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The NxStage Water Purification System is a stand-alone water treatment system designed to pretreat and purify water for use in hemodialysis applications. The purified water can be used in preparation of dialysate, equipment rinsing and disinfection, and dialyzer reprocessing. It is intended to be used in a variety of environments, including acute or chronic care facility or home.

The NxStage Water Purification System is a stand-alone water System designed to pre-treat and purify water for use with hemodialysis applications. The purified water can be used in preparation of dialysate, equipment rinsing and disinfection, and dialyzer reprocessing. The System is intended to be used in a variety of environments, including an acute or chronic care facility or the home. There are no known contraindications with the use of the NxStage Water Purification System.

The System is single patient use and is comprised of three major components: 1) a pretreatment system which consists of a check valve, sediment filter and air vent to remove trapped air, sediment, and any impurities, 2) a Pump Controller unit which contains the control and safety software that controls the flow rate, monitors pressure, water quality and system operation and 3) a replaceable resin system that removes organic and inorganic chemical contaminants as well as microbiological contaminants such as bacteria and endotoxins. The System flow rate is specified by the end user.

With proper use, the System will produce water that meets or exceeds the requirements of the standard issued by the American National Standard Institute and the Association for the Advancement of Medical Instrumentation: ANSI/AAMI RD62:2001, Water Treatment Equipment for Hemodialysis Applications.

Here's an analysis of the provided text regarding the NxStage Water Purification System, focusing on acceptance criteria and study details.

Important Note: The provided document is a 510(k) Summary of Safety & Effectiveness and an FDA clearance letter. These documents typically summarize testing and do not contain detailed study protocols, raw data, or comprehensive statistical analyses. Therefore, some information, especially regarding specific sample sizes for training sets, adjudication, or detailed effect sizes for MRMC studies, is not present in this type of document and cannot be extracted. The focus of this document is on demonstrating substantial equivalence to predicate devices and meeting established standards.

Acceptance Criteria and Device Performance

The core acceptance criteria for the NxStage Water Purification System are defined by its ability to meet or exceed the requirements of the American National Standard Institute and the Association for the Advancement of Medical Instrumentation (ANSI/AAMI) RD62:2001, Water Treatment Equipment for Hemodialysis Applications.

Table 1: Acceptance Criteria and Reported Device Performance

Study Information

Based on the provided text, the study conducted was a non-clinical performance testing to demonstrate that the NxStage Water Purification System is substantially equivalent to predicate devices and meets the specified ANSI/AAMI standard.

1. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
* Test Set Sample Size: The document does not specify a numerical sample size for the test set (e.g., number of water samples tested, number of systems tested). It broadly refers to "Performance testing." For a water purification system, this would typically involve testing multiple units over a period of time with various water sources.
* Data Provenance: The document does not specify the country of origin of the data. It is internal testing conducted by "NxStage Medical." The study is described as "performance testing," which implies it was prospective testing of the device's functionality.

2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience):
* N/A. This device is a water purification system, not an imaging or diagnostic device that requires expert interpretation for establishing ground truth. Ground truth for water purity is established through chemical and microbiological laboratory analysis processes against industry standards.

3. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
* N/A. Adjudication methods like 2+1 or 3+1 are relevant for subjective interpretations, often in medical imaging. For a water purification system, the performance is assessed against objective, measurable chemical and microbiological standards, which do not typically involve human adjudication in this manner.

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:
* No. This is not applicable to a water purification system. An MRMC study is relevant for diagnostic devices involving human interpretation.

5. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
* Yes, in essence. The performance testing demonstrated the device's ability to purify water to specified standards "with proper use" of the system itself. While human interaction is required to operate and maintain the system, the purification process and its effectiveness are tested in a standalone manner (device's output measured against standards), independent of human "interpretation" of the water quality. The "Pump Controller unit which contains the control and safety software" functions as the "algorithm only" component controlling the purification process.

6. The type of ground truth used (expert consensus, pathology, outcomes data, etc):
* Objective Laboratory Analysis against Industry Standards. The ground truth for water purity is established by quantitative chemical and microbiological analysis of the treated water samples, compared directly to the specified maximum contaminant levels outlined in the ANSI/AAMI RD62:2001 standard.

7. The sample size for the training set:
* N/A. The concept of a "training set" is typically associated with machine learning or AI models. This device is a physical water purification system with a controller and safety software. While the software itself would have undergone development and testing, there's no mention or implication of machine learning that would necessitate a "training set" in the conventional sense.

8. How the ground truth for the training set was established:
* N/A. As mentioned above, the concept of a training set and its associated ground truth derivation (like for AI development) does not apply to this type of device based on the provided information.

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To produce from EPA-grade drinking water, sterile purified water to be used within 24-hours of collection that is suitable for:

• cleaning and rinsing open wounds; .
• infection control (cleaning equipment used in . medical procedures, medical personnel's hands);
• use as a diluent for enteral, nutritional, oral . vaccine or oral drug preparations; and
• all other uses of sterile purified water the . practitioner, or clinician deems necessary.
• Not for parenteral administration. .

PrISMedical's MainStream™ Water Purification Device (WPD) is a single-use device that will take approximately 3000 mL of drinking water (EPA-grade or equivalent) and remove:

• particulates
• dissolved solids
• organics and inorganics
• microbial contaminants
• endotoxins
  to produce water that meets the quality attributes of USP sterile purified water. This device comes in a 260-mL size to provide up to 3-liters of Sterile Purified Water, USP.
  The device incorporates several complementary processes:
• Prefiltration .
• Depth filtration .
• Deionization .
• Sterilizing membrane filtration ●

Here's a breakdown of the acceptance criteria and study information for the PrISMedical MainStream™ Water Purification Device, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly list quantitative "acceptance criteria" for the device, but rather states that the device produces water that "meets the quality attributes of USP sterile purified water" and "meets the standards of USP Sterile Purified Water." The performance is reported as meeting these standards.

The document also implies removal capabilities, which would be an aspect of performance leading to the USP standard:

• Removal of particulates
• Removal of dissolved solids
• Removal of organics and inorganics
• Removal of microbial contaminants
• Removal of endotoxins

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

• Sample Size for Test Set: Not explicitly stated. The document refers to "the results of our testing," but does not provide details on the number of tests performed or the sample size of water used for testing.
• Data Provenance: Not explicitly stated regarding country of origin or whether it was retrospective/prospective. The testing was conducted by PrISMedical Corporation.

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

• Number of Experts: Not applicable. The "ground truth" here is not established by human experts in the sense of medical image interpretation, but rather by objective chemical and microbial analysis against established compendial standards (USP Sterile Purified Water).
• Qualifications of Experts: Not applicable, as the ground truth is based on objective scientific standards rather than expert consensus on interpretations.

4. Adjudication Method for the Test Set

• Adjudication Method: Not applicable. The "ground truth" is determined by objective laboratory analysis against the USP standards, not by human adjudication of interpretations.

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

• MRMC Study: No, this type of study was not done. An MRMC study is typically used for diagnostic devices involving human interpretation of medical images. This device is a water purification system, and its performance is assessed against objective water quality standards.

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

• Standalone Performance: Yes, in a manner of speaking, the study focuses on the standalone performance of the device. The "algorithm" here is the physical purification process of the device itself. Its performance is measured directly by analyzing the characteristics of the output water against the USP standards, without human intervention or interpretation influencing the water quality assessment. The device operates independently to produce the purified water.

7. The Type of Ground Truth Used

• Type of Ground Truth: The ground truth used is compendial standards, specifically the standards for USP Sterile Purified Water. This is an objective, defined set of chemical, physical, and microbiological criteria that purified water must meet.

8. The Sample Size for the Training Set

• Sample Size for Training Set: Not applicable. This document describes a physical medical device (water purification system), not an AI/machine learning algorithm that requires a "training set" of data. The device's design and manufacturing process are developed through engineering and scientific principles, not by training on a dataset in the way an AI model would be.

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

• How Ground Truth for Training Set Was Established: Not applicable, as there is no "training set" in the context of this device. The design of the device is based on established principles of water filtration and purification to achieve the desired output water quality.

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