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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 O3Z Ozone System is an optional accessory for the Solution Delivery Systems (SDS) manufactured by GE Infrastructure, Water & Process Technologies and is intended to be used for disinfection of the SDS bicarb mixing and distribution system. The mix tank of the SDS system is filled with either RO or deionized water and the mix tank ozone concentration is increased to 0.70 mg/L. The solution is then distributed to the distribution tank of the SDS system. From the distribution tank, the ozonated water is distributed throughout the distribution loop of the SDS system until a minimum ozone concentration level of 0.30 mg/L is established at the end of the SDS bicarb distribution loop. The solution is then recirculated for a minimum of 15 minutes throughout the distribution system. To complete the disinfection process, the system is then rinsed with RO or deionized water until the system is residual free of ozone.

The Ozone Generating System attaches to the Solution Delivery System (SDS) through a valve bypass system and an injector. It is wall mounted in the vicinity of the SDS and is connected to the injector, which is installed in the output piping of the mix pump. The SDS mix tank is filled with RO or DI water; the bypass valves are manually configured for ozone production and then the mix pump is started, causing the injector to draw O3/air mixture into solution. When the proper concentrations of ozone are achieved, the ozonated water is re-circulated throughout the mixing and delivery system to disinfect the fluid path.

Here's an analysis of the provided information regarding the O3Z Ozone System, focusing on acceptance criteria and the supporting study:

The provided document, K043207, is a 510(k) summary for the O3Z Ozone System. It outlines the intended use, device description, and a general statement about performance. However, it does not contain the detailed study results, specific acceptance criteria, or the methodology typically found in a full study report. The information provided is high-level and intended for regulatory submission for substantial equivalence.

Based on the available text, here's what can be extracted and what is missing:

1. Table of Acceptance Criteria and Reported Device Performance

Missing Information:

• Specific quantitative microbial reduction targets (e.g., "reduce total viable counts by 6-log").
• Definition of "acceptable levels" for microorganisms.
• Specific types of microorganisms tested (e.g., bacteria, fungi, viruses).
• Quantitative results of the testing (e.g., initial counts, final counts, percentage reduction).

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

The document does not specify the sample size used for the disinfection efficacy testing (e.g., number of systems tested, number of disinfection cycles).

Data Provenance: The study was conducted by the manufacturer, GE Infrastructure, Water & Process Technologies, as part of their 510(k) submission. It is implicitly a prospective study to demonstrate the performance of their device prior to marketing. The country of origin for the data is USA (Minnetonka, Minnesota, where the manufacturer is located).

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

This information is not provided in the given text. For a disinfection efficacy study, "ground truth" would typically be established by microbiological laboratory testing, not by expert consensus on images or interpretations. The qualifications of the microbiologists or laboratory personnel conducting the tests are not mentioned.

4. Adjudication Method (for the test set)

Adjudication methods (like 2+1, 3+1) are typically used in studies involving human interpretation of data (e.g., image-based diagnostics) where discrepancies between readers need to be resolved. This is a disinfection efficacy study, not an interpretation study. Therefore, an adjudication method in the traditional sense is not applicable or mentioned. The "ground truth" (microbiological counts) would be objective measurements.

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

An MRMC study is not applicable to this type of device (an ozone generator for disinfection). MRMC studies are used to evaluate the impact of a new diagnostic method or AI on human reader performance for tasks involving interpretation (e.g., radiologists reading medical images). The O3Z Ozone System is a physical disinfection system, not an interpretive diagnostic tool. Therefore, no "human readers improve with AI vs without AI" effect size would be relevant or studied here.

6. Standalone Performance

Yes, a standalone performance study was done. The statement "Testing of the ozone generator demonstrated that the disinfection process was effective..." refers to the performance of the device itself (the algorithm, if you consider the ozone generation and delivery process as controlled by an algorithm, or more simply, the device's mechanism of action) in achieving disinfection. The results are based on the device operating independently to achieve the stated purpose.

7. Type of Ground Truth Used

The ground truth used for this study would be microbiological testing results. This involves quantifying the number of viable microorganisms before and after the disinfection process to demonstrate reduction. The document implies this without detailing the specific assays or methods.

8. Sample Size for the Training Set

This device likely does not have a "training set" in the context of machine learning. It's a physical system for disinfection. The design and optimization of the system (e.g., ozone concentration, flow rates, cycle times) would have been developed through engineering studies, prototypes, and empirical testing, rather than training a machine learning model on a large dataset. Therefore, the concept of a "training set" sample size is not applicable here.

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

As explained in point 8, the concept of a "training set" is not applicable here as it's not an AI/ML-based device. The parameters for optimal disinfection (e.g., 0.70 mg/L ozone concentration, 0.30 mg/L minimum at the end of the loop, 15 minutes recirculation) would have been established through a combination of:

• Scientific literature on ozone's antimicrobial properties.
• Laboratory benchtop studies identifying effective ozone concentrations and contact times for relevant microorganisms.
• Engineering testing and optimization on prototype systems to ensure reliable generation, distribution, and measurement of ozone within the SDS system.
• Potentially, pilot studies with a limited number of systems.

These studies would have used microbiological assays (quantification of live microorganisms) as their "ground truth" to determine the efficacy of different ozone concentrations and contact times.

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