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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 is a 510(k) Premarket Notification for the NxStage System One, a high permeability hemodialysis system. It seeks to demonstrate substantial equivalence to a previously cleared predicate device (K141752).

Based on the provided document, here's an analysis regarding acceptance criteria and supporting studies:

1. Table of Acceptance Criteria and Reported Device Performance

The document presents a comparison of technological characteristics between the proposed device and the predicate device in Table 1. However, this table does not directly state acceptance criteria in terms of performance metrics (e.g., minimum accuracy, maximum allowable deviation) against which the proposed device was tested. Instead, it states that the "Proposed Device (NxStage System One)" is "Same" for most parameters compared to the "Predicate Device (NxStage System One)".

The closest the document comes to defining acceptance criteria is under "Effluent Volume Accuracy" for the predicate device, where specifications for different software versions are provided. However, it only states that the proposed device is "Same," implying it meets these same specifications without explicitly presenting the proposed device's performance against them.

Therefore, a table of acceptance criteria and reported device performance cannot be fully constructed from the provided text as the explicit acceptance criteria and quantitative performance results for the proposed device are not detailed, beyond stating they were "met."

Inference of Acceptance Criteria (from Predicate Device Specifications as implied by "Same"):

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

The document states: "No Clinical testing was conducted." All testing mentioned is "Non-Clinical Test/Performance Testing - Bench."

• Sample Size: Not explicitly stated for bench testing. The document refers to "Simulated treatments" but does not give a number of simulations or samples used.
• Data Provenance: Not applicable as no clinical data was used. All testing appears to be in-house bench testing.

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

Not applicable. Since no clinical testing was conducted and all testing was "Non-Clinical Test/Performance Testing - Bench," there was no need for expert ground truth establishment in a clinical context. The "ground truth" for bench testing would be established by the engineering specifications and validated test methods.

4. Adjudication Method for the Test Set

Not applicable, as no clinical testing with human subjects or expert review was performed.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size of How Much Human Readers Improve with AI vs Without AI Assistance

Not applicable. This is a 510(k) for a medical device (hemodialysis system), not an AI-powered diagnostic or interpretive device that would involve human readers.

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

Not applicable in the context of an "algorithm only" performance that would typically compare to human clinicians. This device is a treatment system. The "Non-Clinical Test/Performance Testing - Bench" can be considered a form of standalone performance assessment against engineering specifications, but it's not "algorithm only" in the sense of a software-as-a-medical-device (SaMD) context. It's the performance of the integrated electromechanical control unit with its software and cartridge.

7. The Type of Ground Truth Used

For the non-clinical bench testing, the "ground truth" would be established by:

• Engineering specifications and design requirements: The device's performance was measured against these predefined technical standards and parameters (e.g., flow rates, pressure monitoring ranges, accuracy for effluent volume).
• Physical measurements and simulated conditions: The testing simulates treatment conditions and measures the device's output against expected physical and chemical outcomes.

8. The Sample Size for the Training Set

Not applicable. This device is not an AI/ML model that requires a "training set" in the conventional sense. The "training" for a traditional medical device involves its design, development, and iterative testing/refinement against engineering principles and specifications.

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

Not applicable, as there is no "training set" for an AI/ML model. The "ground truth" for the device's design and development (analogous to a training process for an AI) comes from established medical standards for hemodialysis, regulatory requirements, risk analysis, and engineering principles.

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