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The pre-vacuum steam sterilizer models 3870HSG and 3870HSG-WS are in hospitals and other healthcare facilities (e.g. hospitals, nursing homes, extended-care facilities, freestanding surgical centers, clinics, and medical and dental offices) for the purpose of sterilizing heat stable medical devices: wrapped and unwrapped solids (IUSS), hollow and porous products.

The autoclave models 3870HSG-WS and the 3870HSG are dynamic-air-removal steam-heated sterilizers that are using steam as the sterilizing agent, which are suitable for large medical centers, dental clinics and operating rooms for the purpose of sterilizing heat stable medical devices: wrapped and unwrapped solids (IUSS), hollow and porous products.

The model 3870HSG-WS has an automatic door and is designed to be a fast cycle sterilizer that is mobile and can operate independent of building utilities due to its internal water reservoirs. The autoclave includes the option of water recycling, which allows the operator to manually fill the tap water reservoir with water that will be reused for 10 cycles, after which the reservoir is automatically drained and, in case the device is connected to a water inlet connection, be refilled automatically.

The model 3870HSG has an automatic door and is designed to be a fast cycle sterilizer. Contrary to the 3870HSG-WS, the 3870HSG need to be connected to the building utilities system (the water system). For both autoclave configurations (HSG/HSG-WS) a 9kW built-in steam generator is used to supply the steam for the sterilization process.

The autoclaves are Class B devices equipped with a vacuum system that allows:

• . Removal of residual air from packs and porous load and most kinds of tubes (rubber, plastic etc.) by vacuum at the first stage of the cycle.
• . Better steam penetration into the load; resulting in effective sterilization.
• . Better temperature uniformity.
• . Post sterilization drying phase - during the drying stage draws air through a HEPA filter (0.2um) and pushes that air through the heated chamber to remove moisture and facilitate the drying operation. Drying is performed with the door closed.

The autoclave models 3870HSG-WS and 3870HSG are stand-alone devices that do not need to interact with other devices or to interact with any person(s) or patient(s) besides the current device operator.

The provided text describes the acceptance criteria and the results of a study conducted for the Tuttnauer Pre-vacuum Steam Sterilizer models 3870HSG and 3870HSG-WS. This is a medical device (a sterilizer), and the study focuses on its performance in sterilizing medical devices.

Here's an breakdown of the information requested based on the provided document:

1. Table of Acceptance Criteria and Reported Device Performance

Device: Tuttnauer Pre-vacuum Steam Sterilizer models 3870HSG and 3870HSG-WS

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

• Sample Size for Test Set: The document describes "tests" and "cycles" but does not explicitly state a quantitative sample size (e.g., number of sterilization runs) for each specific test. It implies multiple trials were conducted to meet each acceptance criterion, as performance tests like "Empty chamber tests" or "Biological performance" would typically involve multiple runs to demonstrate consistency and reliability. However, no specific quantitative sample size is provided in the document for the test set.
• Data Provenance: The document does not specify the country of origin of the data. It is a submission to the U.S. Food & Drug Administration (FDA) by Tuttnauer LTD. based in Jerusalem, Israel, implying the tests were conducted by the manufacturer or a contracted lab. The tests are described as non-clinical tests, which means they are laboratory-based and simulated scenarios, not directly from patient data. The context suggests these were prospective tests performed specifically for this 510(k) submission, rather than retrospective analysis of existing data.

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

The document does not mention human expert involvement in establishing ground truth for the test set. The tests described are objective, quantitative performance measurements of a sterilizer (e.g., temperature, pressure, leak rate, biological indicator growth). Ground truth is established by physical measurements and the absence/presence of microbial growth, not by expert consensus on interpretations.

4. Adjudication method for the test set

Not applicable. As noted above, the ground truth is established by objective physical and biological measurements, not through human interpretation requiring adjudication.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, and 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 done.
• This device is a steam sterilizer, not an AI-powered diagnostic imaging device or an AI assistant for human readers. Therefore, the concepts of human readers, AI assistance, or MRMC studies are not relevant to this type of device and its performance evaluation as described.

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

• Yes, in essence, standalone performance was assessed. The device itself is an automated sterilizer. Its "performance" refers to its ability to achieve specific physical parameters (temperature, pressure, dry time) and biological outcomes (sterility assurance level, lack of growth). The tests described (e.g., Bowie & Dick test, air-leak-rate test, empty/full chamber load tests, biological performance tests) directly measure the sterilizer's function without human intervention during the cycle itself. Human operators set up and observe the results, but the "performance" being evaluated is the device's independent operation.

7. The type of ground truth used

The ground truth used for these tests is based on:

• Physical measurements: Temperature (within a specified range), pressure (leak rate), weight change (moisture retention). These are objectively measurable physical properties.
• Biological outcomes: The absence of microbial growth in biological indicators (BIs) or test turbines after sterilization, demonstrating a sterility assurance level (SAL) of 10⁻⁶. Positive controls are used to confirm test viability. This is an objective biological outcome.
• Visual inspection: Uniform color change for the Bowie-Dick test, absence of wet spots for moisture retention.

8. The sample size for the training set

This document describes the validation of a physical device (a steam sterilizer). It is not an AI/ML device, so there is no "training set" in the context of machine learning model development. The device operates based on preprogrammed cycles and physical principles, not on learned data.

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

Since this is not an AI/ML device, there is no training set and therefore no ground truth established for a training set. The performance is assessed against established engineering and biological standards for sterilization.

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