(150 days)
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:
| Component | Test | Outcome (Implicitly met for Substantial Equivalence) |
|---|---|---|
| System (console, monitor, pump, motor) | 30-day reliability | Demonstrated reliability over the intended duration. |
| In Vivo Animal Testing | Demonstrated performance in an in-vivo setting. | |
| Water Ingress Resistance | Verified resistance to water ingress. | |
| Electrical Safety & EMC | Complied with electrical safety and electromagnetic compatibility standards. | |
| Motor | Thermal Operating conditions | Demonstrated safe thermal operating conditions. |
| Fluid Intrusion | Verified resistance to fluid intrusion. | |
| Console & Monitor | Battery life / run time | Verified specified battery performance. |
| Blood Pump | Rough Handling (Shock/Drop/Vibration) | Demonstrated mechanical durability. |
| Environmental Test | Performed as expected under various environmental conditions. | |
| Software validation | Software functions validated. | |
| H-Q performance (Pressure/Flow) | Demonstrated appropriate pressure-flow characteristics. | |
| In Vitro Hemolysis, Platelet count, WBC, RBC, hematocrit, thrombus | Demonstrated acceptable blood compatibility, minimizing hemolysis, and adverse effects on blood components. | |
| Air handling | Demonstrated effective handling of air. | |
| Priming volume | Verified appropriate priming volume. | |
| Leak and burst pressure testing | Demonstrated structural integrity under pressure. | |
| Sterilization | Validated sterilization process and sterility assurance level (SAL). | |
| Transportation distribution / simulation | Demonstrated integrity after transportation simulations. | |
| Shelf life | Validated performance over stated shelf life. | |
| Biocompatibility | Demonstrated to be biocompatible in accordance with ISO 10993-1. | |
| Clinical Study (ELSO Registry analysis) | Propensity matched analysis on seven ECMO-related complications and outcomes | Result: Did not identify any statistically significant or clinically meaningful differences between the CentriMag System and a comparator group in terms of ECMO-related complications and outcomes. This supports the claim of substantial equivalence for its indicated use. |
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.
§ 870.4100 Extracorporeal circuit and accessories for long-term respiratory/cardiopulmonary failure.
(a)
Identification. An extracorporeal circuit and accessories for long-term respiratory/cardiopulmonary support (>6 hours) is a system of devices and accessories that provides assisted extracorporeal circulation and physiologic gas exchange of the patient's blood in 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 main devices and accessories of the system include, but are not limited to, the console (hardware), software, and disposables, including, but not limited to, an oxygenator, blood pump, heat exchanger, cannulae, tubing, filters, and other accessories (e.g., monitors, detectors, sensors, connectors).(b)
Classification —Class II (special controls). The special controls for this device are:(1) The technological characteristics of the device must ensure that the geometry and design parameters are consistent with the intended use, and that the devices and accessories in the circuit are compatible;
(2) The devices and accessories in the circuit must be demonstrated to be biocompatible;
(3) Sterility and shelf-life testing must demonstrate the sterility of any patient-contacting devices and accessories in the circuit and the shelf life of these devices and accessories;
(4) Non-clinical performance evaluation of the devices and accessories in the circuit must demonstrate substantial equivalence of the performance characteristics on the bench, mechanical integrity, electromagnetic compatibility (where applicable), software, durability, and reliability;
(5) In vivo evaluation of the devices and accessories in the circuit must demonstrate their performance over the intended duration of use, including a detailed summary of the clinical evaluation pertinent to the use of the devices and accessories to demonstrate their effectiveness if a specific indication (patient population and/or condition) is identified; and
(6) Labeling must include a detailed summary of the non-clinical and in vivo evaluations pertinent to use of the devices and accessories in the circuit and adequate instructions with respect to anticoagulation, circuit setup, performance characteristics with respect to compatibility among different devices and accessories in the circuit, and maintenance during a procedure.