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NxStage PureFlow Solution is indicated for use with NxStage renal replacement therapy systems that utilize sterile premixed dialysate during hemodialysis for chronic care patients.

The NxStage PureFlow Solution is a family of premixed dialysate solution formulations which are sterile, non-pyrogenic, fully constituted dialysate solutions provided in 5L single use flexible bags.

The provided text describes the 510(k) premarket notification for the NxStage PureFlow Solution, a pre-mixed dialysate for hemodialysis. However, the document does not contain information about a study involving an AI/Machine Learning device or a Multi-Reader Multi-Case (MRMC) comparative effectiveness study.

The document discusses performance testing for the NxStage PureFlow Solution, which is a physical medical device (a liquid solution in a bag), not a software or AI-driven diagnostic device. Therefore, the acceptance criteria and study details requested in the prompt (e.g., sample size for test/training sets, data provenance, expert ground truth, adjudication methods, MRMC studies, standalone algorithm performance) are not applicable to the content of this document.

The performance data mentioned in the document for the NxStage PureFlow Solution are related to:

• Analytical testing: per device specifications and applicable sections of USP and EP.
• Physical testing of container (bag): per device specifications.
• Container closure integrity testing: per ISO 11607-1.
• Temperature excursion testing: per device specifications.
• Stability/Shelf-life testing: per ICH Q1A to support a 24-month shelf life.
• Ship testing: per ASTM D4169-22.
• Biocompatibility testing: in accordance with ISO 10993-1 and FDA guidance, including chemical characterization, toxicological risk assessment, cytotoxicity, sensitization, irritation, pyrogenicity, hemocompatibility, and systemic toxicity.
• Human Factors Validation Testing: in accordance with FDA guidance and AAMI/ANSI/EC 62366-1.
• Electrical Safety and EMC: Not Applicable (the device has no electronic features).
• Software Verification and Validation Testing: Not Applicable (the device has no software features).
• Animal Studies: Not Applicable.
• Clinical Studies: Not Applicable.

The conclusion states that "Verification and validation was conducted to characterize the proposed device and the predetermined acceptance criteria were met." However, the document does not enumerate specific quantitative acceptance criteria or the specific performance metrics achieved in these tests, only the types of tests conducted.

Therefore, I cannot provide the requested information about AI acceptance criteria and study details based on the provided document.

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The NxStage Pureflow Solution is indicated for use with renal replacement therapy systems that utilize sterile premixed dialysate.

The NxStage PureFlow Solutions are sterile, non-pyrogenic dialysis solutions provided in single use flexible PVC bags varying in sizes from 1000 to 5000ml. The dialysis solutions are intended for use with renal replacement therapy systems that utilize sterile premixed dialysate.

The provided document describes a 510(k) submission for a medical device called "NxStage PureFlow Solution," which is a pre-mixed dialysate. This submission is a "Special 510(k) Device Modification" and relies on demonstrating substantial equivalence to a previously cleared predicate device (K022913), rather than conducting a new clinical study with specific acceptance criteria and performance metrics.

Therefore, the document does not contain the information requested regarding acceptance criteria, reported device performance against those criteria, sample sizes for test sets, data provenance, number or qualifications of experts, adjudication methods, MRMC studies, standalone performance, type of ground truth, or training set details.

Instead, the submission for K033386 states the following:

1. Acceptance Criteria and Reported Device Performance:

• The fundamental acceptance criterion is that the modified device "meets design specifications" and is "substantially equivalent" to the baseline device (K022913).
• The document states: "Design validation testing has been performed to ensure that the modified device meets design specifications. The modified NxStage PureFlow Solution has been compared to the baseline as cleared in K022913 and found to be substantial equivalent."
• No specific quantitative acceptance criteria (e.g., accuracy, sensitivity, specificity values) or detailed performance metrics are reported in this document.

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

• Not applicable / Not provided. The document refers to "Design validation testing" but does not specify the sample size of any test sets used or the provenance of the data. Given it's a device modification, the validation likely focused on engineering specifications, material compatibility, and chemical properties, rather than patient-level or expert-reviewed performance data.

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

• Not applicable / Not provided. The concept of "ground truth" established by experts for a specific test set, as would be relevant for an AI/diagnostic device, is not discussed in this submission for a dialysate solution.

4. Adjudication Method:

• Not applicable / Not provided.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done:

• No. This type of study is not relevant for a dialysate solution and was not conducted or mentioned.

6. If a Standalone Performance Study Was Done:

• Not applicable / Not provided. "Standalone performance" in the context of an AI algorithm is not relevant for a dialysate product. The "Design validation testing" is a form of standalone testing for the device's physical and chemical properties, but not in the sense of an algorithm's diagnostic performance.

7. The Type of Ground Truth Used:

• Not explicitly stated in this context. For a dialysate, "ground truth" would relate to its chemical composition, sterility, stability, and functional performance (e.g., pH, electrolyte concentrations, osmolarity) rather than expert consensus on diagnostic images or pathology. The "design specifications" are the de facto ground truth used for validation.

8. The Sample Size for the Training Set:

• Not applicable / Not provided. This document does not describe the development or training of an AI algorithm; therefore, there is no "training set."

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

• Not applicable / Not provided.

Summary of the Study:

The "study" referenced in this document is the "Design validation testing" performed by NxStage Medical, Inc. This testing was carried out to "ensure that the modified device meets design specifications" and to demonstrate its "substantial equivalence" to the predicate device K022913. As a Special 510(k) for a device modification, the focus is on compliance with design controls (21 CFR 820.30) and engineering/performance validation against established specifications of the original device, rather than a new clinical performance study with human readers or AI.

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