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DuraGraft Vascular Conduit Solution is a solution indicated for adult patients undergoing Coronary Artery Bypass Grafting Surgeries and is intended for flushing and storage of the saphenous vein grafts from harvesting through grafting for up to 4 hours.

DuraGraft Vascular Conduit Solution is a single-use, clear, colorless to slightly yellow, non-pyrogenic solution used as a flushing and storage solution during the harvesting and grafting interval in Coronary Artery Bypass Grafting (CABG surgeries). All ingredients are Generally Recognized as Safe (GRAS) and comply with United States Pharmacopoeia (USP) or National Formulary (NF) specifications. No components are of animal or blood origin. The product is aseptically processed using aseptic filling procedures. Stability testing at 25℃ supports a shelf life of 2 years at a storage temperature of 20-25°C (controlled room temperature).

The salts in DuraGraft are intended for buffering (to maintain both ionic balance and isotonicity with respect to vascular conduits. The organic components are intended to provide a non-oxidizing environment for vascular conduits and to maintain additional buffering capability and osmolality. The organic components are all normal constituents of blood and are included for their roles in maintaining the extracellular environment of vascular conduits to prevent ischemic injury.

DuraGraft Vascular Conduit Solution is provided in two aseptically processed containers; Solution A and Solution B. Solution A is an aqueous based solution provided in sterile PETG bottles with white HDPE closures. Solution B is an aqueous based solution provided in sterile Type I borosilicate glass vials with bromobutyl rubber stoppers with aluminum crimps. Solution B are mixed at the point of use to generate DuraGraft Vascular Conduit Solution which is the graft storage and flushing solution.

The mixed solution is used at room temperature and has an osmolality of about 305 Osmol/kg, viscosity of 1.06 cST, a sodium concentration of 155-160 mEq/L (sodium concentration is expressed as a range due to the use of Sodium bicarbonate for pH adjustment of Solution A and is based on review of several (10+) manufacturing batch records), and a potassium concentration of 5.8 mEq/L, and a pH of 7.4 at room temperature.

The provided text is a 510(k) summary for the DuraGraft Vascular Conduit Solution. This document pertains to the regulatory submission for a medical device (a solution for flushing and storing vascular grafts), not a software or AI-powered device. Therefore, the questions related to AI acceptance criteria, training/test sets, expert ground truth, MRMC studies, and human-in-the-loop performance are not applicable to this document.

The core of this 510(k) summary is to demonstrate substantial equivalence to a previously cleared predicate device, specifically by updating the storage conditions and shelf life. The performance data presented focuses on stability testing of the solution itself, rather than the performance of an AI algorithm.

Here's how the provided information relates to the request, addressing points where applicable and noting others as not applicable:

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

The document doesn't define "acceptance criteria" in the context of an AI algorithm's performance metrics (like sensitivity, specificity, AUC). Instead, it discusses the outcomes of stability testing for the solution.

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

• Sample size: Not specified in terms of "test set" for an AI. The "Performance Data" section states "Long-term stability testing was performed at 25°C" but does not detail the number of batches or samples tested.
• Data provenance: Not explicitly stated (e.g., country of origin, retrospective/prospective clinical data for the solution). The testing appears to be laboratory-based (stability testing).

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

Not applicable. This is not an AI device requiring expert adjudication of images or data.

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

Not applicable. This is not an AI 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

Not applicable. This is not an AI device.

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

Not applicable. This is not an AI device.

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

The "ground truth" for this medical device's performance relates to the intrinsic properties of the solution (chemical composition, sterility, stability) and its ability to maintain these properties over time and specific conditions. This "ground truth" is established through standard laboratory testing methods (e.g., analytical chemistry, microbiology) against predefined specifications.

8. The sample size for the training set

Not applicable. This is not an AI device.

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

Not applicable. This is not an AI device.

In summary, the provided document is a regulatory submission for a medical solution, not an AI or software device. Therefore, most of the questions regarding AI-specific acceptance criteria and study methodologies are not relevant to this content.

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