Search Results

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.

Ask a specific question about this device

The Quantum Diagnostic Module is intended for the continuous monitoring of critical clinical parameters during procedures that require extracorporeal circulation. The Quantum Diagnostic Module is an accessory that only works with the Quantum Workstation. Parameters provided by the Quantum Diagnostic Module include:

• · Measurement of up to three blood flow channels and arterial and venous flow differential
• · Indication of gas bubbles
• · Extracorporeal gas flow measurements (02, CO2, gas flow, and CO2 removal)
• · Predicted PO2 and PCO2
• · Temperature
• · Up to three circuit pressure channels
• · Reservoir level indication

The Quantum Diagnostic Module is to only be used by an experienced and trained clinician. The device is not intended to be used by the patient or other untrained personnel.

The Quantum Diagnostic Module is an accessory to the Quantum Workstation that provides continuous non-invasive monitoring of critical clinical parameters during procedures requiring extracorporeal circulation. The Quantum Diagnostic Module is connected to the Quantum Workstation via a cable and positioned between the gas blender and the oxygenator devices in the extracorporeal circuit. When paired with the Quantum Workstation, the combination of the Quantum Workstation and Quantum Diagnostic Module is known as the Quantum Diagnostic System.

The Quantum Diagnostic Module performs three functions:

• 1. Provides measurements from embedded and attached sensors to monitor gases into and out of a blood oxygenator.
• 2. Provides measurements from attached sensors for blood flow, bubble detection, pressure, level and temperature to monitor an extracorporeal blood loop.
• 3. Sends these physiological measurements to the Quantum Workstation for display to the user.

The Quantum Diagnostic Module, with its attached sensors, can measure flow, pressure, reservoir level, temperature and gas diagnostics. The Quantum Diagnostic Module only works with the Quantum Workstation.

The provided text is a 510(k) premarket notification summary for a medical device called the Quantum Diagnostic Module. This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than proving a device meets specific acceptance criteria through a comprehensive clinical study as one might expect for a new, novel device.

Therefore, the document does not contain the detailed information required to answer all parts of your request in the format provided, particularly regarding a multi-reader multi-case study, standalone algorithm performance, or extensive ground truth establishment as would be present for an AI/ML device.

However, I can extract the relevant information regarding performance data and the non-clinical testing performed to support substantial equivalence.

Here's a breakdown of what is and isn't available in the document:

1. Table of acceptance criteria and reported device performance:

The document mentions "In vitro evaluation testing (comparison testing)" as non-clinical testing. While this implies performance was assessed, specific acceptance criteria and detailed reported performance metrics (like accuracy, sensitivity, specificity, etc.) are not explicitly listed in a table within this 510(k) summary. The summary states that the Quantum Diagnostic Module and the predicate M4 Monitor have "equivalent sensor performance" and that the "principles of operation of its sensors are identical or equivalent." This suggests a comparative approach rather than meeting predefined numerical thresholds.

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

The document mentions "In vitro evaluation testing (comparison testing)" but does not specify the sample size used for this test set nor the data provenance (e.g., country of origin, retrospective/prospective).
It also states: "No animal testing was submitted to support the substantial equivalence of the Quantum Diagnostic Module to the M4 Monitor."

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

This information is not provided in the document. The nature of the device (a monitor for physical parameters) suggests that ground truth would likely be established through calibrated reference instruments rather than expert human interpretation.

4. Adjudication method for the test set:

This information is not provided in the document.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, and its effect size:

No MRMC study was done or reported. This type of study is typically for image-based diagnostic AI, which this device is not. The document specifically states: "No clinical data were submitted to support the substantial equivalence of the Quantum Diagnostic Module to the M4 Monitor."

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

The device is a monitor that displays physiological measurements to a user. While it generates data, the concept of "standalone algorithm performance" as typically applied to AI/ML is not directly relevant or discussed in this context. The document mentions "Software verification and validation," which would include testing the algorithms within the device, but not in a "standalone" AI sense.

7. The type of ground truth used:

Given the nature of the device (monitoring blood flow, gas, temperature, pressure, reservoir level), the ground truth for "in vitro evaluation testing" would likely be established using calibrated reference instruments or standardized test methods known to provide highly accurate measurements of these physical parameters. Explicit details are not provided.

8. The sample size for the training set:

This information is not provided. The device is a monitor, not an AI/ML model that undergoes a training phase with a dataset.

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

This information is not provided, as the concept of a "training set" in the AI/ML sense does not apply to this device.

Summary of Device Performance (Extracted from the document):

The regulatory submission for the Quantum Diagnostic Module argues for substantial equivalence to the predicate device (Spectrum Medical Ltd's M4 Monitor, K110957) based on several factors, including:

• Identical/Equivalent Principles of Operation: "the principles of operation of its sensors are identical or equivalent to those of the M4 Monitor."
• Equivalent Sensor Performance: "Spectrum Medical Ltd's M4 Monitor and Quantum Diagnostic Module have the same manufacturer, clinical application, clinical setting, target patient population, and equivalent sensor performance."
• Non-Clinical Testing:
  • Electrical safety
  • Electromagnetic compatibility (EMC)
  • Electrosurgery interference
  • Hardware testing of printed circuit boards
  • Software verification and validation
  • In vitro evaluation testing (comparison testing)
  • Usability validation

The document concludes that "Based on the indications for use, technological characteristics, results of non-clinical testing, and comparison to predicate devices, the Quantum Diagnostic Module has been shown to be substantially equivalent to legally marketed predicate devices."

In essence, the "study" proving the device meets acceptance criteria in this context is the collection of non-clinical tests demonstrating that the Quantum Diagnostic Module performs equivalently to its predicate and meets safety/performance standards, rather than a clinical trial with specific performance metrics against a defined ground truth for complex diagnostic tasks.

Ask a specific question about this device