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The Hach CM130 is an instrument that is intended for use by hemodialysis professionals to automatically monitor low levels of total chlorine (i.e. total chloramines plus free chlorine) in feed water used to prepare dialysate in hemodialysis systems.

The CM130 is a component of the complete water treatment system for hemodialysis and does not treat or alter the water used in dialysate. The CM130 instrument's automated monitoring records total chlorine values in feed water at intervals between 5 and 20 minutes.

The Hach CM130 Chlorine Monitor is a microprocessor-controlled analyzer used to monitor the chlorine content of water which is used to prepare dialysate for hemodialysis. The monitor is mounted in the water room in a location that allows sampling of feed water between the primary (scrubbing) and secondary (polishing) carbon tanks. Water that flows into the CM130 exits the device to a drain. The water samples, once tested, are also discarded to a drain.

The monitor measures and displays total chlorine (free chlorine and combined chloramines) as Cl2, ranging from 0.03 to 0.20 mg/L.

The CM130 Chlorine Monitor employs a DPD Colorimetric Method for the detection of total chlorine. The analyzer introduces N,N-Diethyl-p-phenylenediamine (DPD) indicator with potassium iodide and a buffer to the water sample under test. The indicator and buffer are allowed to react with the chlorine and chloramines present in the water. The reaction results in a dye which forms a red color in the water sample. The intensity of the red color is proportional to the total chlorine concentration. It is measured photometrically and the results are automatically recorded and displayed.

The Remote Indicator (RI) is a subsystem that is mounted in the patient treatment area, typically near the ceiling, so that it can be easily seen. Its primary function is to communicate the status of the chlorine concentration of the feed water and the status of the analyzer to the staff while they are working in the patient treatment room.

The CM130 Chlorine Monitor and the Remote Indicator will each provide both an audible and a visual signal.

The provided text describes the HACH CM130 Chlorine Monitor, a device intended to automatically monitor total chlorine levels in feed water for hemodialysis systems. The document is a 510(k) premarket notification summary submitted to the FDA.

Based on the provided text, here's a breakdown of the acceptance criteria and the study proving the device meets them:

Note: This document is a 510(k) summary, which focuses on demonstrating "substantial equivalence" to a predicate device rather than outright clinical efficacy studies. Therefore, many of the typical acceptance criteria for AI/ML medical devices (such as sensitivity, specificity, PPV, NPV) and the detailed study elements like MRMC studies, large-scale ground truth establishment by multiple experts, and specific training set details, are not directly applicable or explicitly stated in this type of submission for this particular device. The focus here is on analytical performance and safety.

Acceptance Criteria and Reported Device Performance

The acceptance criteria are primarily focused on the analytical and safety performance of the device, rather than diagnostic accuracy in a clinical context.

Study Details Proving Device Meets Acceptance Criteria

The studies conducted are primarily non-clinical performance, analytical, and safety validations.

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

   • Test Set Sample Size: Not explicitly stated in terms of a specific number of samples for each test (e.g., how many water samples for bias, how many for repeatability). The document mentions "same solutions and test setups" were used for the CM130 and the predicate device.
   • Data Provenance: The studies were "Non-clinical testing" conducted by Hach Company. The location of the testing or the origin of the solutions is not specified, but it implies laboratory-based or simulated environment testing rather than clinical patient data. The nature is prospective in the sense that the device was actively tested under controlled conditions.

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

   • This is not applicable in the typical sense for this device. The "ground truth" for chemical measurements (total chlorine) was established by a reference method for independent verification of "true" measurement values, not by human expert interpretation like in image analysis. Humans were involved in establishing the "ground truth" for human factors testing (representative users), but their qualifications are not specified beyond being "representative users" in target groups (hemodialysis professionals).

3. Adjudication Method for the Test Set:

   • Not applicable as the primary tests are quantitative measurements against a reference method or engineering standards, not subjective interpretations. Human factors testing involved observation and subjective/objective data collection, but no explicit adjudication method (e.g., 2+1 consensus) is described.

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

   • No, an MRMC comparative effectiveness study was not done. This type of study is typically performed for diagnostic imaging devices where human readers interpret medical images with and without AI assistance to measure improvements in diagnostic performance. The CM130 Chlorine Monitor is a chemical monitoring device, not an imaging diagnostic device.

5. Standalone (Algorithm-Only) Performance:

   • Yes, the core of the performance testing (bias, repeatability, reproducibility, interference) assessed the standalone analytical performance of the CM130 Chlorine Monitor. The "algorithm" here refers to the instrument's measurement and display capabilities. The comparison was made against a "reference method" and the predicate device.

6. Type of Ground Truth Used:

   • Reference Method: For accuracy (bias) testing, a "reference method used to independently verify the 'true' measurement" of total chlorine was utilized. This is equivalent to a highly accurate laboratory standard or gold standard measurement.
   • Engineering Standards: For electrical safety, software validation, and alarm testing, the ground truth was defined by compliance with specific, recognized engineering and performance standards (e.g., IEC61326-1, IEC61010-1, CLSI EP12-A2).
   • Usability Objectives: For human factors testing, the "ground truth" was the ability of representative users to safely and effectively use the device, as assessed against predefined usability objectives and observed performance.

7. Sample Size for the Training Set:

   • Not Applicable / Not Explicitly Stated. The CM130 is not described as an AI/ML device that requires a "training set" in the sense of supervised learning from data. It's a deterministic chemical analyzer. Its "calibration" or internal parameters would be set through engineering and testing, not by training on a large dataset in the AI sense. Software verification and validation refer to traditional software engineering processes, not machine learning model training.

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

   • Not Applicable. Since there isn't a "training set" for an AI/ML model as described in the typical context, this question does not apply. The device's operational parameters would be established through manufacturer specifications, calibration procedures, and adherence to design control processes.

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The AmeriWater Heatsan is an optional accessory for water treatment systems intended for use in hemodialysis applications. The Heatsan is designed to heat water received from the water purification system, and circulate the heated water around the distribution loop at a controlled sanitizing temperature (minimum temperature of 185°F) for a programmed length of time (minimum hold time of 2 hours) to provide heat disinfection of the water distribution loop. The AmeriWater Heatsan is intended for use in hospitals, clinics, or dialysis centers to provide heat disinfection resulting in total viable microbial counts below 50 CFU/ml.

The AmeriWater Heatsan is intended for use in hospitals, clinics, or dialysis centers to provide heat disinfection resulting in total viable microbial counts below 50 CFU/ml. It is an integrated hot water disinfection unit that incorporates equipment to heat water received from a direct feed Water Purification System , and circulate around a distribution loop at a controlled sanitizing temperature of 185°F) for a specified length of time (minimum hold time of 2 hours). 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//SO 26722:2009 Water treatment equipment for hemodialysis applications and related therapies. The operation of the Heatsan unit is controlled entirely through the touch screen panel located on the front of the main control box. The touch screen displays systems performance data and the status of the device. The Heatsan unit incorporates monitoring devices and will report alarms and warnings messages via the user display. The Heatsan is used only during non-treatment hours when there are no patients being dialyzed. There is no patient contact with the device.

The unit can be configured to disinfect up to two distribution loops, either individually or together. The user can set for each day of the week which loop is to be disinfected and in what configuration. The Heatsan has been designed to provide up to 100 gallons of hot water for the purpose of sanitizing connected dialysis equipment. The number of machines that can be disinfected at any one time will be dependent on the requirement of those machines regarding the amount of water each machine needs for disinfection, the time taken to perform heat disinfection and the flow at which they require the hot water. When in "Dual" mode, sanitizing two distribution loops, the unit can potentially supply up to 200 gallons of water so that 100 gallons of water will be available for each distribution loop. Following disinfection of the first loop the unit will refill and reheat to disinfection temperature then proceed automatically to disinfect the second distribution loop.

The system allows the user to input the specific requirements of the dialysis machines to be disinfected, the days requiring heat disinfection and the times which heat disinfection can occur. If the system detects that any of the entered user values cannot be achieved by the Heatsan unit will raise an "Incorrect number" alarm warning the user that the parameters loaded cannot be achieved.

The Heatsan operation stages include Pre-heat. Heating, Hold, Water draw off, and Cool down. The typical stage duration times for disinfection are as follows: Pre-heat 120 minutes, Hold* 120 minutes, Water draw off 60 minutes, Cool down 60 minutes.

Here's an analysis of the provided text regarding the acceptance criteria and study for the AmeriWater Heatsan device, formatted to address your questions:

1. Table of Acceptance Criteria and Reported Device Performance

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

• Sample Size for Microbiological Testing: "A total of three test runs were conducted with each organism." (This means 3 runs for Burkholderia cepacia and 3 runs for Mycobacterium abscessus).
• Data Provenance: Not explicitly stated as country of origin, but the testing was conducted to verify and validate the efficacy of the system in the reduction of bacteria in a water distribution system, simulating worst-case conditions. The study does not specify if it was retrospective or prospective but describes experimental runs, suggesting a prospective experimental design in a laboratory setting.

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

• This information is not provided in the document. The ground truth for microbiological effectiveness appears to be based on direct measurement of microbial reduction, not expert interpretation.

4. Adjudication Method for the Test Set

• This information is not applicable as the ground truth was established through direct microbiological measurement rather than expert review requiring adjudication.

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 performed. This device is an automated heat sanitization system for water distribution loops, not an AI-powered diagnostic or assistive tool for human readers.

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

• Yes, the microbiological performance study describes a standalone performance of the device (heat sanitization system). The system operates automatically to disinfect the water distribution loop.

7. The Type of Ground Truth Used

• For the microbiological performance, the ground truth was based on direct microbiological measurement of bacterial reduction (log reduction) in a water distribution system following an inoculation procedure.
• For biocompatibility, the ground truth was based on analytical testing for conductivity and total organic carbon (TOC) levels.
• For electrical safety, the ground truth was compliance with IEC 61010 standards verified by an ETL listing.
• For software, the ground truth was that the software performs as intended based on validation.

8. The Sample Size for the Training Set

• This device is a hardware system with software control for automated disinfection. It does not rely on a "training set" in the context of machine learning or AI algorithms that learn from data. Therefore, this information is not applicable.

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

• As mentioned above, there is no "training set" for this type of device. The system's operation is based on pre-programmed parameters and physical processes (heating, circulation), not learned patterns from a data set.

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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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