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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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