clinical trials or imaging data. Therefore, the concept of "test set" as typically understood in AI/ML performance evaluation (i.e., human-annotated data) is not applicable here. The "samples" would refer to the physical devices or components tested in the lab.

• Sample size for bench testing: Not explicitly stated as a number of devices or iterations, but implied to be sufficient for demonstrating substantial equivalence.
• Data Provenance: The data is generated from in-vitro bench testing conducted in a laboratory setting by Cardiac Assist Technologies, Inc. There is no mention of country of origin for human data, as no human data was used. All testing appears to be retrospective in the sense that it evaluates the manufactured device against pre-defined standards and a predicate device.

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

Not applicable. This was a medical device approval based on in-vitro bench testing and comparison to a predicate device, not on AI/ML diagnostic performance evaluation. Therefore, there was no "ground truth" derived from expert interpretation of data like images or patient outcomes.

4. Adjudication Method for the Test Set

Not applicable, as there was no expert review or human-in-the-loop assessment requiring adjudication for this type of device approval.

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 centrifugal blood pump, not an AI diagnostic/assistant tool. No MRMC study was conducted.

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

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

7. The Type of Ground Truth Used

The "ground truth" for this device's approval was established by:

• Engineering and Performance Standards: Adherence to established international and national standards for medical devices (e.g., IEC 60601-1, IEC 60601-1-2, IEC 68, ISO 10993-1, ANSI/AAMI/ISO 10993-7:1995).
• Predicate Device Performance: Direct comparison of the AB-180 XC Blood Pump's in-vitro performance (hydraulic, safety, environmental, hemolysis) against the established performance of the legally marketed predicate device, the Medtronic BP-80 Bio-Pump®.
• Biocompatibility Standards: Compliance with FDA Blue Book Memorandum - G95-1 and ISO 10993-1.
• Sterilization Standards: Demonstration of a $10^{-6}$ SAL and compliance with EtO residual limits.
• Pyrogen Standards: Compliance with FDA's 1987 Guideline for LAL testing.

8. The Sample Size for the Training Set

Not applicable. There was no machine learning model or "training set" involved in the approval of this hardware medical device.

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

Not applicable. No training set was used.

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