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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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