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

The NxStage PureFlow-B Solutions (with bicarbonate buffer) are non-pyrogenic dialysis solutions provided in single use flexible bags. The PureFlow-B Solutions are intended for use with renal replacement therapy systems that utilize sterile premixed dialysate. The range of constituents allows the physician to prescribe different electrolyte compositions that meet the specific needs of individual patients.

Acceptance Criteria and Study for NxStage PureFlow-B Solution

This document details the acceptance criteria and the study that "proves" the NxStage PureFlow-B Solution device meets those criteria, based on the provided 510(k) summary.

Note: The provided document is a 510(k) summary for a premarket notification, which focuses on demonstrating substantial equivalence to a previously cleared device. It does not contain an "acceptance criteria" table in the traditional sense of a clinical trial or performance study with numerical targets and measured performance. Instead, the "acceptance criteria" for a 510(k) are met by demonstrating the modified device is as safe and effective as a predicate device.

Therefore, the interpretation of "acceptance criteria" here refers to the requirements for demonstrating substantial equivalence, and "reported device performance" refers to the manufacturer's assertion of meeting those requirements through comparison to the predicate.

1. Table of Acceptance Criteria and Reported Device Performance

Study Information & Details:

Regarding a "study" that proves the device meets (aforementioned) acceptance criteria:

The provided 510(k) summary describes a Special 510(k) Device Modification. For this type of submission, the "study" is primarily a demonstration of adherence to design control principles and a comparison to a predicate device, rather than a traditional clinical study with patient outcomes or a statistical analysis of a "test set."

1. Sample size used for the test set and the data provenance:

   • Sample Size: Not applicable in the context of a traditional performance "test set" with patient data or a specific number of instances. The "test set" here refers to the comparisons and validations performed during the design control process. No specific sample sizes for laboratory tests, stability tests, or other verification activities are mentioned in this summary.
   • Data Provenance: Not explicitly stated as "country of origin" for data, but the submission is from NxStage Medical, Inc. based in Lawrence, MA, USA, and is submitted to the US FDA. The "study" here is a regulatory affirmation based on design controls.

2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

   • Not applicable in the context of expert review of images or clinical cases for ground truth. This is a technical and regulatory comparison, not a diagnostic device evaluation. The "experts" involved would be the engineers, quality assurance personnel, and regulatory affairs specialists at NxStage Medical, Inc., who are responsible for ensuring compliance and technical validity.

3. Adjudication method (e.g., 2+1, 3+1, none) for the test set:

   • Not applicable. Adjudication methods are typically used in clinical studies or reader studies where expert consensus is needed for ambiguous or subjective evaluations, common in diagnostic imaging. This 510(k) is for a manufacturing modification to a dialysate solution.

4. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:

   • Not applicable. This device is a premixed dialysate for hemodialysis, not an AI-powered diagnostic device or an imaging product. MRMC studies are specific to evaluating diagnostic accuracy, often in imaging.

5. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:

   • Not applicable. This device is a chemical solution, not a software algorithm.

6. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):

   • The "ground truth" for this Special 510(k) is the predicate device (K042045). The modified device's performance, safety profile, and efficacy are compared against the known characteristics and performance of the predicate. The "truth" is that the modified device should meet the same specifications and perform comparably to the predicate. The basis for this "truth" would come from physicochemical testing, stability testing, and potentially limited biocompatibility testing if new materials were involved (though not explicitly detailed in the summary).

7. The sample size for the training set:

   • Not applicable. This is not a machine learning or AI device that requires a "training set."

8. How the ground truth for the training set was established:

   • Not applicable. As above, there is no "training set" for this type of medical device submission.

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NxStage PureFlow-B Solution is indicated for use with renal replacement therapy systems that utilize sterile premixed dialysate.

The NxStage PureFlow Solution with bicarbonate (NxStage PureFlow-B Solution) is a non-pyrogenic dialysis solution provided in single use flexible bags. The PureFlow-B Solution is intended for use with renal replacement therapy systems that utilize sterile premixed dialysate.

This is a 510(k) summary for the NxStage PureFlow-B Solution, a premixed dialysate for hemodialysis. This device is classified as a Class II medical device under 21 CFR 876.5820. The submission is a Special 510(k) Device Modification, indicating that the device has undergone modifications from a previously cleared device (K033386) and seeks to demonstrate substantial equivalence to it.

Here's an analysis of the provided information concerning acceptance criteria and the supporting study, addressing your specific points:

1. Table of Acceptance Criteria and Reported Device Performance

The provided 510(k) summary and associated documents do not include a table of acceptance criteria nor specific reported device performance metrics in numerical form.

Instead, the submission relies on demonstrating substantial equivalence to a predicate device (K033386) through compliance with design control requirements and design validation testing. The conclusion states that the modified device "has been shown to meet the minimum requirements that are considered acceptable for its intended use" based on:

• Device indications for use
• Comparison of descriptive and technological characteristics
• Design control certification

This typically means that the acceptance criteria are implicitly met by demonstrating that the modified device performs similarly to the predicate device, especially considering it's a device modification where the fundamental intended use remains the same. The "acceptance criteria" here therefore refer to the device's ability to maintain the safety and effectiveness profile established by the predicate device after modifications.

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

The document does not specify a sample size for a test set. It mentions "Design validation testing has been performed to ensure that the modified device meets design specifications." However, it doesn't detail the nature of this validation testing, whether it involved clinical data, bench testing, or a combination, nor does it provide sample sizes or data provenance (e.g., country of origin, retrospective/prospective).

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

Since clinical data or a "test set" requiring expert ground truth is not explicitly described, this information is not provided in the document. For a fluid solution like a dialysate, "ground truth" would more likely relate to chemical composition, efficacy in solute removal (measured in-vitro or in-vivo), and safety (pyrogenicity, sterility), rather than expert consensus on image interpretation, for example.

4. Adjudication Method for the Test Set

As there is no mention of a test set requiring adjudication from experts, this information is not applicable/provided in the document.

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

No, an MRMC comparative effectiveness study was not done. This type of study is more relevant for diagnostic imaging devices where human readers interpret medical images, often with and without AI assistance to measure improvement in accuracy or efficiency. A dialysate solution does not typically involve human interpretation of outputs in the same way.

6. If a Standalone Performance (Algorithm Only Without Human-in-the-Loop) Was Done

No, a standalone performance study in the context of an algorithm or AI without human-in-the-loop performance is not applicable here. The device is a physical solution (dialysate), not an algorithm or AI system.

7. The Type of Ground Truth Used

The ground truth for a dialysate would primarily be based on:

• Chemical/Physical Specifications: Meeting established purity, concentration, pH, and electrolyte balance standards (e.g., USP monographs, ISO standards, internal specifications).
• Sterility and Endotoxin Testing: Ensuring the solution is non-pyrogenic and sterile.
• Performance in Dialysis Systems: Demonstrating effectiveness in removing waste products and maintaining fluid/electrolyte balance when used with compatible renal replacement therapy systems.

While the document doesn't explicitly state "type of ground truth," the concept of "design specifications" and compliance to "21 CFR 820.30 Design Control requirements" implies that the device was validated against pre-defined, measurable specifications. This would involve laboratory testing and performance evaluations against established chemical and biological criteria.

8. The Sample Size for the Training Set

As this is a physical medical device (a dialysate solution) and not an AI/ML algorithm that requires a "training set" of data, the concept of a training set sample size is not applicable and therefore not provided in the document.

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

Since there is no "training set," this information is not applicable and not provided.

Summary of Key Takeaways from the document:

• The submission is for a device modification of a previously cleared dialysate.
• The primary method of demonstrating acceptability is through substantial equivalence to the predicate device (K033386), compliance with design control requirements (21 CFR 820.30), and performance of design validation testing.
• Specific quantitative acceptance criteria or detailed results of performance testing are not included in this summary document, which is typical for a 510(k) summary relying on substantial equivalence and design control certification for a non-AI/diagnostic device.
• The concepts of "test set," "expert ground truth," "adjudication," "MRMC studies," "standalone algorithm performance," and "training set" are not relevant or applicable to this type of device and submission as presented.

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