(120 days)
The Portaclamp® Flex is indicated to clamp the aorta during minimally invasive cardiac surgery implying the usage of an extra-corporeal circulation.
The Portaclamp® Flex is an aortic clamping device composed of a detachable, reusable handle and a single-use, disposable clamp. It is designed to be used through a standard thoracic port to clamp the aorta during minimally invasive cardiac bypass procedures. The Portaclamp Flex consists of a flexible guide wire, two jaws that are passed over the guide wire and positioned on each side of the aorta, and a mandrel that is slid along the length of the jaws to compress the jaws and clamp the aorta.
The provided text is a 510(k) summary for the Portaclamp® Flex, a vascular clamp. However, it does not contain information on acceptance criteria, a specific study proving device performance against those criteria, or details regarding ground truth, expert opinions, or statistical analysis typically associated with AI/algorithm performance studies.
The document focuses on demonstrating substantial equivalence to predicate devices for mechanical characteristics and intended use, rather than the performance of an AI or algorithm.
Therefore, I cannot provide details on the following based on the provided text:
- A table of acceptance criteria and reported device performance (for an AI/algorithm)
- Sample sizes used for test/training sets or data provenance
- Number of experts or their qualifications
- Adjudication method
- MRMC comparative effectiveness study
- Standalone algorithm performance
- Type of ground truth used
- How ground truth was established
The current document describes a traditional medical device (a vascular clamp), not an AI/algorithm-based device, and therefore the requested information regarding AI/algorithm performance studies is not present.
If you have a different document describing an AI/algorithm-based medical device, please provide that, and I can then attempt to extract the requested information.
§ 870.4450 Vascular clamp.
(a)
Identification. A vascular clamp is a surgical instrument used to occlude a blood vessel temporarily.(b)
Classification. Class II (performance standards).