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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 Return (Arterial) Cannula is indicated for use as an arterial return cannula with an extracorporeal bypass circuit for extracorporeal circulatory support for periods up to six hours.

The CentriMag Drainage (Venous) Cannula is indicated for use with an extracorporeal bypass circuit for extracorporeal circulatory support for periods up to six hours.

The CentriMag™ Circulatory Support System, hereafter referred to as the CentriMag System, was designed to provide temporary mechanical circulatory support. 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)

The Thoratec CentriMag Return (Arterial) Cannula Kit consists of the return (arterial) cannula and several accessories used in the surgical placement procedure. The cannula and all kit accessories are sterile, single-use, disposable devices. The cannula kit is designed for use with the Thoratec CentriMag® Extracorporeal Blood Pumping System.

The Thoratec CentriMag® Drainage (Venous) Cannula Kit consists of the drainage (venous) cannula and several accessories used in the surgical placement procedure. The cannula and all kit its accessories are sterile, single use, disposable devices. The cannula kit is designed for use with the Thoratec CentriMag® Extracorporeal Blood Pumping System.

The provided text is a 510(k) summary for a medical device (CentriMag Acute Circulatory Support System, CentriMag Return (Arterial) Cannula Kit, and CentriMag Drainage (Venous) Cannula Kit).

Based on the content of the document, the device did not undergo a study to prove its performance against acceptance criteria in the typical sense of a new or modified device requiring such evidence. This 510(k) submission is a "Special 510(k)" which implies that the changes being made are minor and do not affect the device's fundamental performance, design, or intended use. Specifically, the document states:

• "The technological characteristics of the CentriMag Acute Circulatory Support System, CentriMag Return (Arterial) Cannula Kit and CentriMag Drainage (Venous) Cannula Kit have not changed from the predicate devices."
• "Components of the CentriMag Acute Circulatory Support System, CentriMag Return (Arterial) Cannula Kit and CentriMag Drainage (Venous) Cannula Kit are not affected by the labeling changes proposed in this Special 510(k) premarket notification. The labeling changes make the contraindications consistent among all labeling, add and/or strengthen warnings and precautions, and generally align and update the content for consistency."
• "The performance characteristics of the CentriMag Acute Circulatory Support System, CentriMag Return (Arterial) Cannula Kit and CentriMag Drainage (Venous) Cannula Kit have not changed. The labeling changes included in this 510(k) are for the Thoratec (now Abbott's) devices (predicates listed above) and do not require performance data to evaluate the change."
• "Clinical testing was not necessary for the labeling changes stated herein since the changes do not impact the design and performance of the devices."

Therefore, I cannot provide a table of acceptance criteria, reported device performance, or details of a study with sample sizes, expert ground truth, adjudication methods, or MRMC studies, as these types of studies were explicitly stated as not necessary for this specific 510(k) submission.

The document argues for substantial equivalence primarily based on the lack of change in technological characteristics and performance from legally marketed predicate devices (K191557, K152161, and K152190).

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