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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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