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These Cannulae are intended for use in conjunction with cardiopulmonary bypass surgery up to six hours or less for delivery of cardioplegia solutions directly to the coronary arteries.

The DLP™ Silicone Coronary Artery Ostial Cannulae feature a soft bulb beveled tip with a silicone body. The Cannulae terminate with a locking female luer fitting. The Cannulae are nonpyrogenic, single use, and sterile.

The provided document is a 510(k) Premarket Notification from the FDA regarding the Medtronic DLP™ Silicone Coronary Artery Ostial Cannulae. It details the substantial equivalence review process for a change made to the device's packaging material, specifically from a Surlyn film pouch to a Nylon film pouch.

Based on the document, this is not a study demonstrating the performance of an AI/ML powered device. Instead, it's a submission for a packaging material change for a physical medical device. Therefore, many of the requested criteria related to AI/ML device performance, ground truth, expert adjudication, and MRMC studies are not applicable to this document.

However, I can extract the relevant information regarding the "acceptance criteria" and the "study that proves the device meets the acceptance criteria" in the context of this specific packaging change.

Here's the breakdown:

1. A table of acceptance criteria and the reported device performance

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

The document does not explicitly state the sample sizes used for the functional testing, biocompatibility assessment, or shelf-life study. It also does not specify the provenance of this data (e.g., country of origin, retrospective/prospective). This information would typically be detailed in the full test reports, not usually summarized in this high-level 510(k) summary.

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

This is not applicable as this is a medical device packaging change, not an AI/ML performance study. The "ground truth" here would be the physical and biological properties meeting specifications, evaluated by standard engineering and laboratory methods, not expert human interpretation of data like medical images.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not applicable. This concept applies to human interpretation of data, typically in AI/ML performance studies to establish a consensus ground truth. For materials testing, the results are objectively measured against pre-defined specifications.

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

Not applicable. This is not an AI/ML device; it's a physical medical device (cannula) with a packaging change.

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

Not applicable. This is not an algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

The "ground truth" in this context is based on objective measurements and established standards for:

• Product Functional Testing: Ensuring the device still operates as intended (e.g., fluid flow, connection integrity). This would involve engineering specifications and validated test methods.
• Biocompatibility Assessment: Ensuring the new packaging material does not cause adverse biological reactions. This is established by ISO standards (e.g., ISO 10993 series) and specific laboratory tests (e.g., cytotoxicity, sensitization).
• Shelf Life Study: Ensuring the device maintains its sterility and functional integrity over its claimed shelf life. This is established through accelerated and/or real-time aging studies and performance testing at various time points.

8. The sample size for the training set

Not applicable. There is no training set as this is not an AI/ML product.

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

Not applicable. There is no training set.

Summary from the document regarding the "study" for the packaging change:

The "study" or rather, the design verification and validation activities performed to prove the device (with the new packaging) meets the acceptance criteria are summarized as:

• Risk-based testing and evaluations
• Product functional testing
• Biocompatibility assessment
• Completion of a product shelf life study

The conclusion explicitly states: "All results pass," thereby demonstrating that the modified DLP™ Silicone Coronary Artery Ostial Cannulae are substantially equivalent to the predicate devices and meet the necessary performance and safety standards despite the packaging change.

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