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The Pure Water, Inc.'s Bicarb Mix, Storage and Distribution system is intended to be used in the mixing, storage and distribution of Bicarb liquid concentrate to be used in the treatment of Hemodialysis patients.

Pure Water, Inc.'s Bicarb Mix, Storage and Distribution System uses Reverse Osmosis, provides for batch mixing of Bicarb liquid concentrate, transfer to storage and delivery to point of use.
The Bicarb Mix Tank allows Bicarb liquid concentrate to be mixed in batches then transferred to a Storage Tank.
The Storage and Distribution components of the system serve to deliver Bicarb liquid concentrate to the point of use.
Pure Water, Inc.'s Bicarb Mix, Storage and Distribution System can be customized to best meet the needs of the user.
Pure Water, Inc.'s Bicarb Mix, Storage and Distribution System meets or exceeds all Association for the Advancement of Medial Instrumentation (AAMI) National Standards for Hemodialysis.

This document describes a medical device called "Pure Water, Inc.'s Bicarb Mix, Storage and Distribution System" which is intended for hemodialysis patients. It is a physical system for mixing, storing, and distributing bicarbonate liquid concentrate. The information provided in the K993272 submission is a summary for regulatory approval, not a performance study report for a diagnostic AI/ML device. Therefore, the requested information regarding acceptance criteria, study details, expert consensus, and training/test set specifics for an AI/ML device is not applicable to this document.

The submission states that the device "meets or exceeds all Association for the Advancement of Medial Instrumentation (AAMI) National Standards for Hemodialysis," which serves as its acceptance criterion for safety and efficacy in its intended use. However, it does not provide specific performance metrics or a study in the format typically associated with AI/ML device validation.

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The Pure Water, Inc. Water Purification System is intended to be used in the purification of water to be used to dilute dialysate concentrate and in the reprocessing of dialyzers for reuse.

The Pure Water, Inc. Water Purification System uses Reverse Osmosis technology to produce pure water. Reverse Osmosis utilizes a semi-permeable membrane and high hydrostatic pressure. Pretreatment is used for the purpose of removing elements present in the source water that can damage the RO membranes. The storage and distribution components of the system serves to deliver pure water produced by the RO to the point of use. The Pure Water, Inc. Water Purification System can be customized to best meet the water needs of the user.

This document is a 510(k) summary for a water purification system, not a study report for a diagnostic or AI-driven device. Therefore, most of the requested information regarding acceptance criteria, study design, expert involvement, and ground truth establishment is not applicable to this submission.

Here's a breakdown of the relevant information from the provided text:

1. Table of acceptance criteria and the reported device performance

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

Not applicable. This is a 510(k) premarket notification for a water purification system, not a study involving a test set of data. The "performance" relates to compliance with engineering standards, not diagnostic accuracy on a dataset.

3. 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)

Not applicable. Ground truth, in the context of an expert establishing it for a test set, is relevant for diagnostic devices or those involving interpretation. This device is a water purification system. Compliance with AAMI standards is typically verified through engineering tests and quality control, not expert review of a "test set."

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

Not applicable. No test set requiring adjudication is described.

5. 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 is not an AI-driven device or one that involves human readers for interpretation.

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

Not applicable. This is a physical water purification system, not an algorithm.

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

The "ground truth" for this device's performance is adherence to the Association for the Advancement of Medical Instrumentation (AAMI) National Standards for Hemodialysis. This is an engineering and quality standard, not a clinical ground truth like pathology or expert consensus.

8. The sample size for the training set

Not applicable. There is no training set for this type of device.

9. How the ground truth for the training set was established

Not applicable. There is no training set for this type of device.

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The Pure Water, Inc. Acidified Storage and Distribution system with Remote Fill is intended to be used in Hemodialysis facilities for the storage and distribution of acid concentrate to be used in the treatment of hemodialysis patients.

Pure Water, Inc.'s Acidified Storage and Distribution System with Optional Remote Fill uses "one-piece molded seamless tanks constructed of linear polyethylene" for bulk storage of acidified concentrate.

The Optional Remote Fill allows the storage tanks to be filled by the vendor from outside the building.

Pure Water, Inc.'s Acidified Storage and Distribution System with optional Remote Fill meets or exceeds all Association for the Advancement of Medical Instrumentation (AAMI) National Standards for Hemodialysis.

This 510(k) summary describes a medical device, the Pure Water, Inc. Acidified Storage and Distribution System, but it is not an AI/ML powered device. Therefore, most of the requested information regarding AI/ML device studies (such as sample sizes for test and training sets, ground truth establishment methods, expert qualifications, adjudication methods, and MRMC studies) is not applicable to this document.

However, based on the provided text, I can infer the following about the device's acceptance criteria and how it aims to meet them:

1. Table of Acceptance Criteria and Reported Device Performance:

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):

• Not applicable. This device is an physical medical device (storage and distribution system), not an AI/ML software device that relies on a "test set" of data for performance evaluation. Its performance is demonstrated through adherence to manufacturing standards and functional equivalence to predicate devices.

3. 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):

• Not applicable. Ground truth in the context of AI/ML testing is not relevant for this physical device. The "ground truth" for this device's acceptance is its compliance with established industry standards (AAMI) and functional equivalence to predicate devices, which are assessed through engineering and manufacturing processes, not expert review of a "test set."

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

• Not applicable. This concept relates to resolving discrepancies in ground truth labeling for AI/ML datasets and is not relevant to the evaluation of this physical device.

5. 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 not an AI-assisted diagnostic or interpretive tool, so MRMC studies are not relevant.

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

• Not applicable. This is a physical device, not an algorithm.

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

• For this physical medical device, the "ground truth" is established by:
  • Compliance with recognized national standards: Specifically, the Association for the Advancement of Medical Instrumentation (AAMI) National Standards for Hemodialysis. These standards themselves are developed through expert consensus and industry best practices to ensure safety and efficacy.
  • Functional equivalence to predicate devices: The FDA's substantial equivalence determination relies on comparing the new device's technological characteristics and performance to those of legally marketed predicate devices. This implies that the predicate devices' prior approval and safe use serve as a form of "ground truth" for the new device's acceptable performance.

8. The sample size for the training set:

• Not applicable. There is no "training set" for this type of physical device.

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

• Not applicable. See point 8.

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