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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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