(43 days)
The Edwards Lifesciences Arterial Perfusion Cannulae II are indicated for arterial perfusion in the extracorporeal circuit for
Edwards Arterial Perfusion Cannulae are polymeric tubes intended to provide a means of returning oxygenated blood to a patient during cardiopulmonary bypass procedures.
The cannulae are available in a range of sizes and in a variety of tip configurations. Some cannulae are reinforced by means of a stainless steel wire entirely encapsulated within the wall of the cannula to minimize the potential for cannula kinking; other cannulae are non-reinforced. Some cannulae are provided with a movable suture ring, a fixed suture ring or a fixed suture bump or flange to facilitate the fixation of the cannula.
The devices are provided sterile, they are non-pyrogenic and they are intended for single use only.
The provided 510(k) summary for the Edwards Lifesciences Arterial Perfusion Cannula II does not contain the kind of detailed information about acceptance criteria, study design, expert ground truth, or statistical analyses that would typically be found in a submission for a device that uses AI or machine learning.
This submission is for a medical device that is a physical product (an arterial perfusion cannula), and its safety and efficacy are demonstrated through comparative analysis and functional/safety testing against a predicate device, not through studies involving AI or complex data analysis with expert consensus.
Therefore, I cannot extract the requested information as it is not present in the provided document.
Here's why and what kind of information is available instead:
- Acceptance Criteria & Device Performance: The document states that the "functional data indicate that the subject devices perform in a substantially equivalent manner when compared with the predicate device." This implies the acceptance criteria were met if the new device's functional performance was deemed equivalent to the predicate. Specific numerical targets or performance metrics are not provided, as this is a traditional medical device submission focused on physical characteristics and performance.
- Study That Proves the Device Meets Acceptance Criteria: The study mentioned is "Functional/Safety Testing" and "Comparative Analysis." These studies demonstrate that the new APC II cannulae are "comparable to the predicate devices in intended use, fundamental scientific technology, material type, principles of operation and functional performance evaluations."
- Points 2-9 (Sample size, data provenance, expert ground truth, adjudication, MRMC, standalone, training set, etc.): These points are specific to studies involving algorithms, data analysis, and expert interpretation (common in AI/ML submissions). They are entirely absent because this submission is for a physical medical device. The "ground truth" for a physical device like a cannula would be its physical integrity, material properties, flow rates, pressure resistance, etc., which are assessed through engineering and bench testing, not expert consensus on interpretations of data.
In summary, the provided text describes a 510(k) submission for a physical medical device, not an AI/ML-powered device. Therefore, the questions related to AI/ML study design and ground truth are not applicable and cannot be answered from the given information.
§ 870.1300 Catheter cannula.
(a)
Identification. A catheter cannula is a hollow tube which is inserted into a vessel or cavity; this device provides a rigid or semirigid structure which can be connected to a tube or connector.(b)
Classification. Class II (performance standards).