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The Quantum Perfusion Hybrid System is intended to collect, defoam and filter venous and suction blood during cardiopulmonary bypass. The device is intended to be used for periods up to six hours. The device is intended for adult patients.

The Quantum Perfusion Hybrid System is a system, including a blood reservoir consisting of an hardshell and softshell reservoir. The combination of defoaming bodies and filtering media of venous/vent and cardiotomy side allows both the filtration of debris and the retention of air bubbles. Product configuration includes, together with the Hybrid System, dedicated spare parts: an adapter 1/2" – 3/8"; a spare cap set; a blood sampling set. The device is intended to be used for periods up to six hours. The Quantum Perfusion Hybrid System is a sterile device with non-pyrogenic fluid pathways, sterilized by ethylene oxide, conceived for single use only and is not to be re-sterilized by the user; the device has a declared shelf life of 2 years.

The provided text is a 510(k) summary for a medical device (Quantum Perfusion Hybrid System) and primarily focuses on proving substantial equivalence to predicate devices through non-clinical testing. It does not contain information about a study proving device performance against specific acceptance criteria for an AI/software-driven device.

Therefore, I cannot provide the requested information, as the document details a traditional medical device submission, not one related to an AI/ML component with associated performance studies (MRMC, standalone algorithm, ground truth establishment, etc.). The document explicitly states: "No clinical data have been included in the current 510(k) submission to support substantial equivalence to legally marketed predicate and reference devices." and "No animal studies have been performed except for mandatory biocompatibility tests...".

The non-clinical testing mentioned is focused on general device performance for a cardiopulmonary bypass blood reservoir, such as pressure drop, mechanical resistance, air handling, and filtration efficiency, verifying it meets established engineering requirements for this type of device, which are inherent to the device's design and function rather than a set of statistical acceptance criteria that would typically be associated with an AI/ML algorithm's performance.

To answer your request, a document detailing an AI/ML device would be needed, specifically discussing its performance study, acceptance criteria, test set details, ground truth, and potentially MRMC study results.

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The Affinity Fusion oxygenator with integrated arterial filter and Cortiva bioactive surface is intended to be used in an extracorporeal perfusion circuit to oxygenate and remove carbon dioxide from the blood and to cool or warm the blood during routine cardiopulmonary bypass (CPB) procedures up to 6 hours in duration. The Affinity Fusion oxygenator with integrated arterial filter and Cortiva bioactive surface is designed to filter from the circuit microemboli larger than the specified micron size for periods up to 6 hours during CPB surgery.

The Affinity Fusion cardiotomy/venous reservoir with Balance biosurface is intended to be used in an extracorporeal perfusion circuit to collect venous and cardiotomy suctioned blood during routine cardiopulmonary procedures up to 6 hours in duration. The CVR is also intended for use during vacuum-assisted venous drainage (VAVD) procedures. The Affinity Fusion cardiotomy/venous reservoir with Balance biosurface is also intended for use after open heart surgery to collect autologous blood from the chest and to aseptically return the blood to the patient for blood volume replacement.

The Affinity Fusion Oxygenator with Integrated Arterial Filter and Balance Biosurface is intended to be used in an extracorporeal perfusion circuit to oxygenate and remove carbon dioxide from the blood and to cool or warm the blood during routine cardiopulmonary bypass procedures up to 6 hours in duration. The Affinity Fusion Oxygenator with Integrated Arterial Filter and Balance Biosurface is designed to filter from the circuit microemboli larger than the specified micron size for periods up to six hours during cardiopulmonary bypass surgery.

The Affinity Fusion Cardiotomy/Venous Reservoir with Balance Biosurface is intended to be used in an extracorporeal perfusion circuit to collect venous and cardiotomy suctioned blood during routine cardiopulmonary procedures up to 6 hours in duration. The CVR is also intended for use during vacuum assisted venous drainage (VAVD) procedures. The Affinity Fusion Cardiotomy/Venous Reservoir with Balance Biosurface is also intended for use after open heart surgery to collect autologous blood from the chest and to aseptically return the blood to the patient for blood volume replacement.

The Affinity Pixie hollow fiber oxygenator with Cortiva bioactive surface are indicated for use for neonate, infant, and small pediatric patients undergoing cardiopulmonary bypass (CPB) procedures requiring a blood flow rate up to 2.0 L/min. The Affinity Pixie hollow fiber oxygenator is intended to be used in an extracorporeal perfusion circuit to oxygenate and remove carbon dioxide from the blood and to cool or warm the blood during routine CPB procedures up to 6 hours in duration.

The Affinity Pixie hollow fiber oxygenator and cardiotomy/venous reservoir with Cortiva bioactive surface are indicated for use for neonate, infant, and small pediatric patients undergoing cardiopulmonary bypass (CPB) procedures requiring a blood flow rate up to 2.0 L/min. The Affinity Pixie hollow fiber oxygenator is intended to be used in an extracorporeal perfusion circuit to oxygenate and remove carbon dioxide from the blood and to cool or warm the blood during routine CPB procedures up to 6 hours in duration. The Affinity Pixie cardiotomy/venous reservoir is intended to be used in an extracorporeal perfusion circuit to collect venous and cardiotomy suctioned blood during routine cardiopulmonary procedures up to 6 hours in duration. The CVR is also intended for use during vacuum-assisted venous drainage (VAVD) procedures.

The Affinity Pixie Hollow Fiber Oxygenator with Balance Biosurface are indicated for use for neonate, infant, and small pediatric patients undergoing cardiopulmonary bypass procedures requiring a blood flow rate up to 2.0 L/min. The Affinity Pixie Hollow Fiber Oxygenator is intended to be used in an extracorporeal perfusion circuit to oxygenate and remove carbon dioxide from the blood and to cool or warm the blood during routine cardiopulmonary bypass procedures up to 6 hours in duration.

The Affinity Pixie Hollow Fiber Oxygenator and Cardiotomy/Venous Reservoir with Balance Biosurface are indicated for use for neonate, infant, and small pediatric patients undergoing cardiopulmonary bypass procedures requiring a blood flow rate up to 2.0 L/ min. The Affinity Pixie Hollow Fiber Oxygenator is intended to be used in an extracorporeal perfusion circuit to oxygenate and remove carbon dioxide from the blood and to cool or warm the blood during routine cardiopulmonary bypass procedures up to 6 hours in duration. The Affinity Pixie Cardiotomy/Venous Reservoir is intended to be used in an extracorporeal perfusion circuit to collect venous and cardiotomy suctioned blood during routine cardiopulmonary procedures up to 6 hours in duration. The CVR is also intended for use during vacuum assisted venous drainage (VAVD) procedures.

The Affinity Fusion Oxygenator is intended to be used in an extracorporeal perfusion blood circuit to oxygenate and remove carbon dioxide from the blood and to cool or warm the blood during routine cardiopulmonary bypass procedures up to 6 hours in duration. The Affinity Fusion Oxygenator contains both an integrated arterial filter and integrated heat exchanger. The Affinity Fusion Oxygenator is a microporous, hollow-fiber, gas-exchange devices available with Cortiva BioActive Surface or Balance Biosurface bonded to the blood contacting surface of the device. The integrated arterial filter is designed to filter from the circuit microemboli larger than the specified micron size from the circuit for periods up to six hours during cardiopulmonary bypass surgery. Some models of the Affinity Fusion Oxygenator are packaged with an Affinity Fusion Cardiotomy/Venous Reservoir (CVR) with Balance Biosurface which is designed to be an integral part of a cardiopulmonary bypass circuit for use during cardiac surgery. The Affinity Fusion CVR is designed to collect venous and cardiotomy suctioned blood during routine cardiopulmonary procedures up to six (6) hours in duration. Additionally, the Affinity Fusion CVR may be used during vacuum assisted venous drainage (VAVD) procedures and collect autologous blood from the chest and to aseptically return the blood to the patient for blood volume replacement during open heart surgery.

The Affinity Pixie Oxygenator is intended to be used in an extracorporeal perfusion blood circuit to oxygenate and remove carbon dioxide from the blood and to cool or warm the blood during routine cardiopulmonary bypass (CPB) procedures up to 6 hours in duration. The Affinity Pixie hollow fiber oxygenator is a single-use, microporous, hollow-fiber, gas exchange device with plasma-resistant fiber and integrated heat exchanger. The primary blood-contacting surfaces of the oxygenator are coated with either Balance Biosurface or Cortiva BioActive Surface. Some models are packaged with an Affinity Pixie Cardiotomy/Venous Reservoir (CVR) which are designed to be an integral part of a cardiopulmonary bypass circuit for use during cardiac surgery. The Pixie CVR associated with the Balance or Cortiva coated Oxygenators are also Balance or Cortiva coated respectively. The Affinity Pixie CVR is designed to collect venous and cardiotomy suctioned blood during routine cardiopulmonary procedures up to six (6) hours in duration. Additionally, the Affinity Pixie CVR may be used during vacuum assisted venous drainage (VAVD) procedures. All are provided sterile, nonpyrogenic, and for single use.

I am sorry, but the provided text does not contain information about acceptance criteria or a study proving device performance in the context of an AI/ML device. The document is a 510(k) premarket notification for a medical device (cardiopulmonary bypass oxygenators) and focuses on the device description, indications for use, and comparison to predicate devices, primarily regarding a material modification. It discusses the device's function (oxygenation, CO2 removal, temperature control, filtering emboli, blood collection) but does not include any performance metrics for AI or ML algorithms, sample sizes for test sets, expert ground truth adjudication, or comparative effectiveness studies involving AI. Therefore, I cannot generate the requested information based on the given input.

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