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The cannula is intended for use during cardiopulmonary bypass surgery for the delivery of cardioplegia retrogradely through the coronary sinus up to six hours or less.

The DLP® Retrograde Coronary Sinus Perfusion Cannulae Without Pressure Monitoring Line devices consist of a silicone or extruded PVC body. The silicone cannulae consist of a kink resistant wirewound body and a beveled tip with two side holes. A smooth manual inflating balloon is located at the distal end of the wirewound body and has an inflation assembly at the proximal end of the cannula that contains a female luer and a one-way valve. The PVC cannula consists of an extruded body with a multi-port tip and a smooth pre-formed auto-inflating balloon. Both silicone and PVC cannulae terminate with a female luer on the proximal end. These devices are offered with either a guidewire stylet or a solid stylet to help position the cannula. The cannula are sterile, non-pyrogenic, disposable, and for single use only.

This is a 510(k) premarket notification for a medical device, which focuses on demonstrating substantial equivalence to a predicate device rather than a comprehensive clinical study to prove novel efficacy or safety against acceptance criteria in the manner usually associated with AI/ML devices. Therefore, many of your requested criteria are not applicable or cannot be found in this type of submission.

Here's a breakdown of what can be extracted and what cannot:

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

The acceptance criteria and performance reported here are for biocompatibility and functional pressure integrity, not for a diagnostic or AI-driven performance metric like sensitivity or specificity.

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

• Sample Size for Biocompatibility Tests: Not explicitly stated in this summary. These tests are typically conducted on a limited number of samples according to ISO standards.
• Sample Size for Functional Testing: Not explicitly stated.
• Data Provenance: Not specified, but likely from laboratory testing conducted by the manufacturer or a contracted lab. This is not clinical data in the sense of patient data.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

Not applicable. This device is not an AI/ML diagnostic tool, and its "ground truth" is established through standardized laboratory test methods and engineering specifications, not expert consensus on medical images or patient outcomes.

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

Not applicable. As above, this is not a diagnostic device requiring expert adjudication of results.

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-assisted device.

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" for this device's performance is based on:

• Established Biocompatibility Standards: Meeting the "PASS" criteria for various toxicology and material interaction tests (e.g., ISO 10993 series).
• Engineering Specifications: The device's functional performance (e.g., pressure integrity) is judged against pre-defined engineering requirements for its components.

8. The sample size for the training set

Not applicable. This is a physical medical device, not an AI/ML model that requires a training set.

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

Not applicable.

Summary of what the document does convey:

This 510(k) submission demonstrates that a modified version of the DLP® Retrograde Coronary Sinus Perfusion Cannulae is substantially equivalent to a previously cleared predicate device. The changes were to non-blood-contacting components (luers, check valve material, ink) and a manufacturing process aid. The proof of substantial equivalence relies on:

• Same Intended Use, Technological Characteristics, Operating Principle, Design Features, and Base Materials as the predicate.
• Successful Biocompatibility Testing: All tests (Cytotoxicity, Sensitization, Intracutaneous reactivity, Acute systemic toxicity, Pyrogen, Genotoxicity, Hemocompatibility) for the material changes passed, demonstrating the materials remain safe for their intended use.
• Successful Bench Testing: Functional pressure integrity testing for the changed check valve components met specified criteria, confirming no degradation in performance.

In essence, this document is a regulatory submission for a minor modification to an existing device, focusing on a robust comparison to a predicate device and demonstrating that the changes do not introduce new safety or efficacy concerns through targeted testing. It is not an evaluation of a novel AI/ML device.

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