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510(k) Data Aggregation
(29 days)
The intended use of the Quantum Workstation 12" Elite is for the non-invasive continuous monitoring of oxygen saturation and hematocrit / hemoglobin concentration of the blood and in an extracorporeal circuit. When using its range of accessories, the Quantum Workstation 12" Elite is configured to measure and display the following measurements:
- · SaO2 Arterial Saturation (%)
- · SvO2 Venous Saturation (%)
- · Hb Hemoglobin (g/L and gm/dl)
- · Hct Calculated Hematocrit (%)
- · Blood Flow 2 channels with arterial and venous flow differentials
- · Pressure & Temperature 4 channels
The Quantum Workstation 12" Elite provides monitoring information to trained clinicians and can be configured by them to set parameter specific alarms.
The workstation's monitoring and alarm functionality does not directly control patient care. The User makes clinical iudgments regarding the treatment of the patient as a result of information displayed by the workstation.
The Quantum Workstation 12" Elite is an on-line, cardiopulmonary bypass, blood gas monitor that is used for extracorporeal monitoring of blood oxygen (arterial and venous) saturation, hematocrit, and hemoglobin levels. The device's enhanced functionality includes the ability to control centrifugal or roller pumps and make blood flow, blood pressure and blood temperature measurements.
The Quantum Workstation 12" Elite consists of a pole-mounted 12.1" landscape high definition touch screen. The touch screen displays individual and trend readings with alarm settings. The Quantum Workstation 12" Elite provides memory storage via an SD (Secure Digital) card. The Quantum Workstation 12" Elite is powered from the AC Mains supply and incorporates a battery backup that automatically switches on in the event of an interruption to the mains power supply. The battery backup is provided via two (2) lithium-ion batteries with a two-hour minimum life.
The Quantum Workstation 12" Elite includes the following ports / connections:
- One (1) sensor port for the Hb / SO2 sensor
- Two (2) sensor ports for blood flow ●
- Two (2) sensor ports for blood pressure/temperature
- One (1) LAN / Ethernet port ●
- Two (2) USB 2.0 ports ●
- Three (3) Spectrum Medical ports
- One (1) User Serial Port
Accessories for the Quantum Workstation 12" Elite include the power supply, mounting arm (long or short), Hb / SQ2 sensor, flow sensors and pressure/temperature sensors.
I am sorry; this document does not contain the information you are looking for. None of the pages reference acceptance criteria or study data demonstrating that the device meets these criteria.
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(193 days)
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:
- A table of acceptance criteria and reported device performance related to diagnostic accuracy.
- Sample sizes and data provenance for a test set.
- Number and qualifications of experts for ground truth establishment.
- Adjudication methods for a test set.
- MRMC comparative effectiveness study results.
- Standalone algorithm performance.
- Type of ground truth used (e.g., pathology, outcomes data).
- Sample size for the training set.
- 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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(102 days)
The Quantum Smart Occluder is indicated for use as an accessory with the Quantum Pump Console for up to 6 hours in the extracorporeal circulation of blood for cardiopulmonary bypass procedures, when used by a qualified medical professional who is experienced in the operation of this or similar equipment.
The Quantum Smart Occluder is a clamping system for the occlusion of both arterial and venous blood lines. The Quantum Smart Occluder is designed to work with the Quantum Pump Manager software application, as part of the Quantum Pump Console (K173834). The operation of the Quantum Smart Occluder is managed from the Quantum Workstation (K163657).
The Quantum Smart Occluder has the availability for 5 sensor attachments:
- . 2 Flow Sensors
- 2 Pressure Sensors
- 1 Level Sensor .
These sensors are identical with the use of the same sensor PCB boards previously cleared with the Quantum Diagnostic Module (K173591) and Quantum Ventilation Module (K181942). These sensor connections can be used in conjunction with the sensor connections used on the Quantum Diagnostic Module (K173591) or Quantum Ventilation Module (K181942) to provide additional readings. Or used solely on the Quantum Smart Occluder to reduce the amount of cabling that is attached to the Quantum Pump Console (K173834).
This document is a 510(k) summary for the Quantum Smart Occluder. It describes a medical device, its intended use, and compares it to predicate devices to establish substantial equivalence. The document does not contain information related to specific acceptance criteria or a study proving that the device meets those criteria, particularly in the context of an AI/ML device.
The Quantum Smart Occluder is a mechanical device (an electronic tube clamp) that is an accessory to a cardiopulmonary bypass system. The performance data mentioned relates to non-clinical testing of electrical safety, EMC, electrosurgery interference, hardware, and software verification/validation. This is standard for a non-AI/ML medical device.
Therefore, I cannot provide the requested information from this document. The questions you've asked are typically relevant for AI/ML-driven devices where performance is measured against clinical ground truth and involves statistical analysis of algorithm output. This document describes a traditional medical device submission.
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