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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: .
• flow/bubble sensor O
• o level sensor including level sensor pad
• venous probe for blood gas monitoring and measurement of venous temperature o
• external sensors for temperature and pressure O
• different holders o
• connection cables ಂ
• . various disposables, that can be driven by CARDIOHELP-i, including the previously cleared HLS/HIT tubing sets and the Quadrox-iR disposables (part of the predicate CARDIOHELP System (K102726).

This document describes the CARDIOHELP System, a cardiopulmonary support device. The submission is a Special 510(k) for modifications to an existing device (K102726). As such, the focus of the testing is on demonstrating that the modified device is substantially equivalent to the predicate, and much of the information typically found in a clinical study for a novel device is not presented.

Here's an analysis based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not provide a table of explicit acceptance criteria with specific numerical thresholds for performance metrics. Instead, it broadly states that "Performance testing has resulted in data that demonstrates that the CARDIOHELP System performs within its specifications and within the acceptable limits of the applied performance standards."

The performance characteristics reviewed include:

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

No specific sample size for a "test set" (in the context of clinical data for AI/ML) is mentioned, as no clinical evaluation of the modified device was conducted or required. The assessment relied entirely on non-clinical testing.

The provenance of data is not applicable as the testing was non-clinical and conducted by the manufacturer, MAQUET Cardiopulmonary AG, based in Rastatt, Germany.

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

Not applicable, as no clinical studies with a "test set" requiring expert ground truth were conducted. The device is not an AI/ML diagnostic tool, but rather a medical device with an enhanced user interface and new sensors.

4. Adjudication Method for the Test Set

Not applicable, as no clinical studies with a "test set" requiring adjudication were conducted.

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

No MRMC study was mentioned or performed. This is not an AI/ML-driven diagnostic device where human reader improvement with AI assistance would be relevant.

6. Standalone (Algorithm Only) Performance Study

Not applicable. The CARDIOHELP System is a physical medical device for cardiopulmonary support, not an algorithm. Its performance is assessed through hardware, software, and system-level testing, not as a standalone algorithm without human interaction, as a human operator is integral to its function.

7. Type of Ground Truth Used

For the non-clinical tests, the "ground truth" would be established by:

• Requirements specifications: Defining the expected behavior and performance of the device and its components.
• Engineering standards: Adherence to relevant industry and regulatory standards for medical device safety and performance.
• Predicate device performance: The performance of the previously cleared CARDIOHELP System (K102726) served as the benchmark for substantial equivalence comparisons. This acts as a form of "ground truth" for comparative effectiveness.

8. Sample Size for the Training Set

Not applicable. This device is not an AI/ML medical device that uses a "training set." The development process involved hardware and software engineering, testing, and validation, not machine learning model training.

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

Not applicable, as there is no "training set" for this 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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