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The TANGO3 Water Storage Tank with Ozone Disinfection System is intended to be used for disinfection of the water distribution system of a dialysis facility. The tank of the TANGO3 is also used as the water holding tank of the distribution system. The disinfection process is completely automated. Ozone concentration during disinfection is between 0.2 ppm and 0.3 ppm. Weekly disinfection cycles should be for four periods of 30 minutes with adequate water flushes between them and after the last cycle. In addition to the weekly disinfection cycle, a 45 minute disinfection cycle with at least two rinse cycles may also be performed multiple times weekly for additional reduction of bioburden as determined by user facility monitoring. At the end of disinfection, the distribution loop will have less than 0.1 mg/l. (0.1 ppm) of ozone, in accordance with AAMI/ISO 26722:2009 (4.2.13.5).

The TANGO3 Water Storage Tank with Ozone Disinfection System is specifically designed to facilitate ozone induction into the storage tank, and then distribute the ozonated water through the distribution water loop during non-operational hours of a hemodialysis facility. The storage tank of the TANGO3 system is filled with adequate water and the ozone concentration is increased. The ozonated water is distributed throughout the distribution loop. The solution is recirculated throughout the distribution system. To complete the disinfection process, the system and distribution loop are then rinsed with adequate water. The described process is accomplished with 4 consecutive 30 minute cycles of ozone disinfection weekly. In addition, a disinfection cycle of 45 minutes multiple times per week may also be used for additional reduction of bioburden (as determined by user facility monitoring). After disinfection TANGO3 will leave the distribution loop with less than 0.1 mg/l. (0.1 ppm) of ozone, in accordance with AAMI/ISO 26722:2009 (4.2.13.5).

The TANGO3 Water Storage Tank with Ozone Disinfection System is intended for disinfection of the water distribution system of a dialysis facility. The device's performance was evaluated through reliability validation, disinfection validation, and field testing.

1. Table of Acceptance Criteria and Reported Device Performance:

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The AmeriWater Ozone Disinfection System is an optional accessory for the AmeriWater Bicarb Solution Mix and Distribution System (SDS) cleared for market under K051031 and the AmeriWater Water Purification System (WPS) for Hemodialysis cleared for market under K991519. It is intended for use in hospitals and dialysis clinics for the disinfection of the AmeriWater SDS and WPS system. The disinfection process is completed during off-hours when the SDS or WPS are not being used for patient treatment. The AmeriWater Ozone Disinfection System provides dissolved aqueous ozone concentrations of at least 0.5 ppm with a contact time of at least 30 minutes for disinfection of the WPS and SDS systems (the entire disinfection process takes approximately 2 hours to complete and longer contact times may be necessary based on microbial loads). The Ozone Disinfection System is designed to produce water with a microbial count of 50 CFU/ml or less.

The AmeriWater Ozone Disinfection System is a compact portable device that connects to the AmeriWater Bicarb Solution Mix and Distribution System (SDS) and the AmeriWater Water Purification System (WPS) for Hemodialysis for disinfection of the systems. Microbial reduction is achieved by a combination of disinfection by ozone and by physical removal by draining, flushing, and refilling the system being disinfected with fresh water. The Heatsan system has been designed to be in compliance with the requirements of ANSI/AAMI/ISO 13959:2009 Water for hemodialysis and related therapies and ANSI/AAMI/ISO 26722:2009 Water treatment equipment for hemodialysis applications and related therapies.

The AmeriWater Ozone Disinfection System uses a high technology corona discharge process for producing ozone. Ozone is manufactured by drawing oxygen (O2) into the ozone generator and exposing it to multiple high voltage electrical discharges. This causes a percentage of the oxygen molecules to dissociate and reassemble as ozone (03). The ozone is drawn into the water by a venturi injector / mixer allowing the ozone to be injected into the water under a vacuum condition. The AmeriWater Ozone Disinfection System is a complete unit with ozone generator, venturi injector mixer, gas off chamber with excess ozone gas destruct, feed water flow meter, oxygen flow meter, and vacuum gauge.

The driving force of the AmeriWater Ozone Disinfection System is the distribution pump on the WPS water loop and the mix and distribution pumps on the SDS. A valve arrangement installed on the outlet of the WPS distribution pump and the SDS pumps allow for the diversion of purified water flow into the AmeriWater Ozone Disinfection System and back into the SDS or WPS storage tanks. The pumps force the purified water from the WPS storage tank into the Ozone Disinfection System, which enriches it with ozone and returns it to the WPS storage tank. Likewise, the purified water from the SDS mix and distribution tanks is pumped into the Ozone Disinfection System where it is enriched with ozone and returned to the tanks. When the water flow has been adjusted properly, a vacuum will draw oxygen (from a medical grade oxygen source) into the ozone generator and ozone will be created. The ozone generator has a vacuum switch and will not operate without an adequate vacuum from the venturi injector as indicated on the Ozone Disinfection System vacuum gauge.

The purified water from the WPS or SDS flows into the Ozone system through the feed flow meter and into a venturi injector creating a vacuum that draws the oxygen through the generator creating ozone in concentrations greater than 0.5 ppm. The ozone is then mixed in the ozone rich water enters the gas off tank to remove any excess, un-dissolved ozone gas. The water-ozone mixture enters and exits at the bottom of the gas off tank. The excess (un-dissolved) ozone will slowly displace the water in the tank and is vented at the top of the tank. The excess ozone gas then enters the ozone destruct chamber where it is destroyed while the ozone-rich water is directed back to the system being disinfected. Ozone concentrations are monitored using RPC Ozone Test strips, cleared for market under K132344.

The intended disinfection endpoint for the AmeriWater Ozone Disinfection System with the AmeriWater Water Disinfection System (WPS) and the AmeriWater Solution System (SDS) following disinfection and rinse is a total bacterial count less than or equal to 50 CFU/mL; when the system being disinfected is properly maintained (with bacterial counts

The AmeriWater Ozone Disinfection System is designed to disinfect the AmeriWater Bicarb Solution Mix and Distribution System (SDS) and the AmeriWater Water Purification System (WPS) for Hemodialysis. The overall goal is to produce water with a microbial count of 50 CFU/ml or less.

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

1. Table of Acceptance Criteria and Reported Device Performance

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The Isopure Sodium Bicarbonate Mixing and Distribution System is intended to be used in Hemodialysis facilities for the mixing, storage and distribution of Bicarb liquid concentrate to be used in the treatment of Hemodialysis patients.

The Isopure Sodium Bicarbonate Mixing and Distribution System is designed to mix sodium bicarbonate powder into a liquid solution based on the recommended mixing procedures from the powder manufacturers. Once the powder is mixed into a liquid solution and verified for content accuracy, the solution is transferred to an independent distribution tank for transfer through a loop to the individual dialysis machines or to fill jugs which then can be transported to the individual dialysis machines when no distribution loop exists. The Isopure Sodium Bicarbonate Mixing and Distribution System features the patented SOLUBILIZER™, which utilizes a large volume of water spinning in a vortex manner to dissolve dry powder into a liquid solution that is drawn into a mix tank. The solution is mixed with AAMI quality water according to specifications outlined by the manufactures for the bicarbonate powder. Once the solution has been dissolved and mixed, the solution can be transferred from the mixing tank to the storage delivery tank for distribution to the loop or jugs. The tanks and the SOLUBILIZER™ are sealed to reduce microbial contamination. The sealed design also facilitates CO2 recovery and gassing off of CO2 during the mixing procedure. The entire system is controlled by programmable control logic (PLC), which operates the system. The PLC will control the mixing, the delivery and disinfection of the complete system. The system PLC is operated through an HMI touch screen which displays the critical aspects of the system. including the operational stages, real-time indication of various steps, and alarm conditions.

The provided text describes a 510(k) premarket notification for the Isopure Sodium Bicarbonate Mixing and Distribution System. This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than proving safety and effectiveness through extensive de novo clinical trials. Therefore, the information typically requested in your prompt (e.g., acceptance criteria with reported device performance in a table, sample sizes for test/training sets, number and qualifications of experts for ground truth, MRMC studies, standalone performance, type of ground truth) is not explicitly present in the provided document.

The document primarily focuses on comparing the technological characteristics of the new device to its predicate and outlining non-clinical testing performed to establish equivalence.

Here's an analysis based on the available information:

1. Table of Acceptance Criteria and Reported Device Performance:

The document doesn't present a table with explicit acceptance criteria and corresponding reported device performance metrics in the format typically used for performance studies. Instead, it states that the system "was tested repeatedly for proper operation" and "each mix batch was tested for the target conductivity of the solution to confirm the correct mixture."

The implied acceptance criterion is:

• Target conductivity of the solution: The mixed sodium bicarbonate solution must achieve the "target conductivity" to confirm correct mixture.

The reported device performance is:

• "each mix batch was tested for the target conductivity of the solution to confirm the correct mixture, and then transferred to the Distribution Tank."
• "The distribution function was then tested to ensure that circulation of the solution through the loop occurred as expected."
• "The system has undergone 100% testing to ensure substantial equivalence to the Pure Water, Inc. predicate device. Both systems are fully capable of meeting the mix requirements specified for a suitable sodium bicarbonate solution."

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

• Sample Size: The document does not specify a numerical sample size for the test set. It states the system "was tested repeatedly" and "each mix batch was tested for the target conductivity." This suggests multiple batches were tested for each selectable volume.
• Data Provenance: The testing was non-clinical. The "testing area consists of all components of a water room that would normally be present at a dialysis clinic." It utilized "the same brand of bicarbonate typically used in an operating clinic." This implies the testing environment and materials were representative of real-world use within a dialysis facility. The country of origin for the data is implicitly the US, as the submitter is an American company and the approval is from the US FDA. The testing was prospective within the context of the device development and validation.

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

• Experts: Not applicable. The "ground truth" for the device's function (correct mixing and distribution) was established through objective measurements (conductivity) and functional assessments (circulation). This is a technical performance verification, not a clinical interpretation requiring expert consensus.

4. Adjudication Method for the Test Set:

• Adjudication Method: Not applicable. The "ground truth" (correct mixture via conductivity, proper circulation) was determined by direct measurement and observation, not expert review or adjudication.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done:

• MRMC Study: No, an MRMC comparative effectiveness study was not done. This device is a medical equipment system for mixing and distributing solutions, not an imaging or diagnostic device that would involve human readers interpreting cases.

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

• Standalone Performance: Not applicable in the context of typical AI/algorithm standalone performance. The device itself is an automated system controlled by a PLC, and its performance was assessed directly. There isn't a separate "algorithm" for human-in-the-loop interaction in the way AI diagnostics are often evaluated. The testing described focuses on the machine's ability to execute its programmed functions (mixing, distribution) correctly and automatically.

7. The Type of Ground Truth Used:

• Type of Ground Truth: The ground truth was based on objective technical measurements and functional verification. Specifically:
  • Conductivity Readings: To confirm the correct mixture of the sodium bicarbonate solution (compared against a target conductivity).
  • Functional Assessment: To ensure proper circulation of the solution through the distribution loop.
  • Compliance with Manufacturer Recommendations and Standards: Adherence to powder manufacturers' recommendations and AAMI RD52-2004 requirements for mixing procedures.

8. The Sample Size for the Training Set:

• Training Set Sample Size: Not applicable. This device is not an AI/machine learning model in the conventional sense that would require a "training set" of data to learn from. Its operation is governed by pre-programmed logic (PLC) and engineering design, not statistical learning from a dataset.

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

• Training Set Ground Truth: Not applicable, as there is no training set for this type of device. The operating parameters and expected performance are established through engineering specifications, manufacturer guidelines, and relevant industry standards (like AAMI RD52-2004).

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The TANGO3 Water Storage Tank with Ozone Disinfection System is intended to be used for disinfection of the water distribution system of a dialysis facility. The tank of the TANGO3 is also used as the water holding tank of the distribution system. The disinfection process is completely automated. Ozone concentration during disinfection is between 0.2 ppm and 0.3 ppm. The distribution system will be exposed to ozone for one (1) period of 45 minutes and three (3) subsequent periods of 30 minutes with adequate water flushes between them and at the end, leaving the distribution loop without ozone.

The TANGO3 Water Storage Tank with Ozone Disinfection System is specifically designed to facilitate ozone induction into the storage tank, and then distribute the ozonated water through the distribution water loop during non-operational hours of a hemodialysis facility. The storage tank of the TANGO3 system is filled with adequate water and the ozone concentration is increased. The ozonated water is distributed throughout the the disinfection process, the system and distribution system. To complete the disinfection process, the system and distribution system. To complete The described process is repeated three (3) more times. After the last cycle TANGO3 will leave the system residual free of ozone. To accomplish this, TANGO3 has a corona discharge generator that generates ozone from a source of dry air. The air dryer consists of two heat regenerative desiccant modules. The ozone if om a injected into the tank by means of a venturi based injection system. Once in the tank, the ozonated water is sent to the distribution loop with a centrifugal pump. Ozone levels are monitored at the return of the loop. Two (2) flow sensors, located at the input and output of the distribution loop will assure that the dialysis facility is not utilizing water while ozone is present in the loop.

Here's an analysis of the provided text, outlining the acceptance criteria and the study details for the TANGO3 Water Storage Tank with Ozone Disinfection System:

Acceptance Criteria and Reported Device Performance

The acceptance criteria for the TANGO3 device are implied through its intended use and the description of its disinfection process, which must result in a disinfected water distribution system. The key performance metric is the ability to disinfect.

Study Details

Based on the provided text, the available information regarding the studies is limited.

1. Sample Size Used for the Test Set and Data Provenance:

   • In vitro testing: The sample size for the waterborne organisms used is not specified.
   • Field test: This involved "facilities with known water contamination issues." The number of facilities (sample size) is not specified.
   • Data Provenance: The text does not explicitly state the country of origin. Given it's a 510(k) submission to the FDA, it's reasonable to infer the data was generated in support of US regulatory requirements, but specific locations are not provided. Both in vitro and field tests suggest prospective data collection for the purpose of the submission.

2. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications:

   • This information is not provided in the text. The concept of "ground truth" as typically applied to expert consensus for diagnostic imaging or similar scenarios isn't directly applicable here, as the studies involve scientific testing of disinfection efficacy and functional performance. The "ground truth" for disinfection would be the actual reduction in waterborne organisms measured post-disinfection.

3. Adjudication Method for the Test Set:

   • This information is not provided and is not typically relevant for this type of device and testing. Adjudication methods like "2+1" or "3+1" are usually employed in studies where human readers interpret data (e.g., medical images) and their agreement (or disagreement leading to a tie-breaker) is resolved. The TANGO3 studies are focused on direct physical and biological performance.

4. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:

   • No, an MRMC comparative effectiveness study was not done. This type of study assesses how human readers' diagnostic performance changes with and without AI assistance, which is not applicable to a water disinfection system.

5. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study:

   • Yes, in essence, standalone performance was evaluated. The disinfection system operates automatically as described. The in vitro and field tests evaluated the system's performance (disinfection capabilities, functional performance) without direct human intervention in the disinfection process itself, beyond initiation and monitoring. The "algorithm" here would be the automated sequence of ozone generation, circulation, and flushing.

6. Type of Ground Truth Used:

   • For the in vitro testing, the ground truth would be the measured reduction in viable waterborne organisms (e.g., colony-forming units) before and after disinfection. This would be objective microbiological data.
   • For the field test, the ground truth would be the measured water quality parameters and microbial counts in the dialysis facilities, showing a reduction in "known water contamination issues" after using TANGO3. This would be a combination of microbiological and chemical analysis.
   • For functional testing, the ground truth would be the actual performance against design specifications (e.g., ozone concentration, timing, ozone-free residual).

7. Sample Size for the Training Set:

   • This information is not provided. The text describes performance testing, not the development of a machine learning model that would typically require a training set. The "training" here would be the engineering design and iteration process.

8. How the Ground Truth for the Training Set Was Established:

   • As there's no mention of a traditional machine learning training set, this question is not applicable. The "ground truth" in the context of engineering development would be established through established scientific principles, engineering standards, and iterative design and testing.

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The bicarbonate mixing and distribution system and its components consisting of; tanks, pumps, piping, and controls, are designed to consistently, safely, and effectively mix and distribute bicarbonate solutions for hemodialysis treatments.

NOTE: Federal Law restricts this device to sale by or on the order of a physician for use as a bicarbonate mixing and distribution system for hemodialysis.

Device is designed to provide the user with a system for consistent and easy to use system by which they may be able to mix and distribute bicarbonate solution for use in a hemodialysis clinic.

The provided text describes a 510(k) submission for the TYPHOON Bicarb Mixing and Distribution System, focusing on its substantial equivalence to a predicate device. However, the document does not contain information on acceptance criteria or a study proving the device meets specific performance criteria in the manner expected for a typical medical device performance study.

Instead, the submission focuses on demonstrating substantial equivalence to a predicate device (USFilter Bicarbonate Mixing and Dispensing System, K031502) by comparing technical specifications and intended use. The rationale is that since the TYPHOON system utilizes similar technology, components, and fluid contact materials as previously cleared devices, it is safe and effective.

Here's a breakdown of the requested information based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

As mentioned, explicit quantitative acceptance criteria and corresponding reported device performance values (e.g., accuracy, sensitivity, specificity) for a clinical or in-vitro performance study are not present in the provided document. The performance is assessed through a comparison of technical specifications and the assertion of similar technology and components to a predicate device.

The table below summarizes the comparison of technical specifications between the TYPHOON device and its predicate, which serves as the basis for demonstrating "performance" in this context of substantial equivalence.

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

• Sample Size: Not applicable. The submission does not describe a clinical or performance study with a test set of data points or cases. It relies on a comparison of device specifications to demonstrate substantial equivalence.
• Data Provenance: Not applicable. There is no test set data mentioned.

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

Not applicable. There was no test set or ground truth established by experts in the context of a performance study for this submission. The device is a physical system for mixing and distributing bicarbonate solution.

4. Adjudication Method for the Test Set

Not applicable, as there was no test set.

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 mechanical system for mixing and distributing solutions; it does not involve AI or human readers for diagnostic interpretation.

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

Not applicable. This device is a mechanical system; it does not have an algorithm for standalone performance evaluation in the usual sense of AI/software devices.

7. The Type of Ground Truth Used

Not applicable. There is no concept of "ground truth" (e.g., pathology, outcomes data) in the context of this 510(k) submission, as it relates to a mechanical system rather than a diagnostic or interpretive device. The "truth" of its performance relies on its physical and functional specifications meeting the intended use and being similar to a predicate.

8. The Sample Size for the Training Set

Not applicable. The device is a mechanical system for which a "training set" in the context of machine learning or AI is not relevant.

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

Not applicable, as there is no training set.

Summary of the Study (or lack thereof) Proving Device Meets Acceptance Criteria:

The provided document indicates that the Dialysis Services, Inc. TYPHOON Bicarb Mixing and Distribution System relies on substantial equivalence to a predicate device (USFilter Bicarbonate Mixing and Dispensing System, K031502) rather than a novel performance study with explicit acceptance criteria.

The "study" to prove the device meets acceptance criteria consists of:

• Comparison of Technical Specifications: The submission provides a detailed table comparing the technical specifications and requirements of the TYPHOON system with those of its predicate device, demonstrating functional and material similarity (Section {2}).
• Similar Technology and Intended Use: The submitter explicitly states that both devices utilize "similar technology" and share the same "intended use" to consistently mix and distribute bicarbonate solution for hemodialysis (Sections {1} and {3}).
• Non-Clinical Performance Data: The document states that the TYPHOON system "utilizes similar components and fluid contact materials as other items currently cleared for use in hemodialysis" (Section {3}, 4.12).
• Biocompatibility Testing: The submitter certifies that most materials and components are "identical to those previously cleared and registered with the FDA," with additional testing provided in Section 9.0 (not included in the provided text snippet) (Section {3}, 4.14).
• Absence of Clinical Testing: The submission explicitly states "N/A" for clinical testing, indicating that such a study was not deemed necessary due to the substantial equivalence claim (Section {3}, 4.13).

In conclusion, the acceptance criteria are not quantitative performance metrics from a specific study, but rather the qualitative determination by the FDA that the device is substantially equivalent to a legally marketed predicate device based on its design, materials, and intended use, and therefore meets the safety and effectiveness requirements without the need for a separate clinical or detailed performance study beyond the comparison provided.

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The AmeriWater Solution Mix and Distribution System for Hemodialysis is intended to be used in a hemodialysis facility to mix and deliver, to the point(s) of use, bicarbonate and acid solutions necessary for hemodialysis. Federal law restricts this device to sale by or on the order of a physician for use in hemodialysis applications.

AmeriWater Bicarb Mix and Distribution System, Models 00BC55-55, 00BC100-100, and 00BC100-200 (Dual Tanks): The AmeriWater Bicarb Mix and Distribution System for Hemodialysis is intended to be used in a hemodialysis facility to mix and deliver, to the point(s) of use, bicarbonate solutions necessary for hemodialysis. Federal law restricts this device to sale by or on the order of a physician for use in hemodialysis applications.

AmeriWater Solution Mixing System, Model 00BC100 (Single Tank): The AmeriWater Solution Mixing System is intended to be used in a hemodialysis facility to mix and deliver, to the point(s) of use, bicarbonate solutions necessary for hemodialysis. Federal law restricts this device to sale by or on the order of a physician for use in hemodialysis applications.

AmeriWater Acid Concentrate Distribution System, Models 00AS130, 00AS300, and 00AS500: The AmeriWater Acid Concentrate Distribution System is intended to be used in a hemodialysis facility to store and deliver, to the point(s) of use, acid concentrate solutions necessary for hemodialysis. Federal law restricts this device to sale by or on the order of a physician for use in hemodialysis applications.

AmeriWater Wallboxes for Dialysis: The AmeriWater Wallbox for Dialysis is intended to be used in a hemodialysis facility as the point of connection for purified water, bicarbonate, and acid solution, for use in hemodialysis applications. Federal law restricts this device to sale by or on the order of a physician for use in hemodialysis applications.

The AmeriWater Bicarb Mix and Distribution System utilizes purified water from the dialysis facility's water purification system to mix bicarbonate solution and to distribute the solution to the point(s) of use. The system features automatic fill and mix, high vortex pumped mixing action, lightly pressurized distribution, and efficient disinfection. A single tank version, the AmeriWater Solution Mixing System, is also available to mix solutions from concentrate.

The AmeriWater Acid Concentrate Distribution System is used to store and distribute the acid concentrate(s) required for hemodialysis to the point(s) of use. Solution stored in and distributed by the Acid Concentrate Distribution System is mixed prior to being transferred to the system. Lightly pressurized distribution and recirculation provides steady, consistent delivery.

AmeriWater Wall Boxes are recessed boxes located at the point(s) of use that are intended to provide acid, bicarb, and/or water connections for the dialysis machine fittings used in the hemodialysis facility. Wall boxes are available in several configurations. Wall dialysis machine fittings are professionally installed by AmeriWater.

I am sorry, but the provided text describes a medical device, the "AmeriWater Solution Mix and Distribution System for Hemodialysis," and its regulatory clearance (510(k) K051031). It does not contain information about acceptance criteria, device performance studies, sample sizes, expert qualifications, or ground truth establishment. This document is a regulatory submission for substantial equivalence, not a scientific study report.

Therefore, I cannot fulfill your request to describe the acceptance criteria and the study that proves the device meets them, as that information is not present in the provided text.

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The USFilter Bicarbonate Mixing and Dispensing (Bicarb) System is intended to be used in a Hemodialysis facility to allow safe and effective delivery of concentrates as well as central mixing and delivery of sodium bicarbonate solution necessary for a hemodialysis treatment.

The consistent mixing and delivery of bicarbonate solution for use in hemodialysis

The provided document is a 510(k) summary for the USFilter Bicarbonate Mixing and Dispensing (Bicarb) System. It focuses on demonstrating substantial equivalence to a predicate device rather than presenting a study proving a device meets specific acceptance criteria based on performance metrics like sensitivity or specificity.

Therefore, many of the requested categories for a study proving device performance (such as sample size for test sets, number of experts for ground truth, MRMC studies, standalone performance, training set details) are not applicable to this type of submission.

However, I can extract information related to the comparison with the predicate device, which serves as the basis for demonstrating equivalence.

Here's a breakdown of the information that can be extracted and the reasons why other requested categories are not applicable:

1. Table of Acceptance Criteria and Reported Device Performance

Instead of traditional performance metrics like sensitivity/specificity, the "acceptance criteria" here relate to demonstrating that the new device is fundamentally similar and performs comparably to a legally marketed predicate device. The document uses a comparison table to show substantial equivalence in specifications and intended use.

2. Sample size 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 as this is a device submission for substantial equivalence based on design and technical specifications, not a performance study on a test dataset. The "test set" would effectively be the device itself being compared to the predicate.

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, in the context of device performance, typically refers to a gold standard used to evaluate the accuracy of a diagnostic or analytical device. This submission is for a mixing and dispensing system where "ground truth" would not be established by experts in the same way.

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

This is not applicable. Adjudication methods are used in studies where there's disagreement among reviewers establishing ground truth, which is not relevant for this type of device submission.

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 pertains to the evaluation of diagnostic performance, often with AI assistance for human readers. This device is a bicarbonate mixing and dispensing system, not an AI-powered diagnostic tool.

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

This is not applicable. This question relates to the performance of an algorithm independently of human involvement, which is relevant for AI or diagnostic software. The USFilter Bicarb System is a physical medical device.

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

This is not applicable. As discussed above, "ground truth" in the typical sense of a performance study is not relevant for demonstrating substantial equivalence for this device. The "ground truth" for this submission is the accepted safety and effectiveness of the legally marketed predicate device.

8. The sample size for the training set

This is not applicable. Training sets are used for machine learning algorithms, which are not involved in this device or its submission.

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

This is not applicable for the reasons mentioned in point 8.

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BiPro Model SDS-CB200 is intended for use in a hemodialysis facility for mixing and distribution of sodium bicarbonate (bicarb) to remote points of use. The bicarb is then mixed with purified water and acid to create the dialysate solution used in hemodialysis.

The Medical Solutions BiPro Models provide semi-automatic mixing of bicarb concentrates and RO water for distribution as a hemodialysis patient stations. A mix tank is used for the mixing of bicarb concentrates and RO water. After mixing the bicarb solution, it is transferred to a loop (day) tank, via the mix pump, where the bicarb solution is distributed to the dialysis machine.

The provided text is a 510(k) summary for the BiPro Model SDS-CB200, a mixing and distribution system for bicarbonate used in dialysis. This document focuses on demonstrating substantial equivalence to an existing device, rather than detailed performance against acceptance criteria in a traditional clinical study. As such, the information typically found in a study proving a device meets acceptance criteria (like specific performance metrics, sample sizes, expert ground truth, MRMC studies, standalone performance, training set details) is not present in this type of submission.

Therefore, many of the requested sections will be marked as "Not Applicable" or "Not Provided" based on the content.

Here's an analysis based on the provided text:

1. A table of acceptance criteria and the 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)

• Sample size for test set: Not provided. The submission focuses on compliance with a safety standard and functional equivalence, not a clinical test set.
• Data Provenance: Not applicable/Not provided. The "study" mentioned is a voluntary testing against an engineering standard (ANSI/AAMI RD62: 2001), not a study with 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)

• Number of experts: Not provided.
• Qualifications of experts: Not provided.
• Reason: This type of information is not relevant to a submission based on substantial equivalence and adherence to an engineering standard.

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

• Adjudication method: Not applicable/Not provided.

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

• MRMC study done? No.
• Effect size: Not applicable.
• Reason: This device is a mixing and distribution system for bicarbonate, not an AI-powered diagnostic or interpretive tool.

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

• Standalone performance done? Not applicable.
• Reason: This device is a hardware system for mixing and distributing solutions, not an algorithm.

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

• Type of ground truth: Not applicable. The "ground truth" equivalent would be the specifications and performance requirements outlined in the ANSI/AAMI RD62: 2001 standard. The device's performance was compared against these technical specifications, not against medical ground truth from patient data.

8. The sample size for the training set

• Sample size for training set: Not applicable/Not provided. This device is not an AI/ML algorithm that requires a training set.

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

• How ground truth was established: Not applicable.

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The intended use of the Dialysis Systems Inc. Bicarbonate Mixing System is the mixing of water and sodium bicarbonate powder for hemodialysis treatment and the delivery of the mixture to the treatment floor.

Dialysis Systems Inc.'s Bicarbonate Mixing System provides for batch mixing of bicarbonate liquid concentrate and transfer to a loop tank. The mixing tank works in conjunction with an external closed-loop mixing circuit that includes a pump and an eductor. The pump circulates liquid from the mixing tank, through the eductor and back into the mixing tank. The eductor is connected to a sodium bicarbonate additive hopper. A measured amount sodium bicarbonate additive is drawn into the mixing tank by the flow of fluid through the eductor. Mixing of the powder to create a bicarbonate liquid concentrate is accomplished by the mixing action of the eductor, the return flow to the mix tank and by further mixing action created by nozzles as the fluid is re-circulated back into the mix tank.

The provided text is a 510(k) summary for the DSI Bicarb Mixing System. It focuses on administrative details, device description, and substantial equivalence to a predicate device, but does not contain any information about acceptance criteria or a study proving the device meets them.

Therefore, I cannot fulfill your request to describe acceptance criteria and a study from this document, as the information is not present. The document mainly outlines the device's intended use and its substantial equivalence to a previously approved device (K970674).

No information is available regarding:

• A table of acceptance criteria and reported device performance.
• Sample sizes, data provenance, or details about test sets.
• Number or qualifications of experts for ground truth.
• Adjudication methods.
• MRMC comparative effectiveness studies.
• Standalone algorithm performance studies.
• Type of ground truth used.
• Sample size for the training set or how its ground truth was established.

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The Solution Delivery System Local and Solution Delivery System Remote are intended to be used in a hemodialysis facility for mixing and distribution of sodium bicarbonate (bicarb) and the distribution of acid concentrates to remote points of use where they are mixed with purified water to create the dialysate solutions used in hemodialysis. The Acid Delivery System is intended to be used in a hemodialysis facility for the distribution of acid concentrates to remote points of use where they are mixed with bicarb and purified water to create the dialysate solution used in hemodialysis.

The Osmonics Solution Distribution System (SDS) provides semi-automatic mixing of bicarb concentrate and the distribution of bicarb and acid concentrates from storage to hemodialysis patient stations. The mixed bicarb solution is automatically transferred to an elevated reservoir (head tank). The SDS, depending on the model purchased, can transfer up to three different acid concentrates to elevated head tanks from 55-gallon drums or larger bulk acid storage tanks. Bicarb and acid then flow via gravity from the head tanks to the dispensing stations.

The provided document describes the Osmonics Medical Systems Solution Delivery System (SDS) and its 510(k) premarket notification (K023011). However, the document does not contain information regarding acceptance criteria, device performance metrics, sample sizes, ground truth establishment, expert qualifications, adjudication methods, or specific study designs (like MRMC or standalone performance evaluations) as typically found in detailed performance studies.

Instead, the document states:

• Performance: "The Solution Delivery Systems have been manufactured and tested to meet the safety requirements of CSA and UL. The SDS systems comply with CAN/CSA C22.2 no. 601-1-M90: Safety of Medical Electrical Equipment, Part I, General Requirements for Safety and UL std No. 2601-1: Safety of Medical Electrical Equipment, Part I: General Requirements for Safety as certified by Canadian Standards Association."

This indicates that the device's performance was evaluated against safety standards for electrical and medical equipment, rather than clinical performance metrics or accuracy in specific measurements (which would be more relevant for an AI/CAD device). The document focuses on regulatory compliance based on safety and substantial equivalence to a predicate device, not on diagnostic performance or AI model evaluation.

Therefore, I cannot populate the requested table or answer the detailed questions about acceptance criteria, study design, and performance metrics as they are not present in the provided text. The document pertains to a medical device's safety compliance and regulatory clearance, not the performance evaluation of an AI-driven, diagnostic, or image analysis device.

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