Search Results

The Mar Cor Purification Millenium HX Portable Reverse Osmosis Water Purification System is intended to be used as a dialysis accessory to produce water through reverse osmosis for use with hemodialysis equipment.

The Millenium HX can be connected to hemodialysis equipment used in hospitals, clinics and in home environments, in conjunction with the appropriate pre and post treatment units, as a part of a water treatment system designed to meet current AAMI and Federal (U.S) standards.

The device is a portable water purification system that uses reverse osmosis to remove contaminants from water that is used to dilute dialysis concentrate to form dialysate for use in hemodialysis equipment. Feed water enters the unit and is directed through a pump into a RO membrane. The pump applies a high hydrostatic pressure that forces water from the concentrated (feed) side to the dilute (product) side of the RO membrane. As water flow across the membrane all types of water contaminants except dissolved gasses are removed and the purified product water is then supplied to hemodialysis equipment.

The Millenium HX is capable of generating purified water that meets AAMI water quality requirements for hemodialysis at a minimum of 0.26 US gallons/minute (1.0 liters/min). It must be used with appropriate pre and post treatment units, including at a minimum carbon adsorption media pretreatment in order to remove chlorine/chloramines. Additional pre and post treatment requirements may vary and are dependent on the quality of the local feed water supply and individual facility requirements.

The Millenium HX system is designed to maintain low microbiological levels in the flow pathway through regular heat disinfection and chemical sanitization. Notable components and features of the Millenium HX include:

• RO membrane .
• System pump .
• Water quality monitoring system .
• Operating panel and programmable logic controller (OPLC) .
• Heat disinfection and chemical sanitization capability .
• Audible and visual alarms .
• Automatic divert to drain mode upon start-up and anytime product water TDS is . above the quality set-point
• System control via a touch-screen user interface .

The provided text is a summary of a 510(k) premarket notification for a medical device (Millenium HX Portable Reverse Osmosis Water Purification System). It does not describe a clinical study of the type that would typically involve acceptance criteria, sample sizes for test/training sets, expert adjudication, or MRMC studies for AI devices.

Instead, this document focuses on demonstrating substantial equivalence to existing predicate devices through non-clinical performance data. Here's a breakdown based on the information provided, highlighting why it doesn't align with the requested format for AI device studies:

1. A table of acceptance criteria and the reported device performance

The document doesn't present a table with specific, quantitative acceptance criteria and corresponding reported device performance values in the way one would for an AI algorithm's diagnostic accuracy. However, it does state that the device is "capable of generating purified water that meets AAMI water quality requirements for hemodialysis at a minimum of 0.26 US gallons/minute (1.0 liters/min)." This implies a performance criterion related to water flow and quality.

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

This information is not applicable. The device is a water purification system, and its performance is evaluated through engineering tests, not a clinical test set of patient data.

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)

This is not applicable. Ground truth for a water purification system is established through laboratory measurements and adherence to engineering standards (like AAMI water quality), not expert consensus on medical images or diagnoses.

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

This is not applicable. Adjudication methods are relevant for subjective assessments, typically in clinical studies, not for the objective performance validation of a mechanical device like a water purification system.

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

This is not applicable. An MRMC study is used to evaluate the impact of an AI algorithm on human reader performance, which is not relevant for a water purification device.

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

This is not applicable. The Millenium HX is a physical device, not an AI algorithm.

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

The "ground truth" for this device's performance would be the objective measurements of water quality and flow rates, verified against established standards such as AAMI water quality requirements for hemodialysis and potentially other federal (U.S.) standards.

8. The sample size for the training set

This is not applicable. The concept of a "training set" is relevant for machine learning algorithms, not for a physical water purification system undergoing engineering validation.

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

This is not applicable for the same reason as point 8.

Summary of the Study and Device Performance (based on provided text):

The "study" refers to the non-clinical performance data provided by Mar Cor Purification to the FDA. This data aims to demonstrate that the Millenium HX is safe and effective for its intended use and is substantially equivalent to predicate devices.

Acceptance Criteria (Implied) and Reported Device Performance:

Study Details:

• Type of Study: Non-clinical performance data and validation testing, not a clinical trial involving human subjects or an AI algorithm evaluation.
• Data Provenance: The studies were conducted by the manufacturer, Mar Cor Purification. Country of origin not explicitly stated, but the company address is in Minneapolis, MN, USA. The nature of the tests suggests they are prospective engineering and laboratory validations.
• Ground Truth: Objective measurements against established engineering and water quality standards (e.g., AAMI RD62:2006).

Conclusion from document: Mar Cor Purification concluded that the Millenium HX is safe and effective for its intended use based on the provided information and performance data, and is substantially equivalent to legally marketed predicate devices. The FDA subsequently cleared the device.

Ask a specific question about this device

The AmeriWater Purification System for Hemodialysis is used to remove organic and inorganic substances and microbial contaminants from water. Purified (or treated) water will then be used to prepare and dilute dialysate concentrate to form dialysate and/or rinse dialyzers for multiple-use dialyzers. AmeriWater does not recommend nor endorse any other use for water treated with AmeriWater systems. AmeriWater further does not endorse any specific hemodialysis or reprocessing procedures or equipment.

The AmeriWater Purification System for Hemodialysis may include pretreatment components, reverse osmosis and/or deionization, post-treatment components, and a distribution system. All or some of the following components may be included in an AmeriWater Purification System for Hemodialysis based on the customer's needs: Tempering Valve, Float and Pressure Control, Temperature Gauge, Return Flow Diffuser, Backflow Preventor, Booster Pump(s), Multimedia Filter, Water Softener, Carbon Filtration, Micron Prefilter, Chemical Feed System, Reverse Osmosis, Pressure Gauges, Storage Vessel, Deionization, Submicron Filter, Distribution System, Distribution Pump(s), PVC Pipe and Fittings, PVC Ball Valves, PVC Labcock Valves, Automatic Lockout, and System Alarms.

System design is determined by the customer's needs and the water conditions at their facility. Components for the water system are selected based on a survey of the customer's requirements and a complete chemical analysis of the water to be treated. The system is complete with monitors and audible/visible alarms with remote activation in the area of patient care to notify staff of problems if they occur.

The AmeriWater Chemical Feed System is a pretreatment device that is designed to deliver chemicals to the city tap water in order to adjust various chemistries in the water. The chemical feed system is located at the front-end of a water treatment system and may be used for pH adjustment, or to mitigate certain water contaminants to help improve the performance of the complete water system.

I am sorry, but based on the provided text, there is no information about acceptance criteria or a study that proves a device meets specific acceptance criteria.

The document is a 510(k) summary for the AmeriWater Purification System for Hemodialysis. It describes the device, its intended use, and lists components that can be included. It also details the specific components for which this 510(k) submission (K021560) is seeking clearance, primarily the AmeriWater Chemical Feed System and the combination of various previously cleared Reverse Osmosis (RO) units with the AmeriWater system.

The core of the document is the FDA's determination of substantial equivalence (K021560) to legally marketed predicate devices, which allows the device to be marketed. This is a regulatory clearance process, not a report on a performance study with acceptance criteria.

Therefore, I cannot provide the requested information about acceptance criteria, device performance, sample sizes, ground truth, or details about a comparative effectiveness study.

Ask a specific question about this device

The Pure Water, Inc. Acidified Storage and Distribution system with Remote Fill is intended to be used in Hemodialysis facilities for the storage and distribution of acid concentrate to be used in the treatment of hemodialysis patients.

Pure Water, Inc.'s Acidified Storage and Distribution System with Optional Remote Fill uses "one-piece molded seamless tanks constructed of linear polyethylene" for bulk storage of acidified concentrate.

The Optional Remote Fill allows the storage tanks to be filled by the vendor from outside the building.

Pure Water, Inc.'s Acidified Storage and Distribution System with optional Remote Fill meets or exceeds all Association for the Advancement of Medical Instrumentation (AAMI) National Standards for Hemodialysis.

This 510(k) summary describes a medical device, the Pure Water, Inc. Acidified Storage and Distribution System, but it is not an AI/ML powered device. Therefore, most of the requested information regarding AI/ML device studies (such as sample sizes for test and training sets, ground truth establishment methods, expert qualifications, adjudication methods, and MRMC studies) is not applicable to this document.

However, based on the provided text, I can infer the following about the device's acceptance criteria and how it aims to meet them:

1. Table of Acceptance Criteria and Reported Device Performance:

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

• Not applicable. This device is an physical medical device (storage and distribution system), not an AI/ML software device that relies on a "test set" of data for performance evaluation. Its performance is demonstrated through adherence to manufacturing standards and functional equivalence to predicate devices.

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. Ground truth in the context of AI/ML testing is not relevant for this physical device. The "ground truth" for this device's acceptance is its compliance with established industry standards (AAMI) and functional equivalence to predicate devices, which are assessed through engineering and manufacturing processes, not expert review of a "test set."

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

• Not applicable. This concept relates to resolving discrepancies in ground truth labeling for AI/ML datasets and is not relevant to the evaluation of this physical device.

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 not an AI-assisted diagnostic or interpretive tool, so MRMC studies are not relevant.

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

• Not applicable. This is a physical device, not an algorithm.

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

• For this physical medical device, the "ground truth" is established by:
  • Compliance with recognized national standards: Specifically, the Association for the Advancement of Medical Instrumentation (AAMI) National Standards for Hemodialysis. These standards themselves are developed through expert consensus and industry best practices to ensure safety and efficacy.
  • Functional equivalence to predicate devices: The FDA's substantial equivalence determination relies on comparing the new device's technological characteristics and performance to those of legally marketed predicate devices. This implies that the predicate devices' prior approval and safe use serve as a form of "ground truth" for the new device's acceptable performance.

8. The sample size for the training set:

• Not applicable. There is no "training set" for this type of physical device.

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

• Not applicable. See point 8.

Ask a specific question about this device