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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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HEMOCLEAN® is intended for the disinfection of artificial kidney machines (hemodialysis machines). It should be used under the following the dilution rate and contact condition:

HEMOCLEAN® is a single component germicide that does not require mixing or activation. HEMOCLEAN® is a stabilized mixture of hydrogen peroxide 5.3%(<6.0%) and peracetic acid 1.7%; inert ingredients are 93%. The product is a clear colorless liquid, high acid, and completely soluble in water. HEMOCLEAN® finally breaks down to carbon dioxide, water, and oxygen. The product is used full strength with automated dilution by the hemodialysis machine for the intended use. It is packaged in five liters polyethylene containers with a vent filter on the cap and is shipped in two 5-liter containers per box. The shelf life of the concentrate is one year when properly stored.

HEMOCLEAN® is indicated for the disinfection of hemodialysis machines. To use HEMOCLEAN® in automated hemodialysis machines, the user should follow the manufacture's recommendations for dilution of peracetic acid-based disinfectants. AAMI-quality water for hemodialysis must be used for diluting HEMOCLEAN® in the hemodialysis machine.

The provided text describes the device HEMOCLEAN®, a germicide for hemodialysis machines, and references non-clinical and clinical tests performed during its 510(k) submission. However, the document does not contain specific acceptance criteria with numerical targets or detailed results that demonstrate how the device "meets" those criteria in a quantitative sense as typically seen for AI/ML device performance.

Instead, the submission focuses on establishing substantial equivalence to a predicate device (Minntech/Renal Systems Actril®) by demonstrating similar technological characteristics and performance for its intended use as a hemodialysis machine disinfectant. The "acceptance criteria" appear to be implicit in demonstrating safety and effectiveness comparable to the predicate device.

Here's an analysis based on the information provided, attempting to fit it into the requested structure:

1. Table of Acceptance Criteria and Reported Device Performance

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

• Sample Size for Test Set: Not explicitly stated. The document mentions "In vitro performance testing" and "Testing was performed in a dialysis clinic in hemodialysis machines," but does not provide details on the number of runs, machines, or specific samples tested for these assessments.
• Data Provenance: The "clinical test results" were from "a dialysis clinic." The country of origin for the data is not specified, but the submitter (KRD CO., LTD.) is based in Korea. The submission date is March 29th, 2004, indicating retrospective data collection relative to the submission.

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

This information is not provided in the document. The concept of "ground truth established by experts" is more common for diagnostic imaging or AI/ML evaluations. For a chemical germicide, performance is typically assessed through standardized microbiological testing and chemical analysis, rather than expert consensus on subjective findings.

4. Adjudication Method for the Test Set

This information is not applicable/provided. Adjudication methods (like 2+1, 3+1) are typically used in studies involving human interpretation (e.g., radiologist reads) to establish a consensus ground truth. This is not described for the testing of HEMOCLEAN®.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size

This information is not provided and is not applicable to this type of device. MRMC studies evaluate the performance of human readers, sometimes with and without AI assistance, for diagnostic tasks. HEMOCLEAN® is a chemical disinfectant, not a diagnostic imaging device.

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

This information is not applicable as HEMOCLEAN® is a chemical germicide, not an algorithm or AI/ML device. Its performance is chemical and biological efficacy.

7. The Type of Ground Truth Used

The "ground truth" for a chemical disinfectant would typically be established through:

• Microbiological assays: Demonstrating specified log reductions of various microorganisms (bacteria, spores, fungi, viruses) under defined conditions.
• Chemical analysis: Confirming the breakdown of the disinfectant into non-toxic components and verifying residual levels are within safe limits.
• Predicate device comparison: Using the established performance characteristics and safety profile of the legally marketed predicate device (Actril®) as a benchmark.

The document indicates "In vitro performance testing" and "Testing was performed in a dialysis clinic in hemodialysis machines," which would likely involve these types of ground truth assessments, though specific metrics are not detailed.

8. The Sample Size for the Training Set

This information is not applicable as HEMOCLEAN® is a chemical germicide, not an AI/ML device that undergoes "training."

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

This information is not applicable for the same reason as above.

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