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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:

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

• Reliability Validation: The system was tested to simulate 10 years of use. This implies continuous or simulated continuous operation for that duration to assess component function. The specific number of cycles or days of testing is not explicitly stated beyond "10 years of use". Data provenance is not specified, but typically, this type of testing is conducted in a controlled laboratory environment by the manufacturer.
• Disinfection Validation: Not explicitly stated how many tests or samples were used for each organism. The testing was conducted to validate the disinfection performance. Data provenance is not specified, but likely laboratory-based.
• Field Testing: Conducted in four (4) dialysis facilities. These facilities had documented histories of water contamination issues. This is retrospective for identifying the facilities, but the testing within those facilities with the TANGO3 system was prospective, conducted under a standard protocol.

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

This is a medical device for water disinfection, not an AI/imaging device requiring expert interpretation for ground truth. Therefore, the concept of "experts" and their qualifications to establish ground truth data in the context of diagnostic accuracy is not directly applicable here. The "ground truth" for the disinfection tests would be established through laboratory analytical methods (e.g., bacterial culture, LAL assays) and chemical analysis (e.g., ozone concentration measurements) performed by qualified laboratory personnel.

4. Adjudication method for the test set:

Not applicable. This device's performance is measured by objective physical and chemical parameters and microbiological counts, not subjective interpretation 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:

Not applicable. This is not an AI diagnostic imaging device evaluating human reader performance.

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

The device itself is a standalone system with an automated disinfection process. The performance documented (O3 generation, disinfection efficacy, ambient ozone detection) is considered standalone performance. There isn't an "algorithm only" in the sense of a software-based diagnostic tool, but the device operates autonomously in its disinfection functions once initiated.

7. The type of ground truth used:

• Reliability Validation: Engineering specifications and objective measurements (e.g., ozone sensor readings, pump velocity measurements, alarm detection).
• Disinfection Validation: Microbiological assay results (e.g., bacterial counts, LAL endotoxin levels) compared against AAMI RD 62:2006 action levels. Chemical analysis for ozone concentration.
• Field Testing: Bacterial counts and endotoxin levels obtained through standard laboratory water testing methods, compared against AAMI RD 62:2006 recommendations.

8. The sample size for the training set:

The term "training set" is typically used in the context of machine learning. This device does not appear to use machine learning in a way that requires a distinct "training set" of data for an algorithm. The system is designed based on established principles of ozone disinfection and validated through engineering tests and biological efficacy studies.

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

Not applicable for the reasons stated in point 8. The device's operational parameters (like ozone concentration, cycling times) are based on scientific evidence for microbial inactivation, not trained on a data set. Relevant ground truth is established through scientific literature, consensus standards (like AAMI/ISO), and previous laboratory research on ozone's bactericidal and virucidal properties.

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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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