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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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The Venous Hardshell Cardiotomy Reservoir, non-vacuum-tight, is designed to collect, store and filter the blood in an extracorporeal circuit during cardopulmonary bypass procedures up to six hours in adult surgery. It can be integrated into almost all perfusion systems. The Venous Hardshell Cardiotomy Reservoir is designed and sold for use only as indicated.

The Venous Hardshell Cardiotomy Reservoir, vacuum-tight model, is designed to collect, store and filter the blood in an extracorporeal circuit during cardopulmonary bypass procedures with or without vacuum assisted venous return up to six hours in adult surgery. It can be integrated into almost all perfusion systems. The Venous Hardshell Cardiotomy Reservoir is designed and sold for use only as indicated. This reservoir is also designed to be used postoperatively as a drainage and autotransfusion reservoir (e.g. for chest drainage) to return autologous blood shed from the chest to the patient for volume replacement.

The Venous Hardshell Cardiotomy Reservoir is a reservoir with integrated filters and a defoamer. It is designed to be open or vacuum-tight. It may be marketed both as single product and as pre-assembled combination with the QUADROX-i Adult microporous membrane Oxygenator with and without integrated Arterial Filter with Softline Coating (K082117).

Here's an analysis of the provided text regarding the acceptance criteria and supporting study for the MAQUET Venous Hardshell Cardiotomy Reservoirs with Softline Coating:

It's important to note that the provided documents (a 510(k) Summary and an FDA determination letter) describe a substantial equivalence determination for a medical device. This type of submission typically focuses on demonstrating that a new device is as safe and effective as a legally marketed predicate device, rather than performing a clinical investigational study to prove de novo efficacy or safety against a set of clinical acceptance criteria. Therefore, the "acceptance criteria" and "study" described below are primarily focused on the engineering and performance characteristics of the device and its coating, not on its clinical performance compared to a baseline or an alternative treatment in a human population.

Acceptance Criteria and Reported Device Performance

The acceptance criteria for this device are implicitly tied to demonstrating substantial equivalence to its predicate devices. The study performed focuses on verifying that the new device, despite a change in coating, performs identically or acceptably compared to the predicate regarding crucial safety and performance aspects.

Study Information Table

Given the nature of a 510(k) submission focused on substantial equivalence with a minor change (coating), the "study" is primarily a series of engineering and biological tests rather than a large-scale clinical trial.

Summary of the "Study" and its Rationale:

The study conducted was a series of evaluations and tests focused on four main areas:

1. Integrity: To ensure the structural soundness and leak-proof nature of the reservoir.
2. Performance: To verify that the reservoir performs its intended functions (collecting, storing, filtering blood) as effectively as the predicate devices.
3. Biocompatibility: To confirm that the materials, especially the new Softline Coating, are safe for contact with human blood, referencing the fact that the same coating is already used in another cleared device (K082117).
4. Sterility: To ensure the device can be and is sterilized to appropriate medical device standards.

The primary goal of these evaluations was to demonstrate substantial equivalence to the predicate devices. Since the only change from the predicate "Jostra Venous Hardshell Cardiotomy Reservoirs with Safeline Coating" was the replacement of "Safeline Coating" with "Softline Coating," the study heavily leveraged the prior clearance of the "QUADROX-i Adult microporous membrane Oxygenator with ... Softline Coating (K082117)." This means the biocompatibility and performance of the Softline coating itself were likely already established and understood from the K082117 submission, simplifying the current submission by demonstrating that the system (reservoir + Softline coating) functions comparably to the predicate system (reservoir + Safeline coating) and that the Softline coating behaves as expected in this new device.

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The QUART Arterial Filter with SOFTLINE COATING is designed for use in an extracorporeal circulation system during surgical procedures involving a cardiopulmonary bypass. Within the cited flowrates, the arterial filter removes particulate and gaseous micro-embolisms from the extracorporeal circulation system. The eliminated gas can be removed via the purge line. The max. flow rate of the QUART Arterial Filter is 71/min.

The decision regarding the method in which the arterial filter is to be employed rests solely with the treating physician.

The unit may not be continuously employed for more than 6 hours. We do not recommend longer contact with the blood.

The QUART Arterial Filter serves as a filter during extracorporeal circulation procedures to safely remove gaseous embolisms and aggregates from blood components in the arterial blood line.

Utilization of the QUART Arterial Filter therefore reduces the patient risk of injury from a micro-embolism resulting from gases or solids.

This 510(k) summary describes a device modification rather than the development of a new AI/ML device. Therefore, the requested information regarding acceptance criteria, study details for AI/ML performance, sample sizes, expert involvement, and ground truth establishment, which are typical for AI/ML device submissions, are not applicable here.

The submission focuses on demonstrating substantial equivalence of the modified device (QUART Arterial Filter with SOFTLINE COATING) to its predicate devices by comparing technical characteristics and performance based on standard medical device testing, not AI/ML algorithm validation.

However, I can extract the relevant information presented in the document regarding the device modification and the testing performed to demonstrate substantial equivalence.

Device Description:
The QUART Arterial Filter serves as a filter during extracorporeal circulation procedures to safely remove gaseous embolisms and aggregates from blood components in the arterial blood line, reducing patient risk from micro-embolisms.

Device Modification:
The QUART Arterial Filter with SOFTLINE COATING is identical to the QUART Arterial Filter with Safeline Coating, with the only exception that it has been coated with SOFTLINE. The SOFTLINE COATING is the same as that used with the QUADROX-i Adult microporous membrane Oxygenator with and without integrated Arterial Filter with SOFTLINE COATING. Besides this difference, both QUART Arterial Filters are the same in design, intended use, method of operation, components, packaging, and fundamental scientific technology.

Acceptance Criteria and Reported Device Performance (as implied by the substantial equivalence determination):

The submission does not list specific numerical acceptance criteria in a table format, as would be expected for AI/ML performance metrics. Instead, it asserts that the modified device's performance aligns with the predicate devices through evaluation and testing. The "reported device performance" is essentially that it meets the expected standards for an arterial filter and is substantially equivalent to the predicate devices.

Study Information (for a device modification, not an AI/ML algorithm):

1. Sample sizes used for the test set and the data provenance: Not applicable. This submission concerns a physical device modification, not a software algorithm tested on data sets. The "testing" refers to bench testing and material compatibility, not analysis of a data set.
2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth establishment with experts is relevant for diagnostic AI/ML algorithms, not for evaluating a physical device modification.
3. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable. Adjudication methods are used in AI/ML studies to resolve disagreements among experts in ground truth labeling.
4. 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: Not applicable. This is a physical medical device.
5. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is a physical medical device.
6. The type of ground truth used (expert consensus, pathology, outcomes data, etc): Not applicable. "Ground truth" in this context would relate to the physical properties and biological interactions of the device materials and function, assessed through standard engineering and biological testing (e.g., biocompatibility testing, flow rate performance, particulate removal efficiency against a known standard).
7. The sample size for the training set: Not applicable. This is a physical medical device, not an AI/ML algorithm.
8. How the ground truth for the training set was established: Not applicable. This pertains to AI/ML algorithm development.

Conclusion stated in the 510(k):
"The data given demonstrate that the QUART Arterial Filter with SOFTLINE COATING is substantially equivalent to the named predicate devices which hold currently market clearance."

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The RotaFlow Centrifugal Pump is indicated as a component of the extracorporeal circuit for pumping liquid matter e.g. blood and can be used in conjunction with the RotaFlow Console. The utilization period of this device is restricted to six hours. The device is not designed or intended for use except as indicated.

The RotaFlow Centrifugal Pump is a non-occlusive pump. The pump has a spinning rotor with flow channels which imparts rotary motion to incoming liquid, directing it through a spiral housing to the outflow port.

This submission (K090515) is for a medical device called the MAQUET RotaFlow Centrifugal Pump with Softline Coating. It's important to note that this 510(k) summary does not contain acceptance criteria or a study proving the device meets those criteria in the way you've outlined for AI/software-driven devices.

This is a premarket notification for a Class III physical medical device (a centrifugal pump for cardiopulmonary bypass). The submission focuses on demonstrating substantial equivalence to existing legally marketed predicate devices, not on showing performance against specific, quantifiable acceptance criteria typically associated with software or AI performance.

Therefore, many of your specific questions are not applicable to the information provided in this 510(k) summary. I will address the relevant sections and explain why others cannot be answered from the provided text.

1. A table of acceptance criteria and the reported device performance

This information is not provided in the 510(k) summary for K090515. For physical devices like this, the "performance" demonstrated for substantial equivalence typically involves engineering tests (e.g., flow rates, pressure handling, durability, biocompatibility) rather than quantifiable metrics like sensitivity or specificity seen in diagnostic AI. The summary states that "Performance" was evaluated, but it does not present specific criteria or results in a table.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

This information is not provided. As this is a physical device, "test sets" in the context of data points for algorithm evaluation are not relevant here. The evaluation would involve physical prototypes or manufactured units of the pump.

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)

This information is not provided and is not applicable to a physical medical device submission like this. Ground truth, in the context of expert consensus, is typically for diagnostic interpretation, not for evaluating the mechanical function of a pump.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

This information is not provided and is not applicable.

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

This information is not provided and is not applicable. This type of study relates to the performance of diagnostic AI with human readers, not a physical pump.

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

This information is not provided and is not applicable. There is no algorithm discussed for diagnostic or interpretative purposes in this submission.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

This information is not provided and is not applicable in the way you've described. For a physical pump, "ground truth" might refer to engineering specifications, validated test methods for flow, pressure, material integrity, and biocompatibility standards. The submission highlights that "Integrity", "Performance", "Biocompatibility", and "Sterility" were evaluated, implying various testing methodologies were used, but details are not given.

8. The sample size for the training set

This information is not provided and is not applicable. There is no training set for an AI/ML algorithm in this submission.

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

This information is not provided and is not applicable.

Summary of Relevant Information from the K090515 Submission:

• Device Name: RotaFlow Centrifugal Pump with Softline Coating
• Submission Type: 510(k) Premarket Notification
• Purpose of Study/Evaluation: To demonstrate substantial equivalence to legally marketed predicate devices.
• Predicate Devices:
  • RotaFlow Centrifugal Pump with BIOLINE Coating (K080470) - for the pump design and function.
  • QUADROX-i Adult microporous membrane Oxygenator with and without integrated Arterial Filter with Softline Coating (K082117) - for the Softline Coating material.
• Key Differences from Predicate: The only stated difference from the primary predicate is the coating (Softline instead of BIOLINE). The Softline coating itself is identical to a coating already approved in another predicate device.
• Evaluated Areas (for demonstrating substantial equivalence):
  • Integrity
  • Performance
  • Biocompatibility
  • Sterility
• Conclusion: The data demonstrated that the RotaFlow Centrifugal Pump with Softline Coating is substantially equivalent to the named predicate devices.

In essence, this 510(k) is for a manufacturing change (a new coating) on an already cleared device, leveraging the prior approval of both the pump design and the specific coating material on other devices. It does not involve AI or software development that would require the kind of performance metrics and study designs you've detailed.

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