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The water treatment system and its components consisting of; pretreatment, reverse osmosis machine, and the product water distribution components, are designed to remove microbiological, organic, and inorganic contaminants from the tap water to supply dialysis machines for the preparation of dialysate solutions for hemodialysis treatments.

NOTE: Federal Law restricts this device to sale by or on the order of a physician for use as a water treatment device for hemodialysis.

The water treatment system and its components consisting of; pre-treatment, reverse osmosis machine, and the product water distribution components, are designed to remove microbiological, organic, and inorganic contaminants from the tap water to supply dialysis machines for the preparation of dialysate solutions for hemodialysis treatments.

Pretreatment components can include a tap water retroutinem, blending valve, sediment filtration, boosting Systems, water softeners, and all the carbon roll of reconnecting plumbing. The purpose of this part of the system is to ensure that properly conditioned water is supplied to the reverse oonditionsachine to ensure its safe and trouble free operation. The blending valve ensures that the operation: The proper temperature when entering the reverse osmosis machine. The tap water booster system helps ensure that the reverse osmosis systhine has adequate water pressure and volume so it can produce the desired amount of water. The i sediment filters can be in the form of an automatic backwashing filter (such as a multi-media depth filter), or as a replaceable filter cartridge. The carbon filters are installed primarily to remove the amount of chlorine and chloramines from the water to meet the necessary water quality standards and can be in the form of automatic backwashing tanks, or portable exchange tanks. The water softener(s) are in place to remove the hardness from the tap water to both meet water quality standards, and to protect the reverse osmosis membranes from scaling and therefore not performing to specifications.

After the tap water has been pre-treated, it then enters the R.O. (reverse osmosis), where total dissolved solids are removed to pertinent water quality standards. This is accomplished by utilizing a membrane separation process, whereby the incoming water is separated into a product stream, and a concentrate stream. The molecular weight cut-off determines what and how many contaminants are passed through into the product stream. R.O.s used for this application typically remove 95-99% of all total dissolved solids and bacteria.

The product water distribution part of the system is in place to store, provide additional purification if needed, and deliver the purified water to wherever needed. These components can include such things as a storage tank, deionization tanks, final filters (for bacteria and endotoxins), and delivery pumps and controls. Some systems can also utilize an ultraviolet light for additional sterilization properties.

Here's an analysis of the provided text regarding the acceptance criteria and study for the Performance Water Treatment System:

The provided document (K033648) is a 510(k) Summary of Safety and Effectiveness for a medical device. This type of submission focuses on demonstrating substantial equivalence to a predicate device, rather than proving efficacy through clinical studies with strict acceptance criteria often seen with novel high-risk devices.

Therefore, many of the typical elements you'd expect for acceptance criteria and a study design proving a device meets those criteria (like sample size, number of experts, adjudication methods, MRMC studies, standalone performance metrics, training set details) are not present in this type of document for this class of device.

The "study" here is essentially a non-clinical performance data assessment to show compliance with a recognized standard.

Acceptance Criteria and Reported Device Performance

Explanation: The acceptance criterion is the mandate to meet the specific AAMI standard for water quality in hemodialysis. The reported device performance is a statement that the device does indeed comply with this standard. The K033648 document does not provide specific numerical values for various water parameters (e.g., conductivity, levels of specific contaminants) that would typically be detailed within AAMI RD62-2001. Instead, it makes a general claim of compliance.

Details Pertaining to the "Study" Proving Compliance:

The document does not describe a traditional clinical or performance study with the detailed elements requested. Instead, it refers to "Non-Clinical Performance Data."

1. Sample size used for the test set and the data provenance:

   • Sample Size: Not specified. This would typically involve testing water samples produced by the system.
   • Data Provenance: Not specified, but likely obtained through laboratory testing of the system's output water. The document does not indicate country of origin or whether it was retrospective/prospective. Given it's pre-market, it would inherently be prospective testing for the submission.

2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

   • Number of Experts: Not applicable. The "ground truth" here is objective measurement against established water quality standards (AAMI RD62-2001), not subjective expert interpretation.
   • Qualifications of Experts: N/A.

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

   • Adjudication Method: Not applicable. This is not a study requiring human interpretation or adjudication. Compliance is based on analytical measurements.

4. 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:

   • MRMC Study: No. This is a water purification system, not an AI-assisted diagnostic device.

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

   • Standalone Performance: The "standalone performance" is the system's ability to produce compliant water on its own without human intervention (beyond operation and maintenance). The statement of compliance with AAMI RD62-2001 serves as the evidence of this. There is no algorithm in the sense of AI.

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

   • Type of Ground Truth: Established objective physical and chemical water quality standards as defined by AAMI RD62-2001. These standards specify maximum allowable concentrations for various contaminants (e.g., chemical, microbiological, endotoxin).

7. The sample size for the training set:

   • Sample Size for Training Set: Not applicable. This is not a machine learning or AI algorithm.

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

   • Ground Truth for Training Set: Not applicable.

Summary of Approach in K033648:

The K033648 submission for the Performance Water Treatment System primarily relies on demonstrating substantial equivalence to a legally marketed predicate device (Better Water, Inc. Water Purification System for Hemodialysis, K#920186/C).

The "study" or evidence to support the claim of safety and effectiveness, in this context, is the non-clinical performance data showing that the product water produced by the device complies with the AAMI RD62-2001 standard. For water purification systems in this class, meeting recognized standards is the primary method of demonstrating performance and safety, as opposed to complex clinical trials or AI performance evaluations involving human readers.

The document states: "Both the predicate device systems and the Performance Water Treatment System utilize reverse osmosis technology as the primary means of purification, and all utilize an R.O. which has 510(k) clearance from the FDA." This further reinforces the substantial equivalence argument based on similar technology and intended use, along with demonstrating compliance to critical water quality standards.

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