Search Results

The preCARDIA device is intended for use in selectively stopping or controlling blood flow of the inferior and superior vena cava in applications including perioperative procedures in patients requiring emergency control of hemorrhage, and for blood pressure monitoring.

The preCARDIA System is for use in selectively stopping or controlling blood flow of the inferior and superior vena cava, in applications including perioperative procedures in patients requiring emergency control of hemorrhage, and for blood pressure monitoring. The System includes a Balloon Occlusion Catheter (Catheter), Controller and Console. The Catheter has an atraumatic endovascular balloon that has been attached to the proximal portion of a commercially available Thermodilution (TD) Catheter. The single use, 110 cm disposable catheter comes in two balloon locations, 34 and 36 cm measured from the distal end of the catheter and is provided sterile. The catheter placement procedure is performed under fluoroscopy by clinicians trained in endovascular techniques. The balloon includes proximal and distal radiopaque markers to allow for visualization and confirmation of proper placement in the IVC or SVC. Following placement and securement of the catheter, the patient can be transferred to the operating room or other appropriate care location where selectively stopping or controlling blood flow in the SVC or IVC will continue alongside other standard of care treatments. The primary operating principle of the preCARDIA System is the selective stopping or controlling of the blood flow in the IVC or SVC through either sustained inflation or successive inflation and deflation cycles of the balloon as regulated by the Controller.

The provided text is a 510(k) summary for the preCARDIA Occlusion System. It details the device, its intended use, and a comparison with predicate devices. While it lists various performance tests conducted, it does not contain specific acceptance criteria or the reported device performance for an AI/ML-based device.

The document outlines bench testing and an animal study to evaluate the performance of the preCARDIA Catheter. However, it does not provide:

• A table of acceptance criteria and reported device performance.
• Sample sizes for a test set or data provenance for an AI/ML context.
• Information on expert ground truth establishment (number of experts, qualifications, adjudication method).
• Details on MRMC studies or a standalone algorithm performance.
• The type of ground truth used relevant to AI/ML (e.g., pathology, outcomes data).
• Sample size for a training set or how ground truth was established for AI/ML training data.

The text is for a physical medical device (vascular clamp/occlusion system), not an AI/ML algorithm. Therefore, the concepts requested in the prompt, such as "acceptance criteria for an AI/ML model," "training set," "test set," "ground truth," "expert consensus," and "MRMC study," are not applicable to the content provided.

Based on the provided document, I cannot fulfill the request as it pertains to AI/ML device validation. The document describes the regulatory submission for a physical medical device and its associated non-AI/ML performance testing.

Ask a specific question about this device