(196 days)
The Sarns™ Soft-Flow Aortic Cannula is indicated for perfusion of the ascending aorta during cardiopulmonary bypass surgery for up to 6 hours of use.
The design of the Sams™ Soft-Flow Aortic Cannula allows patient blood to re-enter the body after the blood has routed through an extracorporeal circuit for blood oxygenation. The design of the cannula is simple in that it consists of a tubular conduit with a tip that can be positioned into the patient's anatomy (ascending aorta) to allow the blood to re-enter the vascular blood stream.
The provided text describes the 510(k) summary for the Sarns™ Soft-Flow® Aortic Cannula, which is a medical device. The document does not describe a study involving an AI device or algorithm, but rather a conventional medical device (an aortic cannula).
Therefore, I cannot provide an answer that includes details about AI-specific acceptance criteria, sample sizes for test/training sets, expert ground truth, adjudication methods, MRMC studies, or standalone algorithm performance, as these concepts are not addressed in the provided document.
The document discusses performance evaluations for the physical device through bench studies.
Here's the information about the acceptance criteria and the "study" (bench studies) for the Sarns™ Soft-Flow® Aortic Cannula based on the provided text:
Acceptance Criteria and Reported Device Performance
| Acceptance Criteria / Performance Evaluation Type | Reported Device Performance |
|---|---|
| Force at break | Satisfies appropriate device performance specifications; no appreciable differences from predicate devices. |
| Liquid and air leak | Satisfies appropriate device performance specifications; no appreciable differences from predicate devices. |
| Ink adhesion | Satisfies appropriate device performance specifications; no appreciable differences from predicate devices. |
| Hemolysis | Satisfies appropriate device performance specifications; no appreciable differences from predicate devices. |
| Pressure drop | Satisfies appropriate device performance specifications; no appreciable differences from predicate devices. |
| Exit velocity | Satisfies appropriate device performance specifications; no appreciable differences from predicate devices. |
Explanation: The document states that "Terumo Cardiovascular has conducted performance studies with the modified devices to ensure that they all continue to satisfy appropriate device performance specifications and to ensure that they satisfy customer needs. There are no appreciable differences between the subject devices and the predicate devices." While specific numerical acceptance thresholds are not provided, the general statement indicates compliance with established specifications for each evaluation type.
Study Details (Bench Studies for a Conventional Medical Device)
- Sample size used for the test set and the data provenance: Not explicitly stated. The studies were "bench studies," meaning they were conducted in a laboratory setting, not with patient data.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Bench studies for physical device performance typically rely on engineering specifications and measurement standards, not expert interpretations of data like in AI studies.
- Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable.
- If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance: Not applicable. This device is not an AI algorithm.
- If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This device is not an AI algorithm.
- The type of ground truth used (expert consensus, pathology, outcomes data, etc): Engineering specifications and physical measurements.
- The sample size for the training set: Not applicable. Bench studies for physical device performance typically do not have a "training set" in the context of machine learning.
- How the ground truth for the training set was established: Not applicable.
Additional Notes from the Document:
- Clinical studies involving patients were deemed "not necessary to demonstrate the safety and effectiveness of the subject devices."
- The purpose of the submission was due to cumulative non-significant changes to the device design since its original clearance. The performance evaluations were conducted to ensure the modified device still met specifications and was substantially equivalent to the predicate devices.
§ 870.4210 Cardiopulmonary bypass vascular catheter, cannula, or tubing.
(a)
Identification. A cardiopulmonary bypass vascular catheter, cannula, or tubing is a device used in cardiopulmonary surgery to cannulate the vessels, perfuse the coronary arteries, and to interconnect the catheters and cannulas with an oxygenator. The device includes accessory bypass equipment.(b)
Classification. Class II (performance standards).