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The Gambro WRO 300 Water Purification System is intended to be used as a dialysis accessory device in conjunction with one dialysis machine to produce water used to prepare and dilute dialysis concentrate to form dialysis fluid by using the reverse osmosis concept.

The Gambro WRO 300 water purification unit is designed to be used as a dialysis accessory device to produce water used to prepare and dilute dialysis concentrate to form dialysis fluid by using the reverse osmosis concept. It is intended for use in conjunction with one dialysis machine, provided that the input flow and pressure demands correspond to the output of the WRO 300 unit.

Here's an analysis of the provided text regarding the Gambro WRO 300 Water Purification System, focusing on the requested acceptance criteria and study details.

Based solely on the provided 510(k) summary, the device is a water purification system for hemodialysis, not an AI/ML powered device. Therefore, many of the requested fields related to AI/ML device performance (like MRMC studies, standalone algorithm performance, number of experts for ground truth, sample sizes for test/training sets, adjudication methods, and effect sizes) are not applicable to this document.

The acceptance criteria for such a device are primarily focused on meeting specific water quality standards for hemodialysis, and the "study" is typically a non-clinical verification or validation demonstrating that the system produces water meeting those standards.

Here's the information extracted and interpreted based on the context of a medical device submission for a water purification system:

1. Table of Acceptance Criteria and Reported Device Performance

Note: The provided 510(k) summary is a high-level overview. Detailed performance specifications, such as specific particulate counts, conductivity, ion levels, or bacterial limits, which would constitute the explicit "acceptance criteria" for purified water, are typically found in the full design verification and validation reports, and accompanying standards (e.g., AAMI standards for water for hemodialysis), which are not part of this summary document. The "reported device performance" here is limited to the statements made in the summary.

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

• Sample Size for Test Set: Not applicable in the context of an AI/ML device. For this hardware device, the "test set" would refer to the number of units tested or the number of batches of water processed. This is not specified in the summary.
• Data Provenance (e.g., country of origin of the data, retrospective or prospective): Not applicable for this type of device and submission summary. The testing mentioned ("Testing verified that the reverse osmosis method...") would have been internal engineering and quality testing, likely conducted at the manufacturer's facilities.

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

• Not Applicable. This is a hardware device. "Ground truth" in the AI/ML sense (e.g., expert annotation of images) is not relevant. The "ground truth" for a water purification system is objectively measurable chemical and biological properties of the water, verified by laboratory analysis, often against established standards.

4. Adjudication Method (e.g., 2+1, 3+1, none) for the Test Set

• Not Applicable. This concept is for resolving discrepancies in expert labeling or decision-making for AI/ML validation. For a hardware device, "adjudication" would refer to how test results are accepted or rejected, typically against specified engineering tolerances or regulatory standards, handled by quality control/assurance personnel.

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 purification system, not an AI/ML diagnostic aid. Human readers, cases, or AI assistance are not relevant to its function.

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

• Not Applicable. This device is a hardware system, not an algorithm.

7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.)

• Objective Measurements/Standards Compliance: The "ground truth" for this device would be established through objective analytical measurements of the purified water's chemical, physical, and microbiological properties, compared against established regulatory standards for water used in hemodialysis (e.g., AAMI standards, or other national/international standards). For example, conductivity measurements, specific ion concentrations, endotoxin levels, and bacterial counts.

8. The Sample Size for the Training Set

• Not Applicable. This is a hardware device; it does not have a "training set" in the context of machine learning.

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

• Not Applicable. No training set exists for this hardware device.

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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.

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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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Virginia Water Systems' Water Purification for Hemodialysis is intended to remove organic, inorganic, and microbial contaminants from water used to make dialysate and reprocess dialyzers as well as rinsing and disinfection of the dialysis equipment. When used as a medical device, Federal law restricts this device to sale by or on the order of a physician.

Virginia Water Systems' Water Purification for Hemodialysis is complete water treatment system used in the production of ultrapure water used in hemodialysis facilities. The components consist of the following: Blend Valve, Inlet Booster Pump, Multimedia Filter, Softener, Carbon Tanks, Reverse Osmosis Unit, Water Storage Tank, Repressure Pumps, Deionizer, Ultraviolet Light, Submicron Filter, Hollow Fiber Filter.

The provided document is a 510(k) summary for the Virginia Water Systems' Water Purification for Hemodialysis. It outlines the device description, intended use, and claims substantial equivalence to predicate devices. However, it does not contain information related to specific acceptance criteria, device performance studies, sample sizes, expert ground truth establishment, adjudication methods, multi-reader multi-case studies, or standalone algorithm performance in the sense typically associated with AI/ML-driven medical devices.

The document is for a physical water purification system, not a software algorithm, and therefore the concepts of "acceptance criteria" and "study that proves the device meets the acceptance criteria" as defined in the prompt (e.g., related to sensitivity, specificity, PPA, NPA, expert adjudication, training/test sets, etc.) are not applicable here.

Instead, for this type of medical device, "acceptance criteria" would refer to its ability to meet water quality standards (e.g., AAMI standards for hemodialysis water) and "proof" would be through engineering specifications, performance testing of the physical components, and comparison to existing predicate devices. The document explicitly states:

"Virginia Water systems claims equivalence in terms of technological characteristics, including design, material, chemical composition, and energy source as the predicate devices."

Therefore, I cannot extract the requested information because it is not present in the provided text.

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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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