(14 days)
The Levitronix CentriMag Primary Console is indicated for use with the Levitronix CentriMag Extracorporeal Blood Pumping System. The Levitronix 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 Primary Console is a microprocessor-based device. The microprocessor generates the primary Motor control signal, monitors system sensors, generates front display outputs, and provides alarm functions. The microprocessor acquires the sensor data for use in generating operator displays and alarms. An alphanumeric screen is used to display monitored data, system options, and menus. Operator adjustable alarms and parameters are accessible via the system menus.
This document is a 510(k) summary for a medical device called the "Levitronix CentriMag Primary Console". It describes the device, its intended use, and its comparison to a predicate device to demonstrate substantial equivalence. However, it does not contain acceptance criteria for device performance or a study demonstrating the device meets those criteria in the way typically expected for an AI/software device that makes diagnostic or interpretive claims.
This device is a cardiopulmonary bypass pump console, which is hardware that controls a blood pumping system. The 510(k) is primarily focused on demonstrating that a new version of the console, specifically with "Software Version 3.00", is substantially equivalent to a previously cleared version (Software Version 2.02).
Therefore, I cannot extract the requested information as it is not present in the provided text. The questions posed relate to the evaluation of AI or diagnostic software, which this device is not.
Here's why the requested information isn't applicable or available in this document:
- Acceptance Criteria for Performance: For a mechanical device like this, acceptance criteria would typically involve engineering specifications (e.g., flow rate accuracy, pressure monitoring accuracy, alarm response times, battery life). These are not detailed in a way that can be presented in a performance table as if it were a diagnostic AI. The document only generally states: "The performance characteristics of the Levitronix CentriMag Primary Console were tested and compared with Levitronix performance specifications established for the device and with the commercially available predicate device." No specific performance metrics or their achieved values are reported in this summary.
- Study Proving Acceptance Criteria: The "study" mentioned is a comparison to a predicate device and internal performance specifications. This is not a study in the sense of a clinical trial or performance evaluation using a test set with ground truth as would be done for an AI algorithm.
- Sample Size for Test Set/Data Provenance/Experts/Adjudication/MRMC/Standalone/Ground Truth (for test set)/Training Set/Ground Truth (for training set): These are all concepts related to the validation of AI or diagnostic algorithms using clinical data. This document describes a medical device (a pump console) that does not make diagnostic interpretations or use AI in the way implied by these questions. The software mentioned (V3.00 Application Software) is for controlling the pump, monitoring sensors, and displaying data, not for making diagnostic decisions based on patient data.
In summary, the provided text is a regulatory submission for a hardware medical device with embedded software for control, not a diagnostic or AI-driven system. Therefore, the questions are largely not applicable to the content provided.
§ 870.4380 Cardiopulmonary bypass pump speed control.
(a)
Identification. A cardiopulmonary bypass pump speed control is a device used that incorporates an electrical system or a mechanical system, or both, and is used to control the speed of blood pumps used in cardiopulmonary bypass surgery.(b)
Classification. Class II (performance standards).