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OCS™ Lung Solution is intended for flushing, storage and transportation of isolated lungs after removal from the donor in preparation for eventual transplantation into a recipient.

The OCS Lung Solution is a colorless, sterile, pyrogen-free solution for cold flushing, storage and transport of donor lungs for transplantation. The OCS Lung Solution is a colloid-based extracellular low potassium solution for cold flushing and storage of donor lungs for transplantation. The OCS Lung Solution is used to flush and store a lung after removal from the donor. Administration of the solution at the recommended temperature will effectively cool the organ to reduce its metabolic requirements.

This document, K211314, is an FDA 510(k) Premarket Notification for the OCS™ Lung Solution. A 510(k) submission primarily focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than proving the device meets specific performance acceptance criteria through the kind of studies typically associated with AI/ML evaluations.

Therefore, the information required to answer your prompt about "acceptance criteria and the study that proves the device meets the acceptance criteria" in the context of an AI/ML device is largely not present in this 510(k) summary.

Specifically, the document states:

• "Software Verification and Validation Testing: Not applicable. The device contains no software."
• "Clinical Data: Not applicable. Clinical studies are not necessary to establish the substantial equivalence of this device."
• "Animal Testing: Not applicable. Animal studies are not necessary to establish the substantial equivalence of this device."

This indicates that this is a medical solution (a chemical product), not an AI/ML device, and thus the type of performance evaluation typically performed for AI/ML devices (e.g., assessing accuracy, sensitivity, specificity, or human reader improvement with AI assistance) was not conducted.

However, I can extract information regarding the "device" as described in this 510(k) submission, even if it doesn't align with an AI/ML context:

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

Since this is a solution and not an AI/ML device, typical "performance" metrics like accuracy, sensitivity, or specificity are not applicable. The closest aspects to "acceptance criteria" for a solution would be its chemical composition, sterility, and shelf life. The document focuses on demonstrating substantial equivalence to an existing predicate device (Perfadex®) rather than meeting defined performance criteria through a study.

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

This information is not applicable as no "test set" in the context of an AI/ML algorithm was used. The evaluation for this device focused on bench testing (chemical analyses) and demonstrating similarity to a predicate device.

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)

This information is not applicable. No ground truth for an AI/ML test set was established. The "ground truth" for this product type is its chemical composition, sterility, and demonstrated biocompatibility, which are verified through standard laboratory testing methods and comparison to an established predicate.

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

This information is not applicable. No test set or expert adjudication was performed in the context of an AI/ML device.

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, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. This device is a solution, not an AI-assisted diagnostic tool.

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

This information is not applicable. There is no algorithm, so no standalone performance testing was conducted.

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

Since this is a medical solution and not a diagnostic AI/ML device, the concept of "ground truth" as typically defined for AI/ML is not directly applicable. For this product, "ground truth" would relate to:

• Chemical Analysis: Verifying the exact composition of the solution.
• Sterility Testing: Verifying the absence of microorganisms.
• Biocompatibility Testing: Verifying that the materials do not elicit adverse biological responses.
• Bench Testing: Comparison to established standards for solutions for organ preservation.

8. The sample size for the training set

This information is not applicable. There is no AI/ML model, and therefore no training set.

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

This information is not applicable. There is no AI/ML model or training set.

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