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The LIFEBRIDGE SYSTEM is indicated for use as an extracorporeal blood oxygenation system for patients needing short term, 6 hours or less, cardiac and/or pulmonary support.

The LIFEBRIDGE SYSTEM is a compact, pre-assembled, modular system consisting of:

1. Patient module housing an extracorporeal circuit comprised of several previously 510k-cleared devices. The circuit includes a rigid reservoir bag, a centrifugal pump, oxygenator, arterial filter, active air management system, tubing and connectors.
2. Sensors, including flow, pressure, level and bubble to read system parameters.
3. Control module that contains the electronics and user interface.
4. Base module that contains a touch screen, the main power connection and acts as a stable frame for the svstem.
   The modification to the current Lifebridge System is to exchange the current oxygenator, BioCor 200, used in the patient module, for the Medtronic Affinity NT oxygenator with Trillium Biopassive surface coating.

This document describes a Special 510(k) submission for the LIFEBRIDGE SYSTEM, specifically concerning a modification to exchange one 510(k) cleared oxygenator (BioCor 200) for another (Medtronic Affinity NT oxygenator with Trillium Biopassive surface coating). As such, the study described is a performance validation to demonstrate equivalence and safety of the modified device rather than a study to establish primary efficacy or diagnostic accuracy.

Therefore, many of the requested categories related to diagnostic AI (e.g., sample size for test set, data provenance, number of experts for ground truth, adjudication method, MRMC study, standalone performance, training set details) are not applicable to this type of device modification submission.

1. Table of Acceptance Criteria and Reported Device Performance

The submission details that "Performance testing has been carried out to validate the mitigations and to ensure that the change to the patient module is safe, does not create any new risks and that performance of the modified module is equivalent to that of the original." While specific numeric acceptance criteria and detailed performance results are not provided in this summary document, the FDA's clearance indicates that these criteria were met and the performance was found acceptable for substantial equivalence.

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

This is not applicable as this is a device modification for a cardiopulmonary support system, not an AI diagnostic device. The "test set" in this context refers to the samples used in performance validation testing (e.g., in-vitro or in-vivo testing of the oxygenator's function), not a diagnostic image dataset. The document does not specify the number of units or test conditions used in this performance testing. The data provenance would be from laboratory or animal testing specific to the device modification, not human retrospective/prospective data from specific countries.

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

Not applicable. Ground truth for a cardiopulmonary support system's performance typically involves established engineering and medical standards for oxygenation efficiency, blood parameter maintenance, pressure limits, flow rates, and biocompatibility, verified through laboratory testing against benchmarks, rather than expert consensus on diagnostic images.

4. Adjudication Method for the Test Set

Not applicable. Adjudication methods like 2+1 or 3+1 are used for resolving disagreements in expert labeling of diagnostic data. Performance testing of a medical device like an oxygenator would rely on validated measurement techniques and adherence to pre-defined specifications.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size

Not applicable. MRMC studies are designed to assess the performance of diagnostic devices or AI algorithms when interpreted by multiple human readers, often comparing AI-assisted vs. unassisted reading. This submission is for a physical medical device (an oxygenator) and does not involve human readers interpreting diagnostic cases.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

Not applicable. This is not an AI algorithm.

7. The Type of Ground Truth Used

The "ground truth" for this device modification is based on established performance specifications for oxygenators in cardiopulmonary bypass, including oxygen transfer efficiency, CO2 removal, blood compatibility, pressure drop, and absence of hemolysis. These are verified through bench testing and potentially in-vivo animal models (though not specified in this summary). The fact that the Medtronic Affinity NT oxygenator itself was "previously 510k-cleared" implies that its performance capabilities are already well-established and accepted. The current testing would focus on ensuring these capabilities are maintained when integrated into the LIFEBRIDGE SYSTEM.

8. The Sample Size for the Training Set

Not applicable. This is not an AI algorithm.

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

Not applicable. This is not an AI algorithm.

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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 LIFEBRIDGE SYSTEM is indicated for use as an extracorporeal blood oxygenation system for patients needing short term, 6 hours or less, cardiac and/or pulmonary support.

The LIFE.BRIDGE SYSTEM is a compact, pre-assembled, modular system consisting of:

1. Patient module housing an extracorporeal circuit comprised of several previously 510k-cleared devices. The circuit includes a rigid reservoir bag, a centrifugal pump, oxygenator, arterial filter, active air management system, tubing and connectors.
2. Sensors, including flow, pressure, level and bubble to read system parameters.
3. Control module that contains the electronics and user interface.
4. Base module that contains a touch screen, the main power connection and acts as a stable frame for the system.
   The modification to the current Lifebridge System is to exchange the current oxygenator, BioCor 200, used in the patient module, for the Medtronic Affinity® NT oxygenator. The Affinity NTC Oxygenator is available with either a Carmeda® BioActive surface coating or a Trillium Biopassive surface coating.

This document refers to a Special 510(k) submission for a modification to a cardiopulmonary support system (LIFEBRIDGE SYSTEM). The modification involves exchanging one 510(k)-cleared oxygenator (BioCor 200) for another (Medtronic Affinity NT oxygenator). The document focuses on demonstrating that the modified system is substantially equivalent to the original and that potential risks have been mitigated.

Let's break down the requested information based on the provided text.

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

The document does not explicitly present a table of acceptance criteria with corresponding performance data in a quantitative manner typical for algorithm performance. Instead, it refers to a process of demonstrating safety and equivalency.

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

The document does not specify a "test set" in the context of an AI/algorithm evaluation with a defined sample size of cases or patients. The performance testing mentioned is for the physical device components (oxygenator) rather than a diagnostic algorithm. Therefore, information about data provenance and retrospective/prospective nature is not applicable in the context of an imaging AI device.

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 applicable. The device is a cardiopulmonary support system, not an imaging AI device requiring expert-established ground truth on a test set of images.

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

This information is not applicable. There is no mention of a test set requiring adjudication in the context of an algorithm or diagnostic performance.

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 applicable. The document describes a physical medical device (cardiopulmonary support system), not an AI-assisted diagnostic or imaging device. Therefore, MRMC studies and human reader improvement with AI are irrelevant to this submission.

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

This information is not applicable. The device is a physical cardiopulmonary support system, not a standalone algorithm.

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

This information is not applicable in the context of an AI/algorithm. For this device, the "ground truth" would be related to established engineering and physiological performance standards for oxygenators and overall cardiopulmonary support systems, demonstrated through a combination of in vitro testing, animal studies, and potentially human clinical data if significant changes were made (though for a 510(k) modification, focusing on equivalence to a cleared device, extensive new clinical ground truth may not be required). The document indicates performance testing was done to validate mitigations and ensure safety and equivalence.

8. The sample size for the training set

This information is not applicable. The device is not an AI/machine learning algorithm that requires a training set.

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

This information is not applicable. The device is not an AI/machine learning algorithm that requires a training set with established ground truth.

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The LIFEBRIDGE B2T System is indicated for use as an extracorporeal blood oxygenation system for patients needing short term, 6 hours or less, cardiac and/or pulmonary support.

The LIFEBRIDGE B2T SYSTEM is a compact, pre-assembled, modular system consisting of: 1. Patient module housing an extracorporeal circuit comprised of several previously 510k-cleared devices. The circuit includes a rigid reservoir bag, a centrifugal pump, oxygenator, arterial filter, active air management system, tubing and connectors. 2. Sensors, including flow, pressure, level and bubble to read system parameters. 3. Control module that contains the electronics and user interface. 4. Base module that contains a touch screen, the main power connection and acts as a stable frame for the system. The following LIFEBRIDGE ByT SYSTEM components have been previously 510(k)-cleared for use in cardiopulmonary bypass: oxygenator, arterial filter, centrifugal pump, level sensors, and bubble detector.

The provided document is a 510(k) summary for the LIFEBRIDGE B2T System, a cardiopulmonary support system. It focuses on demonstrating substantial equivalence to predicate devices rather than providing detailed acceptance criteria and a study proving device performance against those criteria in the way one might expect for novel technology or a software algorithm.

Here's an analysis based on the provided text, addressing your points where information is available:

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

The document does not specify quantitative "acceptance criteria" or present a table of reported device performance in the context of a formal study demonstrating compliance with such criteria. Instead, it states:

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

The document does not describe a clinical "test set" with a specific sample size or data provenance. The assessment for this device appears to be based on:

• Non-clinical tests: The document mentions "Non-clinical tests performed on the LIFEBRIDGE B2T SYSTEM provide evidence of the safety and effectiveness of the device for its intended use." Details of these tests (e.g., number of runs, specific parameters) are not provided.
• Comparison to predicate devices: The primary argument for approval is based on substantial equivalence to existing, legally marketed cardiopulmonary bypass systems. This implies that the safety and effectiveness of the components and overall system are inferred from the established performance of the predicate devices.

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 applicable to this 510(k) submission. There is no mention of an expert-adjudicated test set or ground truth establishment in the context of human expert review. The submission relies on non-clinical testing and comparison to predicate device characteristics.

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

Not applicable. No expert adjudication method is described because there is no expert-adjudicated test set in the provided document.

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

Not applicable. This document describes a medical device (a cardiopulmonary support system), not an AI algorithm. Therefore, an MRMC study related to AI assistance is not relevant to this submission.

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

Not applicable. This is a hardware medical device, not a standalone algorithm.

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

The concept of "ground truth" as typically applied in AI/diagnostic device studies (e.g., expert consensus, pathology, clinical outcomes) is not explicitly detailed in this 510(k) summary. The "ground truth" for demonstrating safety and effectiveness of a cardiopulmonary support system in this type of submission is typically derived from:

• Engineering specifications and performance standards: Non-clinical tests verify the device meets these standards (e.g., flow rates, pressure limits, oxygenation efficiency, material biocompatibility).
• Established performance of predicate devices: The "truth" of what constitutes a safe and effective cardiopulmonary bypass system is based on the long history and regulatory clearance of the predicate devices.

8. The sample size for the training set

Not applicable. This pertains to an AI/machine learning model, which is not what the LIFEBRIDGE B2T System is.

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

Not applicable. This pertains to an AI/machine learning model, which is not what the LIFEBRIDGE B2T System is.

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The Stöckert Centrifugal Pump Console (SCPC System) is a software-controlled cardiopulmonary bypass device containing an uninterruptable power supply (UPS) and S3 Sensor Modules that is designed for operation of the Stöckert Centrifugal Pump (SCP) and monitoring the cardiopulmonary bypass circuit. The SCPC System, in combination with the SCP and the COBE Revolution Pump Head, is indicated for speed-controlled pumping through the cardiopulmonary bypass circuit for typical durations of six hours or less.

The SCPC System has been qualified only for durations appropriate to cardiopulmonary bypass procedures and has not been qualified through in vivo, or clinical studies, for long term use as a bridge to transplant, pending recovery of the natural heart, or extracorporeal membrane oxygenation (ECMO) procedures.

The SCPC System provides electrical power and sets specific operational parameters for the Stöckert Centrifugal Pump Control Panel and Drive Unit described in K011838. The SCPC System also monitors the following parameters of the cardiopulmonary bypass circuit:

• . Pressure
• Temperature .
• Level monitoring/bubble detection .
• Elapsed time .

The SCPC System provides procedural flexibility for use of the Stöckert Centrifugal Pump, allowing the pump to be used as a component of other legally marketed heartlung machine consoles.

The provided document, K020571 for the Stöckert Centrifugal Pump Console, describes performance testing but does not explicitly detail acceptance criteria in a quantitative table or the specific results against such criteria for the device itself. Instead, it broadly states that testing was performed to confirm that the proposed SCPC System performed as designed and met user requirements.

The document outlines the types of testing performed rather than specific performance metrics against pre-defined acceptance thresholds.

Re-interpreting for Acceptance Criteria and Study Information:

Given the nature of the device (a cardiopulmonary bypass system console) and the information provided, the "acceptance criteria" can be inferred to be compliance with relevant standards and successful functionality as per design specifications and user requirements. The "study" refers to the performance testing conducted.

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

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

• Sample Size: Not explicitly stated. The document refers to "testing" performed, which generally implies a test set of devices or scenarios, but no specific numbers are given for units tested or duration of tests beyond the "typical durations of six hours or less" for use.
• Data Provenance: Not explicitly stated, but based on the manufacturer's location (Munich, Germany) and the regulatory submission to the FDA (USA), the testing was likely conducted in a controlled environment, potentially in Germany, for submission to US regulatory bodies. The nature of the device suggests in-vitro testing.

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 and hence not provided in the document. This device is a medical instrument console, not an AI/diagnostic software. "Ground truth" in the context of expert consensus or pathology is typically relevant for diagnostic devices or AI algorithms. The "ground truth" for this device would be its adherence to engineering specifications and regulatory standards, evaluated by engineers and regulatory compliance experts.

4. Adjudication method for the test set:

• Not applicable as this is not a diagnostic device involving human interpretation requiring adjudication. Performance was assessed against engineering and regulatory standards.

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:

• Not applicable. This device is a physical medical instrument (a pump console), not an AI-assisted diagnostic or interpretive system. Therefore, MRMC studies are not relevant.

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

• Not applicable. This is a hardware console with integrated software, not a standalone algorithm. Its performance is assessed as an integrated system.

7. The type of ground truth used:

• The "ground truth" for this device is its adherence to:
  • Engineering specifications and design requirements: The device was tested to confirm it "performed as designed."
  • User requirements: Confirmed it "met user requirements."
  • Regulatory standards: Demonstrated "conformance with the appropriate standards" for electrical safety and EMC.
  • Compatibility: Demonstrated successful interaction with other specified heart-lung machine consoles.

8. The sample size for the training set:

• Not applicable. This is not an AI/machine learning device that requires a training set in the conventional sense. The "training" for such devices involves design, prototyping, and testing phases to ensure functionality, not data-driven model training.

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

• Not applicable for the same reasons as point 8.

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The Stöckert Compact System is an integrated heart-lung machine consisting of pumps, monitoring, and control elements on a single chassis. It is indicated for speed controlled pumping through the cardiopulmonary bypass circuit for typical durations of six hours or less, left ventricular venting, cardiotomy suction, administration of cardioplegia solution, when used by a qualified perfusionist who is experienced in the operation of the SC System.

The SC System has been qualified only for durations appropriate to cardiopulmonary bypass procedures and has not been qualified through in vitro, in vivo, or clinical studies, for long term use as a bridge to transplant, pending recovery of the natural heart, or extracorporeal membrane oxygenation (ECMO) procedures.

The Stöckert Compact System is a modification of the Stöckert S3 System, which integrates its components into a single chassis. There is no change to the indications for use or the fundamental technological characteristics.

The provided document, K982014, describes a Special 510(k) for a device modification of the Stöckert Compact System (SC System). A Special 510(k) is used when a modification to a legally marketed device does not alter the fundamental technology or intended use, and therefore the determination of substantial equivalence relies heavily on the equivalence to the predicate device and the validation of the modifications according to design control procedures. This type of submission typically does not involve a traditional "study" in the sense of a clinical trial or performance study with acceptance criteria being met by reported device performance against a ground truth.

Instead, the "acceptance criteria" for a Special 510(k) are typically the demonstration that the modified device remains substantially equivalent to the predicate device in terms of intended use, technological characteristics, safety, and effectiveness. The "study" proving this usually involves design validation and verification activities.

Based on the provided text, here's an analysis against your requested information:

1. Table of acceptance criteria and the reported device performance

The document does not present a formal table of acceptance criteria with reported device performance in the manner requested for a new device submission. Instead, the "acceptance criteria" are implied by the nature of a Special 510(k) and the claim of substantial equivalence.

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

The document does not mention a "test set" in the context of a performance study with a specific sample size. The validation performed focused on the modifications to the existing S3 system. There is no information about data provenance like country of origin or retrospective/prospective nature because it's not a performance study on a new clinical dataset.

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

Not applicable. No "test set" or "ground truth" was established by experts in the context of a new performance study. The validation relates to engineering and design control processes.

4. Adjudication method for the test set

Not applicable. There was no test set requiring adjudication in the context of a performance study.

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

Not applicable. This device is a heart-lung machine, not an AI-powered diagnostic or assistive technology for human readers.

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

Not applicable. This device is a heart-lung machine, not an algorithm.

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

Not applicable. The "ground truth" for this submission is the established safety and effectiveness of the predicate S3 System, and the demonstration that the modifications to create the SC System do not alter this. This is validated through design, engineering, and quality system procedures, not comparison to a clinical "ground truth" dataset.

8. The sample size for the training set

Not applicable. This is not an AI/ML device, and therefore does not have a "training set."

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

Not applicable. As above, this is not an AI/ML device.

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