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The Quantum Centrifugal Drive is a cardiopulmonary bypass speed control device indicated for use for exclusively with the Quantum PureFlow Centrifugal Blood Pump for speedcontrolled pumping through the extracorporeal circuit for typical durations of six hours or less.

The Quantum Centrifugal Drive is a cardiopulmonary speed control device intended to be used for pumping arterial blood through the cardiopulmonary bypass circuit. The Quantum Centrifugal Drive is available in two models - High Pressure and Low Pressure.

The Quantum Centrifugal Drive is designed to work with the Quantum Pump Manager software application, as part of the Quantum Pump Console (K173834). The Quantum Centrifugal Drive is magnetically coupled exclusively with Quantum Pureflow Centrifugal Blood Pumps, designed and manufactured by Qura s.r.l. The operation of the Quantum Centrifugal Drive is managed from the Quantum Workstation (K163657).

The provided document, an FDA 510(k) summary for the Quantum Centrifugal Drive, focuses on establishing substantial equivalence to a predicate device rather than presenting a performance study with detailed acceptance criteria for an AI/device's diagnostic or predictive capabilities.

Therefore, the document does not contain the information requested regarding:

1. A table of acceptance criteria and reported device performance related to diagnostic accuracy.
2. Sample sizes and data provenance for a test set.
3. Number and qualifications of experts for ground truth establishment.
4. Adjudication methods for a test set.
5. MRMC comparative effectiveness study results.
6. Standalone algorithm performance.
7. Type of ground truth used (e.g., pathology, outcomes data).
8. Sample size for the training set.
9. How ground truth for the training set was established.

The document states:

• "No animal testing was submitted to support the substantial equivalence of the Quantum Centrifugal Drive to the Sorin/LivaNova Stöckert Centrifugal Pump."
• "The following non-clinical testing was performed to support the substantial equivalence of the Quantum Centrifugal Drive to the legally marketed predicate:
  • Electrical safety
  • Electromagnetic compatibility (EMC)
  • Electrosurgery interference
  • Hardware testing
  • Software verification and validation"
• "No clinical data were submitted to support the substantial equivalence of the Quantum Centrifugal Drive to the Sorin/LivaNova Stöckert Centrifugal Pump."

This indicates that the substantial equivalence was primarily based on non-clinical engineering and software validation tests (electrical safety, EMC, electrosurgery interference, hardware, and software V&V) rather than a study evaluating diagnostic performance parameters against ground truth established by experts or other clinical gold standards. The device is a "Cardiopulmonary bypass pump speed control," which is a mechanical device, not typically a diagnostic AI tool that would involve ground truth derived from expert consensus or pathological findings.

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