(158 days)
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
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Meets or exceeds all Association for the Advancement of Medical Instrumentation (AAMI) National Standards for Hemodialysis. | The Pure Water, Inc. Water Purification System meets or exceeds all Association for the Advancement of Medical Instrumentation (AAMI) National Standards for Hemodialysis. |
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.
§ 876.5665 Water purification system for hemodialysis.
(a)
Identification. A water purification system for hemodialysis is a device that is intended for use with a hemodialysis system and that is intended to remove organic and inorganic substances and microbial contaminants from water used to dilute dialysate concentrate to form dialysate. This generic type of device may include a water softener, sediment filter, carbon filter, and water distillation system.(b)
Classification. Class II (special controls). The device, when it is a water purification subsystem disinfectant, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 876.9.