Search Results

The DIASAFE®plusUS is intended for the preparation of ultrapure dialysis fluid (for the 2008-series machines and 5008X machines) and sterile, non-pyrogenic substitution fluid (for the 5008X machines) from pretreated water and is not intended to provide primary purification. Attention must still be given to the chemical and microbiological quality of water and concentrates and the maintenance of supply systems (e.g. RO system, central delivery system). The microbiological quality (microbial count [CFU/mL] and endotoxin measurement [EU/mL]) of the incoming water should be < 200 CFU/mL and < 2 EU/mL, respectively.

The DIASAFE®plusUS can only be used with Fresenius Medical Care hemodialysis machines fitted for use with the DIASAFE®plusUS.

The DIASAFE®plusUS is a non-sterile dialysis fluid filter that produces ultrapure dialysis fluid (for the 2008-series machines and 5008X machines) and sterile, non-pyrogenic substitution fluid (for the 5008X machines) for use in chronic and acute hemodialysis and hemodiafiltration. The DIASAFE®plusUS reduces microbial contaminants including endotoxin in the dialysate during treatments. The DIASAFE®plusUS is available in one (1) configuration and is compatible for use with 2008 series and 5008X hemodialysis machines. It is installed on the hemodialysis machines using the DIAFIX™ Lock System. The DIAFIX™ Lock System is a standard feature on the hemodialysis machines and is installed during machine production.

The 2008 series hemodialysis machines use 1 DIASAFE®plusUS. Mixed dialysis fluid is forced through an open filter port across the fibers of the DIASAFE®plusUS. A closed bypass valve at the other end forces the dialysis fluid across the fiber membrane. Dialysis fluid passes through the porous membrane and into the filtrate compartment where it is allowed to flow through the uncapped side ports and into the hemodialyzer. Microorganisms and molecules too large to pass through the membrane are trapped in the fibers until they are flushed out, and/or disinfected during a routine cleaning cycle.

The 5008X hemodialysis system uses two (2) DIASAFE®plusUS for preparation of the dialysis and substitution fluid which can be used for up to 100 on-line HDF treatments. The dialysis fluid is filtered by the first DIASAFE®plusUS. A second DIASAFE®plusUS is used to filter the ultrafiltered dialysis fluid a second time to prepare the substitution fluid. The substitution fluid can be infused in the post-dilution mode (i.e., after the blood has passed through the dialyzer), in the pre-dilution mode (i.e., before the blood enters the dialyzer), or combined.

N/A

Ask a specific question about this device

The AquaA water purification system is a modular reverse osmosis unit intended for use with hemodialysis systems to remove organic and inorganic substances and microbial contaminants from the water used for treating hemodialysis patients or related therapies. This device is intended to be a component in a complete water purification system, and is not a complete water treatment system. The reverse osmosis unit must be preceded by pre-treatment devices, and may need to be followed by post-treatment devices as well, to meet current AAMI/ANSI/ISO and Federal (U.S.) standards.

The Visual LED Indicator is used to remotely monitor the operating status of a connected device (e.g., the reverse osmosis water treatment system).

The AquaDETECTOR leakage monitoring system provides full leakage monitoring of a dialysis center, typically during non-treatment hours. The central control unit can be programed to switch off dialysis water supply systems, dialysis concentrate preparation systems, dialysis concentrate supply systems, booster pump assemblies, and pre-filtration devices when a leak is detected.

The AquaA system is a software controlled electromechanical device. It is a reverse osmosis (RO) water purification system that uses pretreated soft water to produce dialysis water for hemodialysis (HD) devices and for the preparation of dialysis concentrates.

The AquaA system is a modular system consisting of a base module that can be used on its own or in conjunction with other modules. AquaA is the base module. AquaA2 is a second RO unit that can be added to increase the quality of dialysis water. AquaHT is a flow heater unit that can be added to provide heat disinfection for the RO system including membranes and ring main. The AquaHT module can also supply hot product water to connected HD devices. AquaUF is an ultrafiltration module for the AquaA system intended to improve dialysis water quality by retaining constituents such as endotoxins and bacteria.

The AquaA system is configured by combining the different modules with the AquaA base module. The system configurations are:

• AquaA (Single stage RO system)
• AquaA + AquaUF (Single stage RO system with ultrafiltration)
• AquaA + AquaHT (Single stage RO system with heat disinfection)
• AquaA + AquaHT + AquaUF (Single stage RO system with heat disinfection and ultrafiltration)
• AquaA + AquaA2 (Double stage RO system)
• AquaA + AquaA2 +AquaUF (Double stage RO system with ultrafiltration)
• AquaA + AquaA2 + AquaHT (Double stage RO system with heat disinfection)
• AquaA + AquaA2 + AquaHT + AquaUF (Double stage RO system with heat disinfection and ultrafiltration)

The Visual LED Indicator, Aqua DETECTOR, and Connecting Tube PVDF are accessories to the AquaA system.

The Visual LED Indicator is a required accessory installed in the dialysis clinic. It reproduces the AquaA's visual indicator color signals in the clinic and communicates the AquaA system's operating status (including visual and audible alarm states) to the user.

The AquaDETECTOR system monitors leakage throughout a dialysis center. The AquaDETECTOR system consists of a monitoring control center and up to 40 leakage sensors connected to 1–3 BUS lines.

The Connecting Tube PVDF is used to connect the fluid path of the installed modules while maintaining placeholders for future modular expansion.

The AquaA water purification system uses pretreated soft water to produce dialysis water for HD devices and for the preparation of dialysis concentrates. The system features the following main operating modes:

• STANDBY – The system is on and dialysis water is not being produced
• SUPPLY – The system produces dialysis water, controls the programmed yield, and monitors all relevant parameters
• RINSE – The system is cleaned with water by rinsing all tubing sections and by replacing the specified dialysis water volume
• CLEANING – The cleaning mode is used to decalcify or alkaline clean the RO system including membranes. (NOTE: The water distribution system is not included.) An acidic or alkaline solution is circulated in the system for a programmed time period. A Disinfection phase is initiated and followed by a Rinse phase.
• DISINFECTION – The system, including the ring main, is chemically disinfected. The disinfectant is circulated throughout the system for a programmed time period and then a Rinse phase is initiated.
• HEAT DISINFECTION – The AquaA system with the AquaHT module allows for heat disinfection of the AquaA system including RO membranes, ring main, and HD device interfaces
• EMERGENCY OPERATION – In the event of a system malfunction if emergency mode is initiated, AquaA or AquaA2, depending on which RO module failed, begins emergency operation as a single stage RO system. Dialysis water is still produced to complete any HD therapy that is in progress. Dialysis water conductivity (AquaA and AquaA2) and temperature (AquaA) are monitored.

N/A

Ask a specific question about this device

The Chlorine Sentinel II is intended for use by hemodialysis professionals as a secondary chlorine device to provide continuous monitoring of Combined Chlorine. It is not intended to replace the primary method of monitoring chlorine as part of the hemodialysis water treatment system. It functions completely independent of the water treatment system does not come into direct contact with feed water used to prepare dialysate.

Chlorine Sentinel II is a complete system that attaches to the drain of a hemodialysis water treatment system sample port. It detects dissolved combined chlorine in concentrations at or above 10 PPB by primary detection technology. It self-monitors for maintenance-required conditions and loss of electrical power.

The Chlorine Sentinel II is self-testing. It uses chlorinated city water to automatically test the chlorine detecting functionality of the device once a day and records if the test passed, failed to detect chlorine, or didn't rinse out after detecting chlorine.

The device is designed to use as little water as possible. The sampling water is only used for the length of time that it takes for the chlorine test to be completed. The customer determines how frequently the test needs to be taken from every 5 minutes to every 20 minutes. The user also sets the start time and end time for each day of the week.

The Chlorine Sentinel II has two combined chlorine concentration set points. The user can set a warning set-point at a value of 0.01 PPM to 0.09 PPM. Once the chlorine concentration exceeds this value, the device will alarm at 2-HZ to warn the user of chlorine present at that set-point. The second set-point is factory set at 0.10 PPM.

A chlorine concentration equal to or above the 0.10 PPM set-point will activate the buzzers and the red chlorine alarm indicators at 5 HZ for as long as the condition exists. The buzzers can only be muted for 3 minutes (then automatically reset) for as long as the condition exists. The alarms can be by-passed. When by-passed the pulsing lights will turn solid and the buzzer will double click over 15 minutes.

The front cover of the device has two screens. The screen of the chlorine monitor indicates the presence of combined chlorine when the value is not 0.000. The touch screen is used to enter user data and show the statuses of the device.

This FDA 510(k) clearance letter for the Chlorine Sentinel II provides limited specific details on acceptance criteria and study methodologies, particularly concerning clinical performance. The focus is on demonstrating substantial equivalence to a predicate device through technological comparison and bench testing.

Here's an analysis based on the provided document:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state numerical acceptance criteria for clinical performance that can be directly compared to reported device performance metrics like sensitivity, specificity, or accuracy. Instead, the substantial equivalence is drawn based on similar intended use, technological characteristics, and performance verified through bench testing.

Based on the "Detailed Comparison of the Subject and Predicate Devices" (Page 8-10) and "Testing" (Page 14), here's a synthesis of what can be inferred about performance:

Note: The document primarily focuses on technological equivalence and adherence to safety/testing standards rather than presenting quantitative performance metrics against specific clinical acceptance criteria for sensitivity, specificity, or accuracy in a diagnostic context. This device is a water purification system component, not a diagnostic tool.

2. Sample Size for Test Set and Data Provenance

The document describes "Performance – Bench" testing but does not specify a "test set" in the context of clinical data, nor does it provide a sample size in terms of number of cases or data provenance (country, retrospective/prospective). The studies are bench-level evaluations of the device's technical specifications and linearity.

3. Number of Experts and Qualifications for Ground Truth

The document does not mention the use of experts to establish ground truth for a test set. The validation appears to be against established analytical standards (CLSI EP06-A, EP17-A2) for linearity and detection limits, and engineering standards for safety and electromagnetic compatibility.

4. Adjudication Method

As there is no mention of human expert review or a "test set" in a clinical sense, there is no adjudication method described.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

No MRMC study was done, as this device is a water purification system component and not a diagnostic device involving human interpretation of medical images or data. Therefore, there is no effect size reported for human readers improving with AI assistance.

6. Standalone (i.e., algorithm only without human-in-the-loop performance) Study

The device operates standalone in its function of monitoring chlorine. The "Performance – Bench" testing described would fall under a standalone performance evaluation, but not in the sense of a medical AI algorithm. It's a measurement device whose performance is assessed against technical specifications and analytical standards.

7. Type of Ground Truth Used

The ground truth used for performance validation appears to be:

• Analytical Standards: CLSI standard EP06-A for linearity and CLSI standard EP17-A2 for limit of blank, limit of quantitation, and limit of detection.
• Functional Specifications: The device's ability to detect chlorine at specified concentrations (e.g., 0.10 PPM alarm, 0.01 PPM warning) and perform self-tests.
• Engineering Standards: IEC 61010-1 for electrical safety and IEC 60601-1-2:2020 for electromagnetic compatibility.

This is not "expert consensus, pathology, or outcomes data" as typically seen in diagnostic device clearances.

8. Sample Size for the Training Set

The document does not mention a "training set" as it would be understood for machine learning or AI algorithms. The device's operation is based on a polarographic sensor and PLC control, not a learned model from a dataset.

9. How Ground Truth for the Training Set Was Established

Not applicable, as there is no training set in the context of machine learning or AI for this device.

Ask a specific question about this device

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.

Ask a specific question about this device

The Moda-flx Hemodialysis System™ is indicated for use in patients with acute and/or chronic renal failure, with or without ultrafiltration, in an acute, post-acute, or chronic care facility. Treatments must be administered under a physician's prescription, by a trained person who is considered competent in the use of the device.

Treatment types available include: Intermittent Hemodialysis (IHD), Sustained Low Efficiency Dialysis (SLED/ SLEDD), and Prolonged Intermittent Renal Replacement Therapy (PIRRT).

The Moda-flx Hemodialysis System™ Cartridge is a single use, disposable arterial and venous bloodline set, with dialysate tubing, intended to provide extracorporeal access during hemodialysis. The Moda-flx Hemodialysis System™ Cartridge is compatible only with the Moda-flx Hemodialysis System TM.

The Moda-flx Hemodialysis System™ is a transportable hemodialysis system that consists of three parts: Hemodialysis Delivery (HD) Device. Dialysate Generator (DG) Device, and a single use Moda-flx Hemodialysis System™ Cartridge that provides extracorporeal access during hemodialysis. The Moda-flx Hemodialysis System™ Cartridge is only compatible with the Modaflx Hemodialysis System™. The system creates purified water from tap water; from this purified water and chemical concentrates, the system creates dialysate in real time. The chemicals used to create the dialysate are standard 45X concentrates.

Ultrafiltration is achieved by controlling the dialysate going in and coming out of the dialyzer independently, using pumps on the HD Device to control fluid flow from both the inlet and outlet of the dialyzer. An external bag of saline is used to provide solution infusions to combat hypotensive episodes. Saline is also used to prime the Moda-flx Hemodialysis System™ Cartridge prior to use.

Prescribed blood flow rate is generated by a peristaltic pump, while heparin is administered to prevent blood coagulation. All fluid pathways are disposable and easily installed and replaced. Once installed, the device will check the connections of the fluid pathways and the system will automatically prepare itself for treatment.

This document is a 510(k) summary for the Moda-flx Hemodialysis System and Cartridge. It outlines the device's indications for use, its description, and a comparison to predicate devices, but does not provide the acceptance criteria or results of a study designed to prove the device meets specific acceptance criteria related to its clinical performance.

The "Performance Data" section lists various tests conducted, such as biocompatibility, electrical safety, software verification, and bench performance (including clearance, transport, and dialyzer integrity testing). It explicitly states that "no clinical studies were required to support this submission." This indicates that the FDA's substantial equivalence determination for this device was based on non-clinical performance data and comparison to predicate devices, rather than a clinical study demonstrating specific efficacy or clinical performance acceptance criteria.

Therefore, I cannot provide the requested information about acceptance criteria and a study proving the device meets them, as such a study (specifically a clinical one with performance metrics) is stated as not being required and thus not provided in this document.

However, based on the information provided, here's what can be inferred about the types of performance criteria and tests performed, even if specific numerical acceptance values aren't given:

Inferred Information from the Document:

While specific clinical acceptance criteria are not detailed (as no clinical study was required for this submission), the document does list various performance data provided in support of substantial equivalence. These imply underlying performance criteria for safety and technical functionality.

1. Table of Acceptance Criteria and Reported Device Performance: This information is not provided in the document for clinical performance. The document only lists categories of tests performed.

2. Sample size used for the test set and the data provenance: This information is not provided in the document for any of the listed performance tests. The provenance (e.g., country of origin, retrospective/prospective) is also not provided.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: This information is not applicable/provided, as no clinical study with "ground truth" established by experts is mentioned. For the non-clinical tests (e.g., bench testing, software V&V), the "ground truth" would be the engineering specifications and regulatory standards.

4. Adjudication method (e.g., 2+1, 3+1, none) for the test set: This information is not applicable/provided, as no clinical study requiring adjudication is described.

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 information is not applicable/provided. The device is a hemodialysis system, not an AI-assisted diagnostic tool involving human readers.

6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: This information is not applicable/provided. The device is a medical system, not an AI algorithm in the typical sense of "standalone performance" for diagnostic or predictive tasks. Performance was likely evaluated for the integrated system.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): For the non-clinical tests mentioned (biocompatibility, electrical safety, software V&V, bench performance, etc.), the "ground truth" would be established by relevant engineering standards, regulatory requirements, and internal specifications for the device's functional performance. No clinical ground truth (like pathology or outcomes data) was used or required for this submission according to the document.

8. The sample size for the training set: This information is not applicable/provided. As no clinical study requiring "training data" for an AI model is described, this question is not relevant to the provided text.

9. How the ground truth for the training set was established: This information is not applicable/provided for the same reasons as point 8.

Ask a specific question about this device

The HemoCare® Hemodialysis System is indicated for hemodialysis treatment, including short daily and nocturnal hemodialysis, of renal failure patients. The HemoCare Hemodialysis System is indicated for use in chronic dialysis facilities, self-care dialysis facilities, and the home setting. All treatments must be prescribed by a physician and administered by a trained operator. Treatments must be performed with the assistance or observation of an individual who has been trained and is considered competent in the use of the device. The HemoCare Hemodialysis System is not indicated for solo hemodialysis in the home setting.

The HemoCare® Hemodialysis System is a self-contained, software-controlled device that provides hemodialysis treatments, including short daily and nocturnal hemodialysis, for patients with renal failure. The device is intended for use by a single patient in chronic dialysis facilities, self-care dialysis facilities, and the home setting. The HemoCare® Hemodialysis System is composed of the following components:

• The HemoCare® Treatment Device is a hemodialysis delivery system. When provided a source of water for dialysis, it produces infusion grade dialysate using liquid acid and powder bicarbonate concentrates. The Treatment Device provides secure, 2-way communication with the cloud for transmitting patient registration, physician-prescribed dialysis treatments, patient monitoring, and device status information.
• The HemoCare® Water Device is a water purification system that produces water for dialysis through distillation of EPA drinking water. The Water Device interfaces with the Treatment Device.
• The Blood Treatment Set connects to the patient access site and interfaces with the Treatment Device to provide extracorporeal blood flow through a dialyzer for dialysis treatment. The Blood Treatment Set is terminally sterilized and includes displacement blood pumps, a heparin delivery system, and an access disconnect sensor. The Blood Treatment set can be used for up to 16 treatments.

The provided text describes the HemoCare® Hemodialysis System, a medical device. However, it does not contain the specific information required to complete the detailed table about acceptance criteria and device performance results as requested, nor does it detail a study proving the device meets acceptance criteria in the context of an AI/ML algorithm.

The document is a 510(k) summary for a hemodialysis system, focusing on its substantial equivalence to predicate devices. It outlines performance data categories like Biocompatibility, Electrical Safety, Software Verification and Validation, Bench Performance Testing, Sterilization and Shelf Life, Human Factors, and Clinical Testing.

Importantly, the document does not describe an AI/ML algorithm that would have "acceptance criteria," "test sets," "ground truth," "expert readers," or "MRMC studies" in the context typically associated with an AI/ML medical device submission. The "Software Verification and Validation Testing" section states that "Testing results demonstrate that the device meets all software performance requirements," but it does not specify what those requirements are, nor does it indicate these requirements relate to an AI/ML diagnostic or predictive function.

Therefore, I cannot fulfill the request as the type of information sought (related to AI/ML algorithm performance) is not present in the provided text. The document is about a physical medical device (hemodialysis system) and its regulatory clearance as substantially equivalent to existing devices, not about a software-as-medical-device (SaMD) or AI-enabled medical device performance study with the detailed metrics requested.

Ask a specific question about this device

AquaBplus: The AquaBplus is a modular reverse osmosis unit intended for use with hemodialysis systems to remove organic and inorganic substances and microbial contaminants from the water used for treating hemodialysis patients or related therapies. This device is intended to be a component in a complete water purification system and is not a complete water treatment system. The reverse osmosis unit must be preceded by pre-treatment devices, and may need to be followed by post-treatment devices as well, to meet current AAMI /ANSI/ISO and Federal (U.S.) standards.

AquaB LITE: The AquaB LITE is a modular reverse osmosis unit intended for use with hemodialysis systems to remove organic and inorganic substances and microbial contaminants from the water used for treating hemodialysis patients or related therapies. This device is intended to be a component in a complete water purification system and is not a complete water treatment system. The reverse osmosis unit must be preceded by pre-treatment devices, and mav need to be followed by posttreatment devices as well, to meet current AAMI/ANSI/ISO and Federal (U.S.) standards.

The AquaBplus and AquaB LITE are reverse osmosis (RO) water purification systems that use pretreated soft water to produce dialysis water for hemodialysis (HD) devices and for the preparation of dialysis concentrates.

The AquaBplus system is a modular system consisting of a base module that can be used on its own or in conjunction with other modules. AquaBplus is the base module. AquaBplus B2 is a second RO unit that can be added to increase the quality of dialysis water. AquaBplus HF is a flow heater unit that can be added to provide heat disinfection for the RingMain. The AquaBplus HF module can also supply hot product water to connected HD devices.

The AquaB LITE system is a basic version of the AquaBplus system. Like the AquaBplus, it is a modular system consisting of a base module that can be used on its own or in conjunction with other modules. AquaB LITE is the base module and B2 LITE is a second RO unit that can be added to increase the quality of dialysis water. AquaBplus HF is a flow heater unit that can be added to provide heat disinfection for the RingMain. The AquaBplus HF module can also supply hot product water to connected HD devices.

This document is a 510(k) Premarket Notification letter for the AquaBplus and AquaB LITE water purification systems, which are used for hemodialysis. The document summarizes the device, its intended use, and the performance data that supports its substantial equivalence to a predicate device.

Here's an analysis of the acceptance criteria and the study that proves the device meets the acceptance criteria, based on the provided text:

Important Note: The provided document is an FDA 510(k) clearance letter and its associated summary. This type of document focuses on demonstrating substantial equivalence to a predicate device, rather than providing detailed results from a clinical or AI-driven study with specific acceptance criteria in the manner an AI/ML medical device might. The "performance data" sections focus on safety, general functionality, and adherence to relevant standards rather than a comparative effectiveness study with human readers or standalone AI performance. Therefore, many of the requested points regarding AI/ML study design (e.g., sample size for test/training sets, expert ground truth, MRMC studies) are not applicable or detailed in this type of submission.

The "device" in this context is a water purification system, not an AI/ML algorithm for image analysis or diagnosis.

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

The document does not present a formal table of "acceptance criteria" and "reported device performance" in the way one might for an AI/ML diagnostic device (e.g., sensitivity, specificity, AUC thresholds). Instead, the performance data section outlines the types of tests conducted to demonstrate that the device functions as intended and meets relevant standards to be deemed substantially equivalent. The acceptance criteria are implicitly meeting the specified standards and ensuring safety and effectiveness compared to the predicate.

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 in the context of this device's testing. There is no "test set" of patient data or images as would be seen for an AI diagnostic algorithm. The testing described is hardware and software functional testing, validation against standards, and biocompatibility testing. These are typically performed on a limited number of physical units or material samples.
• Data Provenance: Not applicable. The "data" here refers to test results from engineering and laboratory evaluations, not 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)

• Not applicable. The ground truth for a water purification system is defined by engineering specifications, international standards (e.g., AAMI/ANSI/ISO), and validated chemical/microbiological testing methods, not by expert medical interpretation of images or patient outcomes.

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

• Not applicable. This concept pertains to resolving discrepancies in expert labeling of data for AI/ML models.

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

• No, an MRMC comparative effectiveness study was not done. This type of study is specifically relevant for AI-assisted diagnostic tools that interact with human readers (e.g., radiologists interpreting images). The AquaBplus/AquaB LITE are water purification systems; they do not involve human diagnostic interpretation.

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

• Not applicable. This device is not an AI algorithm. Its "performance" is its ability to purify water according to specified parameters and standards, which is assessed through direct measurement and functional testing, not an isolated algorithm.

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

• The "ground truth" for this device's performance is established by:
  • International and Federal Standards: ISO 23500 series, AAMI/ANSI. These define the acceptable parameters for water quality for hemodialysis.
  • Engineering Specifications: Designed conductivity, temperature, flow rates, and failure modes.
  • Validated Test Methods: Biocompatibility tests (e.g., ISO 10993), disinfection validation protocols, electrical safety, and EMC standards.
  • Predicate Device Performance: The predicate device serves as a benchmark for substantial equivalence.

8. The sample size for the training set

• Not applicable. There is no "training set" as this device does not use machine learning.

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

• Not applicable. As there is no training set for an AI/ML model, there is no ground truth established for one.

Ask a specific question about this device

The Tablo® Hemodialysis System and TabloCart™ is indicated for use in patients with acute and/or chronic renal failure, with or without ultration, in an acute or chronic care facility. Treatments must be administered under physician's prescription and observed by a trained individual who is considered competent in the use of the Tablo Hemodialysis System is also indicated for use in the home. Treatment types available include Intermittent Hemodialysis (IHD), Sustained Low Efficiency Dialysis (SLED/ SLEDD), Prolonged Intermittent Renal Replacement Therapy (PIRRT), and Isolated Ultrafiltration.

The Tablo® Hemodialysis System is a self-contained hemodialysis system intended for acute and chronic dialysis therapy, with or without ultrafiltration, in an acute, chronic care facility or in the home. The Tablo Hemodialysis System consists of: Tablo Console and Software, Tablo Cartridge. The TabloCart™ is an optional accessory to the Tablo Hemodialysis System that raises the height of the Tablo console and includes larger wheels that rotate and lock in more functional directions than the Tablo console without a cart, aiding in overall system mobility. When configured with a Prefiltration Drawer, the cart has replaceable, large-capacity cartridge filters (sediment and/or carbon) that serve as "prefilters" to help remove major sediment and chlorine/chloramines from supply water before it enters the Tablo console's water purification system. The cart with prefiltration also includes backflow prevention and a booster pump to transport water from the incoming water supply to the Tablo console. The TabloCart with Prefiltration Drawer consists of: Tablo Cart Wheeled Platform, Fluidics Drawer and Software.

The provided document is an FDA 510(k) Premarket Notification review letter for the Tablo® Hemodialysis System; TabloCart™ with Prefiltration Drawer (K232776). This document primarily focuses on demonstrating substantial equivalence to a predicate device (Tablo Hemodialysis System, K223248) rather than detailing specific acceptance criteria and a study proving the device meets those criteria in the context of device performance metrics (e.g., accuracy, sensitivity, specificity for an AI/algorithm-based device).

The "acceptance criteria" and "study that proves the device meets the acceptance criteria" as requested in the prompt typically refer to a device's performance against predefined metrics (e.g., clinical accuracy, diagnostic performance, or a specific functional output) which are common for AI/algorithm-based devices. However, the Tablo Hemodialysis System and its accessory cart are not an AI/algorithm-based device in the common sense (e.g., for image analysis or disease diagnosis). Instead, it's a medical device for renal replacement therapy, and the 510(k) submission focuses on demonstrating that the new accessory (the cart with prefiltration) does not alter the fundamental safety and effectiveness of the existing, cleared hemodialysis system.

Therefore, many of the specific questions in the prompt (e.g., sample size for test/training sets, number/qualifications of experts, adjudication methods, MRMC studies, standalone performance, type of ground truth) are not applicable to this type of device and submission. The "study" proving acceptance criteria here is primarily a series of bench performance tests, biocompatibility testing, electromagnetic compatibility (EMC) and electrical safety testing, and software verification and validation testing to confirm that the addition of the cart does not negatively impact the established safety and performance of the base hemodialysis system.

Here's an attempt to address the prompt based on the available information, highlighting what is applicable and what is not:

Acceptance Criteria and Study Proving Device Meets Acceptance Criteria for the Tablo® Hemodialysis System with TabloCart™ with Prefiltration Drawer (K232776)

Given that this 510(k) submission is for an accessory cart to an already cleared hemodialysis system, the "acceptance criteria" revolve around demonstrating that the modified device (system with cart) maintains the same safety and effectiveness as the predicate device (system without cart). The "study" is a compilation of various engineering and performance tests rather than a single clinical trial or AI validation study.

1. Table of Acceptance Criteria and Reported Device Performance

For this type of device and submission, the acceptance criteria are largely implied by demonstrating substantial equivalence to the predicate device. They are not typically laid out as quantitative performance metrics (like accuracy or sensitivity) as would be for an AI diagnostic device. Instead, they relate to maintaining fundamental safety, performance, and functionality.

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

• Not applicable in the context of typical AI/algorithm test sets. The "test set" here refers to the physical device and its components undergoing engineering and functional verification.
• Data Provenance: The testing was conducted by the manufacturer, Outset Medical, Inc., presumably in their facilities (San Jose, CA, USA). The studies are prospective in the sense that they were designed and executed specifically to support this 510(k) submission for the modified device.

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

• Not applicable. This is not an AI/diagnostic device where expert consensus defines a "ground truth" for disease states in a dataset. "Ground truth" for this device is based on engineering specifications, physical measurements, chemical analysis (for water purity), and functional performance verification against design requirements. The "experts" involved would be engineers, quality control personnel, and regulatory specialists within Outset Medical, Inc.

4. Adjudication method for the test set:

• Not applicable. Adjudication methods (like 2+1, 3+1) are for resolving discrepancies in expert interpretations of data (e.g., medical images). For engineering tests, results are typically objective measurements or pass/fail criteria based on predefined specifications.

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 not an AI-assisted diagnostic device, so MRMC studies are irrelevant.

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

• Not applicable. This device is a physical hemodialysis system with an accessory, not a standalone algorithm.

7. The type of ground truth used:

• Engineering Specifications and Physical/Chemical Standards: For example, the ground truth for water quality would be established by relevant water quality standards for hemodialysis (e.g., AAMI standards). For mechanical aspects, it would be the design specifications (dimensions, mobility, filter capacity). For software, it would be the functional requirements and safety standards.

8. The sample size for the training set:

• Not applicable. This refers to machine learning models, which is not what this device is.

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

• Not applicable. See point 8.

Ask a specific question about this device

The AQUAbase nX is intended for use with hemodialysis systems to remove organic and inorganic substances and microbial contaminants from the water used for treating hemodialysis patients. The AQUAbase nX is to be used at dialysis clinics or hospitals.

The AQUAbase nX is a reverse osmosis unit intended to be a component in a complete water purification system, and is not a complete water treatment system. This reverse osmosis unit must be preceded by pre-treatment devices. Whether a particular device is included in an individual water treatment system will be dictated by local conditions. The reverse osmosis unit may need to be followed by post-treatment devices as well.

The AQUAbase nX is designed to meet current AAMI/ISO and Federal (U.S.) standards.

The AQUAbase nX is a single stage reverse osmosis system. A graphical touchscreen allows access and monitoring of all operating parameters at any time. Customized parameters make a high water vield possible, even under poor raw water conditions. Raw water consumption is based solely on the end user's permeate needs. The touchscreen makes it possible for the user to monitor all production parameters as well as design every system function, including disinfection mode, individually and reproducibly.

The AQUAbase nX works on the reverse osmosis principle. Reverse osmosis describes the process of pressure-operated cross-filtration. Water flows at high pressure tangentially over a semipermeable membrane. As is the case with normal filtration, the system is cleaned by allowing one component (water) of the mixture to be separated to pass through the membrane with almost no hindrance, while other components (dissolved and undissolved water contents) are held back to a greater or lesser extent and leave the filtration unit in the concentrate flow. This is a purely physical separation process in the molecular range which does not change the components being separated either chemically, biologically or thermally.

The provided document is a 510(k) summary for the AQUAbase nX, a water purification system for hemodialysis. It details the device's characteristics, intended use, and comparison to a predicate device, along with performance data.

However, the information provided does not contain the details required to describe the acceptance criteria and study that proves the device meets the acceptance criteria in the context of an AI-powered medical device.

The document discusses "performance data" which includes:

• Biocompatibility testing (ISO 10993-1)
• Electrical safety and electromagnetic compatibility (EMC) testing (IEC 60601-1, IEC 60601-1-2)
• Software verification and validation testing (FDA Guidance for Industry and FDA Staff, "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices" as well as the draft FDA guidance recently issued)
• Additional performance bench testing (ISO 23500-3 for performance, chemical and heat disinfection testing, bacterial count and endotoxins)

These are standard engineering and medical device performance tests. There is no mention of an AI algorithm, a test set for AI, ground truth establishment by experts, MRMC studies, or standalone AI performance.

Therefore, I cannot fulfill the request as the provided text does not contain any information about an AI component or a study proving an AI device meets acceptance criteria. The device described is a physical water purification system, not an AI-powered diagnostic or assistive tool.

Ask a specific question about this device

The RenaPure filter is a bacterial and endotoxin retentive filter intended for use in a centralized loop as the final step of a water purification cascade to provide standard dialysis water to machine servicing multiple patients. This filter is not intended to service as the sole means of water purification and therefore must be used in conjunction with other water treatment equipment.

The RenaPure filter is a 20" cartridge style filter in a polypropylene casing that contains dual-layered, 0.22 micron polyethersulfone (PES) pleated membranes which are separated by polypropylene screen layers. The PES membrane is charge modified with a positive charge coating, similar to the predicate device, that aids in removal of endotoxin by charge attraction. Filter configurations are based on an industry standard 222 header design with silicone O-rings at the open end of the filter and flat or fin end caps at the closed end. The filter cartridge is installed in a durable filter housing and operates in a dead-end mode. The filter is designed to remove bacteria and endotoxin from water used in hemodialysis with similar water flow characteristics as the predicate device. The filter provided non-sterile.

The provided text describes the regulatory clearance of the RenaPure Endotoxin Retentive Filter and includes a summary of non-clinical performance assessment, but it does not contain information about:

• Acceptance criteria expressed as specific quantitative thresholds for device performance.
• A comparative study with human readers (MRMC study) or effect sizes of AI assistance.
• Standalone algorithm performance.
• Sample sizes for test sets or training sets in the context of an AI/algorithm study.
• Data provenance, number of experts for ground truth, or adjudication methods for an AI/algorithm study.
• Ground truth type for training data.

The document focuses on the physical and functional performance of a medical device (a filter) through bench testing and biocompatibility assessment, not on the performance of a diagnostic AI algorithm.

Therefore, I cannot fulfill your request as the necessary information regarding acceptance criteria, study details, and AI performance metrics (including expert involvement, sample sizes, and ground truth establishment) is not present in the provided text.

The "Performance (bench) testing" section within the "Non-clinical Performance Assessment" is the closest to describing a study, but it lacks the specific details requested concerning acceptance criteria, ground truth, and expert involvement usually associated with AI algorithm evaluation.

What the document does state about performance assessment:

• Study type: Non-clinical bench testing.
• Tests performed:
  • Flow/Pressure Drop measurements
  • Endotoxin Retention
  • Bacterial Retention
  • Compatibility to Hot Water and Chemical Disinfections
  • Housing Fit tests
  • Compatibility with Deionized water
• Results: "Testing demonstrated that the RenaPure filter met the intended design requirements and will operate as a drop-in replacement to the predicate device."
• Biocompatibility: A series of biocompatibility tests, including exhaustive extraction and toxicological risk assessment, were performed. "All biocompatibility testing passed and the risk of any toxic leachates from the RenaPure filter were considered negligible."
• Ground Truth: For these physical device tests, the "ground truth" would be established by the physical measurements and chemical analyses themselves, validated against engineering specifications and regulatory standards. There are no "experts" in the sense of clinical readers establishing ground truth for perception tasks.

Ask a specific question about this device