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The NxStage System One is indicated for the treatment of acute and chronic renal failure or fluid overload using hemofiltration, hemodialysis, and/or ultrafiltration, in an acute or chronic care facility. The System is indicated for hemodialysis with or without ultrafiltration in the home.

The NxStage System One is also indicated for Therapeutic Plasma Exchange in a clinical environment.

All treatments must be administered under a physician's prescription, and must be observed by a trained and qualified person, considered to be competent in the use of this device by the prescribing physician.

The NxStage System One with Therapeutic Plasma Exchange Cartridge provides therapeutic plasma exchange therapy when used with a commercially available TPE filter. The machine that controls the therapy is called the Cycler. The blood tubing set is the NxStage TPE Cartridge. The TPE Cartridge is a single use extracorporeal blood circuit and fluid management device without a pre-attached filter. Therapeutic plasma exchange requires the use of a commercially available therapeutic plasma exchange filter such as the Asahi Plasmaflo.

The provided text describes the NxStage System One with Therapeutic Plasma Exchange Cartridge. While it details the device's indications, substantial equivalence, and general performance claims, it does not include specific acceptance criteria or the study details to prove those criteria were met in a structured format.

The document states:
"Perfication and validation testing was conducted to characterize performance of the proposed device and the predetermined acceptance criteria was met. Results of this testing have documented that the proposed NxStage System One with TPE Cartidge is substantially equivalent to the predicate devices and is suitable for the labeled indications for use."

However, it does not enumerate what those "predetermined acceptance criteria" were or provide any specifics about the "verification and validation testing" such as sample sizes, ground truth establishment, or expert involvement.

Therefore, I cannot populate the requested table and answer many of the specific questions about the study design because that information is not present in the provided text.

Based on the provided text, here's what can be extracted and what remains unknown:

1. Table of acceptance criteria and reported device performance:

2. Sample size used for the test set and the data provenance: Not specified in the text. The document refers to "verification and validation testing" but does not give details about "test sets" or data provenance.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not specified in the text.

4. Adjudication method for the test set: Not specified in the text.

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. The device described is a medical system for therapeutic plasma exchange, not an AI-assisted diagnostic device requiring human reader performance evaluation.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is a medical system, not an algorithm in the traditional sense for standalone performance evaluation against a ground truth in diagnostic imaging, for example.

7. The type of ground truth used: Not specified in the text. The testing appears to be primarily bench testing for characterizing device performance, rather than clinical ground truth for diagnostic accuracy.

8. The sample size for the training set: Not applicable/Not specified. This is a medical device, not a machine learning algorithm that typically uses a "training set" in the context of AI.

9. How the ground truth for the training set was established: Not applicable/Not specified.

In summary, the provided text confirms that "verification and validation testing" was performed and that "predetermined acceptance criteria" were met, leading to a determination of substantial equivalence. However, the specific details of these criteria and the methodology of the testing (including sample sizes, ground truth, and expert involvement) are not elaborated upon.

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