(80 days)
Carotid Shunts are indicated for use in carotid endarterectomy as a temporary conduit to allow for blood flow between the common and internal carotid arteries.
Not Found
Unfortunately, the provided document is a 510(k) clearance letter from the FDA for a medical device (LeMaitre Carotid Straight Shunt). This type of document primarily confirms that the device is "substantially equivalent" to a legally marketed predicate device and outlines regulatory compliance requirements.
It does not contain the detailed information requested regarding acceptance criteria, specific study designs, performance metrics, ground truth establishment, or expert qualifications that would typically be found in a clinical study report or a premarket approval (PMA) application summary.
Therefore, I cannot fulfill your request for the information outlined in your prompt based solely on the provided text. The document confirms the device's clearance for marketing, but it does not detail the specific studies and criteria used to assess its performance in the way you've asked.
§ 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).