Search Results

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 prescription.

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

The provided text is a 510(k) summary for the NxStage System One, a hemodialysis system. It describes the device, its intended use, and states that it has been found substantially equivalent to a predicate device.

Unfortunately, the document does not contain the specific information requested regarding acceptance criteria, device performance results, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, or ground truth details.

The document states: "Design validation testing has been performed to ensure that the modified device meets design specifications." However, it does not elaborate on what those design specifications (acceptance criteria) were, or the results of that validation testing.

Therefore, I cannot provide a table of acceptance criteria and reported device performance, nor can I answer the specific questions about the study design and data.

The FDA's review simply confirms that the submitted information (which is not fully detailed in this 510(k) summary) demonstrated substantial equivalence based on descriptive and technological characteristics and design control certification.

Ask a specific question about this device