(88 days)
The Medtronic Resting Heart System is intended for use in surgical procedures requiring extracorporeal gas exchange, circulatory support, and thermal regulation. This device is indicated for use in procedures requiring blood flow rate of 1 to 6 liters/min and lasting up to six hours. The system is indicated for use only with the Bio-Console.
The Medtronic Resting Heart System is a low prime volume alternative to existing Cardiopulmonary Bypass (CPB) perfusion circuit. The system is used for patient support during cardiopulmonary procedures lasting up to 6 hours. The System consists of the Medtronic Resting Heart System Controller for Active Air Removal and the Medtronic Resting Heart Disposable Module. The venous return portion of the CPB circuit is connected to a Venous Air Removal Device (VARD) that is equipped with an automated air removal system connected to the vent port on the device. The VARD is an AFFINITY Arterial Filter (38 micron) moved to the venous side of the circuit and equipped with ultrasonic crystals that sense the liquid level in the filter. The VARD replaces the Affinity Cardiotomy Venous Reservoir (CVR) or the Affinity Venous Reservoir Bag (VRB) that is normally used to remove air from the venous blood entering the CPB circuit.
The provided text is a 510(k) summary for the Medtronic Resting Heart System, a medical device used in cardiopulmonary bypass surgery. It describes the device, its intended use, and compares it to predicate devices to establish substantial equivalence.
However, the document does not contain information related to specific acceptance criteria as quantitative performance metrics (e.g., sensitivity, specificity, accuracy, or specific physiological parameters with thresholds) for an AI/algorithm-driven device, nor does it describe a study in the context of evaluating such an algorithm's performance against ground truth.
Instead, the performance data mentioned refers to engineering and physiological performance of the hardware components of the system (e.g., "Air Handling capabilities, blood trauma, pressure drops") and "Software Verification and Validation" for the Active Air Removal Controller. This type of documentation is typical for hardware devices and their embedded software, rather than for advanced AI/ML algorithms requiring extensive clinical validation against a gold standard for diagnostic or predictive accuracy.
Therefore, I cannot populate the table or answer most of the questions as the requested information (related to AI/algorithm performance, ground truth, expert consensus, sample sizes for test/training sets in an AI context, etc.) is not present in the provided text.
Based on the nature of the device (Cardiopulmonary Bypass System) and the time of the submission (2003), it's highly unlikely that it involved an AI-driven component as understood in the context of the questions asked. The "Active Air Removal Controller" likely refers to a rule-based or control-system algorithm embedded in the device, not a machine learning model.
If you can provide a document that specifically details the validation of an AI/ML algorithm within a medical device, I would be happy to help.
§ 870.4400 Cardiopulmonary bypass blood reservoir.
(a)
Identification. A cardiopulmonary bypass blood reservoir is a device used in conjunction with short-term extracorporeal circulation devices to hold a reserve supply of blood in the bypass circulation.(b)
Classification. Class II (special controls), except that a reservoir that contains a defoamer or filter is classified into the same class as the defoamer or filter. The device, when it is a cardiopulmonary bypass blood reservoir that does not contain defoamers or blood filters, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 870.9.