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The NxStage System One is indicated for the 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 prescription.

The NxStage System One, consisting of hardware, software and a sterile disposable cartridge, is indicated for the 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 prescription.

The provided text does not contain information about acceptance criteria or a study that proves the device meets specific performance criteria. Instead, it describes a Special 510(k) Device Modification for the NxStage System One, a hemodialysis system.

Here's what can be inferred from the text regarding the nature of the submission and the evidence provided:

• Type of Submission: This is a Special 510(k) Device Modification, which relies on demonstrating compliance with Design Control requirements (21 CFR 820.30) for minor changes to an already cleared device. It's not a de novo submission requiring extensive clinical performance studies.
• Basis of Substantial Equivalence: The key argument for substantial equivalence is based on:
  • Comparison of descriptive and technological characteristics: The modified device with "one modified warning" was compared to the predicate device (baseline NxStage System One, K030470) and a comparable device (Fresenius 2008K). This implies that the changes were minor enough that new performance data wasn't deemed necessary.
  • Design control certification: The sponsor provided certification that the device complies with 21 CFR 820.30 Design Control requirements, indicating that the design changes were controlled and verified internally.
• Focus on Labeling: The conclusion specifically states, "the modified NxStage System One device labeling has been shown to meet the minimum requirements that are considered acceptable for its intended use." This further suggests that the primary modification addressed in this 510(k) was a change to a warning in the device labeling, rather than a significant change to the device's fundamental performance.

Therefore, the requested information about acceptance criteria and a study proving the device meets them (especially in the context of accuracy, sensitivity, specificity, etc.) is not present in the provided text because this type of 510(k) submission typically does not involve such studies. It focuses on demonstrating that a minor modification to an existing, cleared device does not alter its safety or effectiveness or that the modification was made under strict design controls.

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