(84 days)
The 2nd Generation CentriMag Primary Console and Mag Monitor are indicated for use with the CentriMag Extracorporeal Blood Pumping System. 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 2nd Generation CentriMag Primary Console is a microprocessor based device. The microprocessor generates the primary motor control signal, monitors system sensors, generates display outputs, interprets the inputs through the front keypad, provides alarm functions and handles the Mag Monitor interface. The Console is intended to be operated on single phase AC power; however, it also has a built-in rechargeable battery with a battery charger. The rechargeable battery is field replaceable. In addition, an optional external modular battery (UPS) can be used to power the CentriMag Primary Console. The human interface of the CentriMag Primary Console consists of a graphical screen to display data and system options and touch pads to change the system status. The 2nd Generation CentriMag Primary Console is intended to be used together with the Mag Monitor: however it can be also operated as a stand-alone unit.
The Mag Monitor provides a redundant user interface containing a display and touch pads. The Mag Monitor is a non-sterile, reusable device that is designed to work only with the 2nd Generation CentriMag Primary Console. The Mag Monitor is a 12V DC-powered device and receives its power directly from 200 Generation CentriMag Primary Console via a power connector that mates with a connector on the back-panel of 2nd Generation CentriMag Primary Console. Based on the design of its power connector, the Mag Monitor cannot be plugged into a hospital AC power outlet. The Mag Monitor's core function is to provide multi-color alphanumerical and graphical displays of information it receives from the 200 Generation CentriMag Primary Console.
The Mag Monitor is a processor based device, with a flat color screen (e.g. LCD). In addition, it is equipped with touch pad to allow the user to enter commands. In the hospital-setting configuration, the user is able to operate and monitor the performance of the CentriMag System through the Monitor. The Monitor can control the functions of the 2nd Generation CentriMag Primary Console, and therefore, of the CentriMag System. The Monitor only displays data and stores user commands without interacting directly with the primary motor control which is managed by the 2nd Generation CentriMag Primary Console. The Mag Monitor is connected to the 200 Generation CentriMag Primary Console through one cable, which includes data and power lines. Power is provided by the 200 Generation CentriMag Primary Console.
The redesigned Mag Monitor is compatible with both the current 200 Generation Console and the redesigned 2nd Generation Console. However, when plugged into the current Console, the redesigned Mag Monitor will only operate when the Console is connected to AC power. It will not operate when the current Console is run on Battery power
The provided text describes a 510(k) summary for the Thoratec 2nd Generation CentriMag Primary Console and Mag Monitor. This documentation focuses on demonstrating substantial equivalence to predicate devices for regulatory approval, rather than detailing a clinical study with specific acceptance criteria and performance metrics for an AI-powered diagnostic device.
Therefore, the information required to answer your prompt, particularly regarding AI device performance, sample sizes for test/training sets, expert adjudication, MRMC studies, standalone performance, and ground truth establishment, is not present in the provided 510(k) summary.
This document focuses on the device itself (a cardiopulmonary bypass pump console and monitor), its design, intended use, and a comparison of its technological characteristics and performance (functional testing, safety, environmental, etc.) against existing predicate devices. It explicitly states: "Clinical testing was not performed." (Section I. Clinical Performance).
As such, I cannot create the requested table or provide details about AI device performance from this document. If you have a different document describing an AI-powered diagnostic device, please provide it.
§ 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).