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The Sarns™ High-Flow Aortic Arch 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™ High-Flow Aortic Arch 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 a 510(k) submission for the Sarns™ High-Flow Aortic Arch Cannula, which is a modification of a previously cleared device. The submission asserts substantial equivalence to predicate devices and does not involve an AI device. Therefore, many of the requested details related to AI performance studies are not applicable.

Here's an attempt to extract relevant information and explain why other sections are not applicable:

Acceptance Criteria and Device Performance for Sarns™ High-Flow Aortic Arch Cannula (K133151)

This 510(k) submission is for a medical device (aortic cannula) and not an AI/ML-based diagnostic or therapeutic device. Therefore, many of the requested criteria related to AI performance, such as sample sizes for test sets, expert ground truth, adjudication methods, MRMC studies, and standalone performance, are not applicable.

The submission focuses on demonstrating substantial equivalence to existing predicate devices through bench testing and comparison of design, materials, and intended use.

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state "acceptance criteria" in a quantitative table format for the modifications. Instead, it lists "Performance Evaluations" conducted to ensure the modified devices "continue to satisfy appropriate device performance specifications and to ensure that they satisfy customer needs." The implicit acceptance criterion is that the modified device performs comparably to the predicate device and retains its safety and effectiveness.

Note: 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." This implies that the modified device met the performance standards established for the predicate device across these evaluations.

2. Sample Size Used for the Test Set and Data Provenance

Not applicable in the context of an AI device. For this medical device, the "test set" would refer to the samples of the Sarns™ High-Flow Aortic Arch Cannula that underwent the bench performance evaluations. The document does not specify the exact number of cannulas tested for each evaluation. The provenance of the data is from Terumo Cardiovascular Systems Corporation's internal bench testing activities. These studies are prospective from the perspective of evaluating the modified device.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications

Not applicable. Ground truth for the performance evaluations of a physical medical device (like an aortic cannula) is established through laboratory measurements and engineering specifications, not expert interpretation of outputs.

4. Adjudication Method for the Test Set

Not applicable. Adjudication methods are typically relevant for human interpretation or consensus in diagnostic or prognostic studies, not for the direct measurement of device performance characteristics.

5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study was done

No, an MRMC comparative effectiveness study was not done. This type of study is relevant for evaluating the performance of AI algorithms in diagnostic tasks, often comparing human readers with and without AI assistance. This submission pertains to a physical medical device.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done

Not applicable. This is not an AI algorithm. The performance evaluations listed ("force at break," "liquid and air leak," etc.) measure the physical properties and function of the device itself.

7. The Type of Ground Truth Used

For the performance evaluations, the "ground truth" would be the engineered specifications and performance characteristics of the predicate device, against which the modified device's performance was compared. This is based on engineering specifications and direct physical measurements rather than expert consensus, pathology, or outcomes data in the typical sense of AI/clinical studies.

8. The Sample Size for the Training Set

Not applicable. This is not an AI/machine learning device that requires a training set.

9. How the Ground Truth for the Training Set was Established

Not applicable. There is no training set for this type of medical device submission.

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