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The CentriMag™ Pre-connected Pack is indicated for use with the CentriMag™ Acute Circulatory Support System to provide physiologic gas exchange of the blood and to pump a patient's blood through an extracorporeal circuit for periods lasting less than six (6) hours for the purpose of providing either:

(i) Full or partial cardiopulmonary bypass during open surgical procedures on the heart or great vessels; or

(ii) Temporary circulatory bypass for diversion of flow around a planned disruption of the circulatory necessary for open surgical procedures on the aorta or vena cava.

CentriMag Pre-connected Pack is to be used with the CentriMag™ Acute Circulatory Support System components (console, motor, flow probe and monitor) to provide extracorporeal circulation for full or partial cardiopulmonary bypass support for less than 6 hours. The CentriMag™ Pre-connected Pack contains sterile disposable components: a blood pump, oxygenator, and priming bag pre-connected by tubing. The pack also includes disposable accessories commonly used in the setup of pump and oxygenator connections to the cardiopulmonary bypass extracorporeal circuit.

Several types of performance testing were conducted to demonstrate the substantial equivalence of the CentriMag Pre-connected Pack. Unfortunately, the provided document does not contain all the information requested. Here's a breakdown of what information is available and what is missing:

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample size used for the test set and the data provenance

The document does not specify the sample size used for any of the performance tests. It also does not explicitly state the data provenance (e.g., country of origin, retrospective or prospective nature of the data). All tests appear to be laboratory-based performance tests, not clinical studies involving patient data.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

This information is not applicable as the tests described are performance tests of a medical device's physical and functional characteristics, not studies that require expert interpretation of patient data to establish ground truth.

4. Adjudication method for the test set

This information is not applicable for the same reason as point 3.

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

An MRMC study was not conducted. This document describes the performance testing of a physical medical device (CentriMag Pre-connected Pack), not an AI-assisted diagnostic or interpretative system.

6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done

This information is not applicable as an algorithm or AI system is not the subject of this 510(k) submission.

7. The type of ground truth used

For the performance tests, the "ground truth" would be the established engineering and medical standards for device performance, as referenced by the "Guidance for Cardiopulmonary Bypass Oxygenators 510(k) Submissions Final Guidance for Industry and FDA Staff" and ISO 10993-1 for biocompatibility. The tests aim to demonstrate that the device meets these pre-defined physical, chemical, and biological requirements.

8. The sample size for the training set

This information is not applicable as this is not an AI or machine learning device that requires a training set.

9. How the ground truth for the training set was established

This information is not applicable as this is not an AI or machine learning device that requires a training set.

Summary of the Study:

The studies conducted for the CentriMag Pre-connected Pack were a series of performance tests in accordance with FDA guidance and international standards for cardiopulmonary bypass oxygenators and biocompatibility. These tests aimed to demonstrate the device's integrity, durability, and functionality, as well as its biological safety. The document explicitly states that "No animal studies or clinical studies are required." The performance testing and comparative testing with reference devices (Rotaflow Centrifugal Pump, Quadrox-iD Adult Oxygenator, HLM Tubing Set, CentriMag Acute Circulatory Support System, Eurosets PMP Sterile Oxygenator) were used to demonstrate substantial equivalence to the predicate device, the OXY-1 System (K200109). The conclusion is that the CentriMag Pre-connected Pack is substantially equivalent as the technological characteristics and performance testing do not raise different questions of safety and effectiveness compared to the predicate device.

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The CARDIOHELP System is a blood oxygenation and carbon dioxide removal system used to pump blood through the extracorporeal bypass circuit for circulatory and/or pulmonary support during procedures requiring cardiopulmonary bypass (for periods up to six hours). It is also intended to provide circulatory and/or pulmonary support during procedures not requiring cardiopulmonary bypass (for periods up to six hours).

The CARDIOHELP System in configuration with the HLS/HIT Set Advanced is intended to be used within the hospital environment and outside the hospital environment (for periods up to six hours), e.g. for intra- and inter-hospital transport.

The CARDIOHELP System in configuration with the QUADROX-iR is intended to be used in extracorporeal circulation during cardiopulmonary bypass in cardiac surgery (for periods for up to six hours).

The CARDIOHELP System is a compact perfusion system consisting of the following components:

• the CARDIOHELP-i drives suitable disposables using an integrated pump, controls and monitors the extracorporeal circulation and can communicate with other devices
• the CARDIOHELP Emergency Drive is used in emergencies to manually drive the disposable if the CARDIOHELP-i fails
• different accessories:
  • o flow/bubble sensor
  • o level sensor including level sensor pad
  • o venous probe for blood gas monitoring and measurement of venous temperature
  • external sensors for temperature and pressure
  • o different holders
  • o connection cables
• various disposables, that can be driven by CARDIOHELP-i
  • o HLS/ HIT Set Advanced are tubing sets, that contain the HLS Module Advanced oxygenator with integrated centrifugal pump, which fits into the CARDIOHELP-i. These sets are available in different configurations and will be compiled as customized tubing sets
  • o QUADROX-iR is an oxygenator with integrated centrifugal pump and will be provided with or without integrated arterial filter

The provided text details a 510(k) submission for the MAQUET CARDIOHELP System. This submission focuses on establishing substantial equivalence to predicate devices rather than proving performance against specific acceptance criteria in a clinical study with a set number of cases and experts. Therefore, much of the requested information about clinical study specifics (sample sizes, ground truth establishment, expert qualifications, etc.) is not present in this document.

Here's an analysis based on the available information:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not provide a table of explicit, quantifiable acceptance criteria with corresponding performance metrics like sensitivity, specificity, or accuracy for a specific disease or condition. Instead, the acceptance criteria are generally implied as demonstrating "substantial equivalence" to predicate devices through various technical and performance tests.

2. Sample Size Used for the Test Set and Data Provenance

This document does not describe a clinical test set with a specific sample size for evaluating a diagnostic AI algorithm. The testing described focuses on the device's engineering performance and safety characteristics. The data provenance is primarily from non-clinical testing conducted by the manufacturer, Maquet Cardiopulmonary AG, in Germany.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications

Not applicable. The document describes non-clinical engineering and performance testing, not a study involving expert-established ground truth for a diagnostic task.

4. Adjudication Method for the Test Set

Not applicable. There was no clinical test set requiring expert adjudication.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

No, an MRMC comparative effectiveness study was not performed as described in this document. This submission is for a medical device (a cardiopulmonary support system), not an AI algorithm for diagnostic image interpretation. Therefore, there's no mention of human readers improving with or without AI assistance.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study

Not applicable. This document is for a medical device system, not a standalone AI algorithm. The CARDIOHELP System is a human-operated device, albeit with advanced control and monitoring features.

7. Type of Ground Truth Used

The "ground truth" in this context refers to established engineering specifications, industry standards, and the performance characteristics of predicate devices. For example, for "measurement accuracy," the ground truth would be precise reference measurements obtained from calibrated instruments. For "biocompatibility," the ground truth is defined by relevant biocompatibility standards.

8. Sample Size for the Training Set

Not applicable. The CARDIOHELP System is a physical medical device, not a machine learning model that requires a training set of data.

9. How the Ground Truth for the Training Set Was Established

Not applicable, as there is no training set for a machine learning model.

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