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H2Only Water Purification System for Hemodialysis is intended for use in hemodialysis treatment. It is intended to remove organic and inorganic substances and microbial contaminants from water used to dilute dialysate concentrate to form dialysate. When used as a medical device, Federal law restricts this device to sale by or on the order of a physician.

The H2Only Water Purification System for Hemodialysis is a complete water purification system and consists of either one (1) or two (2) reverse osmosis units (RO). Our recommendation to use an RO individually is based upon feed water quality and the demand of water to be used. Pretreatment includes activated carbon filtration media to remove organics, namely chlorine and chloramines. In order to optimize the performance of the RO system, the following items, are utilized: 1) a water break tank or back flow preventer as required; - booster pumps as required to increase the feed pressure to the treatment equipment; 2) - a water softener to remove scale-forming minerals; 3) - cartridge filters to remove suspended solids; 4) - a temperature blending valve to produce the desired water temperature. 5) In order to compensate for fluctuations in demand, an air-tight storage tank with a 0.2 micron vent filter, level control and internal spray array is utilized to store RO product water until needed. The first RO system feeds the storage tank, the second RO system is fed from the storage tank and its product water is directly fed to the distribution plumbing. What ever water is not used in the distribution loop is returned to the storage tank, thus a constant recirculation flow is maintained in the distribution plumbing loop. - when only one RO system is utilized, Ultraviolet disinfection, Deionization Exchange 6) Tanks and Ultrafilters are also incorporated into the system design. By utilizing this twin RO system concept a few components can be eliminated from the system design. These components are: Deionization backup tanks, ultraviolet sanitizer, ultrafilters and repressurization pumps. The elimination of these additional components improves system reliability and reduces overall system operational costs . Also by using the twin RO design the system may be safely operated on either RO system feeding the distribution loop, this feature provides system backup and eliminates down time. When feed water quality demands or when requested by the facility physician, optional devices can include the following components: - cartridge filtration for the removal of silt or feed water sediment; 1) - 2) automatic backwashing multimedia fitter for the removal of suspended solids; - 3) ultraviolet disinfection to reduce bacteria either in the influent water supply or on the product supply; - 4) a booster pump to increase influent water pressure sufficient to provide adequate flow and pressure to the water treatment system. Water treatment components are recommended based on the demand of water required, a feed water analysis, and the ability to produce water which meets AAMI standards. H2Only Water Systems will always recommend a water purfication system which will exceed Hemodialysis Water Quality Standards as set forth by AAMI.

The provided text describes the H2Only Complete Water Purification System for Hemodialysis. However, it does not contain information about specific acceptance criteria, a detailed study proving performance against those criteria, or the methodology typically associated with validating AI/software-based medical devices (like sample sizes for test/training sets, ground truth establishment, expert adjudication, or MRMC studies).

Instead, the document is a 510(k) submission summary for a physical water purification system, focusing on its design, components, and how it achieves "substantial equivalence" to predicate devices. The performance is generally stated in terms of compliance with AAMI standards for water quality in hemodialysis.

Therefore, I cannot populate most of the requested fields because the information is not present in the provided text. I will indicate "Not Applicable" or "Not Provided" where the information is missing or not relevant to this type of device submission.

Here's a breakdown of the available and missing information based on your request:

1. Table of acceptance criteria and the reported device performance:

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
Not provided. This is a physical device, and the submission does not detail a "test set" in the context of data for an AI/software device. Performance is typically validated through engineering tests and adherence to standards.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
Not applicable. No "ground truth" establishment in the context of expert review for a physical water purification system.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
Not applicable.

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 physical water purification system, not an AI-assisted diagnostic tool.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
Not applicable.

7. The type of ground truth used (expert concensus, pathology, outcomes data, etc):
Not applicable in the context of AI/software validation. For this physical device, "ground truth" would be established by laboratory testing of the water quality against AAMI standards.

8. The sample size for the training set:
Not applicable. No training set for an AI/software device.

9. How the ground truth for the training set was established:
Not applicable.

Summary of the "Study" (as presented in the document):

The "study" or validation presented in this 510(k) submission is primarily based on technical specifications, design principles, and claiming substantial equivalence to legally marketed predicate devices.

• Device Meets Acceptance Criteria: The submission implicitly states that the device meets acceptance criteria by asserting its design is engineered to produce water that "meets or exceeds AAMI standards" for hemodialysis water quality. The various components (RO units, carbon filters, softeners, UV, DI tanks, ultrafilters) are described with their specific functions that contribute to achieving these standards by removing organic/inorganic substances and microbial contaminants.
• Proof of Performance: The proof of performance relies on the design and component selection of the H2Only system, stating that "Water treatment components are recommended based on the demand of water required, a feed water analysis, and the ability to produce water which meets AAMI standards." The system is designed to "exceed Hemodialysis Water Quality Standards as set forth by AAMI." Furthermore, the substantial equivalence claim implies that the FDA found sufficient evidence (likely from design documentation and performance claims) that this new device performs as safely and effectively as the predicate devices, which are already known to meet relevant standards.
• Key Design Features for Performance:
  • Reverse Osmosis (RO) Units: Main component for rejecting inorganics, dissolved minerals, suspended solids, and microbiological contaminants.
  • Activated Carbon Filters: Remove chlorine, chloramines, and other organics.
  • Water Softener: Removes calcium and magnesium to prevent scaling of RO membranes.
  • Storage Tank with 0.2 micron vent filter: Prevents airborne bacteria.
  • Ultraviolet (UV) Disinfection Units (optional): For bacterial reduction.
  • Deionization Exchange Tanks (optional): For inorganic and dissolved gas removal.
  • Ultra Filters & Sub micron Post Filters: Remove suspended solids, bacteria, and inhibit pyrogens.
  • Monitoring Devices: Pressure gauges, flow meters, water quality monitors etc., ensure proper performance.

In essence, the "study" for this type of device is the comprehensive engineering design and component selection, coupled with the assertion that this design, when operated correctly, will consistently meet the established (AAMI) water quality standards for hemodialysis. The 510(k) clearance confirms the FDA's acceptance of this evidence for substantial equivalence, allowing the device to be marketed.

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