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Extracorporeal Membrane Oxygenation

The LifeSPARC System is a centrifugal blood pump system intended to assist in circulation of the patient's blood when part of an extracorporeal circuit including physiologic gas exchange of the patient's blood in adult patients with acute respiratory failure or acute cardiopulmonary failure, where other available treatment options have failed, and continued clinical deterioration is expected or the risk of death is imminent. These may include:

· Failure to wean from cardiopulmonary bypass following cardiac surgery in adult patients;

· ECMO-assisted cardiopulmonary resuscitation in adults.

Cardiopulmonary Bypass

The LifeSPARC System is intended to pump the blood through an extracorporeal circuit for periods lasting less than 6 hours for the purpose of providing either: (i) Full or partial cardiopulmonary bypass (i.e., circuit includes an oxygenator) during open surgical procedures on the heart or great vessels; or (ii) Temporary circulatory bypass for diversion of flow around a planned disruption of the circulatory pathway necessary for open surgical procedures on the aorta or vena cava.

The LifeSPARC Pump is a sterile, single-use, low prime volume centrifugal pump with an integrated motor and a single-point, pivot bearing. It is sterilized using ethylene oxide (EO) and sized to fit in the palm of the hand or to secure to the patient.

The LifeSPARC Controller provides the interface between pump and user, as well as the power and electrical signals to drive the pump. It is a microprocessor-based electromechanical pump drive system designed to operate on standard AC current (100/240 VAC, 50/60 Hz) or on internal, rechargeable batteries for intra-hospital transport.

The provided document is a 510(k) premarket notification summary for the CardiacAssist, Inc. LifeSPARC System. This submission appears to be for a software update to an already cleared device, not for a new device requiring extensive clinical trials to prove its performance against specific acceptance criteria.

The document does not contain the information requested regarding acceptance criteria and a study that proves the device meets those criteria, as such a study would typically be conducted for a novel device or a significant change in intended use, which is not the case here.

Here's why the requested information is absent and what the document does indicate:

1. A table of acceptance criteria and the reported device performance: This is not present. The submission focuses on demonstrating "substantial equivalence" to previously cleared versions of the LifeSPARC System, specifically due to a software update. This means the performance is assumed to be equivalent to the predicate devices, rather than being re-evaluated against new, explicit acceptance criteria.

2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective): Not applicable in the context of this submission. The testing mentioned is "Software Verification and Validation testing (including Cybersecurity)," which typically does not involve human patient data or "test sets" in the clinical sense.

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): Not applicable. "Ground truth" established by clinical experts is relevant for diagnostic or AI-driven devices that interpret complex data (like medical images). This device is a mechanical pump system with a controller, and its "performance" is assessed through engineering and software validation.

4. Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not applicable for the reasons stated above.

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 not an AI diagnostic tool and does not involve "human readers" interpreting data with or without AI assistance.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: The document mentions "Software Verification and Validation testing." This type of testing evaluates the algorithm's performance in isolation (standalone), but it's in the context of a software update for a medical device's control system, not a diagnostic algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not applicable. For software validation, the "ground truth" would be the expected functional behavior of the software as defined by its requirements and specifications.

8. The sample size for the training set: Not applicable. This is not an AI/machine learning model that requires a training set.

9. How the ground truth for the training set was established: Not applicable.

Summary of what the document does state regarding performance and testing:

• Device Change: The submission is for an update to the software version of a currently cleared device (LifeSPARC System). All other aspects of the device are identical to the predicate and reference devices.
• Testing Performed: "Software Verification and Validation testing (including Cybersecurity) was completed for the Subject device with the new software."
• Conclusion: "Testing described in this notification demonstrates that the Subject LifeSPARC System performance is substantially equivalent to the legally marketed Predicate LifeSPARC System (K211830) and Reference device (K232132)." The document explicitly states that "no concerns regarding safety and effectiveness result from the software changes."

In essence, this FDA 510(k) clearance is based on demonstrating that the software update does not change the safety or effectiveness of the device compared to its previously cleared versions, and therefore, it is "substantially equivalent." It is not a submission for a new device requiring extensive new clinical performance data against pre-defined acceptance criteria.

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The LifeSPARC System is intended to pump the blood through an extracorporeal circuit for periods lasting less than 6 hours for the purpose of providing either: (i) Full or partial cardiopulmonary bypass (i.e., circuit includes an oxygenator) during open surgical procedures on the heart or great vessels; or (ii) Temporary circulatory bypass for diversion of flow around a planned disruption of the circulatory pathway necessary for open surgical procedures on the aorta or vena cava.

The LifeSPARC Pump is a sterile, single-use, low prime volume centrifugal pump with an integrated motor and a single-point, pivot bearing. It is sterilized using ethylene oxide (EO) and sized to fit in the palm of the hand or to secure to the patient.

The LifeSPARC Controller provides the interface between pump and user, as well as the power and electrical signals to drive the pump. It is a microprocessor-based electromechanical pump drive system designed to operate on standard AC current (100/240 VAC, 50/60 Hz) or on internal, rechargeable batteries for intra-hospital transport.

The provided text describes a 510(k) premarket notification for the LifeSPARC System, which is a nonroller-type blood pump used for cardiopulmonary bypass. The submission is a software update to an already cleared device, and thus the focus is on testing related to software and electromagnetic compatibility.

Here's an analysis of the requested information based on the provided text:

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

The document does not explicitly state numerical acceptance criteria or specific reported device performance metrics in a table format. It generally states that "Testing of the LifeSPARC Controller demonstrates that no concerns regarding safety and effectiveness result from the changes and updates to the technology; specifically, test data is provided regarding Software and Electromagnetic Compatibility." This implies the device met the necessary standards for these aspects.

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 provide details on the sample size used for the test set or the data provenance. It only mentions "test data is provided regarding Software and Electromagnetic Compatibility" implying a test set was used but without specifying its characteristics.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

This information is not provided in the document. Software and electromagnetic compatibility testing typically rely on engineering specifications and compliance standards rather than expert medical consensus for ground truth.

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

This information is not provided in the document. Given the nature of the testing (software and EMC), an adjudication method in the medical context (like for image interpretation) would not be applicable.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

A multi-reader multi-case (MRMC) comparative effectiveness study was not done. This type of study is relevant for AI systems that assist human readers in tasks like image interpretation, which is not the function of the LifeSPARC System. This submission is for a software update to a mechanical blood pump, focusing on its safe and effective operation, not its diagnostic or interpretative capabilities.

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

The document implies that standalone testing was performed for the software and electromagnetic compatibility aspects of the device. The "Testing of the LifeSPARC Controller demonstrates that no concerns..." suggests the algorithm's performance was evaluated independently against predefined criteria.

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

For software testing, the ground truth would typically be the expected functional behavior and performance defined by engineering specifications and industry standards for medical device software. For Electromagnetic Compatibility, the ground truth is compliance with relevant EMC standards (e.g., IEC 60601-1-2).

8. The sample size for the training set

The document does not mention a "training set" because this is not an AI/ML-driven device in the context of learning from data. The software update is likely a deterministic program, not a model trained on a dataset.

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

As there is no mention of a training set for an AI/ML model, this question is not applicable to the information provided. The ground truth for the device's functionality would be established through its design specifications and validated through testing.

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The LifeSPARC System is a centrifygal blood pump system intended to assist in circulation of the patient's blood when part of an extracorporeal circuit including physiologic gas exchange of the patient's blood in adult patients with acute respiratory failure or acute cardiopulmonary failure, where other available treatment options have failed, and continued clinical deterioration is expected or the risk of death is imminent. These may include:

• Failure to wean from cardiopulmonary bypass following cardiac surgery in adult patients
• ECMO-assisted cardiopulmonary resuscitation in adults

The LifeSPARC Pump is a sterile, single-use, low prime volume centrifugal pump with an integrated motor and a single-point, pivot bearing. It is sterilized using ethylene oxide (EO) and sized to fit in the palm of the hand or to secure to the patient.

The LifeSPARC Controller provides the interface between pump and user, as well as the power and electrical signals to drive the pump. It is a microprocessor-based electromechanical pump drive system designed to operate on standard AC current (100/240 VAC, 50/60 Hz) or on internal, rechargeable batteries for intra-hospital transport.

The provided text describes the LifeSPARC System, an extracorporeal blood pump system, and its substantial equivalence determination by the FDA. The submission focuses heavily on non-clinical testing and an animal study, with a clinical evaluation based on retrospective registry data.

Here's an analysis of the acceptance criteria and the study that proves the device meets them, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria are derived from the "Special Controls" outlined by the FDA. The "reported device performance" is summarized from the "Summary of Non-clinical Testing," "Animal Study," and "Clinical Evaluation" sections.

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

Animal Study (In vivo evaluation):

• Test Set Sample Size: 9 calves were supported with the LifeSPARC System. A control group of 5 calves were supported with the TandemHeart Pump.
• Data Provenance: Prospective animal study (bovine model, presumably conducted in a controlled laboratory setting). The specific country of origin is not stated but is implied by the US FDA submission process.

Clinical Evaluation:

• Test Set Sample Size: The text states, "The study is an enumerative study where all available ECMO data collected in the ELSO registry database that met the study criteria were analyzed." The exact number of patients for the LifeSPARC Pump group and the comparator group(s) is not explicitly stated in the provided text. However, it's inferred to be a large dataset given it's from the ELSO Registry.
• Data Provenance: Retrospective observational data from the Extracorporeal Life Support Organization (ELSO) Registry. The ELSO Registry is an international registry, so the data provenance would likely be multi-national, although this is not explicitly stated. The data was "observational data in a real-world setting."

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

Animal Study:

• The text describes "close monitoring of the systems identified early problems allowing repairs or pump exchange before becoming clinically significant." This implies veterinary or medical expertise for monitoring and assessing animal health.
• The assessment of "clinically significant thromboembolic or bleeding complications, vascular or myocardial injuries, adherent thrombus, or end organ damage" would typically fall under the purview of veterinary pathologists and clinicians.
• Number of experts and qualifications: Not specified.

Clinical Evaluation:

• The ground truth for the clinical outcomes (e.g., pump failure, hemolysis, thrombosis, death) would have been established by the clinicians and medical professionals managing the patients and inputting data into the ELSO Registry. The ELSO statistical group performed the analysis.
• Number of experts and qualifications: Not specified. The ELSO statistical group is mentioned for analysis ("independent statistical analysis," "propensity score analysis was performed by the ELSO group"), but not for establishing the initial ground truth.

4. Adjudication method for the test set

Animal Study:

• The text indicates "close monitoring" and "identified early problems allowing repairs or pump exchange." This suggests continuous assessment by the study team. However, a formal adjudication method for adverse events or outcomes (e.g., blinded review by a panel) is not described.

Clinical Evaluation:

• The clinical evaluation is based on existing data from the ELSO Registry. The ground truth (patient outcomes) would have already been established by the reporting institutions.
• A formal adjudication method for the test set outcomes, beyond the standard data collection and reporting mechanisms of the ELSO Registry, is not described. The analysis by the ELSO statistical group is a statistical comparison, not an adjudication process.

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

• No, an MRMC comparative effectiveness study was not done.
• The device is an extracorporeal blood pump system, not an AI-assisted diagnostic or interpretative device that involves "human readers" or "AI assistance" in the sense of image interpretation or similar tasks.
• The clinical evaluation was a comparison of the device's performance against other similar devices (other centrifugal pumps, including a predicate) using retrospective registry data, not a human-in-the-loop study.

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

• No, this concept is not directly applicable to the LifeSPARC System. This device is a mechanical pump, not an algorithm. Its performance is inherent to its physical operation and interaction with the patient's blood, not an independent algorithmic output. The "standalone" performance is its performance in the animal study and its outcomes as observed in the clinical registry data.

7. The type of ground truth used

Animal Study:

• Clinical observation and physiological measurements from the calves during the 14-day support period.
• Post-mortem analysis for "adherent thrombus, or end organ damage."

Clinical Evaluation:

• Outcomes data / Real-world patient data from the ELSO Registry. This includes clinically recorded events like "pump failure, hemolysis, thrombosis or clots in circuit component, patient death within 24 hours of stopping ECMO, and patient death at discharge," as well as "use of renal replacement therapy (RRT during ECMO, pulmonary hemorrhage, circuit change, central nervous system (CNS) hemorrhage, and CNS infarction." This data is based on reporting by treating clinicians.

8. The sample size for the training set

• The provided text relates to regulatory submission for a medical device (an extracorporeal blood pump system), not a machine learning model. Therefore, the concept of a "training set" in the context of AI/ML is not applicable.
• If interpreted as "data used to inform the device's design or prior evaluations," the text references a "currently-cleared devices" and "reference devices" (TandemHeart System, LifeSPARC System K183623), implying previous testing and clinical experience would have contributed to the device's development, but no specific "training set" size for this purpose is given.

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

• As the concept of a "training set" is not applicable in this context (not an AI/ML device), this question is moot.

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