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Purify water used in hemodialysis treatment in dialysis centers/facilities having multiple treatment stations. Purify water used in hemodialysis treatment in hospital intensive care units, critical care units, pediatric intensive care units, and other acute care applications within a hospital setting.

Water purification system for hemodialysis. The typical customized system is configured with booster pump, multimedia filtration, water softener, carbon filter, reverse osmosis, storage tank, ultra-filtration, deionization tanks, audible and visual alarms, and other components that purify water as a function of feed water quality and required capacity. The system product water complies with the AAMI Standard RD62:2001, Water Treatment Equipment for Hemodialysis Applications.

The provided text describes a water purification system for dialysis and its compliance with relevant standards. Here's an analysis based on your request:

1. Table of Acceptance Criteria and Reported Device Performance

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

• Sample Size: A "sample of the product water produced by the system is taken" after installation. The exact number of samples or the duration of sampling is not specified.
• Data Provenance: The water samples are analyzed by an "independent laboratory." The country of origin of this data is not explicitly stated, but given the submission is to the FDA in the USA, it's likely the testing occurred within the USA or by a lab recognized by US standards. The testing is prospective in the sense that it's conducted after the installation of the system to verify its performance in a real-world setting.

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

Not applicable. This device is a water purification system, and the ground truth for its performance is established through laboratory analysis of water quality against predefined chemical and physical parameters, not through expert human interpretation of medical images or data.

4. Adjudication Method for the Test Set

Not applicable. The "ground truth" (compliance with standards) is determined by laboratory analysis and comparison to AAMI and USP standards, not by human adjudication of differing opinions.

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 a diagnostic device involving human readers or AI assistance in a medical interpretation context.

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. Its performance is measured by the quality of the water it produces.

7. The Type of Ground Truth Used

The ground truth used is based on objective standards and laboratory measurements:

• Compliance with AAMI Standard RD62:2001 for Water Treatment Equipment for Hemodialysis Applications.
• Compliance with USP (United States Pharmacopeia) standards for Total Organic Carbon.
• Comparison of measured contaminant levels to maximum permitted levels for purified water.

8. The Sample Size for the Training Set

Not applicable. This device does not use machine learning or AI that would require a "training set." It's a manufactured system whose performance is validated post-installation.

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

Not applicable, as there is no training set for this type of device.

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The device is intended to remove organic and inorganic substances and microbial contaminants from water that is used to dilute dialysis concentrate to form dialysate and to produce purified water for dialyzer reprocessing and equipment rinse and disinfection.

The WPT Water purification System has been developed around the Osmonics 23G Reverse Osmosis machine and the use of deionizer exchange tanks to demineralize the feed water. The feed water passes through three separate stages in the purification process before the required quality of product water is achieved. These stages are referred to as: Pre-treatment using a Water Softener to remove scale forming minerals, a Multi-media Filter and Pre-Filter to remove suspended particulate solids and Activated Carbon Filters to remove organics e.g. chlorines and chloramines. Primary Treatment using a Reverse Osmosis (RO) Machine and/or Mixed Bed Deionizers (DI), both of which have already been approved by the FDA, to demineralize the water. Post Treatment using Mixed Bed Deionizers (DI), Ultraviolet Disinfection (UV) and a Submicron Post Filter to remove suspended solids and bacteria from product water prior to distribution to the point of use.

The provided document is a 510(k) summary for a Water Purification System intended for hemodialysis. It describes the device, its intended use, and its technological characteristics by comparing it to a predicate device. However, it does not contain any information about acceptance criteria or a study that proves the device meets specific performance metrics in the way a medical diagnostic AI device would.

The document explicitly states:

• Non-clinical tests: "Following the installation of the Water Purification System a sample of the product water, produced by the system, is taken and analyzed by an independent laboratory to determine the level of contaminants present in the water. These laboratory results are compared with the maximum permitted level for each contaminant in order to determine that the water produced by the system meets the customers requirements for purified water."
• Clinical tests: "There are no clinical tests submitted, referenced or relied upon in this submission."

Therefore, I cannot extract the requested information regarding acceptance criteria and performance study details that are typically associated with AI-based medical devices or comparative effectiveness studies. The device is a physical water purification system, not an AI or diagnostic algorithm, and its "performance" is assessed by laboratory water quality analysis against established contaminant levels, not through metrics like sensitivity, specificity, or reader studies.

If you are looking for an example of a device that would contain the information you are requesting in its 510(k) submission, it would typically be a diagnostic imaging AI algorithm or a similar software-as-a-medical-device (SaMD).

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The USFitter water punfication systems discussed in this premarket notification are intended for use in hemodialysis applications. The water purification systems are used to remove organic and inorganic substances and microbial contaminants from the subcent can be dilute dialysis concentrate to form water used to cince broyous began for other Gialysate, and rinse and disinfection.

Water Purification System

The provided documents are a 510(k) clearance letter and an "Indications For Use" statement for a medical device. This type of document from the FDA relates to the regulatory approval process for medical devices and does not contain information about acceptance criteria or a study proving that a device meets those criteria.

The 510(k) clearance process determines "substantial equivalence" to a predicate device, which is a regulatory standard, not a performance standard based on a clinical or performance study with acceptance criteria in the way you've described.

Therefore, I cannot extract the requested information (acceptance criteria, device performance, study details, sample sizes, expert qualifications, ground truth, MRMC study, standalone performance) from the provided text because it is not present in these documents.

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