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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 Stöckert Air Purge Control (APC) System detects air in the venous line and removes air from the venous bubble trap of the Synergy™/ECC.O™ System tubing circuit. The Synergy™/ECC.O™ shall only be used in conjunction with the Stöckert S5 (or any compatible system using the S5 firmware versions of 3.0 or greater) and the SCP Plus System.

The Stöckert S5 System is indicated for speed controlled pumping of blood through the cardiopulmonary bypass circuit for durations of six hours or less, left ventricular venting, cardiotomy suction and administration of cardioplegia solution.

The Stöckert APC System consists of the APC sensor module (Catalog Number: 23-45-22), 3-joint mast holder with fast clamp connectors for two bubble sensors, 420mm (Catalog Number: 23-26-96), bubble sensor for 3/8 inch tubing (Catalog Number: 23-07-50), and ultrasonic gel, bottle, 250 mL (Catalog Number: 96-06-10). All of these components are identical to those used with the Stöckert S5 System (K091008).

The Stöckert APC can be operated automatically and manually using the APC displet of the heart lung machine.

The Stöckert APC bubble trap is placed just before the venous bubble trap of the Synergy™/ECC.OTM. When bubble activity is sensed, the assigned roller pump on the heart lung machine console begins operation to remove a set tubing volume (as determined by tubing size and pump speed (RPM)) or to run for a set time (in seconds) at a perfusionist-selected flow rate. This fluid is pumped into an appropriate blood collection reservoir. The technology of the Stöckert APC is based on the technology of the Stöckert Air Purge Control System (K041558).

The Stöckert APC is used for detecting air in the venous line and removing air from the venous bubble trap of the Synergy™/ECC.O™ System tubing circuit.

Here's an analysis of the provided text regarding the acceptance criteria and study for the Stöckert Air Purge Control (APC) System:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state quantitative acceptance criteria or a detailed "reported device performance" against specific metrics. Instead, it makes a general statement about the device fulfilling "prospectively defined functional acceptance test" criteria.

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

The document does not specify a distinct "test set" in the sense of a dataset for evaluating an algorithm. The testing described is hardware and system validation.

• Sample Size for Test Set: Not applicable as it's not a data-driven algorithmic evaluation. The testing involved the Stöckert APC System itself, integrated with a heart-lung machine.
• Data Provenance: Not applicable. The testing was described as "non-clinical performance testing" and "simulated use/in-use validation testing" of the physical system, likely conducted internally by the manufacturer (Sorin Group Deutschland GmbH).

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

Not applicable. The ground truth for electrical safety, EMC, and functional performance would be established by engineering standards and internal testing protocols, not by expert consensus on a dataset.

4. Adjudication Method for the Test Set

Not applicable. This is not a study involving human reader interpretation or diagnostic output that requires adjudication.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size of How Much Human Readers Improve with AI vs. Without AI Assistance

No. This device is a hardware system for detecting and removing air during cardiopulmonary bypass, not an AI or diagnostic imaging device that would involve human readers.

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

Yes, in a way. The "functional acceptance test and simulated use/in-use validation testing" evaluated the Stöckert APC System's performance in detecting air and initiating removal autonomously (which could be considered its "standalone" performance), even though it operates within the larger Stöckert S5 heart-lung machine system. The device's function is automated.

7. The Type of Ground Truth Used

The ground truth used for this type of device would be:

• Engineering Standards: For electrical safety (IEC60601-1) and electromagnetic compatibility (IEC60601-1-2).
• Physical Principles and Design Specifications: For the air detection and removal capabilities. The "prospectively defined functional acceptance test" would have protocols and metrics based on the expected physical behavior of the system (e.g., ability to reliably detect a certain volume of air, ability to remove air within a specified time).

8. The Sample Size for the Training Set

Not applicable. This is not a machine learning or AI device that requires a training set.

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

Not applicable.

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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 Capiox® Bubble Trap with X-coating " is a device intended to facilitate air bubble removal from the blood flowing through a cardiopulmonary bypass circuit for up to 6 hours.

The Capiox® Bubble Trap with X-coating is comprised of a single outer housing with no inner housing. This outer housing is cylindrical in shape and has a slight conical-shaped lid assembly affixed to the upper area of the cylinder. The lid assembly has an air vent (purge) port on the top outer surface to facilitate air removal during use. The blood inlet port is positioned along the upper-side_axis_of_the_cylinder_housing_and_allows_for the entry of blood ... The base_of_the housing contains the blood outlet port. The cylinder housing contains a screen filter assembly through which blood will pass through for filtration of air bubbles. After the blood has been filtered, it then exits the assembly via the blood outlet port.

Here's an analysis of the provided text regarding the acceptance criteria and the study proving the device meets those criteria:

Acceptance Criteria and Device Performance Study for Capiox® Bubble Trap with X-coating™

The provided document describes the Terumo Capiox® Bubble Trap with X-coating™ and its performance evaluation for substantial equivalence to a predicate device. The core of the performance evaluation is a comparison study.

1. Table of Acceptance Criteria and Reported Device Performance

The document doesn't explicitly state "acceptance criteria" with numerical targets. Instead, it demonstrates "functional equivalence" and "substantial equivalence" to a predicate device, the non-coated BT15 Bubble Trap. Therefore, the "acceptance criteria" are implicitly that the new device performs comparably to the predicate device in the listed performance evaluations. The "reported device performance" refers to the demonstration of this equivalence.

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

The document does not explicitly state the numerical sample sizes for each in-vitro performance evaluation. It only mentions that "the following tests were performed."

• Sample Size: Not explicitly stated for the in-vitro tests.

• Data Provenance: The in-vitro performance evaluations were conducted by "Terumo Corporation, in conjunction with Terumo Cardiovascular Systems Corporation," implying an internal, retrospective (for the purpose of this submission, though the tests themselves would have been prospective investigations) study. No country of origin for the direct test data is specified beyond the Terumo entities.

  An in-vivo animal study was conducted by Terumo Cardiovascular Systems and Sierra Biomedical Laboratories in 1999 to evaluate the X-Coating material itself. This study would be considered retrospective for the current submission.

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

This type of information is not provided in the document. The studies described are primarily in-vitro lab tests and material evaluations, not clinical studies requiring expert ground truth for interpretation of patient data.

4. Adjudication Method (for the test set)

This information is not applicable or not provided. The studies are in-vitro performance evaluations demonstrating equivalence to a predicate, not clinical studies requiring adjudication of medical diagnoses.

5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study was done

No, an MRMC comparative effectiveness study was not mentioned. The studies described are in-vitro performance evaluations and an in-vivo animal study for material safety, not studies involving human readers or comparative effectiveness in a clinical setting.

6. If a Standalone Study (algorithm only without human-in-the-loop performance) was done

This question is not applicable as the device is a physical medical device (bubble trap), not an algorithm or software. The "standalone" performance in this context would be the in-vitro functional performance tests, which were indeed conducted without human intervention in the function of the device itself during the test.

7. The Type of Ground Truth Used

For the in-vitro performance evaluations (Air Removal Efficiency, Hemolytic Effect, Pressure Drop, Mechanical Integrity/Leakage, Prime Volume), the "ground truth" is defined by objective, measurable physical and chemical properties and engineering specifications. The performance of the new device is compared directly against the established performance of the predicate device.

For the X-Coating material's safety, the "ground truth" was established by in-vivo animal study outcomes, specifically looking for "adverse conditions."

8. The Sample Size for the Training Set

This information is not applicable or not provided. The Capiox® Bubble Trap with X-coating™ is a physical medical device, not an AI/ML algorithm that requires a "training set" in the computational sense. The "training" for such a device would be its design, manufacturing processes, and material selection based on established engineering principles and prior device knowledge.

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

This information is not applicable as there is no "training set" in the context of AI/ML for this physical device. The "ground truth" for its development and design would have been established through a combination of engineering principles, material science knowledge, regulatory standards, and performance data from previous device generations (like the predicate device).

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The EDAC™ QUANTIFIER has the intended use as a standalone accessory to detect gaseous emboli in an extracorporeal bypass circuit line.

The EDAC™ QUANTIFIER is a standalone system in which the ultrasonic sensing system consists of a three-channel ultrasonic pulser-receiver unit, a touchpanel computer, ultrasound transducers and clamps for attached the transducers to the circuit. This system is currently being certified according to voluntary medical device safety standards UL 60601-1 . IEC 60601-1-2 and IEC 60601-1-4, covering electrical device safety in medical products and IEC-60601-2-37, covering ultrasonic diagnostic safety. It also employs software and firmware to provide the embedded signal processing needed to detect gas emboli over the range of sizes described.

The EDAC™ QUANTIFIER is an ultrasonic cardiopulmonary bypass bubble detector. The study validates the device's ability to detect gaseous emboli in an extracorporeal bypass circuit.

1. Table of Acceptance Criteria and Reported Device Performance:

The provided document does not explicitly state formal "acceptance criteria" with numerical thresholds. Instead, it describes "performance claims" and then details the testing conducted to validate these claims. Based on the "Technological Characteristics Comparison Summary" and the "Non-clinical Testing" section, the following can be inferred as the performance claims (which act as acceptance criteria) and the reported performance.

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

• Sample Size: Not explicitly stated. The document mentions "extensive non-clinical testing" and refers to a "System Test Plan (Attachment 5.7)" which would contain specific details, but this attachment is not provided.
• Data Provenance: The testing was conducted in a laboratory setting.
  • Country of Origin: Not explicitly stated, but the parent company (Luna Innovations Inc.) is based in Blacksburg, Virginia, USA.
  • Retrospective or Prospective: Prospective, as the tests were performed specifically to validate the device's performance before marketing.

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

This information is not provided. The testing appears to be based on engineering and scientific measurements of bubble detection and sizing, rather than human interpretation of data for ground truth.

4. Adjudication method for the test set:

Not applicable. The ground truth appears to be based on controlled experimental conditions and expected physical phenomena of bubble generation and detection, not on expert consensus or adjudication.

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 standalone bubble detector, not an AI-assisted diagnostic tool that human readers would interpret. Its primary function is automated detection, not to improve human reader performance.

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

Yes, a standalone study was performed. The non-clinical testing was conducted to evaluate the EDAC™ QUANTIFIER's performance as a "standalone accessory," focusing on its ultrasonic sensing system and embedded signal processing. The device is designed to detect gas emboli automatically.

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

The ground truth for the non-clinical testing was established through controlled laboratory conditions using:

• Standardized fluid mimics (28% glycerin solution to mimic blood).
• Biological fluids (canine blood).
• Common medical solutions (crystalloid solution used to prime bypass circuits).
• Presumably, controlled introduction of known sizes and quantities of gaseous emboli into these systems, with measurement of the device's ability to accurately detect and quantify them. The "System Test Plan (Attachment 5.7)" would detail the precise methodology for generating and verifying these "ground truth" emboli.

8. The sample size for the training set:

Not applicable. This device is an ultrasonic sensor with embedded signal processing, not a machine learning or AI model that requires a "training set" in the conventional sense. Its "training" would be more akin to software and firmware development and calibration based on known physical principles and experimental validation.

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

Not applicable, as there is no traditional "training set" in the context of machine learning. The device's operational parameters and signal processing algorithms would have been developed and calibrated based on engineering principles and experimental data derived from various types and sizes of bubbles in different fluid environments, but this is not typically referred to as a "training set" for ground truth establishment in this type of device.

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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 Quest Myocardial Protection System, consisting of the MPS Console and the MPS Delivery Set used together, is intended for use by perfusionist and physicians to deliver whole blood (from any arterial source) and / or cardiopleqia solutions to the heart during open heart surgery on either an arrested or beating heart

The MPS is designed to deliver whole blood or cardioplegia solution. The MPS pumping subsystem coordinates the pumping and mixing of the blood and additives to deliver the desired composition of cardioplegia solution. The pumping subsystem consist of an electro-mechanical pumping device acting on a variety of disposable cassettes to deliver fluid. A set of four pump pistons, each driven by a stepper motor, displace the contents of the mechanically restrained fluid filled cassettes. Pressure sensors located on the end of each piston diagnose the adequacy of the pumping and filling process. The main blood pump consist of two motor driven pistons and a symmetrically designed pump cassette with two chambers. Each chamber is designed to alternately fill and pump blood. A set of valves operate on channels formed within the cassette to control the flow of fluids into and out of the chamber. As one chamber is filled, the other chamber is delivering solutions. This overlapping and alternating operation of the pumping system provides an essentially constant fluid output

Here's a breakdown of the acceptance criteria and study information for the Quest Myocardial Protection System Perfusion Assisted Direct Coronary Artery Bypass (PADCAB) based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

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

The provided text states: "The function test data to support the safety and efficacy of the device has not changed from the predicate device submission. Please refer to paragraph 3 of pages 15 – 16 of TAB 20 of Volume 4 of original submission (#K953838). A copy has been enclosed for your convenience."

Since the detailed K953838 submission is not fully provided, we cannot determine the exact sample sizes for each specific functional test. The data provenance is not explicitly stated as country of origin, nor is it specified as retrospective or prospective, however, functional testing usually implies lab-based, prospective testing conducted by the manufacturer.

For K994274, the provided text directly lists functional testing results, but does not explicitly state sample sizes for these tests.

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

This information is not provided in the given text. The studies described are primarily functional and engineering tests, not clinical studies involving expert interpretation of data or images to establish a ground truth.

4. Adjudication Method for the Test Set

This information is not provided in the given text. As the studies are functional and engineering tests, an adjudication method like 2+1 or 3+1 typically used for clinical assessments or image interpretation algorithms is not applicable.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done, What was the Effect Size of How Much Human Readers Improve with AI vs. Without AI Assistance

A MRMC comparative effectiveness study was not done. The provided document is for a medical device (Cardioplegia Delivery System), not an AI algorithm for diagnostic interpretation that would involve human readers. The document focuses on the functional performance and safety of the device itself, often in comparison to predicate devices, but not on human performance with or without AI assistance.

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

This question is not applicable as the device is a physical medical system (Cardioplegia Delivery System), not an algorithm.

7. The Type of Ground Truth Used

For the functional tests, the "ground truth" is established by engineering specifications, recognized industry standards (e.g., ISO, AAMI, ANSI/HIMA, ASTM), and direct measurement against those specifications. For example:

• "No leaks at 15 psi" implies the ground truth for leakage is verified by applying 15 psi and observing.
• "Detects 100uL size air bubbles" implies the ground truth for air detection is based on the known size of simulated air bubbles.
• "Accuracy of 95% of the flow rates" implies that the true flow rate (ground truth) is measured independently.

8. The Sample Size for the Training Set

This information is not provided in the given text. This device is a hardware system, not an AI algorithm that typically has a "training set." The development of such a device involves design, prototyping, and iterative functional testing, but not machine learning training sets in the conventional sense.

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

This question is not applicable as the device is not an AI algorithm with a training set. The "ground truth" for the device's design and performance during its development would be based on engineering principles, clinical needs, and established medical device standards.

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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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