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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 also indicated for home hemodialysis, including home nocturnal hemodialysis.
All treatments must be administered under physician's prescription, and must be performed by a trained and qualified person, considered to be competent in the use of this device by the prescribing physician.

The NxStage System One is comprised of the NxStage Cycler, an electromechanical control unit; the NxStage Cartridge, a sterile, single-use extracorporeal blood and fluid management circuit (with or without a preattached high permeability filter) that mounts integrally within the NxStage Cycler. The combined system is designed to deliver hemofiltration, hemodialysis and/or ultrafiltration in an acute or chronic care facility. The NxStage System One is also indicated for home hemodialysis, including home nocturnal hemodialysis.

This document describes the NxStage System One, a hemodialysis system. The FDA 510(k) clearance (K141752 dated December 19, 2014) indicates that the device is substantially equivalent to a previously cleared NxStage System One (K140526).

Here's an analysis of the provided information regarding acceptance criteria and the study that proves the device meets those criteria:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria are implicitly defined by the chosen "primary effectiveness endpoint" and "primary safety endpoint" of the pivotal clinical study.

2. Sample Size Used for the Test Set and Data Provenance

• Sample Size: A total of 58 End Stage Renal Disease (ESRD) patients participated in the clinical study. 39 completed the study period, and 19 discontinued.
• Data Provenance: The study was a US prospective, multi-center clinical study.

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

This information is not explicitly provided in the document. The "ground truth" for the clinical study was based on patient outcomes, delivered therapy volumes, and reported adverse events during the observational clinical trial. The study was conducted "under physician's prescription," implying medical oversight, but specific details about expert adjudication for individual patient data points are not detailed.

4. Adjudication Method for the Test Set

This information is not explicitly provided. The clinical study collected data on delivered therapy and adverse events. The assessment of these outcomes would have been part of the clinical trial protocol, but there is no specific mention of an independent adjudication committee for all events or for the effectiveness endpoint.

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

This question is not applicable to the provided document. The NxStage System One is a hemodialysis device, not an AI-powered diagnostic or interpretive tool that would involve human readers or AI assistance in the interpretation of medical images or data. The study compared two different treatment regimens (Nocturnal Hemodialysis vs. Daily Hemodialysis) using the same device, not human performance with and without AI.

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

This question is not applicable. The device is a hemodialysis system, not an algorithm, and it always involves a human-in-the-loop (trained and qualified person, prescribing physician, and patient). The "effectiveness" measurement was based on the system's ability to deliver therapy, not an independent algorithmic output.

7. The Type of Ground Truth Used (Expert Consensus, Pathology, Outcomes Data, etc.)

The ground truth for the clinical study was based on patient outcomes data, specifically:

• Effectiveness: Measured by the actual delivered volume of therapy compared to the prescribed volume.
• Safety: Measured by the occurrence and rates of intradialytic and interdialytic adverse events.

8. The Sample Size for the Training Set

The document does not describe a "training set" in the context of machine learning or AI. For the clinical study, the patients (all 58 of them) effectively served as the "test set" for evaluating the performance of the device in the two different treatment regimens. If "training set" refers to data used for initial device development and non-clinical testing, that information is not detailed here beyond "System Verification and Software Validation" and "Simulated dialysis treatments."

9. How the Ground Truth for the Training Set Was Established

As there is no explicit "training set" described in the context of a machine learning or AI algorithm, this question is not fully applicable. For the non-clinical testing (System Verification and Software Validation, Regression testing, etc.), the ground truth would have been established through engineering specifications, validated test protocols, and simulated conditions to ensure the device performs as designed.

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