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(231 days)
Mueller Water Conditioning's Water Purification System for Hemodialysis is intended for use in hemodialysis treatment. The System is used to dilute dialysate concentrate to form dialysate and to remove organic and inorganic substances and microbial contaminants from water used to dilute dialysate. When used to produce purified water for dialyzer reprocessing, equipment rinse and disinfection. When used as a medical device, Federal law restricts this device to sale by or on the order of a physician.
The Mueller RO/Di system for hemodialysis treats incoming facility water to provide water conforming to AAMI standards for hemodialysis use in respect to organic and inorganic substances as well as microbial. The water is intended for use as dilute dialysate, as dilute dialysate, as dilute dialysate, bicarbonate, acetate and sterilant for dialyzer reprocessing.
The core components of the system include carbon filters along with reverse osmosis (RO) unit and portable exchange deionization tanks along with alarms to remove oxidants from the water that are harmful to patient health. The specific configuration of the equipment will depend upon the customer's water quality desires (specifications) beyond the minimum AAMI standards.
Pretreatment is used before the RO unit to match the specific influent water quality to those required by the RO unit manufacturer's specifications. Pretreatment will include multi-media filtration, water softening, carbon filtration, and sediment filtration.
Post treatment is used after the RO unit to polish and monitor the water of any remaining contaminants. Deionization tanks, final filters, UV lamps, storage tanks, repressurization and recirculation pumps, flow meters, and resistivity monitors are examples of post treatment machines.
The Mueller Water Conditioning, Inc. (MWCI) water purification system utilizes no new water treatment technologies. Multimedia filtration, cartridge filtration, carbon filtration, reverse osmosis (R.O.), deionization, ultraviolet light and particulate filtration are the core methods of treatment for this system. The storage, piping, repressurization, recirculation, emergency bypasses, sanitization, labeling, training and customer service round out the efforts to ensure proper delivery of the treated water. All components of the claimed device use identical scientific principles to perform their function.
Here's an analysis of the provided text regarding the Mueller RO/DI System for Hemodialysis, focusing on acceptance criteria and the study proving it.
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria for the Mueller RO/DI System for Hemodialysis are the AAMI (Association for the Advancement of Medical Instrumentation) standards for water used in hemodialysis. The reported device performance is presented as a list of chemical component concentrations in the treated water.
| Component | Acceptance Criteria (Reference/AAMI Standard) | Reported Device Performance (Result) | Units | Meets or Exceeds AAMI Standards |
|---|---|---|---|---|
| Sodium Water | 70 | 0.054 | mg/L | Yes |
| Potassium, Water | 0.8 | <1.000 | mg/L | Yes |
| Aluminum, Water | 0.01 | <0.008 | mg/L | Yes |
| Calcium, Water | 0-2 | <0.050 | mg/L | Yes |
| Copper, Water | 0-0.1 | <0.005 | mg/L | Yes |
| Magnesium, Water | 0-4 | <0.050 | mg/L | Yes |
| Selenium, Water | 0-0.09 | <0.005 | mg/L | Yes |
| Zinc, Water | 0-0.1 | <0.005 | mg/L | Yes |
| Chromium, Water | 0-0.014 | <0.005 | mg/L | Yes |
| Chlorine | 0.5 | 0.0 | mg/L | Yes |
| Chloramine | 0.1 | 0.0 | mg/L | Yes |
| Lead, Water | 0-0.005 | <0.002 | mg/L | Yes |
| Arsenic, Water | 0-0.005 | <0.002 | mg/L | Yes |
| Mercury, Water | 0-0.0002 | <0.0002 | mg/L | Yes |
| Cadmium, Water | 0-0.001 | <0.0010 | mg/L | Yes |
| Beryllium, Water | 0-0.0004 | <0.0004 | mg/L | Yes |
| Antimony, Water | 0-0.006 | <0.006 | mg/L | Yes |
| Thallium, Water | 0-0.002 | <0.002 | mg/L | Yes |
| Silver, Water | 0-0.005 | <0.003 | mg/L | Yes |
| Barium, Water | 0-0.1 | <0.001 | mg/L | Yes |
| Fluoride, Water | 0-0.20 | <0.10 | mg/L | Yes |
| Nitrate, Water | 0-2.0 | <0.2 | mg/L | Yes |
| Sulfate, Water | 0-100 | <1.0 | mg/L | Yes |
| pH | (Not specified) | 5.7 | UNITS | (N/A) |
| Resistivity | (Not specified) | 0.769 | (N/A) |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: The document does not explicitly state the numerical sample size for the test set. It refers to "the following data was obtained from a test system installed at our facility in Houston, TX." This implies a single test system operating under specific conditions to generate all the listed chemical measurement results.
- Data Provenance: The data was collected from a "test system installed at our facility in Houston, TX." This indicates it is prospective data, specifically collected for the purpose of demonstrating the device's performance. The country of origin for the data is the USA (Houston, Texas).
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
The document does not describe the use of human experts to establish ground truth for this type of device. The ground truth here is based on analytical laboratory measurements of water quality, compared against established AAMI standards.
4. Adjudication Method for the Test Set
There is no mention of an adjudication method in the context of expert review for the test set. The validation is against a standardized chemical analysis.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
A Multi-Reader Multi-Case (MRMC) comparative effectiveness study is not applicable to this type of device. This device is a water purification system, and its performance is evaluated by objective chemical and physical measurements of the treated water, not by human interpretation of medical cases. Therefore, there is no "human readers improve with AI vs without AI assistance" effect size to report.
6. Standalone Performance (Algorithm Only without Human-in-the-Loop Performance)
The study presented here is effectively a standalone performance evaluation of the water purification system. The "algorithm" in this context is the physical and chemical processes of the device itself. The data reported (concentrations of various substances) directly reflects the output of the device without human intervention or interpretation in the performance measurement itself. Human operators set up and maintain the system, but the water purification process and its measurable output are standalone.
7. Type of Ground Truth Used
The type of ground truth used is analytical laboratory measurements of water quality, compared to established industry standards (AAMI Standards). For example, the measurement of "Sodium Water" at 0.054 mg/L is compared directly to the AAMI reference standard of 70 mg/L.
8. Sample Size for the Training Set
The document does not mention a training set. This is because the Mueller RO/DI System is a physical device, not an AI/machine learning algorithm. Therefore, it does not undergo a "training" phase in the computational sense. Its design and components (carbon filters, RO unit, deionization tanks, etc.) are based on established water treatment principles and engineering, not on data-driven machine learning.
9. How the Ground Truth for the Training Set Was Established
As there is no training set in the context of AI/machine learning, this point is not applicable. The "ground truth" for the device's design and functionality is based on scientific principles of water purification and manufacturing specifications for its components, ensuring they can achieve the desired water quality according to AAMI standards.
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