(116 days)
The Affinity Fusion™ Oxygenator with Integrated Arterial Filter with 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 (CPB) procedures up to 6 hours in duration. The Affinity Fusion™ Oxygenator with Integrated Arterial Filter with Balance™ Biosurface 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 volume replacement.
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 NT™ 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 (CPB) procedures up to 6 hours in duration.
The Affinity® NT Hollow Fiber Oxygenator with Plasma Resistant Fiber (PRF) with Trillium™ 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® NT Integrated CVR/Membrane Oxygenator with Plasma Resistant Fiber is intended to be used in an extracorporeal perfusion circuit to collect venous and cardiotomy suctioned blood, cool or warm the blood and oxygenate and remove carbon dioxide from the blood during routine cardiopulmonary bypass procedures up to 6 hours in duration.
The Affinity NT® Integrated CVR/Membrane Oxygenator with Trillium® Biosurface (Plasma Resistant Fiber [PRF] Oxygenator with Trillium Biosurface) is intended to be used in an extracorporeal perfusion circuit to collect venous and cardiotomy suctioned blood, cool or warm the blood and oxygenate and remove carbon dioxide from the blood during routine cardiopulmonary bypass procedures up to 6 hours in duration.
The Affinity® NT Integrated Trillium™ CVR/Membrane Oxygenator (Plasma Resistant Fiber [PRF] Oxygenator with Trillium™ Biosurface) is intended to be used in an extracorporeal perfusion circuit to collect venous and cardiotomy suctioned blood, cool or warm the blood and oxygenate and remove carbon dioxide from the blood during routine cardiopulmonary bypass procedures up to 6 hours in duration.
The Affinity NT™ Oxygenator with 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 NT™ Integrated Uncoated CVR/Oxygenator with Cortiva™ BioActive Surface is intended to be used in an extracorporeal perfusion circuit to collect venous and cardiotomy suctioned blood, cool or warm the blood and oxygenate and remove carbon dioxide from the blood during routine cardiopulmonary bypass (CPB) procedures up to 6 hours in duration.
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The provided document is an FDA 510(k) clearance letter for various models of Affinity™ Oxygenators and related devices. It specifies the indications for use for each device. However, this document does not contain any information regarding acceptance criteria, study designs (e.g., sample sizes, human expert involvement, ground truth establishment, or multi-reader multi-case studies) or performance metrics for AI/ML-driven devices.
The devices listed are traditional medical devices used in cardiopulmonary bypass procedures, such as oxygenators and cardiotomy/venous reservoirs. There is no mention of any AI or machine learning components associated with these devices. Therefore, I cannot extract the information required to answer your prompt about acceptance criteria and studies proving an AI device meets those criteria.
To answer your prompt, I would need a document describing the validation study of an AI/ML-driven medical device.
§ 870.4350 Cardiopulmonary bypass oxygenator.
(a)
Identification. A cardiopulmonary bypass oxygenator is a device used to exchange gases between blood and a gaseous environment to satisfy the gas exchange needs of a patient during open-heart surgery.(b)
Classification. Class II (special controls). The special control for this device is the FDA guidance document entitled “Guidance for Cardiopulmonary Bypass Oxygenators 510(k) Submissions.”