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The Moda-flx Hemodialysis System™ Cartridge is a single use, disposable arterial and venous bloodline set, with dialysate tubing, intended to provide extracorporeal access during hemodialysis. The Moda-flx Hemodialysis System™ Cartridge is compatible only with the Moda-flx Hemodialysis System ™

The Moda-flx Hemodialysis System™ Cartridge is a single use blood tubing set that provides extracorporeal access during hemodialysis and is only compatible with Moda-flx Hemodialysis System™

The provided text is a 510(k) Summary for the Moda-flx Hemodialysis System™ Cartridge. It describes the device, its intended use, and comparability to a predicate device. However, it does not contain specific acceptance criteria, reported device performance metrics in a table, sample sizes, information about expert-established ground truth, adjudication methods, or MRMC study details. The document states that "No animal or clinical studies were required to support this submission," which implies that a standalone performance study as typically understood for AI/ML devices involving human-in-the-loop or standalone algorithm performance was not conducted.

Therefore, many of the requested details about acceptance criteria and study particulars cannot be extracted from this document.

Here's a summary of what is available based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance:

The document lists performance tests that were conducted but does not provide specific acceptance criteria or quantitative performance results in a table format. It only states that the tests supported the substantial equivalence determination.

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

Not explicitly stated. The tests performed are engineering/performance verification tests of the device's physical components and functionality, not clinical test sets with patient data.

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

Not applicable, as this is not a diagnostic device relying on expert-established ground truth from clinical data.

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

Not applicable, as this is not a diagnostic device relying on expert adjudication of clinical data.

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, an MRMC study was not done. The document explicitly states: "No animal or clinical studies were required to support this submission." This type of study is relevant for diagnostic devices, particularly those incorporating AI, which this device is not.

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

No, a standalone performance study for an algorithm was not done. This device is a physical hemodialysis cartridge, not an AI/ML algorithm.

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

Not applicable in the context of clinical ground truth. The "ground truth" for the performance tests would be established by engineering specifications and industry standards for medical device functionality and safety.

8. The sample size for the training set:

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

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

Not applicable. This device is not an AI/ML model.

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