(13 days)
The Levitronix CentriMag Back-Up 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 Back-Up 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.
The provided document is a 510(k) summary for the Levitronix CentriMag Back-Up Console. It describes the device, its intended use, and its comparison to a predicate device. However, it does not contain the detailed information necessary to answer all parts of your request regarding acceptance criteria and a study proving those criteria are met. This document is a regulatory submission for premarket notification, not a clinical trial report or a performance validation study report.
Here's what information can be extracted and what is missing:
Information Present:
- Device Name: Levitronix CentriMag Back-Up Console
- Intended Use: To pump blood through the extracorporeal bypass circuit for extracorporeal circulatory support for periods up to six hours, both for complete cardiopulmonary bypass and other circulatory support systems.
- Comparison to Predicate Device: The document states that the device has "technological characteristics similar to the predicate device," "indications for use which is substantially equivalent," "is composed of the same or equivalent materials," "has equivalent design features," and "has functional characteristics which are the same or equivalent to those of the predicate device." It concludes that "Due to the equivalency of indications for use, materials of composition, design features, and functional characteristics, the device raises no new safety or effectiveness issues."
- Summary of Performance Data: The document briefly mentions: "The performance characteristics of the Levitronix CentriMag Back-Up Console were tested and compared with Levitronix performance specifications established for the device and with the commercially available predicate device."
Information NOT Present (and likely not found in a 510(k) summary of this type):
The document does not provide the following:
- A table of specific acceptance criteria and the reported device performance against those criteria.
- Sample sizes used for any test set or the data provenance (e.g., country of origin, retrospective/prospective).
- Number of experts used to establish ground truth or their qualifications.
- Adjudication method for a test set.
- Details of a multi-reader multi-case (MRMC) comparative effectiveness study, or effect size of human readers with/without AI assistance. (This is a medical device, not an AI diagnostic tool).
- Details of a standalone (algorithm only) performance study. (Again, this is a hardware console, not an AI algorithm).
- Type of ground truth used (e.g., pathology, outcomes data).
- Sample size for a training set.
- How ground truth for a training set was established.
Based on the provided text, I cannot complete the requested tables and sections related to specific acceptance criteria, study sizes, expert involvement, and AI performance metrics. The document focuses on demonstrating substantial equivalence to a predicate device rather than detailing specific performance validations with quantitative acceptance criteria.
The "Summary of Performance Data" section (H) only states that tests were performed "compared with Levitronix performance specifications established for the device and with the commercially available predicate device." It doesn't present those specifications or the detailed test results.
§ 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).