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The CentriMag Extracorporeal Blood Pumping System is a non-roller-type cardiopulmonary and circulatory bypass blood pump used to pump a patient's 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 CentriMag™ Blood Pump for use with the 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™ Acute Circulatory Support System, hereafter referred to as the CentriMag System, was designed to provide temporary mechanical circulatory support. To date, the CentriMag system in the United States (US) is indicated as a component of an extracorporeal bypass circulatory support circuit for use during cardiopulmonary bypass (CPB) surgery (up to 6 hours), it is also indicated for controlling blood flow as part of an extracorporeal membrane oxygenation (ECMO) circuit. The CentriMag System provides circulatory assistance for patients in acute hemodynamic compromise, a population whose treatment options are limited. The CentriMag System is composed of: - CentriMag Primary Console - CentriMag Motor - CentriMag Blood Pump - CentriMag Flow Probe - · Mag Monitor The CentriMag Motor is a reusable, non-sterile component of the CentriMag System. The CentriMag Motor holds the blood pump and drives the impeller inside the blood pump. The motor turns the magnet (and impeller) within the blood pump (Full MagLev™ technology) at a speed that is set on the console by the user. When the impeller is rotated, a pressure gradient develops between the center and outside edge of the pump, causing blood to flow from the inflow to the outflow port of the pump. The amount of flow through the pump depends on the speed of the impeller, and the difference between the inlet and outlet pressures.

The provided documents describe a 510(k) submission for the Abbott CentriMag™ Acute Circulatory Support System. This submission is a "Special 510(k)," which means it addresses a modification to an already cleared device. The primary change is an update to the CentriMag Motor, specifically a new "snap-in motor locking feature" replacing a "screw locking feature."

Therefore, the acceptance criteria and performance study described are focused on demonstrating that this change does not negatively impact the safety and effectiveness of the device and that the new design is substantially equivalent to the predicate device.

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

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

Since this is a Special 510(k) for a design change (motor locking mechanism), the "performance" is about demonstrating that the new design is as safe and effective as the previous one, and that it conforms to requirements for its intended use. The document doesn't list specific numerical acceptance criteria (e.g., a "failure rate must be less than X%"). Instead, it describes categories of testing performed to ensure the new design performs adequately.

2. 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 for any of the verification or validation tests (e.g., number of motors subjected to durability testing, number of users in human factors testing).
The testing described (Mechanical, Durability, Cleaning, Operating Manual Verification, Human Factors Validation) are typically prospective engineering and usability tests conducted by the manufacturer, not retrospective studies on patient data. The provenance for such tests would be the manufacturer's testing facilities, likely in the US (given the submitter's address in California).

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 section is not applicable in the context of this 510(k) submission. The "ground truth" concept, often associated with clinical diagnostic studies requiring expert review of medical images or patient outcomes, is not relevant here. The studies described are hardware and human factors engineering tests. For human factors, users (not necessarily "experts" in the medical sense, but representative users of the device) would participate to validate the user interface changes. Their qualifications are not specified but would typically align with the intended users (e.g., perfusionists, surgeons, nurses).

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

This is not applicable to the type of engineering and human factors testing described. Adjudication methods like "2+1" are used in clinical studies where multiple experts independently review cases and discrepancies are resolved by a third party.

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 is not applicable. The device is a mechanical circulatory support system (pump, motor, console, flow probe), not an AI-assisted diagnostic or clinical decision support tool that would involve human readers interpreting data.

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

This is not applicable. The device is a physical medical device (mechanical support system), not a software algorithm or AI. Its operation inherently involves a human in the loop (a clinician operating the system).

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

"Ground truth" as traditionally understood in clinical validation studies (e.g., pathology for cancer detection, long-term outcomes for treatment efficacy) is not directly applicable here. For the engineering tests, the "ground truth" is simply the documented design specifications and functional requirements of the device. For human factors, the "ground truth" or success criteria would be based on validated usability principles and the ability of representative users to safely and effectively operate the device with the new feature.

8. The sample size for the training set

This is not applicable. This is a hardware modification to an existing device, not a machine learning or AI algorithm that requires a training set.

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

This is not applicable, as there is no training set for a hardware modification.

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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 CentriMag Extracorporeal Blood Pumping System is indicated to pump blood through the extracorporeal bypass circuit for extracorporeal circulatory support for periods appropriate to cardiopulmonary bypass (up to six hours). It is also indicated for use in extracorporeal circulatory support systems (for periods up to six hours) not requiring complete cardiopulmonary bypass (e.g., valvuloplasty, circulatory support during mitral valve reoperation, surgery of the vena cava or aorta, liver transplants etc).

The CentriMag™ Circulatory Support System, hereafter referred to as the CentriMag System, was designed to provide temporary mechanical circulatory support. To date, the CentriMag system in the United States (US) is indicated as a component of an extracorporeal bypass circulatory support circuit for use during cardiopulmonary bypass (CPB) surgery (up to 6 hours). The CentriMag System provides circulatory assistance for patients in acute hemodynamic compromise, a population whose treatment options are limited.

The CentriMag System is composed of:

• CentriMag Primary Console
• CentriMag Motor
• CentriMag Blood Pump
• CentriMag Flow Probe
• Mag Monitor (optional, not shown)

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. The motor turns the magnet (and impeller) within the blood pump (Full MagLev™ technology) at a speed that is set on the console by the user. When the impeller is rotated, a pressure gradient develops between the center and outside edge of the pump, causing blood to flow from the inflow to the outflow port of the pump. The amount of flow through the pump depends on the speed of the impeller, and the difference between the inlet and outlet pressures.

The provided text describes a 510(k) premarket notification for a design modification to the CentriMag™ Acute Circulatory Support System, specifically a redesigned motor cable with enhanced bend protection. This is a medical device, and the submission focuses on proving the substantial equivalence of the modified device to its predicate, rather than establishing clinical effectiveness for a new-to-market device or an AI algorithm.

Therefore, the typical metrics and study designs used for AI/algorithm performance (e.g., sensitivity, specificity, MRMC studies, expert consensus for ground truth of an AI algorithm) do not apply in this context. The acceptance criteria and "study" are focused on mechanical and electrical performance to ensure the modified cable is at least as safe and effective as the original, and does not introduce new safety concerns.

Here's a breakdown of the requested information based solely on the provided text, recognizing its limited scope for AI-specific metrics:

Acceptance Criteria and Device Performance (for a Medical Device Component Modification)

The acceptance criteria for this device modification are focused on maintaining or improving the mechanical and electrical integrity of the motor cable compared to the predicate device.

Table of Acceptance Criteria and Reported Device Performance

Study Details (Bench Testing for a Device Component Modification):

1. Sample sizes used for the test set and data provenance:

   • Sample Size: The text states "Comparison bench testing was performed" and refers to "both designs" (redesigned and current/original cable designs). It does not specify the number of individual cables or test repetitions for each test (Endurance and Kink test).
   • Data Provenance: The testing was carried out by Thoratec (now part of Abbott) as part of their 510(k) submission, implied to be internal company testing. The country of origin of the data is not explicitly stated beyond the company's US address (Pleasanton, CA). This was not a human clinical study, but rather laboratory bench testing. The term "retrospective or prospective" doesn't directly apply here; it's a controlled bench test evaluating a manufactured component.

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

   • Not Applicable (N/A) / None specified: For these types of mechanical and electrical bench tests, "ground truth" is established by direct measurement and observation of physical parameters, not by expert interpretation in the way it is for diagnostic imaging or clinical outcomes. Engineering specifications and industry standards (like IEC 60601-1) serve as the "truth" against which performance is measured.
   • Qualifications of personnel conducting the tests are not provided, but would typically be engineers or technicians trained in relevant mechanical and electrical testing protocols.

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

   • Not Applicable (N/A): Adjudication methods like 2+1 or 3+1 refer to consensus-building among human readers for subjective data interpretation (e.g., reading medical images). This was a series of objective bench tests with pass/fail criteria based on physical performance and visual inspection. Any "adjudication" would be part of standard quality control and engineering verification processes, not a multi-reader review.

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:

   • No, Not Applicable (N/A): This was a 510(k) for a physical medical device component (motor cable) and not an AI algorithm. Therefore, an MRMC study comparing human reader performance with or without AI assistance was not conducted, nor would it be relevant.

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

   • No, Not Applicable (N/A): This is a physical device, not an algorithm.

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

   • Engineering Specifications and Industry Standards: The "ground truth" for these tests consisted of predefined pass/fail criteria derived from engineering design specifications and compliance with recognized international standards (e.g., IEC 60601-1). Performance data (e.g., integrity of cable after specified bends, absence of short circuits) formed the direct evidence.

7. The sample size for the training set:

   • Not Applicable (N/A): This device modification did not involve machine learning or AI, so there was no "training set."

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

   • Not Applicable (N/A): As there was no training set, this question is not applicable.

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