(28 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. Oneator adjustable alarms and parameters are accessible via the system menus.
The provided text is a 510(k) Summary for the Levitronix CentriMag Primary Console. This document focuses on demonstrating substantial equivalence to a predicate device for regulatory approval, rather than presenting a detailed clinical study with specific acceptance criteria and performance metrics typically associated with AI/software-as-a-medical-device (SaMD) clearances.
Therefore, much of the requested information (acceptance criteria table, sample sizes, expert qualifications, adjudication methods, MRMC study details, standalone performance, training set details) cannot be found in the provided text because the device is a hardware medical device (a cardiopulmonary bypass pump console), not an AI/SaMD product.
However, I can extract the relevant information from the document regarding its "performance data" in the context of a hardware device submission.
Here's a breakdown based on the provided text, indicating what is present and what is absent:
1. A table of acceptance criteria and the reported device performance
The document does not provide a formal table of acceptance criteria and reported device performance in the manner typically seen for SaMD or diagnostic devices (e.g., sensitivity, specificity, AUC). Instead, it makes a general statement about performance testing against established specifications.
- Acceptance Criteria (Implied): "Levitronix performance specifications established for the device" (Section H). These are not detailed in the summary.
- Reported Device Performance: "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." (Section H). No specific quantitative performance metrics are provided in this summary document. The comparison confirms functional equivalency rather than specific diagnostic accuracy metrics.
2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)
- Sample Size: Not specified. Performance testing in this context typically refers to engineering bench testing and verification/validation activities of a hardware system, not a clinical test set with patient data.
- Data Provenance: Not applicable, as this refers to hardware performance testing, not patient data.
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)
- Not applicable. This device is a hardware pump console, and its "performance" would be assessed against engineering specifications and predicate device behavior, not by expert interpretation of clinical data.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set
- Not applicable. This is not a clinical study involving human readers or interpretation.
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. This is a hardware device; no MRMC study involving human readers and AI assistance was conducted or is relevant for this type of device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable. This is a hardware device, not an algorithm. Its "standalone" performance would refer to its operational characteristics without external human intervention, which would be part of standard engineering testing.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- Ground Truth: For a hardware device like this, the "ground truth" would be established engineering specifications, design requirements, and the known performance/characteristics of the predicate device. It is not clinical "ground truth" like pathology or expert consensus.
8. The sample size for the training set
- Not applicable. This is a hardware device, not a machine learning model.
9. How the ground truth for the training set was established
- Not applicable. This is a hardware device, not a machine learning model.
Summary of the Study that Proves the Device Meets Acceptance Criteria (based on the provided text):
The document states under "H. Summary of Performance Data":
"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."
This indicates that:
- Study Type: This was a performance testing and comparison study (likely involving bench testing, verification, and validation activities common for hardware medical devices).
- Objective: To demonstrate that the new CentriMag Primary Console performs according to its internal Levitronix performance specifications and is functionally equivalent to the predicate device (Levitronix CentriMag Console, K020271).
- Key Finding: The submission implies that these tests confirmed the device meets its specifications and is substantially equivalent, raising "no new safety or effectiveness issues" (Section G).
However, specific details of these tests (e.g., number of test cycles, specific parameters measured, quantitative results, pass/fail criteria) are not included in this 510(k) summary document. These details would typically be found in the full 510(k) submission attachments, but not in the publicly available summary.
§ 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).