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The NxStage System One is indicated for treatment of renal failure or fluid overload using hemofiltration, hemodialysis, and/or ultrafiltration. All treatments must be administered by a health care provider, under physician's prescription.

The NxStage System One consists of the NxStage Cycler and the NxStage Cartridge Extracorporeal Blood and Fluid Circuit.

The NxStage Cycler is an electro-mechanical device that interfaces with the NxStage Cartridge. The NxStage Cartridge is a single-use extracorporeal blood circuit and fluid management device that mounts integrally within the NxStage Cycler. The NxStage Cartridge Express is a single-use extracorporeal blood circuit and fluid management device with a pre-attached high flux (permeability) hollow-fiber filter.

This is an interesting case where the provided document (a 510(k) summary for a medical device) doesn't contain a conventional study demonstrating the device meets specific performance acceptance criteria. Instead, it details a "Special 510(k) Device Modification" which relies on different evidence.

Here's a breakdown based on the provided text:

Acceptance Criteria and Device Performance

This document does not present a table of specific quantitative acceptance criteria (e.g., "filtration rate >= X L/hr") and corresponding reported device performance values. Instead, the "acceptance criteria" here is met through a "design control certification" and demonstration of "substantial equivalence" to a predicate device.

The overarching acceptance criterion is Substantial Equivalence to the predicate device (cleared in K032356). The device performance is deemed acceptable because it meets design specifications and the modified device (NxStage Cartridge Express) is found to be substantially equivalent to the baseline device (the predicate).

Study Details

Given this context of a "Special 510(k) Device Modification," many of the standard study questions for a new device's efficacy or diagnostic accuracy are not applicable in the usual sense.

1. Table of Acceptance Criteria and Reported Device Performance

As explained above, no such quantitative table is provided in this document. The "acceptance criteria" revolve around demonstrating design control compliance and substantial equivalence.

2. Sample Size for the Test Set and Data Provenance

• Sample Size for Test Set: Not explicitly mentioned as a distinct "test set" for performance evaluation in the traditional sense. The document refers to "Design validation testing," which implies testing was done, but the sample size of units/cartridges tested is not specified.
• Data Provenance: Not specified. It's implied to be internal testing by NxStage Medical, Inc.

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

Not applicable. This is not a study requiring expert readers or ground truth establishment for diagnostic accuracy.

4. Adjudication Method for the Test Set

Not applicable. This is not a study requiring expert reader adjudication.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done

No, an MRMC comparative effectiveness study was not done, as this is not a diagnostic imaging device requiring human interpretation.

6. If a Standalone (algorithm only without human-in-the-loop performance) was done

Not applicable. This is an electro-mechanical device and fluid circuit, not an algorithm.

7. The Type of Ground Truth Used

Not applicable in the typical sense of a diagnostic or predictive device. The "ground truth" here is compliance with "design specifications" and the functionality/performance matching that of the predicate device for "substantial equivalence."

8. Sample Size for the Training Set

Not applicable. This document does not describe a machine learning algorithm or a "training set."

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

Not applicable.

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