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This product is intended for use with cardiopulmonary bypass as an arterial return cannula.

The EOPA Elongated One-Piece Arterial Cannulae have a flexible, thin wall wirewound body with a tapered distal tip. The tip features depth markings and an adjustable radiopaque suture ring to indicate insertion depth. The proximal end of the cannula terminates in a vented or non-vented 3/8" (0.95 cm) connector. A plastic tapered tip introducer with porous plug is provided to facilitate cannula insertion and priming. The introducer features a guidewire port for use with a 0.038" (0.1 cm) guidewire. Some models include a guidewire while some do not. The devices are marketed in 18, 20, 22, and 24 Fr. diameters. The devices may include a Carmeda® coating.

The provided text is a 510(k) summary for a medical device (EOPA Elongated One-Piece Arterial Cannula), but it does not contain the specific information requested in the prompt regarding acceptance criteria, a detailed study proving performance, sample sizes, expert involvement, or ground truth establishment for AI/ML device evaluation.

The 510(k) summary focuses on demonstrating "substantial equivalence" to predicate devices, which is a different regulatory pathway than providing detailed performance metrics against pre-defined acceptance criteria, especially in the context of AI/ML performance.

Therefore, I cannot populate the table or answer the specific questions about the study's methodology as the information is not present in the provided document.

Here's what I can extract based on the available text, noting the limitations:

1. Table of acceptance criteria and the reported device performance:

2. Sample size used for the test set and the data provenance:

• Sample Size (Test Set): Not specified.
• Data Provenance: Not specified (implied to be internal Medtronic testing, but country/retrospective/prospective not mentioned).

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

• Number of Experts: Not applicable. This study refers to functional and physical testing of a medical device, not the interpretation of data/images by experts to establish ground truth for an AI/ML algorithm.
• Qualifications of Experts: Not applicable.

4. Adjudication method for the test set:

• Not applicable. This was not a study involving human-in-the-loop data adjudication.

5. 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:

• No, an MRMC comparative effectiveness study was not done. This device is a physical medical cannula, not an AI/ML-driven diagnostic tool.

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

• Not applicable. This is not an AI/ML algorithm.

7. The type of ground truth used:

• For the physical tests (visual, dimensional, functional, coverage, bio-activity, leaching), the "ground truth" would be established by engineering specifications, material standards, and validated laboratory methodologies. It is not "expert consensus, pathology, or outcomes data" in the typical AI/ML context.

8. The sample size for the training set:

• Not applicable. This is not an AI/ML algorithm.

9. How the ground truth for the training set was established:

• Not applicable. This is not an AI/ML algorithm.

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