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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 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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