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The DCX Disposable Cassette, as part of the Kidney Perfusion System, is intended to be used for the pulsatile hypothermic machine perfusion (RM4 Kidney Perfusion System) of kidneys for preservation and eventual transplantation into a recipient only in healthcare professional environment.

The DCX Disposable Cassette, provides a sterile fluid pathway, houses and protects the kidneys during perfusion and it has a gravity flow system which allows circulation of perfusate through the kidneys.

The kidneys are placed in an organ chamber filled with perfusate. The perfusate flows from the organ chamber to the pumphead. Then, it is pumped through the heat exchanger to the bubble trap where it is delivered to the cannulated kidney(s). The perfusate then returns to the organ chamber via the kidney vein to repeat the perfusion cycle.

The cassette can provide circulation of perfusate to one or two kidneys, attached individually or in bloc.

The provided FDA 510(k) clearance letter and summary for the DCX Disposable Cassette (K243998) primarily focuses on demonstrating substantial equivalence to its predicate device through non-clinical testing. It does not detail a clinical study with acceptance criteria often associated with device performance in diagnostic or therapeutic efficacy. Instead, the acceptance criteria are met through various non-clinical tests verifying safety, sterility, biocompatibility, and functional performance.

Here's a breakdown of the requested information based on the provided document:

Acceptance Criteria and Reported Device Performance

The acceptance criteria for the DCX Disposable Cassette are primarily focused on safety, sterility, biocompatibility, and functional performance, aligning with regulatory standards and ensuring it operates as intended without posing new risks compared to its predicate.

Table of Acceptance Criteria and Reported Device Performance

Study Details

The provided document describes a non-clinical testing study rather than a clinical trial focused on diagnostic accuracy or therapeutic outcomes in patients.

1. Sample Size Used for the Test Set and Data Provenance:

   • The document does not specify a "test set" in the context of patient data or samples. The testing described is primarily for device components and materials (e.g., biomaterial samples for ISO 10993 testing, samples for sterility testing, units for stability testing).
   • The provenance of the data is from Institut Georges Lopez (IGL), based in France, the manufacturer of the device.

2. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts:

   • This information is not applicable as the described study is a non-clinical device performance and safety evaluation (e.g., sterilization validation, biocompatibility testing, stability testing), not a study requiring expert consensus on clinical findings.

3. Adjudication Method for the Test Set:

   • This information is not applicable as the described study is a non-clinical device performance and safety evaluation. Adjudication methods (like 2+1 or 3+1) are typically used in clinical studies for interpretation of imaging or clinical outcomes where multiple experts assess the same case.

4. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done:

   • No, an MRMC comparative effectiveness study was not done. This type of study is relevant for evaluating the impact of an AI-assisted diagnostic tool on human reader performance, which is beyond the scope of this device (a disposable cassette for organ perfusion).

5. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done:

   • No, this refers to an algorithm's performance, which is not applicable to a disposable cassette.

6. The Type of Ground Truth Used:

   • The "ground truth" for this device's evaluation is based on established regulatory standards and engineering specifications. For example:
     • Sterility: Achieved by verifying results against ISO 11135 and ISO 10993-7.
     • Biocompatibility: Achieved by verifying results against ISO 10993 (cytotoxicity, sensitization, irritation, hemolysis, acute systemic toxicity).
     • Stability: Achieved by verifying that product specifications remain within acceptable limits after aging tests for the specified shelf life.
     • Functional Performance: Achieved by demonstrating that the device "performs as expected and meets the requirements set for the device" when used with compatible components (RM4 Control Unit and perfusion accessories).

7. The Sample Size for the Training Set:

   • This information is not applicable. The DCX Disposable Cassette is a physical medical device, not a machine learning algorithm that requires a training set.

8. How the Ground Truth for the Training Set Was Established:

   • This information is not applicable for the same reason as point 7.

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