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UPT Series Medical Reverse Osmosis Water Treatment System is intended to be used to remove organic and inorganic contaminants from a tap water supply to dilute a dialysate concentrate for hemodialysis treatments, as well as for use for dialyzer reprocessing and dialysis equipment disinfecting and rinsing.

This System is for multi patient use, such as for a dialysis clinic or hospital serving multiple patients with a Central Water Purification System.

The UPT Series Medical Reverse Osmosis Water Treatment System and its components consisting of; pretreatment, reverse osmosis, post-treatment, 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 boosting system, blending valve, sediment filtration, carbon removal filters, water softeners, and all the necessary interconnecting plumbing. The purpose of this part of the system is to ensure that properly conditioned water is supplied to the reverse osmosis machine to ensure its safe and trouble-free operation.

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 post treatment and 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 items such as a storage tank, final filters (for bacteria and endotoxins), and delivery pumps and controls. Some systems can also utilize an ultraviolet light for additional disinfection properties if needed.

Here's an analysis of the provided text regarding acceptance criteria and study information for the UPT Series Medical RO Water Treatment System:

Summary of Acceptance Criteria and Study Details from the Provided Document K250514

Based on the provided document, the K250514 submission is for a modification to an existing device (UPT Series Medical Reverse Osmosis Water Treatment System, primary predicate K151637), specifically a clarification to its Indications for Use. Therefore, the document explicitly states that no new verification or validation performance testing was required or conducted for this update.

The conclusion section states: "Inclusive of this labeling update, the UPT Series Medical Reverse Osmosis Water Treatment System continues to meet all of its established acceptance criteria that were based upon performance of the primary predicate device." This means that the acceptance criteria and the studies proving the device meets them were originally established and performed for the primary predicate device (K151637). This current submission is a reaffirmation that the existing device still meets those established criteria despite the minor labeling change.

Therefore, the requested information cannot be fully populated from this document for the K250514 submission itself, as it refers back to the original predicate device's evaluation.

Detailed Response based on the provided K250514 document:

1. Table of Acceptance Criteria and Reported Device Performance:

   Acceptance Criterion	Reported Device Performance (for K250514)
   Water purification standards for hemodialysis (e.g., removal of microbiological, organic, and inorganic contaminants)	"The UPT Series Medical Reverse Osmosis Water Treatment System continues to meet all of its established acceptance criteria that were based upon performance of the primary predicate device."
   Safe and effective operation for hemodialysis treatments.	"This demonstrates that the device function is as safe, as effective, and performs as well as the primary predicate device."

   Explanation: The document does not list specific numerical or qualitative acceptance criteria beyond general statements that the system meets established standards for hemodialysis water purification. It refers to the performance established for its primary predicate device (K151637).

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

   • Sample Size: Not applicable. "No verification or validation performance testing was required for this labeling update."
   • Data Provenance: Not applicable for K250514. The original studies would have been associated with the primary predicate (K151637).

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 as no new performance testing was conducted for K250514.

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

   • Not applicable as no new performance testing was conducted for K250514.

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 a water treatment system, not an AI-assisted diagnostic tool for human readers.

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

   • Not applicable. This device is a water treatment system, not an algorithm. However, the system itself operates in a standalone capacity to purify water (without human cognitive input in its core function). The functional performance evaluation related to water quality would constitute its "standalone performance." The current submission states this performance was previously established for the predicate device.

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

   • For the original predicate device (K151637), the ground truth for its performance would likely have involved chemical and microbiological analytical testing of the treated water to ensure it met relevant AAMI standards (e.g., ANSI/AAMI RD52, ANSI/AAMI EQ82) for hemodialysis water quality. The document does not provide details on the specific "ground truth" methods used for the predicate.

8. The sample size for the training set:

   • Not applicable. This device is a water treatment system, not an AI/machine learning algorithm that requires a training set.

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

   • Not applicable. This device is a water treatment system, not an AI/machine learning algorithm.

In conclusion, K250514 is a submission for a minor labeling change to an already cleared device. It explicitly states that no new performance testing was required or conducted. All acceptance criteria and proof of meeting those criteria refer back to the studies performed for the original primary predicate device (K151637). To get detailed information about the original acceptance criteria and validation studies, one would need to consult the 510(k) submission for K151637.

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UPT Series Medical Reverse Osmosis Water Treatment System is intended to be used to remove organic and inorganic contaminants from a tap water supply to dilute a dialysate concentrate for hemodialysis treatments, as well as for use for dialyzer reprocessing and dialysis equipment disinfecting and rinsing.

This System is strictly for multi patient use, such as for a dialysis clinic or hospital serving multiple patients with a Central Water Purification System and is intended for use only with conventional hemodialysis treatments. It is not intended for use with high-flux, CRRT, or any other form of dialysis.

The UPT Series Medical Reverse Osmosis Water Treatment System is an accessory device that is intended for use with hemodialysis applications and is intended to remove orqanic and inorganic substances and microbial contaminates from tap water used to dilute dialysis concentrate to form dialysate. The UPT Series Medical Reverse Osmosis Water Treatment System will produce water as prescribed by the Association for the Advancement of Medical Instrumentation (AAMI) Standard ANSI/AAMI/ISO 13959:2014 Water for Hemodialysis and Related Therapies provided adequate flow rate of the feed (tap) water and compliance with existing drinking water standards and proper pre-treatment.

The provided document is a 510(k) premarket notification decision letter and summary for a water purification system. It does not contain information about software or AI, and therefore does not have the kind of performance data, study designs, or ground truth information typically associated with AI/ML device submissions.

The document discusses the UPT Series Medical Reverse Osmosis Water Treatment System, which is a physical device intended to remove contaminants from tap water for hemodialysis. The criteria and "study" proving its acceptance are based on its ability to produce water meeting known standards, rather than statistical performance metrics of an AI model.

Here's a breakdown based on the information available:

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample size used for the test set and the data provenance

The document does not describe a "test set" in the context of an AI/ML device. The "study" refers to the device's ability to consistently output water meeting specific AAMI standards. The evaluation likely involved testing physical prototypes or production units to verify their functionality and water quality output under various operating conditions. No specific sample size or provenance for such testing is mentioned, as it is a device performance verification, not a data-driven model evaluation.

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

Not applicable. The "ground truth" here is objective water quality standards (AAMI/ISO standards) and functional safety requirements, not expert consensus on medical images or clinical outcomes.

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

Not applicable. This is not a study involving human interpretation of data.

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 a water purification system, not an AI/ML medical device where human reader performance is relevant.

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

Not applicable. This device does not involve an algorithm with standalone performance. Its performance is the physical output of purified water meeting specified quality metrics.

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

The "ground truth" for this device is established regulatory and industry standards for water quality used in hemodialysis:

• ANSI/AAMI/ISO 13959:2014: Water for Hemodialysis and Related Therapies
• ANSI/AAMI/ISO 26722:2014: Water Treatment Equipment for Hemodialysis Applications and Related Therapies
• Electrical Safety Standards: EN/IEC 61000 series, UL, CSA approvals.

These are objective, quantitative standards for the physical and chemical properties of the water produced, and the safety of the equipment.

8. The sample size for the training set

Not applicable. This device is not an AI/ML model that undergoes training.

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

Not applicable. This device is not an AI/ML model that undergoes training using a ground truth dataset.

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