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Low Potassium Dextran Solution with Tris Diluent is indicated for flushing, storage and transportation of isolated lungs after removal from the donor in preparation for eventual transplantation into a recipient.

Low Potassium Dextran (LPD) Solution is a sterile, clear, non-pyrogenic, physiological salt solution for hypothermic flushing, storage, and transportation of human lungs outside the human body. LPD Solution is acidic and is adjusted shortly before use to pH 7.4 by the addition of Tris Diluent.

LPD Solution with Tris Diluent is supplied as 1 liter of LPD Solution in a low density polyethylene (LDPE) bottle (8 per pack), co-packed with one single-use bottle of Tris Diluent. Tris Diluent is also supplied separately in an eight-unit pack. Each container of LPD Solution and Tris Diluent is single-use.

This document is a 510(k) summary for the "Low Potassium Dextran Solution with Tris Diluent." It's a regulatory submission to the FDA, demonstrating substantial equivalence to a predicate device, Perfadex® with THAM, rather than presenting a study to prove acceptance criteria for a new, novel device. As such, the information you've requested regarding acceptance criteria, study design, and performance metrics for a new device's evaluation against those criteria is not directly applicable in this context.

This summary focuses on showing that the new device is as safe and effective as a legally marketed predicate device. The "performance data" section primarily describes validation of the new solution's chemical and physical properties and manufacturing processes, ensuring it is comparable to the predicate.

However, I can extract information related to the comparison of the subject device to the predicate where applicable:

1. Table of Acceptance Criteria and Reported Device Performance:

This document does not present specific acceptance criteria in terms of clinical performance (e.g., sensitivity, specificity, accuracy) that a medical device (like an AI algorithm) would typically have. Instead, it focuses on demonstrating substantial equivalence to a predicate device. The "performance data" described are primarily related to product specifications and manufacturing controls.

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

• Not applicable directly. This document does not describe a clinical "test set" in the sense of a dataset for evaluating an AI algorithm or a diagnostic device's performance against clinical ground truth. The "testing" mentioned refers to laboratory and manufacturing validation activities.

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

• Not applicable. No expert ground truth establishment for a clinical test set is described.

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

• Not applicable. No adjudication method for a clinical test set is described.

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 document describes a medical solution for organ preservation, not an AI-assisted diagnostic or assistive device.

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

• Not applicable. This is not an algorithm or AI device.

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

• Not applicable in the context of clinical ground truth. The "truth" here is based on established chemical, physical, and biological standards (e.g., chemical composition, sterility, biocompatibility standards like ISO 10993-1, USP ).

8. The sample size for the training set:

• Not applicable. This document is for a medical solution, not a machine learning model that requires a training set.

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

• Not applicable. As above, this is not a machine learning model.

Summary of the document's intent:

The document's primary purpose is to demonstrate that the "Low Potassium Dextran Solution with Tris Diluent" is substantially equivalent to the predicate device "Perfadex® with THAM." Substantial equivalence is established by showing that the new device has:

• The identical intended use.
• Similar technological characteristics.
• Any differences in technological characteristics do not raise new questions of safety or effectiveness.

The "Performance Data" section supports the claim of similar technological characteristics and that any differences are not concerning by detailing chemical composition analysis, sterility and pyrogenicity testing, stability testing (shelf-life), biocompatibility testing, and verification of other product specifications like pH adjustment and fill volume.

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